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Home / News / BioBlast®

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BioBlast®

Explore our interactive biosimilar news updates, collating tailored reports by brand, INN, originator/biosimilar applicant, litigation, region, or date. Alternatively, review our weekly BioBlast™ updates below.

2024

March 15, 2024

On 15 March 2024, the Australian Department of Health and Aged Care published the public summary documents considered at the November 2023 PBAC meeting. Decisions included:

March 15, 2024

On 15 March 2024, CuraTeQ Biologics (a subsidiary of Aurobindo) announced that it successfully completed phase I trials for omalizumab biosimilar (BP11), demonstrating pharmacokinetic and pharmacodynamic equivalence to Genentech’s/Novartis’ US and EU-sourced Xolair®.  The trials were conducted on 165 healthy adults in Australia and New Zealand.

CuraTeQ commenced Phase III trials of BP11 in Europe for the treatment of chronic spontaneous or idiopathic urticariaand in India for the treatment of asthma patients.  CuraTeQ expects to seek regulatory approval of BP11 in India in 2024 and in regulated markets in 2025.

Each of Celltrion, Glenmark, Teva, Synermore, Sorrento and Kashiv Biosciences also has omalizumab biosimilars in development.  Celltrion submitted an A-BLA in the US  earlier this week, and applications for approval in Europe in April 2023, Canada in December 2023 and Korea in June 2023.

March 14, 2024

On 14 March 2024, AstraZeneca announced that it has entered into an agreement to acquire Amolyt Pharma, a clinical-stage biotechnology company focused on developing novel treatments for rare endocrine diseases.  Amoylt’s portfolio notably includes eneboparatide (AZP-3601) currently a phase III investigational therapeutic peptide for the hypoparathyroidism.  The deal consists of $800m upfront and then $250m contingent on achieving specified regulatory milestones.

March 11, 2024

Celltrion announced that it has submitted an abbreviated Biologics License Application (A-BLA) in the US for approval of CT-P39, as interchangeable biosimilar to Genentech’s Xolair® (omalizumab).  Celltrion’s application seeks approval for all Xolair® indications, as well as interchangeability status.

Celltrion submitted applications for CT-P39 in Europe in April 2023, Canada in December 2023 and Korea in June 2023.   Celltrion’s is the first reported regulatory submission for omalizumab biosimilars in these jurisdictions.   CuraTeQ Biologics (a subsidiary of Aurobindo), Alvotech/Kashiv Biosciences, Teva, Synermore, Glenmark and Sorrento have also been reported to be developing omalizumab biosimilars.

March 11, 2024

On 11 March 2024, Formycon AG and MS Pharma announced that ranibizumab (FYB201 / Ravegza®), biosimilar to Genentech’s Lucentis®, was approved in Saudi Arabia for the treatment of age-related neovascular (wet) macular degeneration (nAMD) and other serious eye diseases including retinopathies secondary to diabetes.

FYB201 was developed by Bioeq (a JV between Formycon and Polpharma Biologics). Teva entered into a strategic partnership for the exclusive commercialisation of FYB201 in Canada, Europe and selected other countries in mid 2021. FYB201 has been approved in the UK (in May 2022, marketed as Ongavia® by Teva), in the US (in August 2022, marketed as Cimerli® by Coherus) and the EU (in August 2022, marketed as Ranivisio® by Formycon). In January 20204, Sandoz announced that it had signed an agreement to acquire Coherus’ Cimerli® for US$170M.

March 11, 2024

On 11 March 2024, Johnson & Johnson announced that it submitted a supplemental Biologics License Application (sBLA) for TREMFYA® (guselkumab) for the treatment of adults with moderately to severely active ulcerative colitis.  The product is currently approved in the US to treat moderate-to-severe plaque psoriasis and active psoriatic arthritis.

March 11, 2024

On 11 March 2024, Merck (MSD) announced the completion of the acquisition of Harpoon Therapeutics for about USD $650M with the aim of augmenting and diversifying their oncology pipeline.  Harpoon’s lead candidate is MK-6070 and its safety, tolerability and pharmacokinetics profile is currently being evaluated in a Phase 1/2 clinical trial (NCT04471727) in patients with advanced cancers.

March 11, 2024

On 11 March 2024, Korea Biomedical Review reported that Merck Sharp & Dohme (MSD)’s anti-PD-1 therapy Keytruda (pembrolizumab) was approved in Korea as a 1st-line treatment for HER2-negative gastric cancer in combination with fluoropyrimidine and platinum-based chemotherapy.  Keytruda® is the first immuno-oncology drug approved in Korea for the treatment of all types of HER2-positive and negative metastatic gastric cancer.

March 11, 2024

On 11 March 2024, Regeneron announced that the FDA approved Praluent® (alirocumab) injection for treating children with genetic form of high cholesterol on 8 March 2024.  The approval was based on Phase 3 randomized trials in patients aged 8-17.  The results, published in the Journal of the American Medical Association Pediatrics, show that those who received alirocumab every four weeks had 31% lower LDL-C than the placebo group at 24 weeks.

In 2014, Amgen commenced litigation against Sanofi, alleging that Sanofi’s and Regeneron’s Praluent® infringed genus claims of Amgen’s patents relating to Repatha® (evolocumab).  In May 2023, the US Supreme Court published its decision affirming a ruling of the Federal Circuit Court that Amgen’s genus claims were invalid for lack of enablement.

March 10, 2024

On 10 March 2024, Eli Lilly announced results for its ADmirable lebrikizumab study.  This is the first-of-its-kind study of lebrikizumab specifically designed to treat people with moderate-to-severe atopic dermatitis. This is also commonly known as eczema.  The results show that two-thirds of the patients with atopic dermatitis experienced improvements by taking lebrikizumab.  The study lasted for 16 weeks and evaluated a total of 50 patients.

March 9, 2024

On 9 March 2024, Samsung Bioepis presented two papers of study results for its immunology portfolio at the 2024 American Academy of Dermatology (AAD) Annual Meeting being held from March 8 to 12 in San Diego, California, United States.   

For its Humira® biosimilar (adalimumab/SB5), Samsung Bioepis presented further information relating to its Phase 4 (switching) study results, which formed the basis of its sBLA seeking interchangeability filed in November 2023.  Results from the same trials were published in Ocular Immunology and Inflammation in January 2024, and in the BMJ Open Opthalmology in December 2023.  Hadlima™ is FDA approved and has been supplied in the US since 1 July 2023 under a licence from AbbVie entered into in 2018. 

For SB17, biosimilar to Janssen’s Stelara® (ustekinumab), Samsung Bioepis presented the Phase 3 results for SB17 with switching studies, which demonstrated efficacy, safety, and immunogenicity for 52 weeks.  These results were presented at ECCO last month. 

SB5/Hadlima™ is commercialised in the US by Organon.  SB17 will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreement  inked in September 2023.   

March 8, 2024

Novo Nordisk announced that the FDA approved a label expansion for Wegovy® for reducing risks of major adverse cardiovascular events (MACE) including death, myocardial infarction, or stroke in adults with obesity and/or established cardiovascular disease (CVD).  The approval is based on results of the SELECT trial, which demonstrated that Wegovy® reduced MACE by 20%.  It is the first US approved therapy to assist with weight management and reduce cardiovascular risk. 

Novo Nordisk has also requested equivalent label expansion in EU with the decision expected in 2024. 

The approval comes soon after Novo Nordisk announced results of its FLOW study for Ozempic®  (semaglutide) for kidney outcomes.

This news follows the announcement on 5 February 2024 by Novo Holdings (Novo Nordisk’s parent company) that it will acquire global contract development and manufacturing company Catalent for USD $16.5B.  

March 8, 2024

Regeneron announced one-year results from studies show that extended dosing regimens (12 or 16 weeks) for Regeneron’s and Bayer’s Eylea® HD (aflibercept) 8mg injection demonstrated non-inferiority to Eylea® 2mg injection (with 8-week dosing) for the treatment of wet age-related macular degeneration (wAMD) and diabetic macular edema (DME).  The findings are based on the Regeneron and Bayer sponsored Phase III PULSAR (nAMD) and Phase II/III PHOTON (DME) trials. 

High Dose Eylea® is approved in multiple countries including the US (August 2023 – nAMD, DME) and diabetic retinopathy, the EU (January 2024 – nAMD and DME) and Japan (January 2024 – nAMD and DME). 

March 6, 2024

On 6 March 2024, Johnson & Johnson (J&J) announced that it has submitted an application to the European Medical Agency (EMA) for DARZALEX® (daratumumab) for an indication extension for the treatment of transplant-eligible patients newly diagnosed with multiple myeloma.  The application is supported by data from the Phase 3 PERSEUS study, which shows that when daratumumab is administered in a subcutaneous formulation it significantly reduces the risk of myeloma progression or death when compared to standard of care regimen. 

This follows J&J’s announcement on 30 January 2024 that it submitted a sBLA to FDA for the Darzalex Faspro® (daratumumab and hyaluronidase-fihj) Combination 

March 6, 2024

On 6 March 2024, the FDA announced its approval of Bristol-Myers Squibb’s Opdivo (nivolumab) for treatment of adults with unresectable or metastatic urothelial carcinoma.   

Previously in February 2024 and in December 2023, BMS announced that the FDA accepted its sBLA for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC) and also accepted for priority review its sBLA for Opdivo® in combination with cisplatin-based chemotherapy for the treatment of unresectable or metastatic urothelial carcinoma. 

March 5, 2024

Johnson and Johnson (J&J) and Janssen have filed a Motion to Dismiss a class action brought by several US health insurers alleging the companies unlawfully delayed biosimilar competition for Stelara® (ustekinumab) in the US.  J&J/Janssen argue that the alleged facts do not meet the standard of unlawful exclusionary conduct. 

The insurers filed the class action in the US District Court of East Virginia on 7 December 2023, alleging that the companies would lose exclusivity for Stelara® in the US on 25 September 2023 upon expiration of the relevant composition patent, and implemented a scheme to unlawfully prolong patent protection.   

March 5, 2024

On 5 March 2024, the FDA approved Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Genentech’s/Roche’s Actemra®, for the treatment of rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis.  Tyenne® is the second FDA-approved tocilizumab biosimilar, following the approval of Biogen’s IV formulation Tofidence® in September 2023, but is the first approved subcutaneous formulation.  Tyenne® was approved by the FDA in both IV and subcutaneous forms. The US launch date for its tocilizumab products remains confidential following a patent settlement with Roche and Chugai in October 2022.   

Tyenne® has launched in more than 10 countries to date, including in Europe in November 2023 in both IV and subcutaneous formulations.  Fresenius reports that its global roll out will continue through 2024 and 2025. 

March 5, 2024

On 5 March 2024, the FDA approved the first denosumab biosimilars in the US in Sandoz’s Wyost® and Jubbonti®.  The biosimilars are interchangeable with, and approved for all indications of, Amgen’s Xgeva® and Prolia® respectively. 

The US launch date for the newly approved biosimilars is uncertain given ongoing BPCI litigation regarding the products, commenced by Amgen in May 2023 relating to 21 patents. 

The US approval comes weeks after Sandoz announced the approval of Jubbonti® in Canada.  Prolia® biosimilars developed by Boan Biotech and Mabwell were approved in China respectively in November 2022 (BA6101, Byoubei®) and March 2023 (Mailishu®). 

March 5, 2024

Novo Nordisk announced the results of its Ozempic® (semaglutide 1.0mg) FLOW study kidney outcomes.  In this study, semaglutide 1.0 mg was compared to placebo as an adjunct to standard of care for prevention of progression of kidney impairment and risk of kidney and cardiovascular mortality in more than 3,500 people with type 2 diabetes and chronic kidney disease (CKD).  The trial demonstrated a 24% reduction in kidney disease progression, major adverse cardiovascular events (MACE) and death in people treated with semaglutide 1.0 mg compared to placebo.  Novo Nordisk intends to file for regulatory approval for label expansion around the world in 2024. 

This comes as the company is addressing counterfeit products around the world as reported on 1 March 2024 and 5 February 2024.  

March 5, 2024

On 5 March 2024, the Times of India reported that Roche launched Vabysmo® (faricimab) in India for the treatment of age-related macular degeneration (nAMD) and diabetic macular edema (DME).    

Vabysmo® was first approved in the US by the FDA in January 2022 and is now available in multiple countries, including Europe, Canada and Australia.  In October 2023, Roche received a new indication approval by FDA for the use of Vabysmo® to treat macular oedema following retinal vein occlusion.  Since its first launch date, Vabysmo ® has achieved global sales of US$2.7 billion.   

March 5, 2024

A paper published in Nature Communications on 5 March 2024 regarding a Phase II clinical trial sponsored by Arcagy-GINECO showed that FKB238 (bevacizumab biosimilar) + olaparib + durvalumab combination showed better survival for treatment of patients with relapsed ovarian cancer than patients with no treatmentBetween 1 March 2019 and 23 January 20202, a total of 74 patients were enrolled in nine French centres and were treated with the bevacizumab biosimilar FKB238 (15 mg/kg intravenously, once-every-3-weeks), olaparib (300 mg orally, twice daily), and durvalumab (1.12 g intravenously, once-every-3-weeks).  

March 4, 2024

On 4 March 2024, Sandoz announced the completion of its acquisition of biosimilar CIMERLI® (ranibizumab) from Coherus BioSciences. This VEGF inhibitor ranibizumab was approved by the FDA on 2 August 2022 and is indicated for the treatment of retinal diseases. The acquisition includes a biologics license application, product inventory, ophthalmology sales and field reimbursement talent, as well as access to proprietary commercial software. Sandoz announced its USD $170M deal to acquire CIMERLI® on 22 January 2024, and now reports that the deal was completed ahead of schedule.  

March 4, 2024

Amgen announced that Wezlana™ (ustekinumab injection) and Wezlana™ (ustekinumab for injection, solution for intravenous infusion), biosimilar to Janssen’s Stelara®, is now available in Canada.  Wezlana™ is the first biosimilar to be approved by Health Canada for all Stelara® indications, but the second ustekinumab Canadian launch following the launch of  the first ustekinumab biosimilar (Jamteki™) in Canada by JAMP Pharma on 1 March 2024.   

Jamteki™ was developed by Alvotech and was approved by Health Canada in November 2023. 

March 4, 2024

Biocon announced a settlement with Regeneron and Bayer under which it can launch its Yesafili® (aflibercept), biosimilar to Regeneron’s Eylea®, in Canada from 1 July 2025.  The settlement resolves multiple patent infringement proceedings in the Federal Court of Canda involving six patents relating to aflibercept.  The settlement does not appear to have resolved disputes beyond Canada, there being no impact to the ongoing US aflibercept dispute between Biocon and Regeneron.   

Yesafili® was granted tentative approval by Health Canada in March 2023, subject to resolution of patent issues.  Yesafili® was approved in the UK in November 2023 and in EU in September 2023. 

March 4, 2024

On 4 March 2024, Merck filed petitions for inter partes review against four Johns Hopkins University (JHU) patents relating to methods of treatment using pembrolizumab in patients whose cancers have a genetic instability called microsatellite instability-high (MSI-H).    These four IPRs are IPR2024-00622 (against US10,934,356), IPR2024-00623 (against US11,325,974), IPR2024-00624 (against US11,325,975), and IPR2024-00625 (against US11,339,219).  Each IPR is based on anticipation and obviousness.  The petitions have not yet been instituted by the USPTO.

In November 2022 Merck filed a complaint in the United States District Court (District of Maryland) against JHU seeking declarations of breach of contract, non-infringement and promissory estoppel in relation to the same four patents.   The trial has not yet been scheduled.

March 1, 2024

The Australian Financial Review reported that on 1 March 2024 TGA investigators raided Como Compounding Pharmacy in Melbourne and seized ‘off-brand’ Ozempic® (semaglutide) and other allegedly unlawfully made medications.  As reportedly revealed in a confidential TGA letter obtained by Australia’s national broadcaster, ABC, the TGA plans to ban the sale of pharmacy-made versions of Ozempic® due to serious safety concerns.  

The raid resulted in the seizure of compounded semaglutide, peptides, and human growth hormones.  

Ozempic® is manufactured by the Danish drug giant Novo Nordisk.  While it is primarily a diabetes medication, Ozempic® has gained popularity as a weight loss drug.  

The Financial Review reports that originator Novo Nordisk supports the ban, citing safety concerns and the need to halt pharmacy-made versions of its global blockbuster semaglutide product Ozempic®.   

This news follows the release on 31 January 2024 by Novo Nordisk of its 2023 Annual Report, where it presented a global increase in sales by 31% to DKK 232.3B in 2023, representing an increase in its operating profit by 37%. 

March 1, 2024

On 1 March 2024, JAMP Pharma announced that it launched the first ustekinumab biosimilar to Janssen’s Stelara® in Canada.  Jamteki was approved by Health Canada in November 2023 and JAMP’s launch follows a settlement between Alvotech and J&J last month regarding ustekinumab. 

Jamteki was developed by Alvotech and is JAMP Pharma’s second biosimilar launch in Canada in two years, following the Canadian launch of Simlandi® (adalimumab) biosimilar of AbbVie’s Humira® (adalimumab) in 2022.  The approved presentations for Jamteki™ are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

February 29, 2024

The Medicines and Healthcare Regulatory Agency issued a safety update regarding (dupilumab) and ocular side effectsThe regulator warned that side effects can include conjunctivitis and ulcerative keratitis

February 29, 2024

On 29 February 2024, Biocon Biologics Ltd, announced a settlement with J&J and Janssen, under which it can launch its Bmab 1200 (ustekinumab), biosimilar to Janssen’s Stelara®, in the USA from February 2025.  The FDA previously accepted for review Biocon’s Biologics License Application for Bmab 1200. 

The settlement will result in the termination of the pending Inter Partes Review petition filed by Biocon in November 2023 against Janssen’s US method of treatment (severely active ulcerative colitis (UC)) patent 10,961,307 relating to Stelara® (ustekinumab). 

J&J and Janssen recently entered into ustekinumab settlements with Alvotech (launch dates of no later than 21 February 2025 (US), May 2024 (Japan), late July 2024 (EU) and Q1 2024 (Canada)), BioPharma (US launch date of 15 May 2025), Samsung Bioepis (US launch date from 22 February 2025), Celltrion (US launch date of 7 March 2025), Fresenius Kabi and Formycon (US launch date no later than 15 April 2025), and Amgen (US launch date no later than 1 January 2025).  To date, only Amgen has obtained FDA approval for its ustekinumab biosimilar, with its Wezlana® approved in October 2023. 

February 29, 2024

On 29 February 2024, the Medicines and Healthcare products Regulatory Agency (MHRA) granted marketing authorisation for Xgeva® (denosumab) as a 120mg solution for injection in a prefilled syringe.  This Xgeva PFS product is a high concentration product which is a line extension of the original Xgeva® sold as a vial product containing 120mg solution for injection. 

This is the first product to be authorised by the MHRA via the new International Recognition Procedure (IRP) introduced in January this year.    

The IRP allows the MHRA to accelerate the assessment of new medicines by taking into account pre-existing approvals from Australia, Canada, the European Union, Japan, Switzerland, Singapore and/or the United States.  In fast-tracking the authorisation of the new Xgeva® high concentration formulation, the MHRA considered a positive opinion issued by the European Medicines Agency on 25 January 2024. 

February 28, 2024

On 28 February 2024, Celltrion announced that it filed an application with MFDS for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab).  The application seeks registration across the full Actemra® label and is based on Phase 3 results confirming equivalence of CT-P47 to Actemra®.  Celltrion announced that it will use these results to accelerate applications for product approvals in other countries. 

This follows Celltrion’s announcement on 13 February 2024 that it submitted a Marketing Authorisation Application to the EMA for CT-P47.  On 28 January 2024, Celltrion also announced it had submitted a BLA in the US for CT-P47.  

February 28, 2024

On 28 February 2024, Celltrion announced that its first batch of Zymfentra® (SC infliximab) arrived in Atlanta, with three more shipments expected to arrive by early March this year.  Zymfentra® was approved by the FDA in October 2023. 

Zymfentra® (SC infliximab), also known as Remsima SC in Europe, is the world’s first subcutaneous injection of infliximab.  Zymfentra® can be self-administered increasing patient convivence and reducing hospital burden.  Celltrion aims to distribute Zymfentra® to US wholesalers by mid-March.  

Zymfentra® was approved by the FDA in October 2023. 

February 27, 2024

On 27 February 2024, Akeso announced results of a Phase II clinical trial for cadonilimab combined with standard treatment (chemotherapy +/- bevacizumab) for treating recurrent/metastatic cervical cancer The results were published in the American Association for Cancer Research’s Clinical Cancer Research journal and, amongst other things, the results showed that 63.6% of patients experienced tumour reduction of more than 50%. 

February 27, 2024

On 27 February 2024, AbbVie announced that the U.S. Food and Drug Administration (FDA) granted priority review of its supplemental Biologics License Application for EPKINLY® (epcoritamab) for the treatment of Adult Relapsed or Refractory Follicular Lymphoma (R/R FL).  Priority review will decrease the review time to six months, compared to a standard 10 months.  If approved by the FDA, EPKINLY® will be the first and only subcutaneous bispecific antibody to treat adults with R/R FL after two lines of prior therapy. 

On 25 September 2023, AbbVie announced that its Tepkinly® (epcoritamab) received conditional marketing authorisation to Treat R/R DLBCL from the European Commission. 

February 27, 2024

On 27 February 2024, BeiGene, announced that the U.S. Food and Drug Administration (FDA) accepted BeiGene’s Biologics License Application (BLA) for TEVIMBRA® (tislelizumab), in combination with fluoropyrimidine-and platinum-containing chemotherapy, with a PDUFA date set for December 2024.  The product is intended to offer improved treatment options for patients diagnosed with locally advanced unresectable or metastatic gastric or gastroesophageal junction (G/GEJ) adenocarcinoma.  

On 19 September 2023, BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a termination of the previous arrangement between the parties.  Furthermore, BeiGene announced on 26 February 2024, that CHMP issued a positive opinion for its TEVIMBRA® (tislelizumab) to treat NSLC. 

February 26, 2024

On 26 February 2024, AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the use of Voydeya® (danicopan) as an add-on to ravulizumaboreculizumab for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria (PNH) who have residual haemolytic anaemia.   

CHMP based its positive opinion on results from the ALPHA Phase III trial which were published in The Lancet Haematology journal on 27 November 2023.  

February 26, 2024

On 26 February 2024, BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending the approval of TEVIMBRA® (tislelizumab) for the treatment of non-small cell lung cancer (NSCLC). The indications include treatment of squamous, non-squamous and locally advanced / metastatic NSCLC. BeiGene’s Phase 3 clinical trials, enrolling 1,500 patients, showed tislelizumab to be an effective therapy for patients with treatment-naive and treatment-resistant NSCLC. 

On 19 September 2023, BeiGene announced it regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following termination of the previous arrangement between the parties. 

February 26, 2024

On 26 February 2024, the results of an 18 month study sponsored by Takeda Pharmaceuticals were published in Crohn’s & Colitis 360.  The study involved 108 patients switched from IV to a subcutaneous vedolizumab.  The results of the study suggested that switching from an intravenous to a subcutaneous treatment of vedolizumab is convenient and safe. 

February 26, 2024

On 26 February 2024, Daily Pharm Korea reported that Samsung Bioepis received approval from the Korean Ministry of Food and Drug Safety for Afilivu®, biosimilar to Regeneron’s Eylea® (aflibercept).  This is the first aflibercept biosimilar approved in Korea and Samsung Bioepis’ second biosimilar for ophthalmic disease, after its Lucentis® (ranibizumab) biosimilar – Amelivu® – was approved in Korea in May 2022.  Afilivu® is indicated for treatment of wAMD, RVO, DME and mCNV.   

As previously reported, Samsung Bioepis will co-market Afilivu® in Korea with Samil Pharmaceutical, together with ranibizumab biosimilar Amelivu®. 

In the US, aflibercept biosimilars are the subject of patent infringement litigation commenced by Regeneron against Samsung Bioepis, Amgen, Formycon, Celltrion and Mylan and Biocon.  In Europe, Formycon announced in December 2023 that the EMA had accepted its marketing authorisation application for its aflibercept biosimilar FYB203. Biocon has received marketing approval for its aflibercept biosimilar Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). Formycon announced in December 2023 that the EMA had accepted its application for its aflibercept biosimilar FYB203. 

February 26, 2024

On 26 February 2024, Alvotech announced the sale of 10,127,132 ordinary shares at a purchase price of USD 16.41 per share.  Alvotech’s U.S listed shares rose more than 12% to $18 in premarket trading following the announcement on 23 February 2024 that FDA approved Alvotech’s SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to AbbVie’s Humira®.  

February 23, 2024

On 23 February 2024, Samsung Bioepis presented two new study results for ustekinumab SB17 (biosimilar to Janssen’s Stelara®) at the 19th Congress of European Crohn’s and Colitis Organisation (ECCO) in Stockholm, Sweden.  The results demonstrate SB17 is highly similar to Stelara® in structural, physicochemical, and biological attributes.  On 25 February 2024, CHMP provided a positive recommendation for SB17.   

The medicine will be commercialised by Sandoz in the US, Canada, EEA, Switzerland and the UK under an exclusive commercialisation agreemententered in September 2023 

February 23, 2024

Alvotech and Teva Pharmaceuticals announced that FDA approved SIMLANDI® (adalimumab-ryvk/ AVT02) as an interchangeable high concentration, citrate-free biosimilar to Humira®.  SIMLANDI® is the first high concentration adalimumab product to be US approved. It is approved for the treatment of adult rheumatoid arthritis, juvenile idiopathic arthritis, adult psoriatic arthritis, and adult ankylosing spondylitis.  AVT02 is already approved in CA, AU, EG, EC and Saudi 

February 23, 2024

On 23 February 2024, the Australian quoted Eli Lilly’s CEO David Ricks as stating that its Alzheimer’s drug donanemab is expected to receive US approval “any day” with approval elsewhere to follow later this yearThis news comes after Phase 3 clinical trial results for donanemab, presented at the Alzheimer’s Association International Conference in July 2023, showed that the drug significantly slowed cognitive and functional decline for amyloid-positive early symptomatic Alzheimer’s disease patients. 

February 23, 2024

On 23 February 2024, Regeneron and Sanofi announced that the FDA has accepted to priority review their Dupixent®’s supplemental biologics license application (sBLA) for a 6th indication of uncontrolled chronic obstructive pulmonary disease (COPD) in adults. The target action date for the FDA decision is 27 June 2024.  Priority review was granted following positive results from two phase 3 trials. Notably, if approved, Dupixent® would be the first new treatment for COPD in over a decade and the only biologic for this disease. 

February 22, 2024

On February 2024, Artiva Biotherapeutics announced that the FDA granted fast-track designation to its Lupus Nephritis treatment AlloNK®(AB-10) in combination with rituximab or obinutuzumab.  This was supported by the results of a phase I/II multicentre clinical trial in non-Hodgkin lymphoma which demonstrated that this combination can drive deep B-cell depletion in patients with late-line B-cell cancers. 

February 22, 2024

AstraZeneca announced the successful acquisition of Gracell Biotechnologies, a global clinical-stage biopharmaceutical company specialising in cell therapies for cancer and autoimmune diseases. Gracell’s portfolio notably includes GC012F a clinical stage chimeric antigen receptor T-cell therapy, which is potential new treatment for multiple myeloma, autoimmune diseases and haematologic malignancies. The total transaction is valued at $1.2B USD Previously on 12 December 2020, AstraZeneca announced its acquisition of Alexion.  

February 22, 2024

On 22 February 2024, EU’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Samsung Bioepis’s Pyzchiva® (ustekinumab biosimilar).  Pyzchiva® is recommended for the treatment of plaque psoriasis, including paediatric plaque psoriasis, psoriatic arthritis, ulcerative colitis and Crohn’s disease in adults.  Pyzchiva® is intended to be supplied as 45 mg and 90 mg solutions for injection and a 130 mg solution for infusion.  

Pyzchiva® will be commercialised by Sandoz pursuant to a deal entered into in September 2023, between Sandoz and Samsung Bioepis for SB17 which covers the US, Canada, EEA, Switzerland and the UK. 

February 21, 2024

Coherus Bioscience announced its US launch of Udenyca OnBody®, an on-body injector presentation of Undeyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®.  Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.  The on-body injector utilises LTS Lohmann Therapie-Systeme AG’s wearable drug delivery platform. 

Udenyca OnBody® received FDA approval in December 2023. 

February 21, 2024

On 21 February 2023, Polpharma Biologics announced that PB016 (vedolizumab) demonstrated topline pharmacokinetic (PK) and pharmacodynamic (PD) results in comparison to Entyvio® (vedolizumab).  The results came from a double blinded, randomised, single dose study which assessed PB016’s PK/PD and immunogenicity in 120 subjects, and demonstrated that PB016 has comparable PK/PD and immunogenicity to Entyvio®. 

February 21, 2024

Samsung Bioepis announced that it has commenced a Ph 1 clinical trial for SB27, biosimilar to Merck’s Keytruda® (pembrolizumab).  The study will compare the pharmacokinetics, efficacy, safety, and immunogenicity of SB27 with EU and US-sourced Keytruda®, in patients with stage II-IIIA non-small cell lung cancer (NSCLC) following complete resection and adjuvant platinum-based chemotherapy.  This announcement follows the report on 15 November 2023 that Samsung Bioepis had received approval from the Ministry of Food and Drug Safety for a Ph I clinical trial of SB27. 

Each of Formycon, Xbrane and Celltrion announced (on 19 September 2022, 13 December 2021 and 14 February 2018 respectively) that they have pembrolizumab biosimilars in development. A pembrolizumab biosimilar (BCD-201) is currently the subject of clinical trials commenced by Biocad in July 2022. Sandoz is expecting to commence pembrolizumab biosimilar clinical trials in 2024.

February 21, 2024

On 21 February 2024, Regeneron announced that the FDA has accepted for priority review its BLA for Linvoseltamab for relapsed / refractory multiple myeloma.  The target action date is set for 22 August 2024.  Priority review was granted following data from a combined Ph 1 | 2 clinical trial (LINKER-MM1). 

Earlier in February 2024, the European Medicines Agency accepted for review the marketing authorisation application of linovoseltamab for the same indication.  

February 20, 2024

On 20 February 2024, BMS announced that FDA has accepted, for priority review, its supplemental new drug application (sNDA) for KRAZATI® (adagrasib) in combination with cetuximab for treating patients with KRASG12C-mutated locally advanced or metastatic colorectal cancer FDA has assigned 21 June 2024 as the Prescription Drug User Fee Act (PDUFA) goal date. 

February 20, 2024

On 20 February 2024, FDA approved J&J ‘s supplemental biologics license application to use TECVAYLI® (teclistamab) with a reduced dosing frequency for cancer patients This approval increases dosing flexibility in patients on a weight-based dosing regimen TECVAYLI® was originally approved by the FDA in October 2022 for the treatment of adult patients with RRMM who received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory drug, and an anti-CD38 monoclonal antibody. 

February 20, 2024

On 20 February 2024, Sandoz announced that Health Canada approved Jubbonti® (denosumab) biosimilar to Amgen’s Prolia®, for all Prolia® indications.  Jubbonti® is the first and only Health Canada-approved denosumab biosimilar for osteoporosis and increasing bone mass.   

In February 2023 and May 2023 respectively applications for Sandoz’s denosumab biosimilar were accepted by the FDA and EMA.  

In March 2023, Mabwell (Shanghai) Bioscience announced that it received Chinese marketing approval for its Mailishu® (denosumab) and it was reported in December 2023 that Celltrion applied to the FDA for marketing authorisation for its Prolia® biosimilar (CT-P41).  Other companies have Prolia® biosimilars under development including Samsung Bioepis, Alvotech, Intas, and Shanghai Henlius Biotech. 

February 20, 2024

Health Canada announced that Celltrion’s Remsima™ SC (SC infliximab) has been approved for maintenance therapy in adults with moderate to severe active ulcerative colitis and Crohn’s disease.  Remsima™ SC was previously approved by Health Canada for RA on 28 January 2021.  

This follows Celltrion’s success in January 2024 in securing the Norwegian government tender for the supply of Remsima SC until 2026.  

February 19, 2024

On 19 February 2024, AstraZeneca and Daiichi Sankyo announced that FDA has accepted its biologics license application (BLA) for the use of datopotamab deruxtecan in treating adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy FDA has decided the fourth quarter of 2024 as the Prescription Drug User Fee Act date The application was approved based on the Phase III results of study TROPION-Lung01 which showed that datopotamab deruxtecan significantly improved progression-free survival (PFS) in comparison to docetaxel (the current standard of care). 

February 19, 2024

According to the Pharmaceutical Benefits Assessment Committee (PBAC) agenda for March 2024, published on 5 January 2024, the meeting will be jammed with biopharma applications for reimbursement.  The applications for PBS listing additions or amendments that the PBAC will consider at its March 2024 meeting include the following: 

New Listings  Amendment Applications  
Janssen-Cilag’s Stelara® (ustekinumab)  Sanofi-Aventis’s Dupixent® (dupilumab) 
Amgen’s Wezlana® (ustekinumab)  Bristol-Myers Squibb’s Opdivo® (nivolumab) 
Bayer’s Eylea® (aflibercept)  Merck’s Erbitux® (cetuximab) 
AstraZeneca’s Enhertu® (trastuzumab deruxtecan)  AbbVie’s Humira® (adalimumab) 
Celltrion’s Vegzelma® (bevacizumab)   
Celltrion’s Yuflyma® (adalimumab)   
AstraZeneca’s Saphnelo® (anifrolumab)   
Roche’s Tecentriq® (atezolizumab)   
UCB’s Bimzelx® (bimekizumab)   

 

 

 

 

 

 

 

In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to AbbVie’s Skyrizi® (risankizumab), and Novartis’s Cosentyx® (secukinumab). 

February 19, 2024

On 19 February 2024, the Korea Biomedical Review published that Celltrion secured a series of tenders to supply biosimilars in Peru including relating to Herzuma® (trastuzumab biosimilar) Truxima® (rituximab biosimilar) and Yulfyma® (adalimumab)These contracts effectively secure more than 50% of the Peruvian rituximab and trastuzumab markets, and an estimated 20% of the Peruvian adalimumab market. 

February 16, 2024

Genentech announced that FDA has approved Xolair® for the reduction of allergic reactions, including anaphylaxis, in adult and paediatric patients aged 1 year and older with IgE-mediated food allergy.  The announcement states that Xolair® is the first FDA-approved medicine to reduce allergic reactions in people with food allergies.  The approval was based on the Phase III OUtMATCH study in patients allergic to peanuts and at least two other food allergens.  Xolair was previously FDA approved for the treatment of asthma, chronic rhinosinusitis and chronic spontaneous urticaria.  

Parent company Roche announced submission of the BLA for the food allergy indication in December 2023.  Celltrion, Glenmark and Kashiv Biosciences are reported to have omalizumab biosimilars in development. 

February 16, 2024

Regeneron and Sanofi announced that they have received approval in Japan for Dupixent® (dupilumab) for the treatment of Chronic Spontaneous Urticaria (CSU) in people aged 12 and older whose disease is not adequately controlled with existing therapy.  Approval followed a phase 3 trial showing Dupixent® significantly reduced itch severity compared to placebo.  

Last month, FDA approved a new indication of Dupixent® (dupilumab) for the treatment of paediatric patients with eosinophilic esophagitis. 

February 15, 2024

Alvotech announced that it has settled with Johnson & Johnson in the European Economic Area (EEA), Japan and Canada for its ustekinumab biosimilar, AVT04, and has provided guidance on its proposed launch dates in these regions.  AVT04 received regulatory approval in January 2024 in Europe, in September 2023 in Japan and in November 2023 in Canada.  The products will be marketed by Stada (as Uzpruvo®) in Europe from late July 2024, by Fuji Pharma in Japan (as Ustekinumab BS (F)) from May 2024, and by JAMP in Canada (as Jamteki®) from Q1 2024. 

Alvotech’s applications for AVT04 elsewhere around the world are pending, including in the US.   

In June 2023, Alvotech and Teva announced a US settlement with J&J relating to ustekinumab, with a market entry date of no later than 21 February 2025.   

February 14, 2024

BMS announced that the FDA has accepted a priority review for its Augtyro® (repotrectinib) for the treatment of patients 12 years of age and older with solid tumours that have neurotrophic tyrosine receptor kinase (NTRK) gene fusion and are locally advanced or metastatic, or where surgical resection is likely to result in severe morbidity.   

On 15 November 2023, the FDA approved BMS’s Augtyro® (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC. 

February 14, 2024

On 14 February 2024, Galderma announced that the FDA accepted its Biologics License Applications, and the EMA accepted its Marketing Authorization Applications, for use of nemolizumab in the treatment of patients with prurigo nodularis and atopic dermatitis. Galderma plans to make further regulatory submissions this year in additional countries.  

February 13, 2024

On 13 February 2024, Korea IT Times reported that Celltrion has submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for CT-P47, biosimilar to Actemra® (tocilizumab).    

This follows the announcement by Celltrion at the end of January 2024, that that it submitted its US BLA for CT-P47. 

February 13, 2024

A study sponsored by Qilu Pharmaceutical, published in Ophthalmology and Therapy reports that, in a Chinese, randomised, double-blind, phase III trial, Qilu’s QL1207 was equivalent to Regeneron’s Eylea® for neovascular age-related macular degeneration, with similar safety profiles.   

According to the study, QL1207 is the first aflibercept biosimilar developed in China.  

February 13, 2024

A paper published in the journal BioDrugs reported the results of a Phase III study conducted in Eastern Europe and the Republic of Korea comparing the efficacy, safety, pharmacokinetics and immunogenicity of Celltrion’s CT-P43 with Janssen’s Stelara® (ustekinumab).  The study, conducted in 509 patients with moderate to severe plaque psoriasis, demonstrated equivalent efficacy and comparable pharmacokinetic, safety and immunogenicity profiles. 

On 5 February 2024, Rani Therapeutics published positive topline results from its phase I clinical trial on RT-111, an oral formulation of CT-P43.   

February 12, 2024

On February 12, 2024, Chugai, Genentech, and Hoffmann-La Roche filed a motion for voluntary dismissal of their appeals regarding the Patent Trial and Appeal Board’s (PTAB) decision in IPR2022-00578 and IPR2022-00579 The motion records that Celltrion (the petitioner) has not formally agreed to the dismissal and may file a response. 

Previously, Celltrion filed inter partes review (IPR) petitions IPR2022-00578 against Chugai/Genentech/Roche’s MOT (RA) patent no. US8580264 (‘264), and IPR 2022-00579 against Chugai/Roche’s device patent no. US10874677 (‘677).  The PTAB concluded that claims 1-12 of the ‘264 MOT patent and claims 1-8 of the ‘677 patent are invalid in view of the prior art.  Chugai, Genentech, and Hoffmann-La Roche appealed PTAB’s decision and are now seeking to have that appeal dismissed.  

February 12, 2024

Takeda announced it received approval for EOHILIA ® (budesonide oral suspension) for children aged 11 and older with eosinophilic esophagitis (EoE).  Notably, Dupixent® (dupilumab) was approved to treat children with EoE aged 12 and older in May 2022.  

February 12, 2024

On 12 February 2024, SMC published that it has approved Novartis’s Cosentyx® (secukinumab) for treatment of active moderate to severe HS, also known as acne inversa, in those adults who have previously had an inadequate response or lost response to conventional systemic adalimumab HS therapy.  

This comes months after Novartis announced, on 31 October 2023, that the FDA approved Cosentyx® (secukinumab) to treat moderate to severe HS in adults.  

February 12, 2024

On 12 February 2024, Merck announced that Health Canada approved its KEYTRUDA® (pembrolizumab) in combination with trastuzumab and chemotherapy on 6 February 2024. The product is approved as a first-line treatment for patients with advanced positive gastric or gastroesophageal junction adenocarcinoma with tumours expressing PD-L1 (Combined Positive Score [CPS] ≥ 1).  

In January 2024, Merck announced that the FDA approved KEYTRUDA® (pembrolizumab) in combination with chemoradiotherapy for Stage III-IVA cervical cancer. 

February 12, 2024

On 12 February 2024, Biogen announced that the European Commission approved its SKYCLARYS® (omaveloxolone) on 9 February 2024 SKYCLARYS® was approved for treatment of Friedreich’s ataxia (FA) in adults and adolescents aged 16 years and olderThe announcement states that “SKYCLARYS® is the first treatment approved within the European Union for this rare, genetic, progressive neurodegenerative disease”. 

February 9, 2024

On 9 February 2024, Biocon Biologics (Biocon) announced that it has signed a five-year exclusive partnership agreement with Sandoz AG. The agreement provides Sandoz AG the right to promote, sell and distribute Biocon’s OGIVRI® (trastuzumab biosimilar) and ABEVMY® (bevacizumab biosimilar) in Australia.  

This comes months after Biocon announced it has signed a Distribution Agreement with Sandoz granting Sandoz the exclusive right to promote, sell and distribute “adalimumab BS for subcutaneous injection”, a biosimilar to Amgen’s Humira®, in Japan. 

February 8, 2024

A study sponsored by Mabwell (Shanghai) Bioscience Co Ltd and published in JAMA Oncology reports that the results of Chinese randomized, 53-week, phase III trials of Mabwell’s MW032 with Amgen’s Xgeva® in patients with solid tumor-related bone metastases, confirm biosimilarity in efficacy, safety and population pharmacokinetics.   

In March 2023, Mabwell announced that it received Chinese marketing approval for Mailishu® (denosumab), biosimilar to Amgen’s Prolia®, from the National Medical Products Administration (NMPA) for the treatment of osteoporosis in postmenopausal women at high risk of fracture.

February 8, 2024

A Sanofi and Regeneron study published on 11 December 2023 found that dupilumab (compared to placebo) significantly improved lung function in children with uncontrolled asthma. The study was randomised with subjects aged between 6-12 years, and the results showed that by week 12, a higher proportion of patients achieved a clinically meaningful response.

On 25 January 2024, Regeneron and Sanofi announced that the FDA approved Dupixent® (dupilumab) to treat paediatric patients, aged 1 to 11 years and weighing at least 15 kg, with eosinophilic esophagitis (EoE).

February 7, 2024

On 7 February 2024, global contract development and manufacturing company Samsung Biologics announced that it has partnered with LegoChem Biosciences for antibody-drug conjugate (ADC) development and manufacturing.  Under the agreement, Samsung Biologics will provide antibody development and drug substance manufacturing services as part of LegoChem Bioscience’s ADC program designed to treat solid tumours.  LegoChem is aiming to submit an Investigational New Drug (IND) application to the FDA in the first half of 2025.   

Samsung Biologics also reports that it is on track to complete a dedicated ADC facility in South Korea in 2024.  Two weeks ago, Samsung Biologics revealed in its Q4 2024 Earnings its record high operating profit of over ₩1T for 2023. 

February 7, 2024

On 7 February 2024, the Korea IT Times reported that Celltrion announced that it has won the Norwegian government’s tender to supply Remsima SC® (infliximab biosimilar) and Yuflyma® (adalimumab biosimilar) until 2026.  

Celltrion aims to expand further into the Nordic area with plans to enter into Denmark with Remsima SC® sometime in 2024.  

February 7, 2024

On 7 February 2024, Bristol Myers Squibb (BMS) announced the FDA’s acceptance of its supplemental Biologics License Application (sBLA) for neoadjuvant Opdivo® (nivolumab) with chemotherapy followed by surgery + adjuvant Opdivo® in the treatment of resectable stage IIA to IIIB non-small cell lung cancer (NSCLC).  The FDA has assigned a PDUFA goal date of 8 October 2024.   

On 5 December 2023, BMS announced that the FDA has accepted for priority review its sBLA for Opdivo® in combination with cisplatin-based chemotherapy for the treatment of unresectable or metastatic urothelial carcinoma.   

February 5, 2024

On 5 February 2024, Rani Therapeutics published positive topline results from its phase I clinical trial regarding RT-111, a RaniPill® capsule containing Celltrion’s ustekinumab biosimilar, CT-P43 (biosimilar to Janssen’s Stelara®).  The study shows that RT-111 was well-tolerated and delivered ustekinumab with high bioavailability. 

In June 2023, Rani Therapeutics announced that it expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar (RT-105), following their earlier collaboration on ustekinumab (CT-P43). 

February 5, 2024

On 5 February 2024, Novartis announced that it has agreed to acquire MorphoSys AG, a biopharmaceutical company focused on oncology medicines, for around €2.7B.   Upon completion of the acquisition, notably, Novartis would add to its portfolio the ‘next generation medicines’ of pelabresib which downregulates blood cancer and tulmimetostat used to treat endometrial cancer.

February 5, 2024

On 5 February 2024, Glaxo Smith Kline (GSK) announced results from an interim analysis of its DREAMM-7 phase III trial.  The trial compared two treatment combinations, namely: 

  • Blenrep® Combination: Blenrep® (belantamab mafodotin) +  BorDex® (bortezomib plus dexamethasone); and 
  • Daratumumab combination: daratumumab + BorDex® (bortezomib plus dexamethasone) 

The Blenrep® Combination showed: a) 59% further reduction in risk of disease progression or death, b) 23.2 more months of median progression-free survival, and c) 43% reduction in risk of death.   

February 5, 2024

On 5 February 2024, Ultimovacs announced that the FDA has granted a fast-track designation to its therapeutic cancer vaccine UV1 in combination with nivolumab and ipilimumabThis was supported by the results of a phase II clinical trial for the treatment of patients with unresectable malignant pleural mesothelioma. 

February 5, 2024

On 5 February 2024, Novo Nordisk’s parent company Novo Holdings announced that it will acquire global contract development and manufacture company Catalent for USD $16.5B.  

Novo Holdings will secure 50 global sites in the acquisition and intends to sell three fill-finish sites and related assets (located in Italy, USA and Belgium) to Novo Nordisk.  The acquisition is expected to close towards the end of calendar year 2024.  

This news follows the release on 31 January 2024 by Novo Nordisk of its 2023 Annual Report, where it presented an increase in sales by 31% to DKK 232.3B in 2023, representing an increase in its operating profit by 37%. 

February 5, 2024

Novo Nordisk settled two lawsuits over counterfeit versions of Ozempic® (semaglutide) and Wegovy® (semaglutide).  The two companies involved, Cosmetic Laser Professionals Med Spa and Nuvida RxWeight Loss are permanently banned from claiming that their products are approved by the FDA and from using any Novo Nordisk logos or trademarks. 

This news follows the release on 31 January 2024 by Novo Nordisk of its 2023 Annual Report, where it presented an increase in sales by 31% to DKK 232.3B in 2023, representing an increase in its operating profit by 37%. 

February 4, 2024

A study published in Medicina, on 4 February 2024, concluded that Rituximab represents an efficacious and well-tolerated therapeutic option for the management of Autoimmune Bullous Diseases (AIBD) and warrants consideration in cases of refractory AIBD. 

February 2, 2024

Regeneron announced that its marketing authorisation application (MAA) for linvoseltamab to treat adult patients with relapsed/refractory (R/R) multiple myeloma (MM), was accepted for review by the European Medicines Agency (EMA).  The MAA is supported by data from a Phase I/II trial (LINKER-MM1) investigating linvoseltamab in R/R MM.  Regeneron also submitted a Biologics License Application (BLA) to the FDA in December 2023.

February 1, 2024

Shanghai Henlius Biotech announced its phase 1 clinical study for its denosumab biosimilar of HLX14, which met the primary endpoint.

Shanghai Henlius Biotech announced commencement of the study in November 2020.  Organon announceda deal in June 2022 for exclusive global commercialisation rights to Shanghai Henlius Biotech’s denosumab and pertuzumab.

February 1, 2024

Merck published its Q4 and full year financial results, reporting Q4 2023 worldwide sales were US$14.6B, a 6% increase from Q4 2022.  It also reported a 19% increase in sales of Keytruda® (pembrolizumab) worth US$25B across 2023.  Merck explained the Keytruda® sales increase was due to increased global uptake in earlier-stage and metastatic indications.

Merck highlighted that Keytruda® received multiple FDA approvals, including Keytruda® plus Padcev®.  It also reiterated that the FDA granted Priority Review of Merck and Daiichi Sankyo’s Biologics License Application for patritumab deruxtecan to treat certain patients with previously treated locally advanced or metastatic EGFR-mutated non-small cell lung cancer.

February 1, 2024

Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical will co-market SB15, Samsung’s biosimilar of Regeneron’s Eylea® (aflibercept) in Korea.  The agreement intends to utilise Samsung’s R&D capabilities with Samil Pharmaceuticals’ sales and marketing expertise.

On 21 June 2022, Samsung Bioepis and Samil also entered a commercialisation agreement for Amelivu®, a biosimilar to Genentech’s Lucentis® (ranibizumab).

January 31, 2024

On 31 January 2024, the US District Court for the Northern District of West Virginia published a redacted version of Judge Thomas Kleeh’s Memorandum Opinion and Order, setting out the detailed reasons for his previous finding that Mylan and Biocon infringed eight claims of Regeneron’s US patent 11,084,865, in respect of formulations of aflibercept such as Eylea®.  The Judge found asserted claims of two method of treatment patents (11,253,572 and 10,880,601) to be invalid.   

The infringement finding was made in relation to the aflibercept biosimilar Yesafili®.  Mylan filed a Biologics Licence Application (BLA) for Yesafili® in October 2021 seeking FDA approval to market it.  Mylan’s rights in the Yesafili® BLA were later transferred to Biocon, who intended to sell the product in the US. 

On 27 December 2023, Judge Kleeh issued a short-form judgment setting out his conclusions.  At that time, the detailed reasons remained under seal.  Mylan and Biocon and Regeneron filed “protective” notices of appeal from the short form judgment on 26 January 2024, although the parties allege that the 27 December judgment was not a final, appealable one. 

Biocon has received marketing approval for Yesafili® from the UK Medicines and Healthcare products Regulatory Agency (November 2023) and from the European Commission (September 2023). 

January 31, 2024

Novo Nordisk announced in its 2023 Annual Report that it has increased sales by 31% to DKK 232.3B in 2023, and increased its operating profit by 37% in Danish Kroner.  Key developments outlined in the Report include:

  • a 51% net profit increase and 49% increase in share price;
  • a total of DKK75B investment in expanding global production sites in 2023;
  • 40.5M people accessed Novo Nordisk’s diabetes care products;
  • a summary of the SELECT trial which showed cardiovascular benefits of semaglutide, including a 20% reduction in major adverse cardiovascular events compared to a placebo; and
  • an update on Novo Nordisk’s once-weekly insulin product (Insulin icodec).

January 31, 2024

Outlook Therapeutics announced that it has dosed the first subject in its clinical trial (NORSE EIGHT) which aims to evaluate the effect of ophthalmic formulation of bevacizumab (ONS-5010), in patients suffering from neovascular age-related macular degeneration (wet AMD).

On 23 January 2024, Outlook Therapeutics announced that it received approval from FDA under a Special Protocol Assessment for its ONS-5010 clinical trial protocol.

January 31, 2024

Sandoz announced that it launched biosimilar natalizumab (Tyruko®) in Germany on 31 January 2024 for the treatment of adults with highly active relapsing remitting multiple sclerosis (RRMS).  Tyruko® was developed by Polpharma Biologics and is the first biosimilar to Biogen’s Tysabri® (natalizumab) to be launched in Europe.

The EC approved Sandoz’s Tyruko® in September 2023, and it was approved by the FDA in August 2023.

January 31, 2024

Biogen announced it will reprioritise resources allocated to Aduhelm® (aducanumab) to advance Leqembi® (lecanemab) to “develop new treatment modalities”.  Biogen will discontinue development and commercialisation of Aduhelm® 100 mg/mL IV injection and will terminate the current clinical study.

On 22 April 2022, Biogen withdrew its EU MAA for aducanumab following feedback from the CHMP.

January 31, 2024

Astellas announced it submitted a Supplemental New Drug Application (sNDA) to the Japanese Ministry of Health, Labour and Welfare for Padcev® (enfortumab vedotin (genetical recombination)) with Merck’s Keytruda® (pembrolizumab (genetical recombination)) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

On 15 December 2023, Keytruda® in combination with Pfizer/Astellas’ Padcev® (enfortumab vedotin-ejfv) was approved by the FDA to treat locally advanced or metastatic urothelial carcinoma.  On 26 January 2024, the EMA approved a Type II variation for the same indication.

January 31, 2024

A study by the Italian University of Bologna published in Springer Link’s Clinical Drug Investigation, found that Sandoz’s GP2015 (etanercept biosimilar), Samsung Bioepis SB4 (etanercept biosimilar) and Sandoz’s GP2017 (adalimumab biosimilar) have equivalent effectiveness over a long period of time, compared to originator medicines etanercept and adalimumab respectivelyThe study recruited a total of 1598 patients with rheumatoid arthritis and monitored them for over 48 months during treatment

January 30, 2024

Johnson & Johnson announced it submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval for DARZALEX FASPRO® (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomide and dexamethasone for induction and consolidation treatment, and with lenalidomide for maintenance treatment of adult patients who are newly diagnosed with multiple myeloma (NDMM) and are eligible for autologous stem cell transplant.

In December 2021, Xbrane Biopharma announced it was developing a biosimilar to Darzalex® (daratumumab).

January 29, 2024

AstraZeneca and Daiichi Sankyo announced that the FDA has accepted its supplemental Biologics License Application (sBLA) for Enhertu® (trastuzumab deruxtecan) and has granted Priority Review to treat patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC] 3+) solid tumours who have received prior treatment or who have no satisfactory alternative treatment options.

On 18 October 2023, the European Commission approved Enhertu® to treat a new indication: monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

January 29, 2024

Alvotech announced positive top-line results for AVT03, its biosimilar to Amgen Inc’s Prolia® and Xgeva® (denosumab).  The study (AVT03-GL-P01) was a randomised, double-blind, parallel-group study evaluating the pharmacokinetics, safety, and tolerability of AVT03 compared to Prolia® in healthy adult male subjects 28to 55 years old.  The results of the study have not yet been published.

On 7 September 2022, Lupin and partner DKSH announced an exclusive licensing and supply agreement to market Alvotech’s AVT03 and four other Alvotech biosimilar products (golimumab, aflibercept and two undisclosed biosimilars for immunology and oncology) in the Philippines.

January 29, 2024

Astellas announced that on 26 January the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEVTM (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC).

January 28, 2024

Celltrion announced that it has submitted a Biologics License Application (BLA) for CT-P47, biosimilar to Genentech’s Actemra® (tocilizumab), to the FDA.  Celltrion is seeking approval for CT-P47 in both intravenous and subcutaneous formulations. Biogen received FDA approval for Tofidence®, its biosimilar Actemra® on 30 September 2023.  On 1 August 2022 the FDA accepted Fresenius Kabi’s BLA for its tocilizumab biosimilar.

On 14 December 2023, Celltrion revealed that its phase III clinical trial of CT-P47 demonstrated equivalence with Actemra® in patients with rheumatoid arthritis.

January 26, 2024

AbbVie announced it will invest US$233M in its biologics manufacturing facility in Singapore.  The investment will add 24,000L of biologics drug-substance capacity to AbbVie’s manufacturing network.  The expansion intends to support current products and emerging immunology and oncology compounds.  Construction will begin later in 2024, with operations expected to commence in 2026.

January 25, 2024

A study published in Inflammatory Bowel Diseases on 25 January 2024 concluded that 130 US patients with inflammatory bowel disease who switched from Janssen’s Remicade® (infliximab) to two different biosimilars were not associated with flares compared to patients who received Remicade® or underwent a single biosimilar switch.

January 25, 2024

Regeneron and Sanofi announced that the FDA has approved Dupixent® (dupilumab) to treat paediatric patients aged 1 to 11 years (weighing at least 15 kg) with eosinophilic esophagitis (EoE).  Dupixent® is the first and only medicine approved in the US to treat these patients.  It was approved to treat EoE patients 12 years and older in May 2022.

On 6 May 2023, a Regeneron-sponsored study concluded that Regeneron/Sanofi’s Dupixent® (dupilumab) improves histologic, symptomatic, and endoscopic aspects of EoE.

January 25, 2024

Samsung Biologics revealed in its Q4 2024 Earnings that its subsidiary Samsung Bioepis surpassed ₩1T (1 trillion Korean won) annual revenue in 2023 for the first time in the company’s history.  This was due to the 8% growth in revenue from new product launches and sales expansion.

Parent company Samsung Biologics’ operating profit of over ₩1T was also a record high.  On 25 October 2023, Samsung Biologics reported its highest ever quarterly consolidated revenue of over ₩1T.

January 24, 2024

A study published in JAMA Dermatol shows that rituximab had positive shortterm efficacy and safety when compared to a standard corticosteroid regimen for patients with pemphigus.  

January 24, 2024

The Therapeutic Goods Administration (TGA) has approved Samsung Bioepis’ Onbevzi® (SB8), biosimilar to Genentech’s Avastin® (bevacizumab).  It is indicated to treat colorectal cancer, breast cancer, non-squamous small cell lung cancer (NSCLC), renal cell cancer, glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

Onbevzi® is marketed by Samsung Bioepis as Aybintio® in Europe, which was approved by the European Commission on 20 August 2020.

January 24, 2024

Marketscreener reported that Bayer’s application for regulatory approval of Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) has been accepted by the Chinese National Medical Products Administration (NMPA) for review.

On 19 January 2024, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) approved Bayer’s Eylea® 8mg to treat nAMD and visual impairment due to diabetic macular oedema (DMO).

January 23, 2024

WuXi XDC and Celltrion announced that they have signed a memorandum of understanding (MOU) for development and manufacturing of bioconjugates including antibody-drug conjugates (ADCs).  Under the agreement, WuXi will be Celltrion’s primary service provider for its projects, including from process development to GMP manufacturing.

On 11 January 2024, WuXi XDC’s parent company WuXi Biologics signed a $20M research service agreement with BioNTech to develop two monoclonal antibody therapeutics.

January 23, 2024

Outlook Therapeutics announced it received an agreement from the FDA under a Special Protocol Assessment (SPA) for its clinical trial protocol to assess ONS-5010, an ophthalmic formulation of bevacizumab.  Outlook expects to commence the trial in Q1 2024, with potential resubmission of its biologics license application (BLA) by the end of 2024.  Outlook has also entered into securities purchase agreements for up to $172M to fund the advancement of ONS-5010.

Outlook submitted its SPA request to the FDA regarding the design of the study on 19 December 2023.

January 22, 2024

A Bristol Myers Squibb (BMS) study published in the Journal of Clinical Oncology concluded that Opdivo® (nivolumab) plus chemotherapy did not significantly improve progression-free survival versus chemotherapy in patients with epidermal growth factor receptor (EGFR)-mutated metastatic non-small-cell lung cancer previously treated with EGFR tyrosine kinase inhibitors. The study was sponsored by BMS in collaboration with ONO Pharmaceutical Company. 

January 22, 2024

Sandoz announced that it has signed an agreement to acquire Coherus Biosciences’ Cimerli®, biosimilar to Genentech’s Lucentis® (ranibizumab), for US$170M.  The deal includes the biologics license application (BLA), product inventory, ophthalmology sales and field reimbursement talent and access to proprietary commercial software.  Closing is anticipated in the first half of 2024, subject to standard conditions and approvals.

Coherus announced its sales of Cimerli® surpassed 100,000 doses in its first year in the US following launch in October 2022.

January 22, 2024

PulseNews reported that Samsung Bioepis has received approval for Episcli® (SB12), biosimilar to Alexion’s Soliris® (eculizumab), from the Korean Ministry of Food and Drug Safety.  Episcli® is approved to treat nocturnal hemoglobinuria.

On 3 January 2024 Alexion sued Samsung Bioepis in the US District Court for the District of Delaware asserting infringement of six of its eculizumab patents.

January 22, 2024

The Therapeutic Goods Administration (TGA) has approved Amgen’s Wezlana®, the first approved biosimilar to Janssen’s Stelara® (ustekinumab), in Australia.  The vial and pre-filled syringe for subcutaneous injection have been approved to treat plaque psoriasis, psoriatic arthritis, Crohn’s disease (CD) and ulcerative colitis (UC).  The vial for IV infusion is indicated for CD and UC.

The FDA approved Wezlana® as the first biosimilar to Stelara® on 31 October 2023.

January 19, 2024

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved Bayer’s Eylea®8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO).

Eylea® 8mg was approved in Japan on 18 January 2023, and in Europe on 8 January 2024, for nAMD and DMO.  On 18 August 2023, the FDA approved Eylea® 8mg under the brand name Eylea® HD for the above indications, as well as for diabetic retinopathy.

January 19, 2024

Alvotech announced that its facility in Iceland received a form 483 from the FDA with only one observation.  The inspection started on 10 January 2024 and has concluded.  Alvotech said it will provide a response to the FDA in the coming days, and that the observation is “readily addressable”.  The company believes it is in a position to receive FDA approval for AVT02 (adalimumab, biosimilar to AbbVie’s Humira®) and AVT04 (ustekinumab, biosimilar to Janssen’s Stelara®) by their respective goal dates of 24 February 2024 and 16 April 2024.

The European Commission granted marketing authorisation for AVT04 under the brand name Uzpruvo® – the first EU-approved biosimilar to Stelara® – on 10 January 2024.

January 19, 2024

The US Food and Drug Administration (FDA) announced that it is adding a Boxed Warning to the prescribing information for Amgen’s Prolia® (denosumab) about the significant risk of developing severe hypocalcemia (very low blood calcium levels) in patients with advanced chronic kidney disease, particularly patients on dialysis.

The FDA announced its investigation into this risk in November 2022.  Prolia® is approved in the US for the treatment of osteoporosis in men and women, and to increase bone mass in patients receiving certain therapies for prostate cancer and breast cancer.

January 18, 2024
Korea Biomedical Review reported that CanariaBio received a recommendation from Korea’s Data and Safety Monitoring Board (DSMB) that it stop its global phase III clinical trials of oregovomab in ovarian cancer patients, but continue to monitor overall survival.  The recommendation was due to a failure to achieve the necessary statistical value (p-value) in the futility analysis.

January 18, 2024

Bayer announced that the Japanese Ministry of Health, Labour and Welfare (MHLW) granted market authorisation (MA) for Eylea® 8 mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular oedema (DMO).  The approval was based on studies comparing Eylea® 8mg dosed at 12 or 16 week intervals compared to Eylea® 2mg dosed at 8 week intervals, following initial monthly doses.  Eylea® 8 mg is jointly developed by Bayer and Regeneron.  Regeneron maintains exclusive rights to Eylea® (aflibercept 2 mg) and Eylea® HD (8mg) in the US.  Bayer is the licensee of exclusive marketing rights outside the US.

On 8 January 2024, Bayer received MA from the European Commission for Eylea® 8mg for the same indications as Japan.  On 18 August 2023, the FDA approved Eylea® 8mg under the brand name Eylea® HD for the above indications, as well as for diabetic retinopathy.

January 17, 2024

On 17 January 2024 Samsung Bioepis released its fourth US Biosimilar Market Report.  The quarterly report details recent prices of US-launched biosimilars, and market share and price trends.  The report covers the US-approved biosimilars on 14 INNs, of which 45 have been approved (including three in Q4 2023) and 38 launched.  Of note in relation to adalimumab, Samsung Bioepis points out that six months afterthe July 2023 launch of seven biosimilar products, biosimilar adoption in the US is at 2%.

On 18 April 2023, Samsung Bioepis released its first US Biosimilar Market Report, predicting that  biosimilars will save US$181B in five years in the US.  Its second report was published on 11 July 2023, and the third report was published on 10 October 2023.

January 17, 2024

Business Korea reported that Celltrion launched its 80mg dose of Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in the US on 17 January 2024.  It is the same high-concentration (100mg/mL) formulation as the 40mg dosage form already available in the US.  Celltrion will launch a 20mg dose for paediatric patients in Q1 2024.

Last week Celltrion won several European bids to supply Yuflyma®.

January 17, 2024

The Hindu reported that Aurobindo Pharma subsidiary CuraTeQ Biologics has received a recommendation for marketing authorisation for its trastuzumab (biosimilar to Genentech’s Herceptin®) from India’s  Subject Experts Committee of the Central Drugs Standard Control Organization (CDSCO).

In relation to another molecule (ustekinumab), CuraTeq Biologics entered into an exclusive commercialisation agreement with BioFactura in July 2023.

January 16, 2024

A study evaluating results from a Phase 3, randomised, double blind trial sponsored by Samsung Bioepis was published on 16 January 2023 in the journal, Frontiers in Pharmacology. The results show that Samsung Bioepis’ SB8 (bevacizumab biosimilar) had a comparable efficacy to Genentech’s Avastin® (bevacizumab) for treatment of non–small cell lung cancer.

On 24 January 2024, the Therapeutic Goods Administration (TGA) approved Samsung Bioepis’ Onbevzi® (SB8), biosimilar to Genentech’s Avastin® (bevacizumab), to treat colorectal cancer, breast cancer, non-squamous small cell lung cancer (NSCLC), renal cell cancer, glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

January 16, 2024

Roche announced that the European Commission (EC) has granted it marketing authorisation for Tecentriq® SC (atezolizumab) for subcutaneous injection.  The new authorisation applies to all indications already approved for the previous formulation of Tecentriq® (administered by IV infusion) including various lung, liver, bladder and breast cancers.

The Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Tecentriq® SC (the new formulation) on 14 November 2023.

January 16, 2024

Regeneron and Sanofi announced that the FDA has updated the Dupixent® (dupilumab) label to include efficacy and safety data for patients aged 12 years and older with atopic dermatitis with uncontrolled moderate-to-severe hand and/or foot involvement.  The new data has also been added to the Dupixent label in the European Union, with regulatory submissions underway in additional countries.  The data is from the first and only trial evaluating a biologic specifically for this difficult-to-treat population.

On 27 November 2023, Sanofi and Regeneron announced they plan to file a supplemental biologics licence application with the FDA for Dupixent® to treat chronic obstructive pulmonary disease (COPD) by the end of 2023.

January 15, 2024

Korea Biomed has reported that Samsung Bioepis will stop supplying the low concentration formulations of Adalloce®, biosimilar to AbbVie’s Humira® (adalimumab), in Korea.  Samsung Bioepis will continue to supply Adalloce® in two high-concentration formulations: Adalloce® prefilled syringe and pen (both 40mg/0.4mL).

January 15, 2024

Korea Biomed has reported that LG Chem plans to launch Xelenka®, its biosimilar to AbbVie’s Humira® (adalimumab), in Korea in the second half of 2024, despite obtaining approval from the Korean Ministry of Food and Drug Safety on 15 December 2023.  The report states that the company is “still considering sales strategies”.

January 15, 2024

Boan Biotech announced that it has completed enrolment for the international multi-centre comparative clinical phase III study of BA6101 and BA11021, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab) respectively.  The studies are being condu­­cted simultaneously in Europe, the United States, and Japan.

Boan commenced the trials in May 2023.  BA6101 (Boyoubei®) was approved for marketing in China in November 2022, as the first approved Prolia® biosimilar in the world, and China’s NMPA has accepted Boan’s BLA for approval as an Xgeva® biosimilar.

January 15, 2024

Biospectrum India reported that Indian-based Enzene Biosciences announced its plans to establish a continuous manufacturing site in Hopewell, New Jersey.  Enzene intends the manufacturing site to be operational in June 2024.  Enzene also announced its plans to “gradually expand” operations across the EU, US, Canada, Australia, and Japan.

Enzene launched its seventh Indian biosimilar (ranibizumab) on 24 November 2023.

January 12, 2024

Korea Biomedical Review reported that Celltrion has won bids to supply Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab) in Friuli-Venezia Giulia (FVG) and Sicily in Italy, as well as in the south eastern region of Netherlands. Celltrion will supply Yuflyma® for four and a half years in FVG, two years in Sicily, and for the next three years in the Netherlands.  Celltrion also won a bid to supply Remsima®, biosimilar to Janssen’s Remicade® (infliximab) in Sicily for two years.

On 18 September 2023, Celltrion won bids to supply Yuflyma® in five other regions of Italy, amounting to 20% of the Italian adalimumab market.

January 12, 2024

Merck announced that the FDA has approved Keytruda® (pembrolizumab) in combination with chemoradiotherapy to treat patients with FIGO (International Federation of Gynecology and Obstetrics) 2014 Stage III-IVA cervical cancer.

On 15 December 2023, Keytruda® in combination with Pfizer/Astellas’ Padcev® (enfortumab vedotin-ejfv) was approved by the FDA to treat locally advanced or metastatic urothelial carcinoma.

January 11, 2024

WuXi Biologics announced that it has signed a research service agreement with BioNTech under which Wuxi will receive a $20M upfront payment, and BioNTech is granted exclusive rights to develop therapeutic candidates from two undisclosed preclinical investigational monoclonal antibodies discovered by WuXi.  WuXi is eligible for additional payments including for R&D, regulatory and commercial milestones, and tiered royalties.

January 11, 2024

Eisai announced that the Scientific Advisory Group (SAG) will meet to discuss Eisai’s marketing authorisation application (MAA) for Leqembi® (lecanemab) which is under review by the European Medicines Agency (EMA).  The SAG is expected to meet before 31 March 2024.  The SAG is being convened at the request of the Committee for Medicinal Products for Human Use (CHMP) of the EMA to provide independent advice on scientific or technical matters relating to products under evaluation.

On 9 January 2024, the Chinese NMPA approved Leqembi® as a treatment for mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia.  

January 11, 2024

Celltrion announced in a corporate filing that it applied to the FDA seeking interchangeable status for CT-P17 (Yuflyma®), biosimilar to AbbVie’s Humira® (adalimumab), on 9 January 2024.  On 2 October 2023 the FDA approved Celltrion’s Yuflyma® in 20mg (pre-filled syringe) and 80mg (pre-filled autoinjector and pre-filled syringe) dosages, in addition to the 40mg dose approved on 24 May 2023.

January 10, 2024

Regeneron filed a Compliant in the US District Court for the Central District of California against Amgen asserting infringement of 32 aflibercept patents.  The Complaint states that on 31 October 2023, Amgen announced that the FDA accepted its abbreviated Biologics Drug Application (aBLA) for ABP938, Amgen’s biosimilar to Regeneron’s Eylea® (aflibercept). Regeneron is seeking a preliminary and permanent injunction against Amgen, a finding of willful infringement, damages (including enhanced damages for wilful infringement) and costs.

Regeneron filed its fourth aflibercept complaint in the US District Court for the Northern District of West Virginia against Formycon on 29 November 2023.  Regeneron has also sued Samsung Bioepis (on 21 November 2023), Celltrion (on 8 November 2023) and Mylan (on 3 August 2022) over their respective aflibercept biosimilars.

January 10, 2024

Alvotech and STADA announced the European Commission (EC) has granted centralised marketing authorisation (MA) for Uzpruvo® (AVT04), the first EU-approved biosimilar to Janssen’s Stelara® (ustekinumab).  The marketing authorisation is valid in all European Economic Area countries, including the 27 European Union Member States as well as in Iceland, Liechtenstein, and Norway.  The announcements state the approval ‘paves the way’ for market entry as soon as possible after expiry of a European Supplementary Protection Certificate (SPC) for Stelara® in July 2024.

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for Uzpruvo® (AVT04) on 10 November 2023.

January 10, 2024

Celltrion announced the next phase of its strategic transformation to focus on new drug development at the JP Morgan Healthcare Conference in San Francisco, California.  Celltrion discussed the company’s strategic priorities and progress, including its vision to move beyond biosimilars through the 2024 launch of Zymfentra® (the first and only FDA-approved subcutaneous infliximab product) and expansion into digital healthcare.  Celltrion will continue to develop a pipeline of biosimilars including antibody-drug conjugates, immune checkpoint inhibitors and multi-specific (bi/tri-specific) antibody drugs. Celltrion aims to have a portfolio of 11 drugs by 2025 and a total of 22 drugs by 2030.

January 9, 2024

The Patent Trial and Appeal Board (PTAB) in found that Regeneron’s patents 10,130,681 and 10,888,601 relating to methods of treatment using Eylea® (aflibercept) are invalid.  The PTAB held in IPR2022-01225 and IPR2022-01226 that all challenged claims of the two patents were anticipated by a journal publication which disclosed aflibercept for age-related macular degeneration (AMD), and disclosed phase I and II data relating to its use in neovascular AMD.  The inter partes review (IPR) proceedings were filed by Mylan in July 2022 and instituted in January 2023.

On 23 March 2023, PTAB instituted Celltrion’s IPR challenge to ‘601 and ’681 and Samsung Bioepis’ IPR challenge to ‘601.  PTAB also granted Celltrion and Samsung Bioepis’ motions to join the Mylan IPRs. Samsung Bioepis’ IPR2023-00442 challenge to the ‘681 patent is still pending before the PTAB.

 

 

January 9, 2024

A study published in Ocular Immunology and Inflammation found that switching patients with non-infectious uveitis (NIU) from AbbVie’s Humira® to Samsung Bioepis’ Adalloce® (SB5) did not result in clinically significant efficacy or safety differences.  The study was funded by the National Research Foundation of Korea.

On 19 December 2023, a Samsung Bioepis study published in BMJ Open Ophthalmology demonstrated SB15 was comparable to Regeneron’s Eylea® (aflibercept).

January 9, 2024

Biogen and Eisai announced that Leqembi® (lecanemab) has been approved by the National Medical Products Administration (NMPA) in China for the treatment of mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia.  Eisai has begun preparation for launch in Q3 2024.

On 22 December 2023, it was reported that Eisai will apply to the US FDA to expand approval for Leqembi® for prevention of AD as soon as April 2026.  Leqembi® was approved in Japan on 25 September 2023, and received traditional approval in the US on 6 July 2023.

January 9, 2024

GSK and Aiolos Bio announced they have entered into an agreement for GSK to acquire Aiolos, a clinical-stage biopharmaceutical company focused on addressing respiratory and inflammatory conditions, for $1B upfront and up to $400M in milestone payments.  Aiolos’ AIO-001 is a monoclonal antibody (mAb) ready to enter phase II clinical development for the treatment of adult patients with asthma, with potential for additional indications including chronic rhinosinusitis with nasal polyps.  AIO-001 was exclusively licensed to Aiolos outside of Greater China by Jiangsu Hengrui Pharmaceuticals.

January 8, 2024

Bayer announced that the European Commission (EC) granted marketing authorisation (MA) for Eylea® 8mg (aflibercept) to treat neovascular (wet) age-related macular degeneration (nAMD) and visual impairment due to diabetic macular oedema (DMO).  Eylea® 8 mg is approved for administration at extended treatment intervals of up to every four months, following three initial monthly doses, and in patients with stable visual outcomes intervals of up to five months may be considered.  Eylea® 8 mg is the only treatment in the EU approved for extended treatment intervals of up to five months in nAMD and DMO.

Eylea® 8 mg is jointly developed by Bayer and Regeneron.  Regeneron maintains exclusive rights to Eylea® (aflibercept 2 mg) and Eylea® HD (8mg) in the US.  Bayer has licensed the exclusive marketing rights outside the US.

On 18 August 2023, the FDA approved Eylea® 8mg under the brand name Eylea® HD for the above indications, as well as for diabetic retinopathy.  The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approval of the 8mg Eylea® for the treatment of nAMD and DMO in November 2023, however Eylea® is not approved for diabetic retinopathy in the EU.

January 5, 2024

The Korea Biomedical Review has reported that Celltrion confirmed it has increased Australian sales of Remsima SC®, biobetter to Remsima® (IV product), biosimilar to Janssen’s Remicade® (infliximab), in the first nine months of 2023 by 48% year on year.  Celltrion expects Remsima SC® to generate annual sales in Australia of more than AUD$17M in 2023.  Remsima SC® was approved by the TGA on 12 November 2020.

January 4, 2024

AGC Biologics announced that it will construct a new manufacturing facility for biologics and advanced therapy medicinal products (ATMPs) in Yokohama Japan.  It expects the site to be operational in 2026.

The 20,000 m² facility will offer pre-clinical through to commercial services for mammalian-based protein biologics, messenger RNA (mRNA) and cell therapy services.

In 2021, AGC Biologics and Xbrane Biopharma entered into an agreement to manufacture Xcimzane™ (certolizumab pegol) for clinical development.

January 4, 2024

Accord BioPharma, a wholly-owned subsidiary of Intas Pharmaceuticals, announced that the US Food and Drug Administration (FDA) has accepted its Biologics License Application (BLA) for DMB-3115, its proposed biosimilar to Janssen’s Stelara®.

DMB-3115 was jointly developed by Dong-A St and Meiji Seika Pharma, which granted Intas exclusive licensing rights worldwide excluding certain Asian countries, in an agreement announced in 2021.  Accord BioPharma will be responsible for US commercialisation.

In the same announcement, Accord announced that in October 2023 it reached a settlement with Janssen that would allow Accord to launch DMB-3115 in the US no later than 15 May 2025, pending FDA approval.

January 4, 2024

Samsung Bioepis, Celltrion and Formycon have filed responses to Regeneron’s Motion for Alternative Service in each of their respective matters before the United States District Court for Northern District Of West Virginia regarding biosimilars to Eylea® (aflibercept).  Regeneron has sought authorisation to serve Samsung Bioepis, Celltrion and Formycon by email to their respective US counsel.  All three defendants submit that they intend to file motions to dismiss their matters for lack of personal jurisdiction, without waiting for service, rendering the issue of service moot.

On 27 December 2023, the US District Court for the Northern District of West Virginia found that Mylan infringed or induced infringement of three Regeneron Eylea® (aflibercept) patents, with two of those patents were invalid for obviousness.

January 3, 2024

Glenmark Pharmaceuticals announced it has launched Lirafit®, the biosimilar to Novo Nordisk’s Victoza®/Saxenda® (liraglutide) in India.  Liralift® is priced at around INR100 for a standard dose (~AUD$1.80), a 70% price reduction compared to the originator product.  Lirafit® is indicated for improving glycaemic control in adult patients with type 2 diabetes mellitus.

January 3, 2024

Alexion filed a complaint against Samsung in the US District Court for the District of Delaware asserting infringement of six US eculizumab patents.  The allegations relate to Samsung’s abbreviated Biologics License Application (aBLA)  for SB12, its biosimilar to Alexion’s Soliris® (eculizumab), accepted by the US Food and Drug Administration (FDA) on 7 July 2023.  Soliris® is a treatment for patients with paroxysmal nocturnal hemoglobinuria (PNH) and other conditions.  On 7 July 2023, Samsung provided its 180-day notice of commercial marketing to Alexion.

In August 2023, Amgen appealed Alexion’s successful preliminary injunction order regarding Amgen’s off-label use of its eculizumab biosimilar Bekemv® in Germany.

January 3, 2024

Alvotech announced positive top-line results for AVT06, its biosimilar to Regeneron’s Eylea® (aflibercept).   The study was a randomised, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea® in patients with neovascular (wet) age-related macular degeneration.  The study met its primary endpoint, with results demonstrating therapeutic equivalence between AVT06 and Eylea®.

In May 2023, Alvotech and Polifarma announced an exclusive commercialisation agreement for AVT06 in Turkey.

January 2, 2024

Coherus Biosciences announced that it has launched Loqtorzi® (toripalimab-tpzi) in the US.  It was approved by the FDA on 27 October 2023 in combination with cisplatin and gemcitabine to treat adults with metastatic or recurrent locally advanced nasopharyngeal carcinoma (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

January 2, 2024

AstraZeneca and Sanofi announced that Beyfortus® (nirsevimab) has been approved by the National Medical Products Administration (NMPA) in China for the prevention of respiratory syncytial virus (RSV) lower respiratory tract infection (LRTI) in neonates and infants entering or during their first RSV season.  The companies anticipate Beyfortus® will be available during the upcoming 2024-2025 RSV season.  Beyfortus® is the first approved preventive option to protect against RSV in a broad infant population.

The FDA approved Beyfortus® for the same indication and to treat children up to two years old who are vulnerable to severe RSV disease through their second RSV season on 17 July 2023.

January 2, 2024

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has confirmed its submission is complete for its marketing authorisation (MA) for repotrectinib.  BMS is seeking approval of repotrectinib as a treatment for ROS1 TKI-naïve and pre-treated adult patients with ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC) and TKI-naïve and -pre-treated adult and paediatric patients 12 years and older with NTRK-positive locally advanced or metastatic solid tumours.

On 15 November 2023 the FDA approved BMS’s Augtyro® (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive NSCLC.

January 1, 2024

Cipla’s Adalicip®, developed by Alvotech (AVT02), biosimilar to AbbVie’s Humira® (adalimumab) has been listed on the PBS (General Pharmaceutical Benefits) in the 40mg/0.4mL dosage in syringes and pen devices.  It is reimbursed to treat various conditions, including Crohn’s disease, ulcerative colitis and rheumatoid arthritis.

Cipla’s public summary document for Adalicip® was published on 27 October 2023, and it was considered at the July 2023 PBAC meeting.

January 1, 2024

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has launched its new International Recognition Procedure (IRP), allowing medicine developers to now submit applications.  The IRP replaces the EC Decision Reliance Procedure after the UK left the EU in 2016, and allows the MHRA to take into account the expertise of trusted regulatory partners in other countries when authorising medicines.  The MHRA will partner with regulators in Australia, Canada, Japan, Singapore, Switzerland and the USA, as well as the European Medicines Agency, individual EU member states and those in the European Economic Area.

2023

December 27, 2023

Regeneron filed a complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting 51 counts of patent infringement.  This is the second suit filed against Samsung Bioepis in the Regeneron aflibercept matters, the first of which was filed on 21 November 2023.  

Samsung has filed IPR petitions against a number of Regeneron aflibercept patents including  US10,464,992 on 18 August 2023, relating to formulations of aflibercept, and method of treatment patents US11,253,572 on April 2023, US10,888,601 on April 2023 and US10,130,681 on January 2023. 

December 27, 2023

Judge Thomas Kleeh of the US District Court for the Northern District of West Virginia has found that Mylan infringed or induced infringement of three Regeneron Eylea® (aflibercept) patents.  The Court published a short form judgment and concluded that:

  • Mylan infringed claims 4, 7, 9, 11, 14, 15, 16, and 17 of the formulation patent no. 11,084,865;
  • Mylan would induce infringement of claims 6 and 25 of method of treatment patent no. 11,253,572 and claims 11 and 19 of patent no. 10,888,601;
  • the relevant claims of ‘865 were valid (Mylan’s arguments they were invalid for lack of novelty, inventive step, written description, enablement or indefiniteness failed);
  • claims 6 and 25 of ‘572 and claims 11 and 19 of ‘601 lacked inventive step.

The valid ‘865 patent expires in the US on 14 June 2027.  Detailed reasons for the findings are under seal.  Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea®.  On 27 April 2023, Regeneron filed a stipulation to narrow the case to the above three patents.  Regeneron’s Complaint asserts that the FDA notified Mylan of acceptance of its aBLA on 28 December 2021.

December 27, 2023

Formycon announced that the European Medicines Agency (EMA) accepted its marketing authorisation application (MAA) for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).

On 29 November 2023, Regeneron sued Formycon in the US for infringement of 39 of its Eylea® patents.

December 27, 2023

The Korea Biomedical Review reported that Celltrion has submitted its marketing authorisation application for CT-P39, its biosimilar to Xolair® (omalizumab) to Health Canada.  The application includes all Xolair® indications, including allergic asthma, chronic rhinosinusitis and chronic urticaria.

Celltrion applied for European marketing authorisation for CT-P39 in April 2023.

December 26, 2023

Coherus Biosciences announced it received FDA approval for Udenyca OnBody® the on-body injector presentation of Udenyca® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®. Udenyca® is administered the day after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.  Commercial availability is planned for Q1 2024.

Coherus resubmitted its Biologics License Application (BLA) supplement for Udenyca OnBody®  to the FDA in October 2023, following a satisfactory resolution of inspection findings at a third-party filler.  The resubmission comes after addressing the sole issue identified in the FDA’s Complete Response Letter it received on 21 September 2023.

December 26, 2023

Celltrion announced in a corporate filing that its phase III clinical trial demonstrated that CT-P17, biosimilar to AbbVie’s Humira® (adalimumab), is interchangeable with Humira® in patients with plaque psoriasis.  Celltrion plans to apply to the FDA for interchangeability status in the US.

December 22, 2023

Nikkei Asia reported that Eisai will apply to the FDA to expand the approval Leqembi® (lecanemab) to use for prevention of Alzheimer’s disease (AD) as soon as April 2026.  Clinical trials are in the final stages.  Leqembi® was co-developed by Eisai and Biogen.

Leqembi® was approved in Japan on 25 September 2023 and received traditional approval in the US to treat AD on 6 July 2023.

December 22, 2023

Biocon Biologics announced it has signed a Distribution Agreement with Sandoz granting Sandoz the exclusive right to promote, sell and distribute “adalimumab BS for subcutaneous injection”, a biosimilar to Amgen’s Humira®, in Japan.

Biocon Biologics acquired the global biosimilars portfolio of Viatris with a deal signed in November 2022.  It completed integration in Europe in November 2023, and in North America in September 2023.  The most recent announcement states that Viatris will continue to provide transition support until Sandoz assumes responsibility for the product from 15 February 2024.

December 22, 2023

Daiichi Sankyo and Merck announced that the FDA has accepted for priority review its Biologics License Application (BLA) for patritumab deruxtecan (HER3-DXd) to treat adult patients with locally advanced or metastatic EGFR-mutated non-small cell lung cancer (NSCLC) previously treated with two or more systemic therapies. The FDA assigned a Prescription Drug User Fee Act (PDUFA) date for its regulatory decision of 26 June 2024.

December 21, 2023

Johnson & Johnson announced it submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) seeking approval of Rybrevant® (amivantamab) combined with lazertinib, as a first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with common epidermal growth factor receptor (EGFR) mutations including exon 19 deletions (ex19del) or exon 21 L858R (L858R) substitution mutations.

December 20, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted two more of Samsung Bioepis’ inter partes review (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent.  The IPRs relate to US patent nos. 10,590,189 and 10,703,809 in IPR proceedings IPR2023-01069 and IPR2023-01070 respectively.  The patents cover method of treatment claims in treating paroxysmal nocturnal hemoglobinuria (PNH).

On 8 December 2023, PTAB instituted three other Samsung Bioepis petitions against Alexion’s Soliris® patent: US patent nos. 9,725,504, 9,718,880 and 9,732,149.  Samsung Bioepis launched Epysqli®, biosimilar to Soliris®, in three European countries on 19 October 2023.  Epysqli® was approved by the EMA on 30 May 2023.

December 20, 2023

The Business Standard reported that AstraZeneca Pharma India said it will launch Enhertu® (trastuzumab deruxtecan) to treat HER2-positive breast cancer in India in January 2024.

December 20, 2023

mAbxience announced it has entered a licence agreement with Intas Pharmaceuticals, under which Intas will gain the right to commercialise etanercept (biosimilar to Amgen’s Enbrel®) in more than 150 countries including Europe and the US for various autoimmune disorders.  mAbxience (majority owned by Fresenius Kabi, partially owned by Insud Pharma) will develop, manufacture and supply the etanercept biosimilar.

On 20 September 2023, mAbxience reached an agreement with Abbott to commercialise several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets in Latin America, Southeast Asia, the Middle East and Africa.

December 19, 2023

A Samsung Bioepis study published in BMJ Open Ophthalmology demonstrated that SB15, its biosimilar to Regeneron’s Eylea® (aflibercept), had comparable efficacy, safety, pharmacokinetics and immunogenicity to Eylea® up to week 56 in patients with neovascular age- related macular degeneration  (nAMD).  The study also showed that switching from Eylea® to SB15 maintained comparable clinical efficacy and safety.  The authors claim that the results support biosimilarity between SB15 and Eylea®.

Samsung Bioepis announced the phase III switching study results for SB15 on 7 October 2023.

December 19, 2023

A study published in Reumatismo found that Samsung Bioepis’ SB4, biosimilar to Amgen’s Enbrel® (etanercept), and Amgen’s ABP501, biosimilar to AbbVie’s Humira® (adalimumab) both have similar safety profiles to their respective originator products in patients with rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis.  The study also found that there was a reduced biosimilar retention rate at 24 months.  It concluded that biosimilars “could be considered a valid, safe, and less expensive alternative to originators”.

December 19, 2023

Outlook Therapeutics announced that it has submitted a Special Protocol Assessment (SPA) request to the FDA regarding the required additional adequate and well-controlled study of ONS-5010.  An SPA is a process in which sponsors ask to meet with FDA to reach agreement on the design and size of certain clinical trials, clinical studies, or animal studies.

On 27 November 2023, Outlook announced it had a ‘Type A’ meeting with the FDA in October 2023 to discuss the Complete Response Letter (CRL) it received in August 2023 regarding its Biologics License Application (BLA) for ONS-5010.  It stated the FDA said Outlook can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment-naïve patients with a primary efficacy endpoint at 2 months.

The FDA is expected to provide a response to the SPA in early February 2024.

December 19, 2023

Roche announced that the FDA has accepted for priority review its Biologics License Application (BLA) for Xolair® (omalizumab) for the reduction of allergic reactions, including anaphylaxis, that may occur with an accidental exposure to one or more foods.  The BLA relates to treatment of adult and paediatric patients aged one year and older with food allergy.  The FDA expects to make a decision on approval in Q1 2024.  In the US Genentech (Roche) and Novartis  co-promote Xolair®.

December 19, 2023

Merck announced that the US FDA has accepted for priority review its new Biologics License Application (BLA) for V116, its investigational 21-valent pneumococcal conjugate vaccine for invasive pneumococcal disease and pneumococcal pneumonia in adults.  The FDA has set a Prescription Drug User Fee Act (PDUFA), or target action date, of 17 June 2024.

December 18, 2023

Korea Biomed reported that the Ministry of Food and Drug Safety (MFDS) has imposed a six week suspension of Samsung Bioepis’ completed clinical trials of SB15, biosimilar to Regeneron’s Eylea® (aflibercept).  According to the report Samsung Bioepis altered the approved validity period of the clinical trial drugs without obtaining approval from the MFDS, and deviated from the approved labelling requirements.  The MFDS confirmed Samsung breached the Pharmaceutical Affairs Act and invoked a suspension of the clinical trial until 2 February 2024, despite the clinical trials having already concluded.

On 7 October 2023, Samsung Bioepis announced its Phase III switching study results for SB15 which confirmed interchangeability and biosimilarity with Eylea®.

December 15, 2023

Korea Biomed reported that LG Chem’s Xelenka®, biosimilar to AbbVie’s Humira® (adalimumab), has been approved by the Korean Ministry of Food and Drug Safety to treat rheumatoid arthritis, psoriatic arthritis, uveitis in adults, Crohn’s disease, and juvenile idiopathic arthritis in children.  LG Chem obtained approval for its adalimumab biosimilar in Japan back in March 2021.

December 15, 2023

Merck announced that the FDA has approved Keytruda® in combination with Pfizer (previously Seagen)/Astellas’ Padcev® (enfortumab vedotin-ejfv) an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.

This approval comes considerably earlier than expected.  Merck announced only in November 2023 that the FDA had accepted (for priority review) its new supplemental Biologics License Application (sBLA) seeking this approval.  At that time the FDA had set a target action date of 9 May 2024.

December 15, 2023

Korea Biomedical Review reported that MSD Korea’s Tukysa® (tucatinib) was approved by Korea’s Ministry of Food and Drug Safety to treat HER2 (human epidermal growth factor receptor)-positive locally advanced or metastatic breast cancer that has recurred after at least two anti-HER2 treatments, in combination with the antibody therapy trastuzumab and the cytotoxic anticancer agent capecitabine.  Tukysa is approved in over 38 countries.

December 15, 2023

Harbour BioMed’s wholly-owned subsidiary Nona Biosciences announced that it has entered into an exclusive license agreement with Pfizer for the global clinical development and commercialisation of HBM9033, Nona’s MSLN-targeted antibody-drug conjugate (ADC).  MSLN is a tumor-associated antigen upregulated in various solid tumors.  Nona will receive up to US$53M in upfront and near-term payments, with potential for payments up to US$1.05B contingent on achievement of development and commercial milestones.

In July 2023, Pfizer reached another large value deal with Samsung Biologics worth US$897M for Samsung’s manufacture of biosimilars.

December 14, 2023

Celltrion filed an inter partes review (IPR) petition challenging Regeneron’s Eylea® aflibercept  patent no. 11,253,572, in IPR proceeding IPR2024-00260.  Celltrion also filed a motion for joinder with Samsung Bioepis’ IPR (IPR2023-00884) of the ‘572 patent which was instituted in November 2023.  The ‘572 patent relates to methods of use of aflibercept in treating angiogenic eye disorders.

December 14, 2023

CSL announced that the FDA accepted its Biologics License Application (BLA), and the EMA has accepted its Marketing Authorisation Application (MAA), for CSL312 (garadacimab) to treat prophylactic treatment for hereditary angioedema (HAE).  If approved, CSL312 would be the first treatment for HAE in the US and Europe to target activated Factor XII.

December 14, 2023

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that its phase III clinical trial of CT-P47, biosimilar to Genentech’s Actemra®/Roactemra® (tocilizumab), demonstrated equivalence with the originator product in patients with rheumatoid arthritis.  Celltrion confirmed it intends to apply for approval for all indications that Actemra®/Roactemra® is approved for.  On 31 May 2023 Celltrion released its phase I data for CT-P47.

December 13, 2023

Amgen announced that the FDA has accepted for priority review its Biologics License Application (BLA) for tarlatamab to treat patients with advanced small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy.  The FDA assigned a PDUFA goal date of 12 June 2024.

December 12, 2023

Eisai and Biogen announced that Leqembi® intravenous infusion (lecanemab) will be launched in Japan on 20 December 2023, after it was scheduled on the Japan National Health Insurance (NHI) Drug Price List.  Leqembi® intravenous infusion was approved in Japan on 25 September 2023 for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease.

December 12, 2023

Sandoz subsidiary Lek announced it has commenced construction of its US$400M biopharmaceutical production centre in Lendava, Slovenia.  The facility aims to be Europe’s most efficient producer of active pharmaceutical ingredients for biologics, and will have approximately 40,000 m2 surface area.  Full operation is planned for the end of 2026.

Sandoz signed an MOU to build the facility on 9 March 2023.

December 11, 2023

Celltrion USA announced that large Medical Benefits Manager Ventegra® will add Vegzelma®, Celltrion’s biosimilar to Genentech’s Avastin® (bevacizumab) on its commercial formulary as a preferred brand. Vegzelma® (bevacizumab-adcd) was approved by the FDA to treat six types of cancer in September 2022.

On 5 October 2023, Celltrion USA announced that Ventegra® will add Yuflyma®, Celltrion’s biosimilar to AbbVie’s Humira® (adalimumab) as a preferred drug to its formulary.

December 11, 2023

Lotus Pharmaceutical announced that it has entered into a partnership with Intas Pharmaceuticals for the commercialisation of Intas’s Prolia® (denosumab) biosimilar in South Korea, Taiwan and certain markets in South East Asia.  According to the announcement, Intas will be responsible for development, manufacture and supply of the biosimilar, and Lotus will be responsible for the regulatory process and obtain commercialisation rights in those territories.

December 8, 2023

The FDA approved Vertex/CRISPR Therapeutics’ Casgevy® and Bluebird Bio’s Lyfgenia®, the first cell-based gene therapies to treat sickle cell disease in patients 12 years and older.  Casgevy® is the first FDA-approved treatment that uses CRISPR/Cas9 to genetically modify a patients’ hematopoietic stem cells.  Lyfgenia® uses a lentiviral vector for genetic modification and is approved to treat patients with a history of vaso-occlusive events.

In each instance, the patient’s blood stem cells are harvested, and treated and the modified stem cells are transplanted into the patient where they engraft within the bone marrow and increase the production of foetal haemoglobin (for Casgevy®) and HbAT87Q, a gene-therapy derived haemoglobin that functions similarly to haemoglobin A (for Lyfgenia®), and in each instance the increased levels of reduce the risk of red blood cells sickling.

December 8, 2023

Bio-Thera announced that its Avzivi® (BAT1706), biosimilar to Genentech’s Avastin® (bevacizumab) is FDA approved with a full indication set (excluding hepatocellular carcinoma).  Bio-Thera is the only Chinese company to have received marketing approval for a biosimilar in the US, and this is the second Bio-Thera biosimilar to be US approved.

The Avzivi trade name is owned by Novartis, but the product will be marketed by Sandoz in the US pursuant to the license and commercialisation agreement entered into between Bio-Thera and Sandoz in September 2021.  Avzivi® is currently under regulatory review by the EMA (MA submitted on 26 November 2020).  Avzivi® has already been approved in China and is being supplied as Pobevcy®.

December 8, 2023

The National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending AstraZeneca/Merck’s Lynparza® (olaparib) with bevacizumab be routinely used in the NHS in England and Wales for maintenance treatment of high-grade epithelial ovarian, fallopian tube or primary peritoneal cancer in adults whose cancer has completely or partially responded after first-line platinum-based chemotherapy with bevacizumab, is advanced (stages 3 and 4) and is HRD positive (BRCA1 or BRCA2 mutation or genomic instability).

On 24 August 2023, AstraZeneca announced the Japanese MHLW expanded the approval for Lynparza® with abiraterone to treat BRCAm mCRPC.

December 8, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) petition challenging Regeneron’s Eylea® (aflibercept) patent no. 10,464,992 in IPR proceeding IPR2023-01312.  The patent claims formulations of aflibercept suitable for intravitreal injection.  Samsung Bioepis also successfully filed a Motion for Joinder requesting to join the proceeding with IPR2023-00462, in which PTAB instituted Celltrion’s IPR against the ‘992 patent.

On 18 August 2023 Samsung Bioepis filed an IPR petition against ‘992 and sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

December 8, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted three of Samsung Bioepis’ inter partes reviews (IPR) petitions challenging Alexion’s Soliris® (eculizumab) patent nos. 9,725,504, 9,718,880 and 9,732,149 in IPR proceedings IPR2023-00999, IPR2023-00998 and IPR2023-00933 respectively.  The patents cover method of treatment, pharmaceutical composition and API claims.

Samsung Bioepis recently launched Epysqli®, biosimilar to Soliris®, in three European countries on 19 October 2023. Epysqli® was approved by the EMA on 30 May 2023.

December 7, 2023

Bioeq and Teva jointly announced that Health Canada granted a Notice of Compliance for Ranopto® (ranibizumab), biosimilar to Genentech’s Lucentis® (ranibizumab).  Ranopto® is indicated for the treatment of neovascular (wet) age-related macular degeneration, the treatment of visual impairment due to diabetic macular oedema or choroidal neovascularization, as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion.

FYB201/Ranopto® was developed by Bioeq (a JV between Formycon and Polpharma Biologics). Teva entered into a strategic partnership for the exclusive commercialisation of FYB201 in Canada, Europe and selected other countries in mid 2021. Following successful approvals in the UK (marketed as Ongavia® by Teva) in May 2022, as well as the US (marketed as Cimerli® by Coherus) and the EU (as Ranivisio®) in August 2022, Ranopto® is expected to launch in Canada in Q1 2024.  MS Pharma will commercialise FYB201 in the Middle East and North Africa (MENA) region following approval by the relevant regulatory authorities.

This is the third ranibizumab biosimilar approved in Canada, after Samsung Bioepis’ Byooviz® was approved in March 2022, and Roche’s Susvimo® was approved in September 2022.

December 7, 2023

Carefirst and another Blue Cross/Blue Shield licensee have brought class action proceedings against Johnson & Johnson (J&J) and Janssen alleging that the companies unlawfully delayed the introduction of biosimilar competition for its Stelara® ustekinumab product onto the US market.  The complaint alleges that J&J would lose exclusivity for Stelara® in the US on 25 September 2023 upon expiration of the relevant composition patent, and that J&J delayed biosimilar competition through a series of unlawful acts to unlawfully prolong patent protection for Stelara® well beyond September 2023.

The acts alleged in the Class Action include defrauding the US Patent and Trademark Office into incorrectly issue a patent to the use of ustekinumab to treat ulcerative colitis, acquiring the company Momenta, which held patents to manufacturing methods for ustekinumab, and suing or threatening suit of would-be biosimilar entrants for patent infringement. 

December 6, 2023

Dr. Reddy’s and Coya Therapeutics today announced that they have entered into a development and license agreement for the development and commercialisation of COYA302, an investigational combination therapy for the treatment of Amyotrophic Lateral Sclerosis (ALS).  COYA302 is a co-pack kit containing a combination of low dose IL-2 and CTLA-4 Ig (abatacept).

Under the agreement Coya granted Dr. Reddy’s an exclusive license to commercialise COYA302 in the US, Canada, the EU and the UK for ALS.  The new agreement is in addition to the exclusive worldwide licensing agreement between the companies to use the Dr Reddy’s abatacept biosimilar (to BMS’ Orenica®) to develop and commercialise COYA302 on 20 March 2023.   Coya retains the right to commercialise COYA302 for patients with ALS in Japan, Mexico and South America. Coya will have responsibility for the clinical development of COYA302 and for seeking regulatory approval in US.

December 6, 2023

SystImmune and Bristol Myers Squibb announced that they have entered into an exclusive  global license and collaboration agreement for SystImmune’s BL-B01D1, a potentially first-in-class EGFRxHER3 bispecific antibody-drug conjugate.  Under the agreement the companies will jointly develop and commercialise BL-B01D1 in the US.  SystImmune through its affiliates will be responsible for development, manufacturing and commercialisation in China and will be responsible for manufacturing certain drug supplies for use outside of China.  BMS will be responsible for development and commercialisation of BL-B01D1 in the rest of the world.

BL-B01D1 is currently being evaluated in a global phase I study (BL-B01D1-LUNG101) for safety and efficacy in individuals with metastatic or unresectable non-small cell lung cancer (NSCLC).

December 5, 2023

Bristol Myers Squibb (BMS) announced that the FDA has accepted for priority review its supplemental Biologics License Application (sBLA) for Opdivo® (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.  The FDA assigned a PDUFA goal date of 5 April 2024.

On 30 October 2023, the European Medicines Agency validated BMS’s type II variation application for Opdivo® for the above condition.

December 4, 2023

The Canadian Federal Court has refused AbbVie’s application for a permanent injunction against JAMP for exploitation of Simlandi® until the expiration of AbbVie’s Humira® patent no. 2,904,458.  Despite JAMP conceding it infringed the ‘458 patent, it successfully argued that the injunction should not be granted for public interest reasons.  It argued that: 

  • there was an alternative remedy available (a reasonably royalty paid by JAMP to AbbVie); 
  • Humira® would not benefit from additional sales if Simlandi® was removed from the market as Simlandi® patients would be switched to another biosimilar for which AbbVie is likely receiving a royalty;  
  • the removal of Simlandi® would deprive patients of the only 80 mg/0.8 mL formulation available in Canada; and 
  • if Simlandi® and Yuflyma® (Celltrion) are removed, all Simlandi® patients will have to switch to a biosimilar with a higher injection volume and possibly citrate, which could increase injection site pain for these patients and cause them harm. 

The Court also found that two of AbbVie’s Humira® dosing regimen patents (nos. 2,504,868 and 2,801,917)were invalid for obviousness.  

December 3, 2023

Roche and Carmot Therapeutics announced a US$2.7B agreement for Roche to acquire Carmot Therapeutics, including its R&D portfolio of clinical stage incretins.  The deal also provides for potential additional milestone payments of up to US$400M.

As part of the acquisition, Roche will acquire:

  • CT-388, the lead asset, a Phase-2 ready, dual GLP-1/GIP receptor agonist for the treatment of obesity in patients with and without type 2 diabetes;
  • CT-996, a small molecule GLP-1 receptor agonist currently in Phase-1 intended to treat obesity in patients with and without type 2 diabetes; and
  • CT-868, a Phase-2, dual GLP-1/GIP receptor agonist intended for the treatment of type 1 diabetes patients with overweight or obesity.

On 9 May 2023, Roche acquired worldwide rights to Zion Pharma’s ZN-A-1041 (oral HER2 TKI).

December 1, 2023

New Zealand’s Pharmac has listed Celltrion’s Herzuma®, biosimilar to Genentech’s Herceptin®, on the Pharmaceutical Schedule for the treatment of breast cancer expressing HER-2 IHC 3+ or ISH+ (including FISH or other current technology). Patients taking Herceptin® will need to move to Herzuma® by 1 June 2024 as Herceptin® will be delisted from the Schedule.

December 1, 2023

The Korea Biomedical Review reported that Celltrion has submitted an application for marketing authorisation to the FDA for CT-P41, its biosimilar to Amgen’s Prolia® (denosumab) for the treatment of osteoporosis and related diseases.  The KBR reported that Celltrion has confirmed CT-P41’s equivalence and similarity in a phase III trial, and is seeking approval as an interchangeable biosimilar.

December 1, 2023

Syngene announced that it has completed the acquisition of a biologics manufacturing facility from Stelis Biopharma (a subsidiary of Strides Pharma Science, located in Bangalore).  Sygene announced the acquisition in July 2023.

November 30, 2023

Samsung announced that has signed a settlement and licence agreement with Johnson & Johnson settling all pending US patent litigation between the companies, with a licence to Samsung to commercialise its Stelara (ustekinumab) biosimilar SB17 in the US from 22 February 2025.

Samsung and J&J subsidiary Janssen previously made reference to a settlement (without reference to the licence date) in their joint motion dated 3 August 2023, to terminate Samsung’s Inter Partes Review (IPR) challenging Janssen’s US patent 10 961 307.

Samsung’s BLA for SB17 is under review with the FDA and if approved will be commercialised in the US by Sandoz.

J&J has also entered into ustekinumab settlements with Celltrion (with a US licence date of 7 March 2025), Fresenius Kabi and Formycon (with a US licence date no later than 15 April 2025), Alvotech and Teva (with US licence date no later than 21 February 2025) and Amgen (with a US licence date no later than 1 January 2025).

November 30, 2023

Merck announced that the FDA has accepted for priority review its new supplemental Biologics License Application (sBLA) seeking approval for Keytruda® in combination with Seagen/Astellas’ Padcev® (enfortumab vedotin-ejfv), an antibody-drug conjugate, for the treatment of adult patients with locally advanced or metastatic urothelial carcinoma.  The FDA has set a target action date of 9 May 2024.

November 29, 2023

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Formycon asserting infringement of 39 US aflibercept patents.  The heavily redacted Complaint states that on 29 August 2023 Formycon announced its aBLA for FYB203 was accepted for review by the FDA, and that this constitutes patent infringement.  The Complaint also states on information and belief that on 30 August 2020 Formycon imported or directed the importation at least one shipment of FYB203 into the US.

This is Regeneron’s fourth aflibercept complaint filed in the US District Court for the Northern District of West Virginia.  Regeneron has also sued Samsung Bioepis (on 21 November 2023), Celltrion (on 8 November 2023) and Mylan (on 3 August 2022) over their respective aflibercept biosimilars.

November 29, 2023

Alvotech announced that its pharmacokinetic study of AVT05, its Simponi®/Simponi Aria® (golimumab) biosimilar, met its primary endpoint.  The study assessed the pharmacokinetics, safety and tolerability of AVT05 compared to Simponi® in healthy adult subjects.

Alvotech announced the study in January 2023.  In May 2023, Alvotech announced a study in adult patients with moderate to severe rheumatoid arthritis.

November 29, 2023

Bio-Thera Solutions announced that its phase III study of BAT2206 demonstrated it is highly similar to Janssen’s Stelara® (ustekinumab) in patients with moderate to severe plaque psoriasis.  Bio-Thera confirmed it will present the results at a future medical meeting or in a publication.

On 16 June 2023, Bio-Thera entered a distribution agreement for BAT2206 in Brazil.  In 2021 Bio-Thera entered into a licence agreement with Hikma for the US (with option to add Europe) and with Pharmapark for Russia and other CIS countries.

November 28, 2023

Samsung Biologics disclosed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has taken ₩3T (US$2.3B) in orders in 2023 after it has entered a new confidential sales/supply contract worth ₩588B (~US$457M).  The contract partner and contract period will be disclosed after 31 December 2025 for confidentiality reasons.

On 25 October 2023, Samsung Biologics announced its Q3/2023 financial results, demonstrating its highest ever quarterly consolidated revenue of ₩1.034T, marking an 18% increase from Q3 2023.

November 28, 2023

Daiichi Sankyo announced that it has received approval from Japan’s Ministry of Health, Labour and Welfare for Daichirona® for IV injection as an Omicron XBB.1.5-adapted monovalent mRNA vaccine against COVID-19.  Daichirona® is the first Japanese-made mRNA vaccine, and will be distributed in the coming days in Japan.

On 19 October 2023, Daiichi and Merck announced a global development and commercialisation collaboration involving Daiichi’s three deruxtecan antibody-drug conjugate candidates: patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan.

November 28, 2023

Alvotech reported unaudited financial results for the first nine months of 2023.  Results included product revenue of US$29.8 million in 2023 compared to US$11.1 million for the same period in 2022, and R&D expenses of US$152.8 million compared to US$133.1 million in 2022.  The 2023 revenue consisted of European and Canadian sales of AVT02, Alvotech’s Humira® (adalimumab) biosimilar.

Alvotech also announced that it has resubmitted its BLA for AVT04 Stelara® (ustekinumab) biosimilar, which the FDA has accepted for review with a BsUFA goal date of 16 April 2024.  It also reported highlights including the FDA’s acceptance for review of its resubmitted BLA for AVT02 with a goal date of 24 February 2024, as well as marketing approvals for AVT04 in Canada and Japan, and a positive CHMP opinion in Europe.

November 28, 2023

Biocon Biologics announced that it has completed the integration of Viatris in 31 countries in Europe.

Biocon Biologics completed the US integration in September 2023.  The multi-billion dollar deal was finalised in November 2022.

November 27, 2023

Formycon AG and Klinge Biopharma GmbH announced that they have applied to the European Medicines Agency (EMA) for marketing authorisation in the EU for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).

Only a few days before on 24 November 2023, Celltrion announced it also applied for EU approval of its aflibercept biosimilar CT-P43.  On 29 August 2023, the FDA accepted Formycon’s BLA for FYB203, its biosimilar to Eylea®.

November 27, 2023

Sanofi and Regeneron have announced they plan to file a supplemental biologics licence application (sBLA) with the FDA for Dupixent® (dupilumab) to treat chronic obstructive pulmonary disease (COPD) by the end of 2023.  This application will be based on two phase III clinical trials.

On 20 October 2023, Sanofi and Regeneron received a complete response letter from the FDA regarding its sBLA for Dupixent® for its use in chronic spontaneous urticaria.

November 27, 2023

Outlook Therapeutics announced that it had a ‘Type A’ meeting with the FDA in October 2023 to discuss the Complete Response Letter (CRL) it received in August 2023 regarding its Biologics License Application (BLA) for ONS-5010, an ophthalmic formulation of bevacizumab, marketed by Genentech as Avastin®, to treat wet AMD.  On 29 September 2023 Outlook Therapeutics requested a Type A meeting with the FDA (an immediately necessary meeting for a drug development program to proceed).  The FDA confirmed in the Type A meeting that Outlook can conduct a non-inferiority study evaluating ONS-5010 versus ranibizumab in a 3-month study of treatment naïve patients with a primary endpoint at 2 months.

In the CRL dated 30 August 2023, the FDA acknowledged the Outlook NORSE TWO pivotal trial met their safety and efficacy endpoints, but suggested the BLA could not be approved due to several chemistry, manufacturing and control issues, as well as open observations from pre-approval manufacturing inspections and a lack of substantial evidence.

November 24, 2023

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that it has applied for marketing authorisation in the EU for its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) on 23 November 2023.  The application is based on the positive results from Celltrion’s Ph III trials of CT-P42 which were reported on 3 April 2023.

November 24, 2023

Express Pharma reported that Enzene Biosciences has launched its biosimilar ranibizumab in India (biosimilar to Genentech’s Lucentis®) for the treatment of neovascular age-related macular degeneration (AMD).  This is Enzene’s seventh Indian biosimilar.

On 7 September 2023, we reported that Enzene would ‘imminently’ launch its biosimilar ranibizumab.

Enzene is on market in India for bevacizumab (biosimilar to Genentech’s Avastin®) launched 29 June 2023, adalimumab (biosimilar to AbbVie’s Humira®) launched 28 February 2023, denosumab (biosimilar to Amgen’s Xgeva®), approved 27 August 2021, romiplostim (biosimilar to Amgen’s Nplate®), approved 10 August 2021, and teriparatide (biosimilar to Eli Lily’s Forteo®), approved 4 February 2021.

November 22, 2023

Biocon Biologics filed an Inter Partes Review (IPR) petition against Janssen’s US patent no. 10,961,307 relating to Stelara® (ustekinumab).  Biocon Biologics is challenging all 34 claims of the patent, relating to methods of treating ulcerative colitis with ustekinumab.

On 9 August 2023, the USPTO Patent Trial and Appeal Board terminated Samsung Bioepis’s IPR challenging the ‘307 patent following Samsung and Janssen’s joint motion for termination on the basis that the parties had resolved the dispute.

November 22, 2023

Chugai Pharmaceutical announced the Japanese launch of Phesgo®, a subcutaneous combination of pertuzumab and trastuzumab (Genentech’s Perjeta® and Herceptin® respectively) to treat HER2-positive breast cancer and advanced or recurrent HER2-positive colorectal cancer that has progressed following cancer chemotherapy and is not amenable to curative resection.

The Japanese National Health Insurance (NHI) reimbursement price list included Phesgo® on the day Chugai launched it. Phesgo® was approved by the Ministry of Health, Labour and Welfare on 25 September 2023.

November 22, 2023

A Phase III study funded by Celltrion compared the efficacy and safety of its ustekinumab biosimilar CT-P43 to Janssen’s Stelara® (ustekinumab).  The study concluded that CT-P43 was equivalent in efficacy in treating patients with moderate to severe plaque psoriasis, and had comparable pharmacokinetic, safety and immunogenicity profiles to Stelara®. 

In April 2023, Celltrion filed an application in Australia seeking approval of CT-P43 for all Stelara® indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. 

November 21, 2023

Sandoz has launched its high concentration formulation (100mg/ml) of Hyrimoz® in Europe, biosimilar to AbbVie’s Humira® (adalimumab).  This citrate-free high concentration formulation is indicated for all conditions for which Humira® is supplied.

Hyrimoz® was granted marketing authorisation in the EU on 3 April 2023.  The same formulation was approved by the FDA on 21 March 2023.

November 21, 2023

BeiGene and Ensem Therapeutics announced that BeiGene will acquire Ensem’s investigational new drug (IND) application-ready oral cyclin-dependent kinase 2 (CDK2) inhibitor as part of an exclusive global licensing deal.  Ensem will receive an upfront payment and is eligible for additional payments upon achievement of development, regulatory, and commercial milestones, totalling up to US$1.33B. Ensem will also receive tiered royalties.

On 19 September 2023, BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a mutual agreement between the parties.

November 21, 2023

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Samsung Bioepis asserting infringement of 37 US aflibercept patents.  The heavily redacted Complaint does not disclose any information about Samsung’s abbreviated Biologics Drug Application (aBLA) for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), an intravitreal treatment for age-related macular degeneration and other VEGF-mediated eye conditions.  However, the Complaint states on information and belief that between 2 July 2019 and 8 June 2023 Samsung entities imported or directed the importation into the US of 36 shipments of SB15.

Samsung has filed IPR petitions against a number of Regeneron aflibercept patents: US10,464,992 on 18 August 2023, relating to formulations of aflibercept, and method of treatment patents US11,253,572 in April 2023, US10,888,601 in April 2023 and US10,130,681 in January 2023.

November 21, 2023

On 21 November 2023, the Canadian Federal Court of Appeals dismissed Janssen’s appeal from a decision of the Federal Court upholding Canada’s Office of Submission and Intellectual Property (OSIP) refusal of Janssen’s application to list Canadian Patent 3113837 on the PMNOC register for two supplementary new drug submissions relating to Stelara® (ustekinumab).

The Federal Court decision was handed down in July 2023.

November 20, 2023

Biocon Biologics filed an Inter Partes Review (IPR) petition against  certain claims of Regeneron’s US patent no. 10,888,601 relating to Eylea® (aflibercept).  The challenged claims relate to methods of treating diabetic macular edema and diabetic retinopathy.  Biocon Biologics’ petition asserts the same grounds as the earlier petition filed by Samsung Bioepis and instituted by the USPTO Patent Trial and Appeal Board (PTAB) in March 2023, and includes a motion for joinder with Samsung’s petition.

November 20, 2023

AbbVie commenced proceedings in the US District Court of Delaware against Sandoz, Hetero Labs, Aurobindo Pharma, Intas Pharmaceuticals, Accord Healthcare and Sun Pharma, alleging infringement of 34 Rinvoq® (upadacitinib) patents, including compound, process and method of treatment patents.  The alleged infringements arise from the respondents’ respective submissions of Abbreviated Biologic License Applications (aBLA) to the FDA seeking approval of their Rinvoq® biosimilars.

AbbVie is seeking injunctions preventing the supply of the upadacitinib biosimilars, and damages.  AbbVie has also sought orders that the effective date of any FDA approval of the respondents’ ANDAs be no earlier than the last expiry date of the allegedly infringed patents (with the earliest expiring patent on 9 June 2029, and the latest expiry is 9 March 2038) or any later exclusivity expiry.

On 18 May 2023, the FDA approved an expanded indication for Rinvoq® to include adults with moderately to severely active Crohn’s disease who have had an inadequate response or intolerance to one or more tumour necrosis factor blockers.

November 20, 2023

Sam Chun Dang Pharmaceutical announced in a corporate filing that it has signed an exclusive 10-year distribution agreement with an unnamed distributor regarding SCD411, biosimilar to Regeneron’s Eylea® (aflibercept), to be supplied to Austria, Germany, Italy, Spain and Switzerland.  Sam Chun Dang will receive up to €20M from the unnamed distributor, with the agreement implementing a 50% profit share arrangement.

On 24 August 2023, Sam Chun Dang licenced SCD411 to Apotex for Canada.

November 20, 2023

CVS Caremark published its Performance Drug List for January 2024, notably removing Amgen’s Amjevita® (adalimumab), the first Humira® biosimilar launched in the US, and replacing it with Sandoz’s Hyrimoz® (adalimumab-adaz) as the preferred adalimumab product.

CVS will remove Regeneron’s Eylea® (aflibercept) and Genentech’s Lucentis® (ranibizumab), preferring either Biogen’s Byooviz® or Coherus’ Cimerli® (both ranibizumab biosimilars).  There are currently no FDA-approved aflibercept biosimilars, however on 31 October 2023 the FDA accepted Amgen’s BLA for ABP938, and on 29 August 2023 the FDA accepted Formycon’s BLA for FYB203.

CVS will de-list Sandoz’s Ziextenzo® (pegfilgrastim), biosimilar to Amgen’s Neulasta®, and prefer Amneal Bioscience’s Fylnetra® and Pfizer’s Nyvepria®.   CVS will also remove Amgen’s Kanjinti® and Pfizer’s Trazimera®, trastuzumab biosimilars to Genentech’s Herceptin®, preferring Teva’s Herzuma® or Biocon Biologics’ Ogivri®.

November 17, 2023

Almirall announced that its received marketing authorisation from the European Commission (EC) for Ebglyss® (lebrikizumab) for the treatment of adult and adolescent patients (12 years and older with a body weight of at least 40 kg) with moderate-to-severe atopic dermatitis who are candidates for systemic therapy.  Almirall will first launch Ebglyss® in Germany and continue distribution in other European countries in 2024.  Almirall licensed the rights to develop and commercialise lebrikizumab in Europe for dermatology indications from Dermira in June 2019, which was acquired by Eli Lilly in January 2020.  Eli Lilly has exclusive rights for Ebglyss’® development and commercialisation in all other jurisdictions outside of Europe.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion of Ebglyss® to treat moderate and severe forms of atopic dermatitis in adults and adolescents.

November 17, 2023

Biogen, Genentech and Roche instigated proceedings against Dr Reddy’s Laboratories and Fresenius Kabi, alleging infringement of 15 patents relating to Genentech/Biogen’s Rituxan®/MabThera® (rituximab) products in the US District Court of New Jersey.  The alleged infringement arises from Dr Reddy’s submission of its Abbreviated Biologic License Application (aBLA) to the FDA seeking approval for DRL_RI, its Rituxan® biosimilar.  The originators allege that Fresenius assisted Dr Reddy’s in its aBLA application.

On 12 July 2023, Dr Reddy’s announced its BLA for DRL_RI was accepted for review by the FDA following acceptance of its DRL_RI dossier by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) filed in April 2023.

November 17, 2023

EirGenix announced that Herwenda®, Eirgenix and Sandoz’s biosimilar to Genentech’s Herceptin® (trastuzumab), received approval from the European Commission for the same indications as Herceptin®: HER2-positive breast cancer and metastatic gastric cancers.  On 30 April 2019, Sandoz and EirGenix inked a deal under which EirGenix develops & makes Herwenda®, and Sandoz commercialises the biosimilar on approval for all regions other than Taiwan, China, Russia, and some Asian countries.

On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Herwenda®.

November 17, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) against Regeneron’s Eylea® (aflibercept) patent no. 11,253,572 in IPR proceeding IPR2023-00884.  The ‘572 patent relates to methods of use of aflibercept in treating angiogenic eye disorders.

On 18 August 2023 Samsung Bioepis filed an IPR petition against Regeneron’s Eylea® patent no. 10,464,992 and sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

November 16, 2023

AstraZeneca (AZ) announced the FDA approved its Truqap® (capivasertib) in combination with Faslodex (fulvestrant) for the treatment of adult patients with hormone receptor (HR)-positive, HER2-negative locally advanced or metastatic breast cancer with one or more biomarker alterations (PIK3CA, AKT1 or PTEN).  Patients will be eligible to receive Truqap® if they have progressed on at least one endocrine-based regimen in the metastatic setting or experienced recurrence on or within 12 months of completing adjuvant therapy. 

On 14 November 2023, AZ announced that China’s NMPA approved its Imfinzi® (durvalumab) for the first-line treatment of adult patients with locally advanced or metastatic biliary tract cancer in combination with chemotherapy (gemcitabine and cisplatin). 

November 16, 2023

Korea Biomed reported that AbbVie’s Skyrizi® (risankizumab) has been approved by the Korean Ministry of Food and Drug Safety (MFDS) for a new indication: to treat adult patients with moderate to severe active Crohn’s disease who have not responded adequately to or cannot tolerate existing therapies or biologics. 

On 28 August 2023, AbbVie submitted applications to the EMA and FDA for Skyrizi® to treat moderately to severely active ulcerative colitis. 

November 16, 2023

Merck announced that the FDA approved its Keytruda® (pembrolizumab) combined with fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma.   

On 7 November 2023, the FDA revised the existing indication for Keytruda® for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ).

November 15, 2023

The French Parliament is debating 2024 budget reform (Social Security Financing Bill for 2024) which would enable pharmacists to substitute originator biologic products with biosimilars two years after the launch of the biosimilarUnder proposed amendments 1156, 2415 and 663, substitution could occur unless the ANSM (Agence Nationale de Sécurité du Médicament et des produits de santé) objectsThe proposed reforms align with the European Medicines Agency April 2023 opinion regarding the interchangeability of biosimilars. 

November 15, 2023

Bristol Myers Squibb (BMS) announced the FDA approved its Augtyro® (repotrectinib) for the treatment of adult patients with locally advanced or metastatic ROS1-positive non-small cell lung cancer (NSCLC).  

On 30 October 2023, FDA approved BMS’s supplemental biologics license application (sBLA) for subcutaneous use of Orencia® (abatacept) to treat juvenile psoriatic arthritis (JPsA) in patients aged two and older. 

November 15, 2023

The Korea Herald reported that Samsung Bioepis has received approval from the Ministry of Food and Drug Safety for a phase I clinical trial of SB27, a biosimilar to Merck’s anti-PD-1 therapy Keytruda® (pembrolizumab).  Samsung appears to be ahead of several other companies in its pembrolizumab biosimilar clinical programme, noting that Samsung must commence its trial within a year of the approval.  Formycon, Xbrane and Celltrion previously announced that they have pembrolizumab biosimilars in development.  Formycon reported in its nine-month financial results for 2023 that its pembrolizumab clinical programme will commence in 2024Xbrane reported in its financial reports for Jan-Jun 2023 that its pembrolizumab biosimilar candidate, Xtrudane™, is in preclinical development.  Celltrion has not provided an update on the status of its development. 

November 14, 2023

Alvotech and JAMP Pharma announced that Health Canada has granted marketing authorization for Jamteki™ (AVT04), the first approved biosimilar to Stelara® (ustekinumab) in Canada.  AVT04 was developed by Alvotech and will be marketed under the name Jamteki® by JAMP in Canada.  The approved presentations are a 45mg/0.5mL and 90mg/mL pre-filled syringe with a passive safety device for subcutaneous injection. 

This is the first approved ustekinumab biosimilar in Canda, and the second biosimilar to receive marketing authorisation in Canada under the exclusive commercialization partnership between Alvotech and JAMP Pharma (following Simlandi®, biosimilar to Abbvie’s Humira® (adalimumab)).  The companies announced their exclusive partnership for the commercialisation of five biosimilars in Canada in January 2020, which was expanded to seven biosimilars in October 2022.

November 14, 2023

Roche announced that the EU CHMP recommended the approval of its subcutaneous (SC) formulation of Tecentriq® (atezolizumab).  The CHMP recommended Tecentriq SC for all indications for which Tecentriq® is approved, including various lung, liver, bladder and breast cancers.

On 27 October 2023, Roche received a new indication approval by FDA  for the use of Vabysmo® (faricimab) to treat macular oedema following retinal vein occlusion. 

November 14, 2023

AstraZeneca announced that China’s National Medical Products Administration (NMPA) approved its Imfinzi® (durvalumab) for the first-line treatment of adult patients with locally advanced or metastatic biliary tract cancer (BTC) in combination with chemotherapy (gemcitabine and cisplatin). 

On 22 February 2023, the European Commission approved Imfinzi® and tremelimumab immunotherapy combination to treat advanced liver and lung cancers. 

November 13, 2023

Biocon Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved its Yesafili®, biosimilar to Regeneron’s Eylea® (aflibercept), to treat neovascular age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion, visual impairment due to diabetic macular oedema and visual impairment due to myopic choroidal neovascularisation This follows the 20 September 2023EC marketing approval Biocon Biologics secured for Yesafili®. 

November 13, 2023

The Korea Herald reported that Celltrion has confirmed in its phase III clinical trial that its omalizumab biosimilar CT-P39 is bioequivalent to Genentech/Novartis’ Xolair®.  The company presented the final results of its 40 week clinical trial during the American College of Allergy, Asthma and Immunology (ACAAI) 2023 conference in California.  

Celltrion is also reported to have submitted its application for approval of CT-P39 in Korea in June 2023 (as well as in Europe in April 2023).

Celltrion reported its 24 week results from the study in April 2023, the same month it reported that it submitted its application to the EMA. 

November 10, 2023

Bayer announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of 8mg Eylea® (aflibercept) intravitreal injection for the treatment of neovascular (wet) age-related macular degeneration (nAMD) and diabetic macular edema (DME), with treatment intervals of up to five months.

The US FDA approved 8mg Eylea® in August 2023.

Aflibercept 8 mg was jointly developed by Bayer and Regeneron.  Bayer reported that Regeneron has exclusive rights to Eylea 2mg and 8mg in the US, and Bayer has the exclusive marketing rights outside the US.

November 10, 2023

Alvotech and its EU partner Stada announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion for ustekinumab Uzpruvo (AVT04), biosimilar to Janssen’s Stelara®.  This is the first positive CHMP opinion for a Stelara® biosimilar.

The Alvotech and Stada MAA was accepted by the EMA in February 2023.

Under their 2019 strategic partnership for seven biosimilars, Alvotech is primarily responsible for developing and manufacturing AVT04, and Stada holds commercial rights within Europe.  In May 2023 Alvotech announced that it had terminated the Stada agreement with respect to three biosimilars (excluding ustekinumab), and entered into an agreement with Advanz for Europe for five biosimilars month.

November 10, 2023

Lupin Limited announced that it has executed an agreement with the pharmaceutical manufacturer Amman Pharmaceuticals Industries for exclusive marketing and commercialisation of a biosimilar to Lucentis® (ranibizumab) in the middle east region, including Saudi Arabia and UAE.

November 10, 2023

Biocon Ltd announced its consolidated financial results, including a 97% increase in revenue year on year for its biologics subsidiary, Biocon Biologics.  Biocon reported that this was largely driven by Biocon Biologics’ acquisition of Viatris’ biosimilars business and growth in market share for its biosimilar portfolio.

November 9, 2023

A pre-filled pen presentation of Janssen-Cilag’s Stelara® (ustekinumab) injection (90mg/1mL and 45mg/0.5mL) has been listed on the Australian Register of Therapeutic Goods.

November 9, 2023

Sandoz announced the inauguration of its new Biosimilar Development Center in Holzkirchen, Germany.  Sandoz invested €25 million in the Holzkirchen lab and received support from the Bavarian State government.  The lab will be a key site for Sandoz biosimilar development.

November 8, 2023

Regeneron filed a Complaint in the US District Court for the Northern District of West Virginia against Celltrion asserting infringement of 38 US aflibercept patents.  The allegations relate to Celltrion’s abbreviated Biologics Drug Application (aBLA) filed with the US Food and Drug Administration (FDA) on 30 June 2023 for CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept), an intravitreal treatment for age-related macular degeneration and other VEGF-mediated eye conditions.

The Complaint states that Celltrion has served a Notice of Commercial Marketing and that its aBLA may be approved as soon as 18 May 2024, the regulatory exclusivity expiry date for Regeneron’s Eylea®.

In March, the US PTAB instituted Celltrion’s IPR challenges to two of these patents, US 10,888,601 and US 10,130,681.

November 8, 2023

The FDA approved Eli Lilly’s Zepbound™ (Tirzepatide) as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with a specified initial body mass index (BMI).  Tirzepatide is a glucose-dependent insulinotropic polypeptide (GIP) receptor and glucagon-like peptide-1 (GLP-1) receptor agonist.  Eli Lilly’s other tirzepatide product, Mounjaro™, was approved in May 2022 as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.

November 8, 2023

Takeda announced that the US Food and Drug Administration (FDA) has approved Fruzaqla™ (fruquintinib) for the oral treatment of adults with Metastatic Colorectal Cancer (mCRC) who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type and medically appropriate, an anti-EGFR therapy. This is the first US approval of fruquintinib.

November 7, 2023

Samsung Bioepis and Organon announced that the US FDA has accepted for review their Supplemental Biologics License Application (sBLA) seeking interchangeability designation for Hadlima™ (adalimumab-bwwd) injection 40 mg/0.4 mL, biosimilar to Humira® (adalimumab).  The sBLA was submitted to the FDA by Samsung Bioepis in August 2023.

Samsung Bioepis and Organon announced the interchangeability results for Hadlima™ in August .

The FDA has designated both Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) and Pfizer’s Abrilada® as interchangeable biosimilars to Humira®.  The FDA has accepted Alvotech’s BLA for AVT02, its high concentration, interchangeable biosimilar, with a goal date of 24 February 2024.  Celltrion is also seeking an interchangeability designation for its approved biosimilar Yuflyma®, which it reported is tentatively expected in Q4 2024.

November 7, 2023

The Korea Economic Daily reported that Celltrion announced record quarterly earnings, with an operating profit of ₩276.6 billion, an increase of 25.2% the same period in 2022, and estimated profit and revenue respectively of ₩220 billion and ₩620 billion.  Celltrion’s key marketed products include biosimilars Yuflyma® (adalimumab), Remsima® SC/Zymfentra® (infliximab), Truxima® (rituximab) and Herzuma® (trastuzumab).

November 7, 2023

The US Food and Drug Administration (FDA) has revised the existing indication for Keytruda® (pembrolizumab) for the first-line treatment of patients with locally advanced unresectable or metastatic HER2-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in combination with trastuzumab, fluoropyrimidine, and platinum-containing chemotherapy.  The updated indication is restricted to patients whose tumors express PD-L1 (Combined Positive Scope [CPS] ≥ 1) as determined by an FDA-approved test.  Both the original and updated indication were approved under accelerated approval regulations.

The same indication was approved in Europe in August 2023, similarly limited to adults whose tumors express PD-L1 ( [CPS]≥1).

November 2, 2023

A pooled analysis study published in Pharmacology Research and Perspectives has concluded that the results support mAbxience’s MB02 bioequivalence to Genentech’s Avastin® (bevacizumab) (EU and US).  No clinically meaningful differences in safety or immunogenicity were observed.

On 13 March 2023, a study found that mAbxience’s MB02 (bevacizumab) was bioequivalent to Genentech’s Avastin®.  In March 2022 Fresenius Kabi obtained a majority (55%) stake in mAbxience.

November 1, 2023

Fresenius Kabi announced it has launched Tyenne®, the first EC-approved biosimilar to Roche’s Actemra®/RoActemra® in the EU Tyenne® was approved by the EC on 19 September 2023 to treat rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis, cytokine release syndrome and COVID-19.

November 1, 2023

Merck announced that the US FDA has approved Keytruda® (pembrolizumab) for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC), in combination with gemcitabine and cisplatin.  This brings the total number of US approved gastrointestinal-related indications for Keytruda® to six.

In October the FDA approved Keytruda® for the treatment of patients with resectable non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery.

October 31, 2023

Amgen announced in its Q3 2023 results that the FDA has accepted its Biologics License Application (BLA) for ABP 938, its biosimilar to Regeneron’s Eylea® (aflibercept).  Amgen did not include the FDA target action date in its announcement.

On 29 August 2023, the FDA accepted Formycon’s BLA for FYB203, its biosimilar to Eylea®.

October 31, 2023

On 31 October 2023, the FDA approved Amgen’s Wezlana® (ustekinumab-auub), as the first FDA-approved biosimilar to Janssen’s Stelara®Wezlana is approved for the treatment of moderate to severe plaque psoriasis and active psoriatic arthritis (each in both adults and paediatric patients six years and older), and the treatment of moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis (in adults)Wezlana® is a subcutaneous injection in a 45mg/0.5mL pre-filled syringe and a 45mg/0.5mL vial

October 31, 2023

Novartis announced that the FDA approved Cosentyx® (secukinumab) to treat moderate to severe hidradenitis suppurativa (HS) in adults.

On 27 October 2023 the National Institute for Health and Care Excellence (NICE) recommended Cosentyx® for moderate to severe HS.

October 30, 2023

A Sandoz study published in Drug Safety found that eight Sandoz biosimilars (adalimumab (Hyrimoz®), epoetin alfa (Binocrit®), etanercept (Erelzi®), filgrastim (Zarzio®), infliximab (Zessly®), pegfilgrastim (Ziextenzo®), rituximab (Rixathon®), and somatropin (Omnitrope®) “can be used as safely as their respective reference biologics” based on real-world experience of all eight marketed products.   The study summarised post-approval cumulative patient exposure and safety experience for the eight products based on the available pharmacovigilance data from Periodic Safety Update Reports (PSURs) and the corresponding PSUR assessment reports authored by health authorities, where available, as of 31 January 2023.  The authors also concluded that “it is reasonable to believe that similar conclusions about safety may be reached for other biosimilars developed and approved to the high standards as are already in place by major health authorities such as the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA)”.

October 30, 2023

The FDA has approved Bristol Myers Squibb’s supplemental biologics license application (sBLA) for subcutaneous use of Orencia® (abatacept) to treat juvenile psoriatic arthritis (JPsA) in patients aged two and older.

On 1 November 2023, changes introduced following the March 2023 PBAC meeting will take effect with a view to encouraging biosimilar uptake in Australia.

October 30, 2023

Aragen announced it is establishing a new US$30M, 160,000m2 biologics manufacturing site in Bangalore, India.  The facility will include multiple GMP manufacturing suites, quality control and process development labs, and downstream purification capabilities.

On 12 October 2023, the Dr Reddy’s biologics manufacturing facility in Hyderabad was issued a Form 483 from the FDA.

October 30, 2023

Bristol Myers Squibb announced that the European Medicines Agency (EMA) has validated its type II variation application for Opdivo® (nivolumab) in combination with cisplatin-based chemotherapy as a first-line treatment for adult patients with unresectable or metastatic urothelial carcinoma.  This validation of the application confirms the submission is complete.

On 22 August 2023 the European Commission expanded the indication for Opdivo® as a monotherapy for adjuvant treatment of patients over 12 with stage IIB or IIC melanoma who have undergone complete resection.

October 28, 2023

Dr Reddy’s informed the Indian National Stock exchange on 28 October 2023 that the FDA issued a Form 483 with ten observations for Dr Reddy’s biologics manufacturing facility in Hyderabad.  The observations were issued as part of a routine cGMP inspection of the facility by the FDA between 19 and 27 October 2023.  Dr Reddy’s confirmed in the announcement that it will address all ten observations within the stipulated timeline.

On 12 October 2023, the FDA issued a Form 483 with nine observations regarding that same Dr Reddy’s biologics manufacturing facility, after a product-specific pre-approval inspection by the FDA between 4 and 12 October. 

October 27, 2023

Sanofi announced that it will separate its Consumer Healthcare Business as soon as the end of Q4 2024, creating a publicly listed company headquartered in France.  Sanofi intends to focus on its biopharma business.

October 27, 2023

The Department of Health and Aged Care has published the public summary documents considered at the July 2023 PBAC meeting.  Documents include:

  • Cipla’s public summary document for Ardalicip®, biosimilar to AbbVie’s Humira® (adalimumab), which was developed by Alvotech (AVT02);
  • Juno Pharmaceuticals’ public summary document for Exarane™ and Exarane Forte™ (Sanofi’s Lovenox®) (enoxaparin); and
  • Sun Pharma’s public summary document for Yonsa Mpred® (Janssen’s Zytiga®) (abiraterone and methylprednisolone).

October 27, 2023

Coherus BioSciences announced that the FDA has approved its Loqtorzi® (toripalimab) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal cancer (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

Coherus acquired toripalimab from Surface Oncology last month on 8 September 2023.

October 27, 2023

Roche announced that the FDA has approved Vabysmo® (faricimab) to treat a new indication: macular oedema following retinal vein occlusion.  The clinical trials demonstrated non inferiority against aflibercept (marketed by Bayer/Regeneron’s as Eylea®).  The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023, which is its third approved indication.

Vabysmo® was first FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022.  Vabysmo® was first  FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022.

October 27, 2023

Novartis announced that the National Institute for Health and Care Excellence (NICE) issued final draft guidance recommending Cosentyx® (secukinumab) to treat active moderate to severe hidradenitis suppurativa (HS) in adults in England and Wales.   It will be recommended for patients with an inadequate response to conventional systemic HS therapy and where adalimumab is not suitable.

On 6 October 2023 the FDA approved Novartis’ new intravenous formulation of Cosentyx® for the treatment of adults with psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.

October 26, 2023

It has been reported that the Munich Regional Court has issued a preliminary injunction against Formycon’s manufacture of FYB202, its Stelara® (ustekinumab) biosimilar, in Germany until expiry of Janssen’s SPC on its basic ustekinumab patent on 20 July 2024.  According to the reports, the decision reflected the arguments submitted by Janssen that in order to rely on the EU manufacturing waiver to export FYB202 before SPC expiry, Formycon was required to produce a relevant marketing authorisation in a country outside the EU in which the SPC was not in force, and had not done so.

FYB202 is not approved in the EU.  Formycon and its commercialisation partner Fresenius Kabi announced in September 2023 that their MAA for FYB202 has been accepted for review by the EMA.

October 26, 2023

Eli Lilly announced that the FDA has approved its Omvoh® (mirikizumab-mrkz) for the treatment of moderately to severely active ulcerative colitis (UC) in adults.

On 1 April 2023, Eli Lilly launched its insulin glargine (Rezvoglar®) biosimilar to Sanofi’s Lantus®, in the US.  

Omvoh® is currently being assessed by the TGA, and was accepted for assessment in July 2022.  It was also approved in the EU by the European Commission on 26 May 2023

October 25, 2023

Samsung Biologics has announced its Q3/2023 financial results, demonstrating its highest ever quarterly consolidated revenue of ₩1.034T, marking an 18% increase from Q3 2023.  Samsung attributed this revenue hike to an increase in the operating rate of Plant 4 and a sales backlog, resulting in a projected over 20% annual growth in consolidated revenue.

Throughout the quarter, Samsung Biologics also expanded its strategic partnerships to a value of over 11.8B and includes “14 of the top 20 global pharmaceutical companies further solidifying the company’s position as a trusted CDMO partner”.

Samsung will also open its new Plant 5 by April 2025, which will add an extra 180,000L of capacity.

On 24 October 2023, Samsung Biologics announced that it and European VC firm Kurma Partners entered a strategic partnership to develop and manufacture biologics for Kurma’s companies.

October 24, 2023

FDA has approved Samsung Bioepis’ sBLA for Byooviz®, as an interchangeable biosimilar to Genentech’s Lucentis® (ranibiziumab) across all approved indications.  Byooviz® was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019 covering the US, Canada, Europe, Japan and Australia.  Byooviz® was FDA approved on 20 September 2021 and launched in the US on 2 June 2022.  FDA has approved Samsung Bioepis’ sBLA for Byooviz®, as an interchangeable biosimilar to Genentech’s Lucentis® (ranibiziumab) across all approved indications.  Byooviz® was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019 covering the US, Canada, Europe, Japan and Australia.  Byooviz® was FDA approved on 20 September 2021 and launched in the US on 2 June 2022.

October 24, 2023

Samsung Biologics announced that it has entered a strategic agreement with European VC firm Kurma Partners to develop and manufacture biologics.  Samsung Biologics will provide chemistry, manufacturing, control and development services to Kurma’s companies under the multi-year deal.

On 18 September 2023, Samsung Biologics announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of a BMS antibody cancer drug.

October 23, 2023

Roche, Genentech, Chugai and Biogen have settled their dispute in the US District Court for the District of Massachusetts regarding Genentech’s Actemra® (tocilizumab) patents.  Roche, Genentech and Chugai instigated proceedings on 23 July 2023, alleging that Biogen’s product, manufactured in China by Bio-Thera, infringed 20 US patents including US patent No 7521052 (method of treating rheumatoid arthritis) and US patent No 8398980 (IL-6R antibody subtype).

Biogen received FDA approval for Tofidence®, its biosimilar to Roche’s Actemra®/ RoActemra® on 30 September 2023, the only approved biosimilar tocilizumab in the US.

October 23, 2023

Celltrion announced that the FDA has approved its subcutaneous formulation of Zymfentra® (infliximab -dyyb), biosimilar to Janssen’s Remicade®, as maintenance treatment for ulcerative colitis (UC) and Crohn’s disease (CD) following treatment with an IV infliximab.  This is the first FDA approved subcutaneous formulation of infliximab.  Zymfentra® is marketed as Remsima SC® in Europe.

On 2 October 2023, Celltrion announced that the FDA approved Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in 20mg (pre-filled syringe) and 80mg (pre-filled autoinjector and pre-filled syringe) dosage forms.

October 23, 2023

On 1 November 2023, changes introduced following the March 2023 PBAC meeting will take effect with a view to encouraging biosimilar uptake in Australia.  This will simplify the procedure for prescribers for obtaining authority to prescribe (ie an authority script) for certain biosimilar medicines which are reimbursed under Australia’s Pharmaceutical Benefits Scheme (PBS).   The affected medicines are:

The intention of these changes is to encourage greater use of biosimilars by easing the administrative burden for prescribers to obtain the necessary authority.  For initial therapy with a biosimilar, authority from Services Australia may be obtained by telephone or online with immediate effect, rather than in writing.  The requirement to obtain prior authority to prescribe the biosimilar for continuing therapy will be removed, with the requirement now ‘Authority Required (Streamlined)’.

For the rheumatoid arthritis medicines, in general brand substitution of a biosimilar with the reference brand will not be permitted where the approval was by telephone, online or by Streamlined prescription.  An exception applies for subsequent continuing therapy where substitution is permitted by the prescriber.

October 20, 2023

Regeneron and Sanofi announced that that FDA has issued a Complete Response Letter (CRL) regarding the sBLA for Dupixent® (dupilumab) for use in chronic spontaneous urticaria (CSU).  Regeneron and Sanofi said FDA’s CRL requires additional efficacy data to support an approval, but did not identify any issues with safety or manufacturing.  The companies confirmed that the ongoing clinical trial is enrolling patients, and results are expected in late 2024.  According to Regeneron and Sanofi, these trials should provide the additional efficacy data required by the FDA.

On 11 July 2023 Sanofi received MA for Dupixent® in India to treat moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are contraindicated.

October 20, 2023

The FDA has issued Samsung Biologics with a Form 483 containing six key observations following site inspections on 21-25, 28-31 August and 1 September 2023.  A Form 483 is issued to companies at the conclusion of an FDA inspection if conditions may constitute violations of the Food Drug and Cosmetic (FD&C) Act and related Acts.  A Form 483 does not constitute a final FDA determination of violation of the FD&C Act or any relevant regulations.  Fierce Pharma has reported that Samsung is taking the FDA’s concerns seriously and has “developed a comprehensive plan” to address the manufacturing shortfalls swiftly.

October 20, 2023

The US Patent Trial and Appeal Board (PTAB) has instituted Samsung Bioepis’ inter partes review (IPR) against Regeneron’s Eylea® (aflibercept) patent no. 10,888,601 in IPR proceeding IPR2023-00739.  The ‘601 patent relates to methods of use of aflibercept in treating age related macular degeneration, diabetic macular oedema, diabetic retinopathy and angiogenic eye disorders.

On 18 August 2023 Samsung Bioepis filed an IPR petition against Regeneron’s Eylea® patent no. 10,464,992 and sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

October 19, 2023

The Korea Herald reported that Samsung Bioepis has launched Epysqli®, its biosimilar to AstraZeneca/Alexion’s Soliris® (eculizumab) in three European countries.  Samsung Bioepis confirmed it is preparing to launch Epysqli® in France and the Netherlands by the end of 2023.

Samsung Bioepis’ Epysqli® was approved by the EMA on 30 May 2023.

October 19, 2023

Merck and Daiichi Sankyo announced a global development and commercialisation collaboration involving Daiichi’s three deruxtecan antibody-drug conjugate candidates: patritumab deruxtecan, ifinatamab deruxtecan and raludotatug deruxtecan. The companies will jointly develop and commercialise the candidates around the world, except for Japan, where Daiichi retains exclusive commercialisation rights. Daiichi is solely responsible for manufacture and supply.

Merck will pay Daiichi a US$4B upfront payment and US$1.5B in continuation payments over the next 24 months. Contingent on Daiichi meeting future milestones, Merck may make additional payments of up to US$16.5B, reaching a total potential consideration of up to US$22B.

On 18 October 2023, the EC approved AstraZeneca/Daiichi’s (trastuzumab deruxtecan) for a new indication as a monotherapy for the treatment of adult patients with advanced non-small cell lung cancer.

October 18, 2023

AstraZeneca and Daiichi Sankyo announced that the European Commission (EC) has approved Enhertu® (trastuzumab deruxtecan) to treat a new indication: monotherapy for the treatment of adult patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

The EMA’s CHMP recommended the indication extension for Enhertu® on 15 September 2023.

October 18, 2023

AstraZeneca announced that the Chinese National Medical Products Administration (NMPA) has approved Soliris® (eculizumab) to treat a new indication: neuromyelitis optica spectrum disorder (NMOSD).  Soliris® is the first and only complement inhibitor approved for the treatment of NMOSD in China.

On 24 August 2023 Soliris® was approved in Japan for a new indication to treat paediatric patients with generalised myasthenia gravis.

October 18, 2023

The FDA approved Amgen’s Enbrel® (etanercept) on 18 October 2023 for a new indication: active juvenile psoriatic arthritis (JPsA) in paediatric patients 2 years of age and older.

On 21 March 2023, one of the largest studies to date examining etanercept biosimilar/originator outcomes found that Biogen’s Benepali® and Novartis’ Erelzi® demonstrated comparable efficacy to Enbrel®.   Erelzi® was the first etanercept biosimilar approved by the FDA on 30 August 2016, with  Samsung Bioepis’ Eticovo® (marketed as Benepali® in Europe) receiving FDA approval on 25 April 2019.

October 17, 2023

On 17 October 2023, AbbVie announced that Health Canada has approved its Rinvoq® (upadacitinib) to for new indication: moderate to severely active Crohn’s disease.  This follows the recent Canadian approval (9 May 2023), of Rinvoq® for the treatment of Active Non-Radiographic Axial Spondyloarthritis.

The FDA approved Rinvoq® for moderate to severely active Crohn’s disease on 18 May 2023.

October 16, 2023

AstraZeneca announced that the FDA accepted for Priority Review its supplemental New Drug Application (sNDA) for Tagrisso® (osimertinib) in combination with chemotherapy has been accepted and granted Priority Review in the US for the treatment of adult patients with locally advanced or metastatic epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC). The FDA expects to decide on the sNDA by Q1 2024.

Last month on 5 September 2023, AZ announced that the Chinese National Medical Products Administration approved its Calquence® (acalabrutinib) to treat a new indication: chronic lymphocytic leukaemia or small lymphocytic lymphoma who have received at least one prior therapy.

October 16, 2023

Korea Biomed has reported that US pharmacy provider CarePartners Pharmacy will exclusively supply Celltrion’s biosimilar adalimumab (Yuflyma®) in the US.  It has removed AbbVie’s Humira® from its product line.  The partnership will be relevant to the supply of adalimumab to more than 10 million patients linked with CarePartners.

On 5 October 2023, Celltrion USA announced that Ventegra® listed Yuflyma® as a “preferred drug” from early October 2023.

October 16, 2023

Merck made two announcements regarding new indications approved for Keytruda® (pembrolizumab):

  • In the US the FDA granted approval for the treatment of patients with resectable non-small cell lung cancer (NSCLC) in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment after surgery. This brings the total number of NSCLC-related indications for Keytruda® in the US to six.
  • In Europe the European Commission (EC) granted approval for Keytruda® as a monotherapy for the adjuvant treatment of adults with SCLC) who are at high risk of recurrence following complete resection and platinum-based chemotherapy.

October 16, 2023

A Zhejiang Hisun Pharmaceuticals sponsored study published in Frontiers in Pharmacology has found that HS016, biosimilar to AbbVie’s Humira® (adalimumab) was safe and effective in Chinese inflammatory bowel disease (IBD) patients.

Hisun completed its stage III clinical trials of HS016 back in early 2020.

October 15, 2023

Samsung Bioepis presented new data on its SB16 (denosumab, biosimilar to Amgen’s Prolia®) at the American Society for Bone and Mineral Research (ASBMR) 2023 Annual Meeting being held from October 13 to 16 in Vancouver, BC, Canada.  The SB16 ph I and III studies demonstrate respectively pharmacokinetic bioequivalence and biosimilarity of SB17 to reference denosumab.

October 15, 2023

An AbbVie sponsored phase 3 study evaluating risankizumab for treatment of Crohn’s disease shows that risankizumab performs better than ustekinumab in primary and secondary endpoints. The study compared risankizumab to ustekinumab for the treatment of adult patients with moderately to severely active Crohn’s disease. The safety results were consistent with the overall safety profile of risankizumab, with no new safety risks identified. 

In November 2023, the Korean MFDS approved AbbVie’s Skyrizi® (risankizumab) to treat Chron’s disease. 

October 15, 2023

A new study abstract published in United European Gastroenterology concluded that patients who switched from Celltrion’s Remsima® (CT-P13) to Samsung Bioepis’ Flixabi®/Reflexis® (SB2), both biosimilars to Janssen’s Remicade® (infliximab) was safe, did not significantly affect effectiveness or pharmacokinetics, and was not associated with major negative psychological implications.

On 26 May 2023, a study published in JAMA Network Open found in a systematic review and meta-analysis that biosimilars of adalimumab, etanercept, and infliximab were associated with clinically equivalent effects in patients with rheumatoid arthritis compared with their reference biologics.

October 13, 2023

Merck announced that it received a positive recommendation from EMA’s CHMP for the approval of Keytruda® (pembrolizumab) in combination with fluoropyrimidine- and platinum-containing chemotherapy, for first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1.

This will be the second indication for Keytruda® for the first-line treatment of such cancers in EU, following approval of Keytruda® in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy in August 2023.

October 12, 2023

Dr Reddy’s informed the Indian National Stock exchange on 12 October 2023 that the FDA issued a Form 483 with nine observations for Dr Reddy’s biologics manufacturing facility in Hyderabad.  The observations were issued after a product-specific pre-approval inspection of the facility by the FDA between 4 and 12 October 2023.

October 12, 2023

Prince Edward Island announced implementation of a biosimilar switching policy consistent with ten other provinces in Canada.  From 12 October 2023, patients covered under PEI Pharmacare program will begin switching biosimilars. Pharmacare beneficiaries will have until 30 June 2024 to work with healthcare providers to switch to a biosimilar.  Patients currently using Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, NovoRapid®, Remicade® or Rituxan® will be transitioned to a biosimilar version by 30 June 2024 to maintain their coverage.

We reported on previous Canadian announcements of Biosimilar switching initiatives, including Newfoundland and LabradorYukon, Ontario, British ColumbiaAlbertaNew BrunswickQuebec, Northwest Territories, Nova Scotia and Saskatchewan.

October 12, 2023

Alvotech announced that FDA has issued a Complete Response Letter (CRL) regarding its aBLA for AVT04, biosimilar to Janssen’s Stelara® (ustekinumab).  The letter relates to certain deficiencies that were conveyed following the FDA’s inspection of Alvotech’s Reykjavik facility in March 2023.  No other deficiencies were noted by the FDA.  Alvotech intends to resubmit the BLA for AVT04 to the FDA shortly.  This will likely trigger a new BsUFA date for Alvotech’s ustekinumab.

In June 2023 Alvotech and Teva (the exclusive commercialization partner for AVT04 in the US), reached a settlement and license agreement with Johnson & Johnson that grants an entry date for AVT04 in the US no later than 21 February 2025.

On 25 September 2023 Alvotech received approval in Japan for AVT04.

October 12, 2023

Amneal Pharmaceuticals, Inc announced that it has added two denosumab products (biosimilars to Amgen’s Prolia® and Xgeva®) to its biosimilar pipeline.  The denosumab products are being developed by mAbxience.  MAbxience is responsibility for development and manufacture and Amneal is responsible for regulatory approval and has exclusive US commercialisation rights.

On 3 October 2022 Amneal Pharmaceuticals announced the US launch of another biosimilar developed by mAbxience: Alymsys® (biosimilar bevacizumab).

October 11, 2023

Samsung Bioepis presented new data on its SB17 (ustekinumab, biosimilar to Janssen’s Stelara®) and Imraldi® (adalimumab, biosimilar to AbbVie’s Humira®) at the European Academy of Dermatology and Venereology (EADV) Congress.  The SB17 phIII study demonstrates that SB17 has equivalent efficacy and comparable safety and PK to Stelara® up to week 28 in patients with moderate to severe plaque psoriasis.  The Imraldi® four-year follow up study indicates that Imraldi can be started or transitioned from AbbVie’s Humira® (adalimumab) in patients with moderate-to-severe psoriasis.

On 11 September 2023, Sandoz and Samsung Bioepis entered an exclusive commercialisation agreement for SB17 in the US, Canada, EEA, Switzerland and the UK.

October 10, 2023

Samsung Bioepis released its third US Biosimilar Market Report.  The quarterly report details recent prices of all biosimilars based on Q4 2023 average sales price (ASPs) published by the Center of Medicare, Medicaid Services (CMS), and market share and price trends of all biosimilars.

The report explores three key influences on biosimilar utilisation:

  1. Independent Medical Guidelines (noting that the influence of respected medical societies on biosimilar use ‘cannot be overstated’)
  2. Duration of Treatment: Acute vs. Chronic Conditions (HCPs are often reluctant to initiate changes in chronic patients who respond well to the medicine)
  3. Access and Rebate Walls (the impact of ‘grandfathering’ allows many patients to continue existing treatment even where biosimilars are available)

On 18 April 2023, Samsung Bioepis released its first US Biosimilar Market Report, predicting that   biosimilars will save US$181B in five years in the US.  Its second report was published on 11 July 2023.

October 7, 2023

Samsung Bioepis announced its Phase III switching study results for SB15, biosimilar to Regeneron’s Eylea® (aflibercept), at EURETINA 2023.  The results comparable clinical efficacy when switching to SB15 from Eylea® for patients with neovascular age-related macular degeneration (nAMD), confirming interchangeability and biosimilarity.

On 8 June 2023, JAMA Ophthalmology published the Ph III trial results for SB15, and demonstrating equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to Eylea® in participants with nAMD.  In April 2023, Samsung Bioepis announced 1-year outcomes of its Ph III study at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

October 7, 2023

Biocon Biologics announced that the FDA issued a Complete Response Letter (CRL) for its BLA for its insulin aspart (biosimilar to Novo Nordisk’s NovoLog®).  The letter did not identify any outstanding scientific issues with the product, but references the requirement for a satisfactory resolution of deficiencies from the pre-approval inspection of the Biocon Malaysia facility.

On 20 September 2023, Biocon Biologics’ Yesafili®,biosimilar to Regeneron’s Eylea® (aflibercept), received marketing approval from the European Commission.

October 6, 2023

Novartis announced that the FDA has approved its new intravenous (IV) formulation of Cosentyx® (secukinumab) for the treatment of adults with psoriatic arthritis (PsA), ankylosing spondylitis (AS) and non-radiographic axial spondyloarthritis (nr-axSpA).

On 1 June 2023, Novartis announced that the European Commission approved Cosentyx® for a new indication to treat active moderate to severe hidradenitis suppurativa in adult patients who have had an inadequate response to conventional systemic HS therapy.

October 5, 2023

Pfizer announced that the FDA has designated Abrilada® as the second interchangeable biosimilar to AbbVie’s Humira® (adalimumab), Following BI’s Cyltezo®.  The designation applies to all approved Abrilada® indications.  Boehringer Ingelheim’s Cyltezo® (adalimumab-adbm) was the first approved  interchangeable adalimumab biosimilar on 15 October 2021.

The FDA accepted Pfizer’s sBLA for interchangeability for its adalimimab biosimilar Abrilada® on 25 February 2022, with a BsUFA goal date in Q4 2022.

October 5, 2023

Celltrion USA announced that large Medical Benefits Manager Ventegra, will add Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab) to its formulary as a “preferred drug” by ‘the first part of October 2023’.

On 2 October 2023, Celltrion announced that it received FDA approval for two additional dosages of Yuflyma®.

October 5, 2023

Coherus BioSciences announced it has resubmitted the Biologics License Application (BLA) Supplement for UDENYCA® ONBODY™, biosimilar to Amgen’s Neulasta® (pegfilgrastim) to the FDA, following a satisfactory resolution of inspection findings at a third-party filler.  The resubmission comes after addressing the sole issue identified in the FDA’s Complete Response Letter it received on 21 September 2023.

On 4 October 2023, Coherus announced its sales of Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis® surpassed 100,000 doses in its first year.

October 5, 2023

Thermo Fisher Scientific announced that it has expanded its St Louis biologics manufacturing facility, adding up to four Thermo Scientific™ bioreactors, each of which can process up to 5,000 liters.

October 4, 2023

Coherus BioSciences announced it has reached a significant milestone as sales of Cimerli® (ranibizumab-eqrn), a biosimilar to Genentech’s Lucentis®, exceed 100,000 doses in the first year.  Cimerli® is the first and only FDA-approved interchangeable biosimilar to Lucentis® for all approved indications.

On 5 October 2023, Coherus resubmitted its BLA to the FDA for Udenyca® OnBody™, biosimilar to Amgen’s Neulasta® after receiving CRL.

October 4, 2023

Novartis announced it successfully completed the spin-off of Sandoz, its former generics and biosimilars business on 4 October 2023.  Sandoz also made its own announcement about the spin-off, noting it completed its first trading day on the Swiss Exchange on 4 October with an opening share price of CHF 24.00.

The proposed spin-off was first announced by Novartis on 25 August 2022, a proposal which was unanimously endorsed by the Novartis board on 18 July 2023 and secured shareholder approval for the spin-off at the Novartis EGM on September 15 2023.

October 3, 2023

A PLOS One study found that there was no difference in the safety profiles or immunogenicity rates in patients who were switched and those who remained on a reference biologic or a biosimilar. The study examined unique studies and switch treatment periods for each reference biologic with an FDA approved biosimilar, including AbbVie’s Humira® (adalimumab), Amgen’s Epogen® (epoetin-alfa), Amgen’s Enbrel® (etanercept), Amgen’s Neupogen® (filgrastim), Sanofi’s Lantus® (insulin-glargine), Genentech/Biogen’s Rituxan® (rituximab) and Genentech’s Herceptin® (trastuzumab).

On 26 May 2023, a study published in JAMA Network Open found in a systematic review and meta-analysis that biosimilars of adalimumab, etanercept, and infliximab were associated with clinically equivalent effects in patients with rheumatoid arthritis compared with their reference biologics.

October 3, 2023

An FDA meta-analysis found that there are no differences in safety profiles or immunogenicity rates in patients who switched to biosimilars compared to those who remained on an originator biologic or biosimilar.  Biologics assessed in the study include adalimumab, epoetin alfa-epbx, etanercept, filgrastim, infliximab, insulin glargine, rituximab, and trastuzumab.  

On 18 September 2023, the FDA released its draft industry guidance for biosimilar and interchangeable biosimilar product labelling.   

October 3, 2023

Alvotech announced it has partnered with Kashiv Biosciences for an exclusive licensing agreement concerning AVT23 (ADL018), a proposed biosimilar to Novartis/Genentech’s Xolair®, extending across 27 EU countries, the UK, Australia, Canada, and New Zealand.  Alvotech will receive exclusive commercialization rights, and Kashiv will oversee development and manufacturing.

On 2 October 2023, Kashiv announced it had enrolled its first patient in a phase III study for ADL018.

October 2, 2023

The Nobel Assembly at Karolinska Institutet awarded the 2023 Nobel Prize in Physiology or Medicine jointly to Katalin Karikó and Drew Weissman for their discoveries concerning nucleoside base modifications that enabled the development of effective mRNA vaccines against COVID-19.   Karikó and Weissman noticed that dendritic cells recognise in vitro transcribed mRNA as a foreign substance, which leads to their activation and the release of inflammatory signaling molecules.  They produced different variants of mRNA, each with unique chemical alterations in their bases, which abolished the inflammatory response by the cells and paving the way for the use of mRNA as a therapy.  

Recently on 11 September 2023, the FDA approved Pfizer & BioNTech’s 2023-2024 COVID-19 vaccine. 

October 2, 2023

Kashiv Biosciences announced that it has enrolled its first patient in a phase III clinical study of ADL018, its biosimilar to Novartis/Genentech’s Xolair® (omalizumab).  The objective of the study is to compare ADL018 and Xolair® in terms of efficacy, safety, tolerability, and immunogenicity in patients with chronic idiopathic/spontaneous urticaria who remain symptomatic on H1 antihistamine treatment (NCT05774639).

On 30 June 2023, Kashiv completed a Phase I clinical trial for ADL-018.

October 2, 2023

FDA has approved Celltrion’s Yuflyma® in 20mg (pre-filled syringe) and 80mg (pre-filled autoinjector and pre-filled syringe) dosages, in addition to the 40mg dose approved on 24 May 2023.

The Celltrion 80mg adalimumab auto-injector and pre-filled syringe were approved by Healthcare Canada on 30 August 2023.

October 2, 2023

Boehringer Ingelheim announced that its unbranded interchangeable biosimilar to AbbVie’s Humira®, is now available at a low wholesale acquisition cost, at a 81% discount to Humira®.  It is also available under the brand name Cyltezo® priced at a 5% discount to Humira®.

Cyltezo® was licensed for supply in the US on 1 July 2023 pursuant to the Boehringer and AbbVie settlement of the ongoing patent dispute on 15 May 2019.

October 1, 2023

Viatris announced it has received an offer for divestiture of most of its Over-the-Counter (OTC) business from Cooper Consumer Health, and has entered into agreements to divest its Women’s Healthcare business (oral and injectable contraceptives) to Insud Pharma, women’s healthcare products Duphaston® and Femoston® to Theramex, and its Active Pharmaceutical Ingredients business to Iquest Enterprises.  It has also agreed to divest commercialisation rights in particular non-core markets that were previously acquired.

On 6 September 2023, Biocon Biologics completed its integration of Viatris in North America.  The multi-billion dollar deal was finalised on 29 November 2022, whereby Biocon Biologics has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.

September 29, 2023

Biogen announced that the FDA has approved Tofidence®, its biosimilar to Roche’s Actemra®/ RoActemra® (tocilizumab) for treatment of moderately to severely active rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and systemic juvenile idiopathic arthritis.  Tofidence® is the first FDA approved tocilizumab biosimilar.

On 19 September 2023, the European Commission approved Fresenius Kabi’s Tyenne®, also a biosimilar to Roche’s Actemra® / RoActemra®, which is the first EU approved biosimilar to tocilizumab.

September 29, 2023

Outlook Therapeutics announced that it requested a Type A meeting with the FDA to discuss its Complete Response Letter (CRL) regarding its BLA for ONS-5010, the first ophthalmic formulation of bevacizumab, marketed by Genentech as Avastin®.  In the CRL dated 30 August 2023, the FDA acknowledged the NORSE TWO pivotal trial met their safety and efficacy endpoints, but suggested the BLA could not be approved due to several chemistry, manufacturing and control issues, as well as open observations from pre-approval manufacturing inspections and a lack of substantial evidence.

September 29, 2023

Formycon and its commercialisation partner Fresenius Kabi announced that the EMA has accepted for review their MAA for FYB202, biosimilar to Johnson & Johnson’s Stelara® (ustekinumab).

In February 2023, Fresenius Kabi and Formycon AG announced they had reached a global agreement to commercialise FYB202. Under the agreement, Fresenius has exclusive commercialisation rights in key global markets, whilst Formycon is responsible for development and registration.  Formycon acquired the rights to FYB202 from Athos in May 2022.

September 29, 2023

ProciseDx announced that its Procise ADL and Procise IFX therapeutic drug monitoring tests for adalimumab (AbbVie’s Humira® and Amgen’s biosimilar Amgevita®) and infliximab (Janssen’s Remicade® and biosimilars Inflectra® (Pfizer) and Renflexis® (Organon)) have received FDA marketing authorization. The tests quantify levels of adalimumab or infliximab in patients with inflammatory bowel disease (IBD) based on time-resolved fluorescence resonance energy transfer immunoassays using the ProciseDx Analyzer and Lumiphore chemistry.

September 26, 2023

Coherus Biosciences announced that the FDA issued a Complete Response Letter (CRL) for its BLA for Udenyca® OnBody™, Coherus’ on-body injector presentation of Udenyca®, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The letter relates to an ongoing review of inspection findings at a third-party filler.  The FDA did not identify issues with clinical efficacy or safety, trial design, labeling, drug substance manufacturing, or device design or manufacturing.

Separately, on 8 September 2023, Coherus announced that it completed its acquisition of Surface Oncology, Inc., a clinical-stage immuno-oncology company.

September 26, 2023

Sandoz and Polpharma Biologics announced that the EC has approved Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®, as a single disease-modifying therapy (DMT) in adults with highly active Relapsing Remitting Multiple Sclerosis. This is the first EC approved biosimilar to Tysabri®.  Tyruko® was developed by Polpharma Biologics, and will be commercialised by Sandoz.

Tyruko® was approved by the FDA on 25 August 2023. The EU CHMP issued a positive opinionrecommending approval of Tyruko® on 21 July 2023. 

September 25, 2023

Novartis confirmed its Sandoz generics and biosimilars business will spin-off, with trading of the new Sandoz Group AG to commence on 4 October 2023.

This follows the Novartis shareholder approval for the spin-off at its EGM on September 15 2023.   The proposed spin-off was first announced by Novartis on 25 August 2022, a proposal which was unanimously endorsed by the Novartis board on 18 July 2023 with a target date of Q4/23.

September 25, 2023

KED Global reported that Celltrion Inc. will provide biosimilars worth ₩423.6B (US$323M) to its global sales and marketing affiliate Celltrion Healthcare Co., Celltrion’s largest supply deal.  The supplies include Yuflyma® (adalimumab, biosimilar to AbbVie’s Humira®), Remsima® and Remsima SC® (infliximab “biobetter” to Janssen’s Remicade®), Truxima® (rituximab, biosimilar to Genentech/Biogen’s Rituxan®) Herzuma® (trastuzumab, biosimilar to Genentech’s Herceptin®), and Vegzelma® (bevacizumab, biosimilar to Genentech’s Avastin®).

On 18 September 2023, Celltrion won bids to supply Yuflyma® in five regions of Italy, and On 11 May 2023, Celltrion won bids to supply Vegzelma® (bevacizumab) in Italy and Belgium.

September 25, 2023

Eisai and Biogen announced that Leqembi® (lecanemab) intravenous infusion was approved in Japan for slowing progression of mild cognitive impairment and mild dementia due to Alzheimer’s disease (AD). On 21 August 2023, the Japanese Ministry of Health, Labour and Welfare committee recommended approval of Leqembi®.

Japan is the second country to grant approval of Leqembi®, following the traditional US FDA approval on 6 July 2023.

September 25, 2023

AbbVie announced that the EC granted conditional marketing authorisation for Tepkinly® (epcoritamab) as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy.

Tepkinly® was co-developed by AbbVie and Genmab, and the companies share commercial responsibilities in the US and Japan.  AbbVie is responsible for further global commercialization and will continue to pursue regulatory submissions for the drug in international markets throughout 2023.

September 25, 2023

Alvotech announced that Fuji Pharma, its commercialisation partner in Japan, has received marketing approval for AVT04 (ustekinumab), a biosimilar to Janssen’s Stelara®, from the Japanese Ministry of Health, Labor and Welfare.  Alvotech reported that, based on publicly available information this is the first ustekinumab biosimilar approved in Japan, and is also the first biosimilar approved under its agreement with Fuji which covers the commercialisation of seven biosimilars in total in Japan.

Alvotech and Fuji Pharma announced their exclusive agreement for the commercialisation of a Stelara® biosimilar in Japan in April 2019.

September 22, 2023

Prestige Biologics, a contract development and manufacturing organization (CDMO), announced it has signed a non-binding MOU with Aurigene Pharmaceutical Services, a wholly-owned subsidiary of Dr Reddy’s Laboratories.  The Korea Economic Daily reported that Prestige Biologics will act as the primary manufacturing, packaging, and distribution hub in South Korea for Dr. Reddy’s extensive biopharmaceutical pipeline. Prestige plans to commence technology transfer next month in order to commence production immediately following execution of product-specific supply agreements.

On 12 July 2023, Dr Reddy’s announced that its proposed biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab) will be reviewed by several global regulatory authorities, including the US FDA, EU EMA and UK MHRA.

September 21, 2023

Meitheal Pharmaceuticals announced an exclusive licensing agreement with Tonghua Dongbao Pharmaceutical to commercialise three insulin biosimilars (insulin aspart, insulin lispro and insulin glargine) in the US. Under the agreement, Meitheal’s parent company Nanjing King-Friend Biochemical Pharmaceutical has the exclusive rights to commercialise the three biosimilars.  Meitheal anticipates regulatory approval of each of the biosimilars in around 2026.

On 1 April 2023, Eli Lilly launched its insulin glargine Rezvoglar®, biosimilar to Sanofi’s Lantus® in the US.

September 20, 2023

Abbott announced it has entered into a commercialisation agreement with mAbxience for several biosimilars focusing on oncology, women’s health and respiratory diseases in emerging markets in Latin America, Southeast Asia, the Middle East and Africa.  The first molecules will launch in 2025, while others are subject to further clinical development and registration. mAbxience will manufacture the biosimilars in Spain and Argentina, and will be responsible for achieving the clinical milestones for the molecules in development. Abbott will register and commercialise the biosimilars.

On 13 March 2023, a study found that mAbxience’s MB02 (bevacizumab) was bioequivalent to Genentech’s Avastin®.  In March 2022 Fresenius Kabi obtained a majority (55%) stake in mAbxience.

September 20, 2023

Biocon Biologics announced that Yesafili®, its biosimilar to Regeneron’s Eylea® (aflibercept), has received marketing approval from the European Commission (EC).  It was approved to treat various ophthalmic conditions such neovascular (wet AMD) age-related macular degeneration, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO), visual impairment due to diabetic macular oedema (DME) and visual impairment due to myopic choroidal neovascularisation (myopic CNV).

This approval follows the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP)  positive opinion for Yesafili® on 21 July 2023.

September 20, 2023

On 20 September, Alvotech announced that the FDA has accepted its resubmitted Biologics License Application (BLA) for AVT02, a high-concentration, interchangeable biosimilar to AbbVie’s Humira® (adalimumab).  The BsUFA goal date for the resubmitted BLA is 24 February 2024.  Alvotech stated that the FDA indicated that the resubmission, which incorporated  additional Chemistry, Manufacturing, and Controls information, is considered to be a completed response to the FDA’s Complete Response Letter (CRL) of 28 June 2023.  Alvotech announced on 13 April 2023 that it had responded to an earlier CRL received in March 2023.

On 31 August 2023, Alvotech announced that it had resubmitted the BLA for AVT02 to the FDA but did not disclose details or the BsUFA goal date.

September 20, 2023

Merck announced the US FDA accepted for priority review its supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA ®, Merck’s anti-PD-1 therapy, in a third cervical cancer indication.  The proposed indication is for KEYTRUDA ® in combination with external beam radiotherapy (EBRT) plus concurrent chemotherapy, followed by brachytherapy (also known as concurrent chemoradiotherapy) as treatment for newly diagnosed patients with high-risk locally advanced cervical cancer.  The FDA has set a PDUFA date of 20 January 2024.

September 19, 2023

BeiGene announced it has regained worldwide rights to develop, manufacture, and commercialise Tevimbra® (tislelizumab) from Novartis, following a mutual agreement between the parties to terminate their previous collaboration and licence agreement entered into in January 2021.  BeiGene now has complete global rights to Tevimbra® without having to pay royalties to Novartis and will supply Novartis with Tevimbra® for its clinical trials.  Beigene stated that Novartis will assist BeiGene to ensure the smooth development and commercialisation of Tevimbra®, including manufacture, regulatory, safety, and clinical facets.

On 21 July 2023, BeiGene received a positive CHMP opinion for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma after prior platinum-based chemotherapy.

September 19, 2023

Fresenius Kabi announced that its Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra® has been approved by the European Commission (EC) for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19.  Tyenne® is the first biosimilar to Actemra® / RoActemra® approved by the EC.

The CHMP issued a positive opinion recommending approval of Tyenne® on 21 July 2023.

September 19, 2023

Korea Biomed reported that Rani Therapeutics has begun its phase I clinical trial for oral ustekinumab (RT-111) using Celltrion’s CT-P43 (ustekinumab), biosimilar to Janssen’s Stelara®.  Rani will evaluate pharmacokinetics and safety of RT-111 in up to 55 participants.

On 5 June 2023, Rani Therapeutics announced that it has expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar RT-105, following their previous collaboration on an ustekinumab biosimilar.

September 18, 2023

Samsung Biologics announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of a BMS antibody cancer drug.  The agreement expands the existing 10-year manufacturing deal signed in 2013, as Samsung Biologics will manufacture the commercial antibody at its latest and largest biomanufacturing facility, Plant 4, in Songdo, South Korea.

Recently, in July 2023, Samsung Biologics entered into agreement with Pfizer  worth US$897M to manufacture biosimilar products for oncology, inflammation and immunotherapy until 2029 in Plant 4.  Samsung also confirmed on 6 June 2023 that it will open its fifth manufacturing plant in April 2025.

September 18, 2023

The FDA has released draft industry guidance for biosimilar and interchangeable biosimilar product labeling.  The guidance includes proposed recommended approaches for:

  • product identification, including when to use the biosimilar or interchangeable biosimilar product name, reference product name;
  • content presentation; and
  • specific sections of labeling, including prescribing information, indications, usage (including specific populations and paediatrics) and clinical pharmacology.

The draft document is open for comments by 17 November 2023.

September 18, 2023

KED Global reported that Celltrion won bids to supply Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in five regions of Italy – accounting for approximately 20% of the Italian adalimumab market.  Yuflyma® recorded ₩54B (USD$40.7M) of sales in the first half of 2023, which Celltrion says is due to its expansion into Europe.

On 11 May 2023, Celltrion won bids to supply Vegzelma® (bevacizumab) in Italy and Belgium.

September 15, 2023

On 15 September 2023, Novartis shareholders approved the proposed Sandoz spin-off, Novartis’ generics and biosimilars business at its Extraordinary General Meeting.   The proposed spin-off was first announced by Novartis on 25 August 2022, a proposal which was unanimously endorsed by the Novartis board on 18 July 2023 with a target date of Q4/23.

September 15, 2023

The EMA’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®), to treat metastatic and early breast cancer and metastatic gastric cancer.

On the same day, Novartis’s shareholders approved the Sandoz spin-off which is scheduled for 4 October 2023.

September 15, 2023

On 15 September 2023, EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Sandoz’s Herwenda® (trastuzumab, biosimilar to Genentech’s Herceptin®) for approval for the treatment of metastatic and early breast cancer and metastatic gastric cancer.

CHMP also recommended an extension of indication for AstraZeneca/Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) as monotherapy for the treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumours have an activating HER2 (ERBB2) mutation and who require systemic therapy following platinum-based chemotherapy with or without immunotherapy.

CHMP also adopted a positive opinion for three new biologics:

  • Eli Lily’s Ebglyss® (lebrikizumab) to treat moderate and severe forms of atopic dermatitis in adults and adolescents;
  • Novartis’ Finlee® (dabrafenib) to treat glioma; andlanadelumab
  • Daiichi Sankyo’s Vanflyta® (quizartinib) to treat patients with diagnosed acute myeloid leukaemia (ACL).

The CHMP recommended indication extensions for the following biologics:

  • Seagen’s Adcetris® (brentuximab vedotin) to treat patients with previously untreated CD30+ Stage III or IV Hodgkin lymphoma;
  • Vertex’s Kaftrio® (ivacaftor/tezacaftor/elexacaftor) two new presentations of (60mg/40mg/80mg and 75mg/50mg/100mg granules in sachet) for use in children aged 2 to 5 years of age;
  • Vertex’s Kalydeco® (ivacaftor) to include treatment of cystic fibrosis in children aged between 2 and 6 years in a combination regimen with ivacaftor/tezacaftor/elexacaftor;
  • Merck’s Keytruda® (pembrolizumab) as monotherapy is indicated for the adjuvant treatment of adults with non-small cell lung carcinoma who are at high risk of recurrence following complete resection and platinum‑based chemotherapy;
  • Eli Lilly’s Olumiant® (baricitinib) to treat moderate to severe atopic dermatitis in paediatric patients 2 years and older who are candidates for systemic therapy; and
  • Takeda’s Takhzyro® (lanadelumab) to prevent recurrent attacks of hereditary angioedema in patients aged 2 years and older.

September 14, 2023

According to the Pharmaceutical Benefits Assessment Committee (PBAC) November 2023 agenda published last week, the meeting will be jammed with biopharma applications for reimbursement.  PBAC will consider the following applications for PBS listing additions or amendments at its November 2023 meeting:

New listing applications: Amendment Applications
1. Organon’s Hadlima® (adalimumab) biosimilar to AbbVie’s Humira® 1. Sanofi-Aventis’ Libtayo® (cemiplimab)
2. GSK’s Jemperli® (dostarlimab) 2. BMS’s Opdivo® (nivolumab)
3. Vertex’s Kalydeco® (ivacaftor) 3. Merck’s Keytruda® (pembrolizumab)
4. GSK’s Menveo® (meningococcal vaccine) 4. AbbVie’s Skyrizi® (risankizumab)
5. Pfizer’s Prevenar 20® (pneumococcal conjugate vaccine) 5. Novartis’ Cosentyx® (secukinumab)
6. Generic Health’s Teriparatide Lupin® (teriparatide) biosimilar to Eli Lily’s Forteo®
7. Gedeon Richter’s Terrosa® (teriparatide) biosimilar to Eli Lily’s Forteo®
8. Beigene’s Tevimbra® (tiselizumab)
9. AstraZeneca’s Enhertu® (trastuzumab deruxtecan) biosimilar to Genentech’s Herceptin®

 
In addition, a number of PBAC recommendations not accepted by applicants are set for review, including relating to Alphapharm’s Hulio® (adalimumab, biosimilar to AbbVie’s Humira®), Pfizer’s Zirabev® (bevacizumab, biosimilar to Genentech’s Avastin®) and Alphapharm’s Rymti® (etanercept) biosimilar to Amgen’s Enbrel®.

On 1 March 2023, the November 2022 PBAC outcomes were announced, with three biologics listed, including Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms, Merck’s pembrolizumab (Keytruda®) and AbbVie’s risankizumab (Skyrizi®).

September 13, 2023

Takeda announced that the FDA accepted its Biologics License Application (BLA) for its subcutaneous formulation of vedolizumab (Entyvio®) for maintenance therapy in patients with moderate to severe active Crohn’s disease after induction therapy with IV Entyvio®.  Currently Takeda’s Entyvio® is formulated and approved in the US for IV use only.

On 30 March 2023, Takeda published a study demonstrating that Entyvio® was more effective than a placebo inducing remission of chronic pouchitis after undergoing ileal pouch–anal anastomosis (IPAA) for ulcerative colitis.  Shortly prior on 27 March 2023 Takeda secured approval in Japan for Entyvio® SC as maintenance therapy for moderate to severe ulcerative colitis in patients with inadequate response to conventional treatment.

September 11, 2023

Sandoz and Samsung Bioepis announced they have entered an exclusive agreement to develop and commercialise SB17 (ustekinumab, biosimilar to Janssen’s Stelara®) in the US, Canada, EEA, Switzerland and the UK.  Others details of the deal are confidential.

This follows a confidential settlement in August 2023 between Samsung Bioepis and Janssen which resolved all pending disputes between the parties.  In that same month, Samsung Bioepis and Janssen filed a joint motion to terminate Samsung Bioepis’ IPR against Janssen’s US patent 10,961,307 filed 2 months earlier.

September 11, 2023

Pfizer and BioNTech announced that the FDA approved their sBLA for their 2023-2024 COVID-19 vaccine for patients over 12 years of age, and granted emergency use authorisation for patients from 6 months to 11 years old.  The vaccine is an omicron XBB.1.5-adapted monovalent vaccine indicated as a single dose for most patients over 5.

On 26 May 2023, Alnylam sued both Moderna and Pfizer for a third time claiming patent infringement regarding COVID-19 vaccines.

September 8, 2023

Coherus Biosciences announced that it completed its acquisition of Surface Oncology, Inc., a clinical-stage immuno-oncology company.  Coherus’ pipeline now has a number of new clinical-stage assets, including:

  • Toripalimab: an anti-PD-1 monoclonal antibody under BLA review for treatment of advanced recurrent or metastatic nasopharyngeal carcinoma (NPC);
  • CHS-006: a TIGIT-targeted antibody currently in a phase I / II study in combination with toripalimab in patients with advanced solid tumours;
  • Casdozokitug (SRF388 or casdozo): a first-in-class IL-27-targeted antibody in phase II clinical trials in lung cancer and liver cancer; and
  • CHS-114 (SRF114): an ADCC-enhanced CCR8-targeted antibody in a phase I / II study as a monotherapy in patients with advanced solid tumors.

On 2 August 2023, Coherus announced its Q2 2023 financial results, reporting that sales of its Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis®, had quadrupled to US$26.7M since the last quarter.

September 7, 2023

The Financial Express reported that Enzene Biosciences, subsidiary of Alkem Labs, plans to imminently launch its ranibizumab biosimilar in India. This will be Enzene’s seventh Indian biosimilar.  Enzene’s CEO confirmed that the company plans to launch two biosimilars every year.

Enzene is on market in India for bevacizumab (biosimilar to Genentech’s Avastin®) launched 29 June 2023, adalimumab (biosimilar to AbbVie’s Humira®) launched 28 February 2023, denosumab (biosimilar to Amgen’s Xgeva®), approved 27 August 2021, romiplostim (biosimilar to Amgen’s Nplate®), approved 10 August 2021, and teriparatide (biosimilar to Eli Lily’s Forteo®), approved 4 February 2021.

September 6, 2023

Biocon Biologics announced that it has completed the integration of Viatris in North America ahead of schedule, effective 1 September 2023.  The target date for the integration of Viatris was end Q3 2023.

On 5 July 2023, Biocon Biologics announced it had completed a third of the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’. The multi-billion dollar deal was finalised on 29 November 2022, whereby Biocon Biologics has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.

September 5, 2023

The Therapeutic Goods Administration (TGA) approved Celltrion’s Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab) for a range of indications, including metastatic colorectal cancer, locally recurrent or metastatic breast cancer, advanced, metastatic or recurrent non-squamous non-small cell lung cancer, advanced and/or metastatic renal cell cancer, grade IV glioma, epithelial ovarian, fallopian tube or primary peritoneal cancer, and cervical cancer.

Although Celltrion is yet to announce its latest approval, it has been reported by Korean news media including the JoongAng Daily and KoreaBioMed.

Celltrion now has six biopharma products approved in Australia: Vegzelma® (bevacizumab, biosimilar to Genentech’s Avastin®) approved 5 September 2023; Yuflyma® (adalimumab, biosimilar to AbbVie’s Humira®) approved on 25 March 2022; Remsima® SC (infliximab “biobetter” to Janssen’s Remicade®) approved on 12 November 2020; Herzuma® (trastuzumab, biosimilar to Genentech’s Herceptin®) approved on 17 July 2018; and Truxima® (rituximab, biosimilar to Genentech/Biogen’s Rituxan®) approved on 14 April 2018.  The TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) to treat COVID-19 on 6 December 2021.

September 5, 2023

The Korea Economic Daily reported that Celltrion, Inc. announced plans to enlarge its finished pharmaceuticals manufacturing facility at its Songdo campus in Incheon, and has allocated about ₩126B (US$95M) for the project.  The expansion is scheduled to be completed by early 2026 and production to begin in 2027, with an annual production capacity of around 8 million liquid vials.

September 5, 2023

AstraZeneca announced that the Chinese National Medical Products Administration (NMPA) has approved its Calquence® (acalabrutinib) to treat a new indication: chronic lymphocytic leukaemia (CLL) or small lymphocytic lymphoma (SLL) who have received at least one prior therapy.

On 24 August 2023 AstraZeneca had Soliris® (eculizumab) approved in Japan for a new indication to treat paediatric patients with gMG.

September 1, 2023

Business Korea reported that Celltrion filed an application with Australia’s Therapeutic Goods Administration (TGA) for approval of CT-P43, its biosimilar to Janssen’s Stelara® (ustekinumab).   Celltrion applied for approval of all Stelara® indications, including plaque psoriasis, psoriatic arthritis, Crohn’s disease, and ulcerative colitis.

Celltrion submitted its aBLA for CT-P43 to the US FDA in June 2023 (and reached a settlement and licence agreement with Johnson & Johnson (J&J) permitting Celltrion to launch CT-P43 in the US on 7 March 2025), and submitted its MAA to EMA in May 2023.

September 1, 2023

Novartis has commenced proceedings in the Federal Court of New Jersey against the US Government two days after the Centers for Medicare and Medicaid Services (CMS) unveiled the first 10 drugs that will undergo new pricing negotiations with the US Government.  These pricing negotiations were introduced as part of President Biden’s Inflation Reduction Act 2022 (IRA).  Novartis’ Entresto® (sacubitril/valsartan) is subject to this first round of negotiations.  Novartis argues that the negotiations are ‘an unprecedented and unconstitutional attempt to compel the nation’s drug manufacturers to sell their products at prices dramatically below their market value’.

August 31, 2023

Alvotech announced in its 2023 Q2 Earnings Presentation that it has resubmitted its interchangeable BLA for AVT02, biosimilar to AbbVie’s high concentration Humira® (adalimumab). The company did not disclose the BsUFA date but anticipated launch in 2024.

The FDA issued a complete response letter (CRL) for Alvotech’s interchangeable BLA on 28 June 2023, noting issues at Alvotech’s facility in Reykjavik, Iceland.

Alvotech also reported that AVT04, its biosimilar to Stelara®, is filed and pending approval in 7 markets including U.S, EU, Japan, and Canada, and it is expecting some approvals to occur before end of 2023.

Alvotech published its financial results on 30 August 2023.

August 30, 2023

Outlook Therapeutics announced the FDA issued it with a Complete Response Letter (CRL) for its BLA for ONS-5010, biosimilar to Genentech’s Avastin® (bevacizumab). The FDA acknowledged the NORSE TWO pivotal trial met its safety and efficacy endpoints, but could not approve the BLA due to several chemistry, manufacturing and controls issues, as well as open observations from pre-approval manufacturing inspections and a lack of substantial evidence.

On 28 October 2022, the FDA accepted Outlook Therapeutics’ BLA for ONS-5010 for the treatment of wet age-related macular degeneration. The FDA has set a PDUFA goal date of 29 August 2023.

August 30, 2023

Celltrion Healthcare Canada announced that Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), is now available in an 80 mg auto-injector and pre-filled syringe. It is the only adalimumab biosimilar available at an 80 mg dose in an auto-injector.

On 1 July 2023, Yuflyma® became commercially available in the US after Celltrion obtained a licence from AbbVie on 27 April 2022.

August 30, 2023

Alvotech published its first half 2023 financial results, reporting a revenue growth to $22.7M for the six months ending 30 June 2023, compared to $3.9M for the same six months of 2022.  Revenue for that period consisted of product revenue from sales of AVT02 (Alvotech’s adalimumab biosimilar) in select European countries and Canada.  As of 30 June 2023 the company has $60.5M in cash/equivalents (excluding $25.2M in restricted cash) and current borrowings of $808.6M.  Its R&D costs for the six month period ending 30 June 2023 were $99.6M.

Recent highlighted reported included Alvotech’s expanded partnership with Advanz Pharma, adding five biosimilar candidates which Advanz Pharma will commercialise in Europe; Alvotech and Teva’s settlement and license agreement with Johnson & Johnson concerning AVT04, Alvotech’s proposed biosimilar to Stelara® (ustekinumab); a complete response letter (CRL) from the US Food and Drug Administration (FDA) for Alvotech’s second Biologics License Application (BLA) for AVT02, an interchangeable high-concentration adalimumab biosimilar; and its expanded strategic partnership agreement with Teva, including exclusive commercialisation rights in the US by Teva for two new biosimilar candidates developed by Alvotech, as well as line extensions of two current biosimilar candidates.

August 29, 2023

The Patent Trial and Appeal Board (PTAB) issued decisions in Celltrion’s two inter partes reviews (IPRs) (IPR2022-00578 and IPR2022-00579), finding Chugai and Roche’s tocilizumab patents (US patent nos. 8,580,264 and 10,874,677) were invalid.  The PTAB found that claims 1-12 of the ‘264 patent were anticipated and/or obvious, and claims 1-8 of the ‘677 patent were obvious.

The PTAB instituted Celltrion’s two IPRs of Chugai and Roche’s tocilizumab patents on 31 August 2022.

August 29, 2023

The Korea Herald reported that Dong-A ST submitted a Marketing Authorization Application to the European Medicines Agency (EMA) for its Stelara® biosimilar DMB-3115.  DMB-3115 was jointly developed by Dong-A and Meiji Seika Pharma, and will be commercialised in Europe by the Intas subsidiary Accord Healthcare.

Dong-A published the results of its global Ph III trials of DMB-3114 in January 2023.

August 29, 2023

Alvotech and Bioventure announced that AVT02, their biosimilar to AbbVie’s Humira® (adalimumab) has been approved (under brand name Adalimumab-EVA®) by the Egyptian Drug Authority.  Bioventure is Alvotech’s exclusive strategic partner for the commercialisation of AVT02 and other biosimilars in the Middle East and North Africa.

On 24 January 2023, Alvotech and Bioventure announced that the Saudi Food & Drug Authority has approved the manufacture and distribution of AVT02 under the brand name Simladi®.

August 29, 2023

Merck announced that the European Commission has approved a new indication for Keytruda® (pembrolizumab) – first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Scope [CPS]≥1), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy.

Merck stated that Keytruda® is the first immunotherapy approved in the EU for the first-line treatment of this patient population.  Keytruda is approved globally for the treatment of a large range of cancers.  In June 2022 the EC approved Keytruda® for expanded melanoma indications.

August 29, 2023

Formycon and Klinge Biopharma announced that the FDA has accepted for review the BLA for FYB203, biosimilar to Regeneron’s Eylea® (aflibercept).  The FDA has assigned a target action date of June 2024.

Formycon submitted the BLA for FYB203 in June 2023.  FYB203 is being developed by Formycon and will be commercialised by Klinge Biopharma.

August 29, 2023

The US Department of Health and Human Services (DHHS), through the Centers for Medicare & Medicaid Services (CMS), announced the first 10 drugs selected for pricing negotiation as part of the Inflation Reduction Act 2022 (IRA).  The negotiations with the relevant pharmaceutical companies will occur in 2023 and 2024, and any price negotiations will come into force in 2026.

The ten drugs selected were:

  • Bristol Myers Squibb / Pfizer’s Eliquis® (apixaban)
  • Eli Lilly / Boehringer Ingelheim’s Jardiance® (empagliflozin)
  • Johnson & Johnson’s Xarelto® (rivaroxaban)
  • Merck’s Januvia® (sitagliptin)
  • AstraZeneca’s Farxiga® (dapagliflozin)
  • Novartis’ Entresto® (sacubitril/valsartan)
  • Amgen’s Enbrel® (etanercept)
  • AbbVie / Johnson & Johnson’s Imbruvica® (ibrutinib)
  • Johnson & Johnson’s Stelara® (ustekinumab)
  • Novo Nordisk’s Novolog®/Fiasp® (insulin aspart)

Only two days after this announcement, on 1 September 2023, Novartis brought proceedings against the US Government, arguing that these pricing negotiations are unconstitutional.  Other pharmaceutical companies have also sued the Government on this same legislation, including Merck, Bristol Myers Squibb, Johnson & Johnson, Boehringer Ingelheim, AstraZeneca and the industry group Pharmaceutical Research and Manufacturers of America.

August 28, 2023

AbbVie announced that it has submitted applications to the FDA and EMA for a new indication for Skyrizi® (risankizumab) to treat moderately to severely active ulcerative colitis (UC).  Skyrizi® is currently approved by both regulatory authorities to treat Crohn’s disease, psoriatic arthritis and psoriasis.

August 28, 2023

Bristol Myers Squibb announced that the FDA has approved Reblozyl® (luspatercept-aamt) to treat anemia without previous erythropoiesis stimulating agent use (ESA-naïve) in adults with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require regular red blood cell (RBC) transfusions.  Reblozyl® is the first and only therapy that has demonstrated better patient outcomes compared to an ESA in MDS-related anemia.

On 1 May 2023, BMS announced that the FDA has accepted its sBLA, and the EMA has validated its Type II Variation Application for Reblozyl® (luspatercept-aamt) to treat the above patient group.

August 26, 2023

A Biogen funded, pan-European study published in BioDrugs found that SB5 (Imraldi®), biosimilar to AbbVie’s Humira® (adalimumab), to be effective and well tolerated in patients with rheumatoid arthritis, axial spondyloarthritis, psoriatic arthritis and Crohn’s disease. The paper noted that “particular consideration should perhaps be given to female patients who are considering switching, since they appear to be more susceptible to discontinuation than their male counterparts”.

SB5 was first approved by the FDA on 24 July 2019; and was launched in the US by Samsung and Organon on 1 July 2023 as Hadlima® at a list price of $1038, an 85% discount compared to Humira®.  Biogen is commercialising SB5 as Imraldi® in Europe.

August 25, 2023

Korea Biomedical Review reported that Celltrion has finalised an agreement with Johnson & Johnson (J&J) permitting Celltrion to launch CT-P43, its biosimilar to Stelara®, in the US on 7 March 2025.  Celltrion submitted its aBLA to the FDA in June 2023, and is seeking to obtain marketing authorisation in 2024.

This follows J&J’s ustekinumab settlements with Fresenius Kabi and Formycon (AG) (with a US licensed entry date no later than 15 April 2025), Alvotech and Teva (with a US licensed entry date no later than 21 February 2025), Amgen (with a licensed entry date no later than 1 January 2025) and with Samsung (for an unknown licensed entry date).

Celltrion filed its MAA with the EMA for CT-P43 in May 2023.

August 25, 2023

Sandoz announced that the FDA approved its biosimilar Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri, for all indications covered by Tysabri®.  It is the first and only FDA-approved biosimilar for relapsing forms of multiple sclerosis (MS).  Tyruko® was developed by Polpharma Biologics pursuant to a global commercialisation agreement with Sandoz reached in 2019.  As part of the agreement, Sandoz has exclusive rights to commercialise and distribute the product in all markets.

This news comes just a week after Sandoz announced its spin-off from Novartis is planned for 4 October 2023.  On 21 July 2023, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion Tyruko® to treat active relapsing remitting MS.

August 24, 2023

AstraZeneca and Merck announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has expanded the indication for Lynparza® (olaparib), to be used alongside abiraterone and prednisolone for adult patients with BRCA-mutated (BRCAm) castration-resistant prostate cancer showcasing distant metastasis (mCRPC).  Lynparza® is the first PARP inhibitor approved in Japan demonstrating significant benefits in tandem with a new hormonal agent.

On the same day AstraZeneca also announced the MHLW expanded approval for Soliris® (eculizumab) to treat paediatric patients with gMG.

August 24, 2023

AstraZeneca announced that Japan’s Ministry of Health, Labour and Welfare (MHLW) has granted approval for the extended use of Soliris® (eculizumab) to treat paediatric patients suffering from generalised myasthenia gravis (gMG).  This approval specifically targets those who are anti-acetylcholine receptor (AChR) antibody-positive and whose symptoms are difficult to control through high-dose intravenous immunoglobulin (IVIG) therapy or plasmapheresis (PLEX).  Soliris® is the exclusive targeted therapy cleared for treating gMG in Japanese children and adolescents.

On the same day AstraZeneca also announced the MHLW expanded approval for it and Merck’s Lynparza® (olaparib) with abiraterone to treat BRCAm mCRPC.

August 24, 2023

Korea Biomedical Review reported that Sam Chun Dang Pharm has licensed its aflibercept biosimilar to Apotex for Canada.  Under the agreement, Sam Chun Dang Pharmaceutical will receive an upfront payment of approximately 4 billion South Korean won.  Additionally, Sam Chun Dang Pharmaceutical expects to receive up to 50% of the gross profit if the PFS product is the first to be listed on drug coverage plans, or if it is listed within three months of the first biosimilar aflibercept PFS product.  If the product is listed within 4-6 months of other biosimilar aflibercept PFS products, Sam Chun Dang will receive 35% of the gross profit.

August 23, 2023

Korea Biomed reported that Celltrion’s Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, has been listed on the formularies of over 10 US insurers since its US launch on 17 April 2023.  One of these includes a top-five insurer in terms of patient enrolment.  While the exact insurers’ names remain undisclosed, the recent listings mean Vegzelma® is now accessible to roughly 30% of the US population. Celltrion aspires to amplify its coverage to surpass 60% of Americans by early 2023.

On 11 May 2023, Celltrion began supplying Vegzelma® in Italy and Belgium.

August 23, 2023

CVS Health has launched Cordavis, a subsidiary that will work with manufacturers to commercialise and/or co-produce biosimilars for the US market.  Cordavis has a contract with Sandoz to commercialize and bring to market Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira®, in Q1 of 2024 under a Cordavis private label.  The list price of the Cordavis Hyrimoz® will be more than 80% lower than the current list price of Humira®.

On 1 July 2023, seven biosimilars to AbbVie’s Humira® (adalimumab), including Sandoz’s Hyrimoz® launched in the US.  Sandoz announced its global adalimumab settlement with AbbVie on 11 October 2018.

August 23, 2023

Reuters has reported that Johnson & Johnson’s Janssen will close part of its vaccine research and development programs.  The restructuring was announced in J&J’s Q2 2023 financial results (see page 56), where it notes the R&D program exits are primarily in infectious diseases and vaccines including the discontinuation of its respiratory syncytial virus (RSV) adult vaccine program, hepatitis and HIV development.

August 23, 2023

Daiichi Sankyo announced that Enhertu® (trastuzumab deruxtecan) has been approved in Japan for a new indication: to treat unresectable advanced or recurrent non-small cell lung cancer (NSCLC) with HER2 (ERBB2) mutations that has progressed after chemotherapy.

On 12 July 2023, Enhertu® was approved in the US for a new indication (unresectable or metastatic HER2-low breast cancer).

August 22, 2023

Celltrion revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that the EMA has partially approved its phase III IND for CT-P53 (ocrelizumab), biosimilar to Genentech’s Ocrevus® to treat multiple sclerosis.  The trial will assess biosimilarity of CT-P53 and Ocrevus®.  The clinical trial plan has been divided into two parts Part 1 (assessment of clinical design and product characteristics) and Part 2 (assessment of national and institution-level documents).  The trial cannot commence until Part 2 has been approved by the EMA.

In the same week on 24 August 2023, Celltrion’s Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, has been listed on more than 10 US formularies since its US launch on 17 April 2023.

Celltrion submitted its phase III IND plan for CT-P53 to the US FDA on 15 May 2023.

August 22, 2023

BMS announced that the European Commission has expanded the indication for its Opdivo® (nivolumab) as a monotherapy for adjuvant treatment of patients over 12 with stage IIB or IIC melanoma who have undergone complete resection.  Opdivo® is now the only PD-1 inhibitor that is indicated to treat stages IIB, IIC, III, and IV resected melanoma.

On 21 July 2023, the CHMP issued a positive opinion for BMS’s Opdivo® (nivolumab) to treat completely resected stage IIB or IIC melanoma.

August 21, 2023

The Japan Times has reported that a Ministry of Health, Labour and Welfare (MHLW) committee has recommended approval of Eisai/Biogen’s Leqembi® (lecanemab).  The article notes that the committee’s endorsement will be followed by approval by the Health Minister in the coming days.

On 6 July 2023, Leqembi® was approved by the FDA in the US to treat Alzheimer’s disease.  The product label notes it should be initiated in patients with mild cognitive impairment or mild dementia stage of disease, the population in which treatment was initiated in clinical trials.

August 18, 2023

Regeneron announced that the FDA approved its 8mg Eylea® (aflibercept) to treat Wet Age-related Macular Degeneration (wAMD), Diabetic Macular Edema (DME) and Diabetic Retinopathy (DR).  The 8mg dose is the only treatment approved in wAMD and DME for immediate dosing at 8-week and up to 16-week intervals following three initial monthly doses.

On 10 August 2023, Regeneron announced the results of two-year (96 week) data from its PULSAR trials investigating aflibercept 8mg in wet age-related macular degeneration.  In June 2023 Regeneron announced that the FDA had issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.

August 18, 2023

Novartis issued an invitation to an Extraordinary General Meeting (EGM) of Novartis shareholders scheduled for 15 September 2023 to vote on the approach to the proposed spin-off of Sandoz, which includes the planned spin-off effective date of 4 October 2023.

On 18 July 2023, Novartis’ board unanimously endorsed a Q4/23 Sandoz spin-off.

August 18, 2023

Regeneron announced that the FDA approved its Veopoz®(pozelimab-bbfg) to treat adult and pediatric patients over one year old with CHAPLE disease, also known as CD55-deficient protein-losing enteropathy.  CHAPLE is an extremely rare, life-threatening hereditary immune disease driven by an overactivation of the complement system, and less than 10 people in the US have the disease.  Veopoz® is a fully human monoclonal antibody designed to block the activity of complement factor C5.

On the same date, 18 August 2023, Regeneron announced that its 8mg Eylea® (aflibercept) was approved by the FDA to treat wAMD, DME and DR.

August 18, 2023

Samsung Bioepis filed an IPR petition against Regeneron’s US10,464,992 relating to formulations of aflibercept.  Samsung Bioepis has sought joinder with the Celltrion IPR filed against the same Regeneron patent on 17 January 2023.

Samsung Bioepis has previously filed petitions against Regeneron’s method of treatment patent US11,253,572 in April 2023 and US10,888,601 in April 2023, with a third IPR previously filed against a third method of treatment patent US10,130,681 in January 2023.

August 17, 2023

Celltrion Group revealed in a corporate filing with the Repository of Korea’s Corporate Filings (DART) that Celltrion, Inc. and Celltrion Health Co., Ltd will merge as part of the initial phase of its merger plan.  Following this stage, the company will proceed with the second phase: a merger of Celltrion and Celltrion Pharm, Inc.  The company said the merger is expected to generate increased revenue through cost reduction and enhancement of cost competitiveness.  The company aims to reach 3.5 trillion KRW revenue and 1.6 trillion KRW EBITDA by 2024 and 12 trillion KRW revenue by 2030.

On 26 July 2023, Celltrion has applied to the Korean Ministry of Food and Drug Safety for marketing authorisation of its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) for all of Eylea®’s indications approved in Korea.

August 15, 2023

The British Generics and Biosimilars Associations (BGMA) has released a report finding that the NHS is projected to lose out on approximately £100M in savings per year by 2028 due to reduced biosimilar competition on the 85 biologics which are due to lose patent exclusivity in the next five years.

The figures were calculated by reference to the UK’s voluntary scheme for branded medicines pricing and access (VPAS) scheme, an agreement between the Department of Health and Social Care (DHSC), NHS England and the Association of the British Pharmaceutical Industry (ABPI).  VPAS sets a 2% per annum cap on the total allowed sales value of branded medicines to the NHS, and sales above that cap are repaid to DHSC through a rebate system.  Biosimilars also fall under this scheme.

Currently members of VPAS currently pay back 26.5% of their medicine sales, which is calculated so that the NHS’ net branded medicines sales increase only to that 2% rate per year.

The BGMA report states that the rising VPAS rate is threatening the launch of new biosimilars, as many manufacturers are not able to absorb the cost of competition as well as the VPAS rebate, ultimately leading to companies prioritising other markets.  The research shows that if on average one company is deterred from entering a biosimilar market where molecule exclusivity has been lost between 2023 and 2028,  the NHS is projected to lose out on around £100M in savings per year by 2028. If two entrants were lost, the figure increases to £250M.

VPAS is in place until 31 December 2023, and negotiations for the next five years are ongoing.  The proposed review of the 2023 scheme to control the cost of branded health service medicines consultation will run until 10 October 2023, and responses can be submitted at the DHSC website.

August 15, 2023

Sandoz published the results from MYLIGHT Ph III trials of its biosimilar aflibercept in patients with wet macular degeneration.  Sandoz reported that the study met its primary efficacy endpoint and showed no clinically meaningful differences to Regeneron’s Eylea®.  Sandoz commenced the MYLIGHT trials in May 2021 and expects to file for regulatory approval for its biosimilar aflibercept in the EU and US in the coming months.

On 18 August 2023, Novartis issued an invitation to an Extraordinary General Meeting (EGM) of Novartis shareholders on 15 September 2023 to vote on the approach to the proposed spin-off of Sandoz.

August 15, 2023

Gilead and Tentarix Biotherapeutics announced have entered three multi-year agreements to leverage Tentarix’s Tentacles® platform to discover and develop multi-functional, conditional protein therapeutics for oncology and inflammatory diseases.  Gilead said that the collaboration may provide access to next-generation, multi-specific biologics.  Tentarix will receive $66M in upfront payments and an equity investment from Gilead, whilst Gilead can acquire up to three select Tentarix subsidiaries containing the programs developed under the collaborations for $80M each.

On 7 August 2023 Gingko Bioworks and Merck announced a US$490M collaboration to improve biologic manufacturing.

August 12, 2023

According to the Business Standard Biocon Biologics’ CEO has confirmed the transition of the North American part of Viatris’ global biosimilars business to Biocon Biologics will complete by the end of this quarter, less than a year after the companies signed a $3.34B acquisition of Viatris’ biosimilars business on 29 November 2022.  Biocon Biologics and Viatris have had a two-year transition services agreement in place following finalisation of the acquisition in November last year.  Biocon Biologics will also consider an IPO once Viatris is integrated.

On 5 July 2023, Biocon Biologics announced it had completed a third of the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’.

August 11, 2023

Zumutor Biologics announced that FDA has granted its Investigational New Drug (IND) application for ZM008 (IgG1 monoclonal antibody) to initiate a phase I clinical study for the treatment of multiple solid cancers. The FDA approved the use of a staggered parallel clinical design for the combination of ZM008 and pembrolizumab which could benefit a wider range of patients whose immune response could be boosted with ZM008.

August 10, 2023

Managing IP has reported that Amgen filed an appeal with Germany’s Federal Court of Justice against a preliminary injunction order made by the Munich District Court on 4 August 2023.  The preliminary injunction prevents Amgen from supplying Bekemv®, its biosimilar to Alexion’s Soliris® (eculizumab), in Germany unless certain conditions are met, including a requirement that Amgen customers, including hospitals, agree not to use Bekemv® off-label.

On 19 April 2023, the EMA approved Bekemv® for the treatment of paroxysmal nocturnal haemoglobinuria (PNH) (after the CHMP provided its positive opinion on 23 February 2023).  Alexion successfully applied to the Munich Regional Court for a preliminary injunction in May 2023, which was upheld by the 4 August 2023 District Court ruling.

The ODE rights expired in June 2019 for PNH.   However Alexion argued that there was a real risk that the biosimilar would be used off-label to treat other conditions over which Alexion still has exclusive rights.  The District Court noted that by sending letters of recommendation to medical practitioners, Amgen contributed to the risk of Bekemv®’s off-label use.

Alexion has also sued Samsung Bioepis in Germany over its eculizumab biosimilar Epysqli®, approved by the EMA on 30 May 2023, with a preliminary injunction hearing scheduled for 16 August 2023.

August 10, 2023

On 10 August 2023, the FDA published draft guidance for industry ‘Classification Categories for Certain Supplements Under BsUFA III’ seeking comment and suggestions by 10 October 2023.

The guidance provides recommendations for applicants and FDA review staff on six classification categories for original and resubmitted supplements to approved applications. The commitment letter associated with the Biosimilar User Fee Amendments of 2022 sets out these supplement classification categories and their associated review performance goals. The guidance intends to help applicants identify the appropriate classification category and review goal date of the supplement being submitted.

August 10, 2023

On 10 August 2023, Regeneron announced the results of two-year (96 week) data from its PULSAR trials investigating aflibercept 8mg in wet age-related macular degeneration.  Regeneron reported that aflibercept 8mg demonstrated durable vision gains at extended dosing intervals (including intervals greater than 12 weeks) and that the safety of aflibercept 8mg remained consistent with the known safety profile of Eylea®.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.  In June 2023 Regeneron announced that the FDA had issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.

August 10, 2023

The UPC has appointed 21 new technically qualified judges (TQJs) across various areas, including chemistry and pharmaceutics, biotechnology, mechanical engineering, electricity and physics.  Following a selection process, the UPC Administrative Committee adopted the final list of recommended candidates on 2 June 2023.  Further appointments of TQJs are expected to take place later in 2023, with interviews to be scheduled in the upcoming weeks.

On 2 June 2023, Sanofi-Aventis filed revocation proceedings in UPC in relation to Amgen’s Repatha® (evolocumab), one of the earliest UPC revocation cases filed – only one day after the Court’s commencement.

August 9, 2023

The USPTO Patent Trial and Appeal Board has terminated Samsung Bioepis’s Inter Partes Review (IPR) challenging Janssen’s US patent 10,961,307 relating to Stelara® (ustekinumab).  The Board’s decision follows Samsung and Janssen’s joint motion, dated 3 August 2023, stating that parties have resolved the dispute and request termination.  The motion states that the parties have entered into  a confidential settlement to resolve all present disputes and to avoid any additional disputes regarding the patent.

Samsung filed the IPR on 21 June 2023, arguing all claims of the patent are invalid, citing (amongst other things) a Janssen clinical overview summary for a phase III clinical trial of ustekinumab.

Samsung also filed a notice of opposition to the grant of an Australian counterpart, AU application no 2019346134, on 12 July 2023.  Law firm Reddie & Grose filed a post-grant notice of opposition (presumed to be on behalf of an unnamed client) to the European counterpart, EP patent no 3883606, on 27 July 2023.

August 9, 2023

News is my Business reported that the Puerto Rico Economic Development Bank (BDE) has approved US$3.85M in funding for Biosimilar Sciences PR LL and Ocyon Bio PR Inc. to facilitate the purchase of specialised biotechnology equipment. This funding comes from the US Treasury’s State Small Business Credit Initiative and represents BDE’s first partnership with a private financial entity, working alongside the Jesús Obrero Credit Union.  Biosimilar and OcyonBio are developing a biosimilar to AbbVie’s Humira® (adalimumab).

On 14 March 2022 OcyonBio and Biosimilar Solutions announced an agreement to create a contract biosimilars development/manufacturing organisation.

August 8, 2023

Regeneron filed an unopposed motion to terminate IPR2023-00620 after disclaiming all claims of the US process patent no 10,406,226. Celltrion filed the IPR in February 2023, and it had not yet been instituted by the PTAB.  All claims of the ‘226 patent relate to a method of making a VEGF antagonist fusion protein involving expressing the fusion protein in CHO, purifying the fusion proteins such that a defined percentage is not an aggregate.

The results of Celltrion’s Ph III trials of CT-P42 were reported on 3 April 2023.  CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regeneron’s Eyela®.  On 30 June 2023, Celltrion filed an NDA for CT-P42 with the FDA, and  announced that it intends to file an ABLA in at least the US and Europe later in 2023.

August 7, 2023

Fresenius Kabi and Formycon AG announced they reached a settlement in the US with Johnson & Johnson relating to their ustekinumab (FYB202), biosimilar to Stelara®.  As part of the agreement, Fresenius and Formycon can launch in the US “no later than 15 April 2025”.  There were no proceedings on foot between the parties on foot in relation to FYB202 at the time of the settlement.

On 25 April 2023, Formycon announced the successful conclusion of its extended Phase I clinical study comparing the pharmacokinetics of FYB202 to Stelara®.   Formycon expects to file its BLA for FYB202 with the FDA later in 2023.

This settlement follows Johnson & Johnson’s previous settlement agreements with Amgen (for a licensed entry date no later than 1 January 2024), and with  Alvotech and Teva (for a licensed entry date for AVT04 in the US no later than 21 February 2025).

August 7, 2023

On 7 August 2023 Gingko Bioworks and Merck announced a collaboration to improve biologic manufacturing.  Gingko will “apply its expertise and capabilities in cell engineering, ultra high-throughput multiplexed screening, protein characterization and process optimization to improve” [Merck’s] “production efficiency and increase yield”.  Merck will pay Gingko up to US$490M under the deal, including research fees, milestone fees and license payments.

This is the second collaboration between the companies, which announced a biocatalysis project to improve Merck’s active pharmaceutical ingredient manufacturing in October 2022.

August 3, 2023

Teva’s CEO confirmed that it will still pursue launching its Alvotech developed adalimumab biosimilar of AbbVie’s Humira® (adalimumab) next year despite seven biosimilars launching in the US on 1 July 2023, and Amgen launching Amjevita® on 31 January 2023.  Teva’s CEO, Richard Francis noted that “it’s always going to be a challenging market but I do see it’s worth the effort for 2024.”

On 24 July 2023, Teva and Alvotech announced they agreed to expand their existing strategic partnership agreement for the US, which already included development of AVT02 (adalimumab).

August 2, 2023

Coherus BioSciences announced its Q2 2023 financial results, reporting that sales of its Cimerli® (ranibizumab), biosimilar to Genentech’s Lucentis®, has quadrupled to $26.7M since the last quarter.  It also reported that its net revenue has risen 81% compared to the previous quarter.  Yumisry®, Coherus’s biosimilar to AbbVie’s Humira® (adalimumab) was launched in the US on 3 July.

August 1, 2023

Astellas announced that China’s National Medical Products Administration (NMPA) has accepted its Biologics License Application (BLA) for zolbetuximab as a first-line treatment for locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2-positive.  The BLA was based on phase III clinical trials which evaluated zolbetuximab with a combination chemotherapy regimen that included capecitabine and oxaliplatin.

August 1, 2023

Samsung Bioepis and Organon announced the topline results for their interchangeability study for SB5 (Hadlima®), a biosimilar to AbbVie’s Humira® (adalimumab).  The Phase 4, randomized, double-blind, parallel-group, multiple-dose, active comparator, multicenter clinical study (NCT05510063) was in patients with moderate to severe chronic plaque psoriasis.  The study found that efficacy profiles, safety profiles and immunogenicity were comparable between patients who received Hadlima® and those who received Humira®.

SB5 was first approved by the FDA on 24 July 2019; and was launched in the US on 1 July 2023 at a list price of $1038, an 85% discount compared to Humira®.

July 27, 2023

AstraZeneca announced that the EMA has approved Soliris® (eculizumab) for a new indication: treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive.  Soliris® is the first and only targeted therapy approved for the treatment of paediatric patients with the disease in the EU.  The company also confirmed that regulatory submissions for Soliris® for the treatment of paediatric patients with gMG are currently ongoing or planned with various health authorities.

The approval follows the CHMP recommendation for approval of the new indication on 26 June 2023.

July 26, 2023

According to the Korea Biomedical Review Celltrion has applied to the Ministry of Food and Drug Safety for marketing authorisation of its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) for all of Eylea®’s indications approved in Korea, including wet age-related macular degeneration and diabetic macular edema.

Celltrion announced the results of its Ph III trials of CT-P42 on 3 April 2023 which demonstrated equivalence and similarity to Eylea®.  CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regeneron’s Eyela®.

On 30 June 2023, Celltrion filed an NDA for CT-P42 with the FDA, and  announced that it intends to file an ABLA in at least the US and Europe later in 2023.

July 25, 2023

STADA and Xbrane announced that their commercialization agreement with Bausch + Lonb has been terminated, and that they are considering options for their co-developed ranibizumab biosimilar  to Genentech’s Lucentis® (Ximluci®) in North America.

Xbrane entered into a co-development agreement with STADA Arzneimittel AG in 2018, and subsequently, in May 2020, the two companies signed an exclusive licensing agreement with Bausch + Lomb to bring the biosimilar candidate to market in the United States and Canada.

After receiving EU approval in November 2022, STADA and Xbrane intend to commercialise the product in the US.  On 22 June 2023, Xbrane announced the FDA has accepted a supplemental Biologics License Application (sBLA) for  (Ximluci®).

July 24, 2023

Teva and Alvotech announced they have agreed to expand their existing strategic partnership agreement for the US with subordinated convertible bonds to be issued to Teva for USD$40M.

The expansion to the existing strategic partnership relates to exclusive commercialisation in the US by Teva of two new biosimilar candidates and line extensions of two current biosimilar candidates in the partnership, to be developed, and manufactured by Alvotech.  The existing partnership includes:  two US biosimilar candidates pending FDA approval:

  • AVT02 (adalimumab), an interchangeable high-concentration biosimilar to AbbVie’s Humira®; and
  • AVT04 (ustekinumab) biosimilar to Janssen’s Stelara®

The agreement also covers milestone payments and shared profits from the commercialization of the biosimilars. All other terms of the expansion remain confidential.

The partnership was entered into between Alvotech and Teva on 5 August 2020.  On 6 January 2023, the two companies announced that the FDA accepted for review their BLA for AVT04, and on 12 June 2023 they reached a settlement and license agreement with Johnson & Johnson for AVT04.

On 12 June 2023, Alvotech and Teva reached a settlement and licence agreement with J&J regarding AVT04 (ustekinumab), biosimilar to Janssen’s Stelara®.

July 22, 2023

A Sandoz/Bio-Thera comparability study has demonstrated similarity between BAT1706  (bevacizumab) and Genentech’s Avastin® (bevacizumab) in terms of all physicochemical and functional attributes.

BAT1706 is currently under regulatory review by the FDA (BLA accepted on 18 January 2021) and the EMA (MA submitted on 26 November 2020).  BAT1706 has already been approved in China and is being supplied as Pobevcy®.

July 21, 2023

The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for three biosimilars:

  • Fresenius Kabi’s Tyenne® (tocilizumab), biosimilar to Roche’s Actemra® / RoActemra®. Tyenne® is intended for the treatment of rheumatoid arthritis, active systemic juvenile idiopathic arthritis, juvenile idiopathic polyarthritis, giant cell arteritis, chimeric antigen receptor T cell-induced cytokine release syndrome, and COVID-19. Tyenne is the first biosimilar for this active substance.
  • Sandoz’s Tyruko® (natalizumab), biosimilar to Biogen’s Tysabri®.  Tyruko® is intended to treat active relapsing remitting multiple sclerosis.
  • BGP Pharma’s Yesafili® (aflibercept), a biosimilar to Regeneron’s Eylea®. It is intended to treat age-related macular degeneration

To obtain approval in Europe, the European Commission needs to approve the above positive recommendations from the CHMP.

During this same July 2023 CHMP meeting, the CHMP also issued a positive opinion for BMS’s Opdivo® (nivolumab) to treat completely resected stage IIB or IIC melanoma and Merck’s Keytruda® (pembrolizumab) to treat HER2-Positive Advanced Gastric or Gastroesophageal Junction.

July 21, 2023

BeiGene announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a positive opinion recommending approval for its tislelizumab product, co-developed with Novartis.  It is seeking approval for tislelizumab as monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic esophageal squamous cell carcinoma (ESCC) after prior platinum-based chemotherapy.

In 2021, BeiGene and Novartis announced a collaboration agreement to jointly develop tislelizumab in the US, Canada, Mexico, member countries of the European Union, the UK, Norway, Switzerland, Iceland, Liechtenstein, Russia, and Japan. Novartis is responsible for regulatory submission and has the right to commercialise in these licensed countries following regulatory approval.

On 10 July 2023, BeiGene and Novartis ended their option for collaboration and licence agreement to commercialise ociperlimab. Earlier this year on 18 January, China’s National Reimbursement Drug List was updated to include four new indications for tislelizumab.

July 21, 2023

Bristol Myers Squibb announced that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Opdivo® (nivolumab) as a monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with completely resected stage IIB or IIC melanoma. If the European Commission approves this recommendation, Opdivo® will become the sole PD-1 inhibitor indicated as an adjuvant treatment for patients in stages IIB, IIC, III, as well as stage IV resected melanoma.

On 30 May 2023, the FDA accepted Priority Review for BMS’s NDA for repotrectinib for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer

July 21, 2023

Merck announced that it received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the approval of Keytruda® (pembrolizumab), in combination with trastuzumab, fluoropyrimidine- and platinum-containing chemotherapy, for the first-line treatment of locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-positive gastric or gastroesophageal junction (GEJ) adenocarcinoma in adults whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1).

If approved, Keytruda® would be the first immunotherapy for the first-line treatment of HER2-positive advanced gastric or GEJ cancer in tumors expressing PD-L1 (CPS ≥1) in the EU.

July 20, 2023

Daiichi Sankyo announced that the FDA has approved its Vanflyta® (quizartinib) in combination with standard cytarabine and anthracycline induction and cytarabine consolidation, and as maintenance monotherapy following consolidation chemotherapy, to treat patients with newly diagnosed acute myeloid leukemia (AML) that is FLT3-ITD positive as detected by an FDA-approved test.  Vanflyta® is the first and only FLT3 inhibitor approved by the FDA for FLT3-ITD positive AML for all three phases of treatment (induction, consolidation and maintenance) in patients without a transplant and newly diagnosed AML.  Daiichi confirmed that Vanflyta® will be available in the US in the coming weeks.

On 12 July 2023, AstraZeneca and Daiichi’s Enhertu® (trastuzumab deruxtan) was approved for a new indication (unresectable or metastatic HER2-low breast cancer).

July 20, 2023

Sandoz announced that it will invest US$90M to build a Biosimilar Technical Development Centre in Ljubljana, Slovenia by 2026.  The site will house an end-to-end drug substance and product development centre, becoming a ‘key location’ for Sandoz’s biosimilar product development.

This news comes only a few months after Sandoz signed an MOU to build a USD$400M biologics facility in Lendava, Slovenia in March 2023.

July 18, 2023

Novartis announced that its Board of Directors has unanimously endorsed the proposed separation of Sandoz from the Novartis Group, by way of a spin-off planned for Q4 of 2023.  Shareholders at Novartis will have the opportunity to vote on the proposed spin-off and share capital reduction at an Extraordinary General Meeting on 15 September 2023.  The spin-off aims to list Sandoz on the SIX Swiss Exchange, and completion is dependent on shareholder approval, meeting specific conditions, and obtaining necessary approvals for the listing of Sandoz shares.

This week on 20 July 2023, Sandoz announced it will build a US$90M Biosimilar Technical Development Centre in Slovenia, due for completion in 2026.

July 18, 2023

BeiGene announced that the FDA has completed a GMP inspection of its tislelizumab manufacturing facility.  Tislelizumab is a PD-1 antibody and potential treatment for oesophageal squamous cell carcinoma (ESSC), and is being commercialised with Novartis.  The Company confirmed that the BLA is moving forward, and it is seeking to gain approval in the EU to treat ESSC, and approval in China to treat hepatocellular carcinoma.

Earlier this year on 18 January, China’s National Reimbursement Drug List was updated to include four new indications for tislelizumab.

July 17, 2023

The Canadian Federal Court upheld a decision of Canada’s Office of Submission and Intellectual Property (OSIP) to refuse Janssen’s application to list Canadian Patent 3113837 (‘837 patent) on the PMNOC register for two supplementary new drug submissions relating to Stelara® (ustekinumab) OSIP refused the application as the ‘837 patent application was filed in Canada after the submissions.

Health Canada approved ulcerative colitis as an indication for Stelara® on 27 January 2020.

July 17, 2023

AstraZeneca and Sanofi announced that the FDA has approved Beyfortus® (nirsevimab) to prevent respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season. It was also approved to treat children up to two years old who are vulnerable to severe RSV disease through their second RSV season.  The companies confirmed Beyfortus® will be available before the 2023/2024 RSV season.  The FDA approval follows a unanimous vote on 8 June 2023 by the Antimicrobial Drugs Advisory Committee (AMDAC) on the favourable benefit-risk profile of Beyfortus® based on the clinical development programme spanning three late-stage clinical trials.

July 14, 2023

Intas Pharmaceuticals announced that the European Medicine Agency (EMA) has confirmed acceptance of its Marketing Authorization Application (MAA) for DMB-3115, a biosimilar of Stelara® (ustekinumab). The MAA was submitted by Accord Healthcare, a wholly owned subsidiary of Intas, on 23 June, and the EMA accepted the MAA submission on 14 July. Intas will commercialize DMB-3115 with its global subsidiaries Accord BioPharma of the US and Accord Healthcare of the EU, UK, and Canada. 

On 22 July 2021, Intas Pharma announced it had signed a commercialisation agreement with Meiji and Dong-A St, under which Intas receives exclusive licensing rights to DMB-3115 worldwide excluding Japan, Korea and certain countries in Asia. 

July 13, 2023

Genentech, Inc., Hoffmann-La Roche, Inc. and Chugai Pharmaceutical Co Ltd sued Biogen MA Inc, and Bio-Thera Solutions, Ltd in the District Court of Massachusetts in relation to Biogen’s BIIB800, (biosimilar tocilizumab).  Genentech alleges that Biogen’s product, manufactured in China by Bio-Thera, will infringe 20 US patents, including US patent No 7521052 (method of treating rheumatoid arthritis) and US patent No 8398980 (IL-6R antibody subtype).  On 9 December 2022 Biogen announced that the FDA had accepted its aBLA for BIIB800. 

July 13, 2023

Senator Mike Lee reintroduced his Biosimilars Red Tape Elimination Bill into the US Senate, which – if implemented, will prohibit the FDA from requiring biosimilars to undergo switching studies to obtain ‘interchangeable’ designation.  Unlike small-molecule drugs, biosimilars cannot be substituted at the pharmacy level without this interchangeability designation. Sen. Lee’s bill would deem biosimilars as interchangeable with their branded equivalent upon their approval by the FDA.  

Sen. Lee previously introduced the bill on 17 November 2022. 

July 12, 2023

Dr Reddy’s announced its Biologics License Application (BLA) for DRL_RI, its proposed biosimilar to Genentech/Biogen’s Rituxan®/MabThera® (rituximab), has been accepted for review by the FDA. This follows acceptance of its DRL_RI dossier for review by the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).  Rituxan®/MabThera® is approved for rheumatoid arthritis, non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, pemphigus vulgaris, granulomatosis with polyangiitis and microscopic polyangiitis. 

We reported on 20 January 2023 that Dr Reddy’s successfully completed clinical studies of DRL_RI for filing in the US, EU and other regions against Rituxan®.  DRL_RI will be commercialised by Fresenius Kabi in the US, and by Dr Reddy’s directly in other jurisdictions. 

July 12, 2023

Prime Therapeutics announced its 2023 recommendations for formularies that include AbbVie’s Humira® (adalimumab).  The pharmacy benefit manager will recommend coverage of the following adalimumab biosimilars to commercial clients: 

  • Amgen’s Amjevita® (low concentration) and Boehringer Ingelheim’s Cyltezo® (interchangeable low concentration); or 
  • Amgen’s Amjevita® (low concentration) and Samsung Bioepis/Organon’s Hadlima® (high and low concentration). 

Prime is also recommending coverage of Cyltezo® for Medicare Part D formularies.  On 10 July 2023, Cigna Health announced its preferred adalimumab biosimilars.  

July 12, 2023

AstraZeneca and Daiichi Sankyo announced that Enhertu®, their engineered HER2-directed antibody drug conjugate (ADC), has been approved in China as a monotherapy to treat patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy.  The approval by China’s National Medical Products Administration is based on the results of the DESTINY-Breast04 Phase III trial 

Based on the same clinical trial, Enhertu® was approved in Japan for the above indication on 27 March 2023.  

July 12, 2023

The Searle Company Limited announced that it has entered into a license agreement with China’s Mabwell Pharmaceuticals, under which Searle will manufacture, register and license the biosimilar drugs in Pakistan. 

In March 2023, Mabwell announced that it had received Chinese marketing approval for Mailishu®, its denosumab biosimilar, from the National Medical Products Administration (NMPA) for the treatment of osteoporosis in postmenopausal women at high risk of fracture. 

July 12, 2023

A study comparing the efficacy, safety, tolerability, pharmacokinetics and immunogenicity between AVT04 (ustekinumab biosimilar) and Janssen’s Stelara® in patients with moderate-to-severe chronic plaque psoriasis (PsO) has been published.   The authors report that the study demonstrates the therapeutic equivalence between AVT04 and Stelara® in patients with moderate-to-severe chronic PsO, with similar safety and tolerability.

Alvotech announced clinical studies supporting biosimilarity and comparability of ATV04 and Stelara® on 17 March 2023, and the data was presented at the American Academy of Dermatology Annual Meeting on 17-21 March in New Orleans.

July 11, 2023

Sanofi Healthcare India announced it has received marketing approval for Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis in adults whose disease is not adequately controlled with topical prescription therapies or when those therapies are contraindicated.  This is the first biologic treatment for this indication approved in India.  

On 21 May 2023 Sanofi and Regeneron announced positive results from their phase III Dupixent® study in COPD patients with chronic obstructive pulmonary disease. 

July 11, 2023

Samsung Bioepis has released its second US Biosimilar Market Report.  The quarterly report has updated price details of all products with launched biosimilars including updated 2023 Q3 average sale price (ASP) trends and wholesale acquisition cost (WAC) trends. For adalimumab: 

  • Organon/Samsung Bioepis’ Hadlima® and Coherus’ Yusimry® have a low WAC: ~85% less than Humira®  
  • Celltrion’s Yuflyma®, Boehringer Ingelheim’s Cyltezo®, and Fresenius Kabi’s Idacio® have a high WAC, only -5~7% below Humira®  
  • Amgen’s Amjevita®, Sandoz’s Hyrimoz®, and Biocon Biologics’ Hulio® are offering two pricing options including both a low and a high WAC    

Samsung Bioepis launched its first US Biosimilars Market Report on 18 April 2023, predicting that biosimilars will save US$181B in five years in the US.  

July 10, 2023

Samsung Biologics announced in a regulatory filing with Korea Exchange that it has signed a 511B (US$390M) contract with Novartis to manufacture its products in Korea from 1 January 2023 through to the end of 2028. The exact products which will be produced at the plant have not been revealed.  

The deal was announced on 7 June last year, when Samsung Biologics and Novartis signed a letter of intent for the deal. It was originally worth ₩100B (US$81M), however the companies have increased the investment by ₩411B.  

On 4 July 2023, Samsung Biologics announced two manufacturing deals with Pfizer worth US$897M.  

July 10, 2023

BeiGene announced in an SEC filing that it and Novartis have entered into a mutual termination and release agreement, terminating their agreement (announced on 19 December 2021) under which BeiGene granted Novartis an exclusive time-based option to receive an exclusive licence to develop, manufacture and commercialise ociperlimab.  BeiGene will continue enrolment in the phase III AdvanTIG 302 trial of ociperlimab in combination with BeiGene’s PD-1 inhibitor tislelizumab for the first-line treatment of patients with locally advanced, unresectable, or metastatic non-small cell lung cancer (NSCLC), whose tumors exhibit high PD-L1 expression and do not harbor EGFR-sensitizing mutations or ALK translocations.  

Earlier this year on 18 January, China’s National Reimbursement Drug List was updated to include four new indications tislelizumab.  

July 10, 2023

Cigna Healthcare, a pharmacy manager, announced it will prefer adalimumab biosimilars Boehringer Ingelheim’s Cyltezo®, Sandoz’s unbranded adalimumab-adaz, and Sandoz’s Hyrimoz high-concentration formulation alongside the originator product, Abbvie’s Humira® on its national preferred, standard, performance, and legacy commercial formularies.  Organon/Samsung Bioepis’ Hadlima®, in both high- and low-concentration formulations, will be preferred alongside Humira® on its value, advantage, and total savings formularies.  The announcement will be effective from 1 September 2023.   

In the first week of July 2023, seven biosimilars to AbbVie’s Humira® were made commercially available in the US. 

July 7, 2023

Aurobindo Pharma announced that its wholly owned subsidiary, CuraTeQ Biologics, has entered into an exclusive license agreement with the USA-based BioFactura Inc, to commercialize BFI-751, BioFactura’s proposed biosimilar to Stelara® (ustekinumab).  Ustekinumab is a recombinant monoclonal antibody for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis.

Under the terms of the agreement, CuraTeQ has exclusive license rights to commercialise BFI-751 in all major ‘regulated’ markets including the US, EU, UK, Canada, ANZ as well as in certain other markets, and the global manufacturing rights.  The product will be produced at CuraTeQ facilities in Hyderabad, India.  BioFactura has plans to begin a global Phase 3 trial of the product.  CuraTeQ intends to file the product in India and ‘emerging markets’ as early as 2024 and in the regulated markets beginning in 2026.

July 6, 2023

Biogen Canada announced that Quebec will reimburse patients receiving BYOOVIZ® (ranibizumab), biosimilar to Genentech’s Lucentis®, for certain retinal conditions such as age-related macular degeneration (AMD) in the presence of choroidal neovascularization, and visual deficiency caused by diabetic macular edema (DME).

BYOOVIZ® is the first biosimilar approved in Canada (on 2 March 2023) to treat neovascular (wet) AMD and DME.

July 6, 2023

Biogen and Eisai announced that the FDA has approved the supplemental Biologics License Application (sBLA) for LEQEMBI® (lecanemab-irmb) to treat Alzheimer’s disease (AD).  On 9 June 2023, the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee unanimously voted that the results of a specific Eisai phase III clinical trial verified the clinical benefit of the use of LEQEMBI® for AD.

On 5 March 2023, Biogen and Eisai Co announced that the FDA has accepted their sBLA and granted priority review for traditional approval of LEQEMBI™ (lecanemab) for treatment of Alzheimer’s disease.  It was approved under the Accelerated Approval Pathway on 6 January 2023 (approval based on ‘surrogate’ marker or endpoint).

July 5, 2023

Biocon Biologics announced it has completed the integration of Viatris’ biosimilars business in over 70 countries in ‘emerging markets’.  This signifies completion of the first stage of implementation of the Biocon buy out, wherein Viatris’ biosimilar operations were fully transitioned to Biocon.

The multi-billion dollar deal was finalised on 29 November 2022, whereby Biocon Biologics has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.  Biocon announced that Biocon Biologics would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.

July 4, 2023

A Hisun phase I study has demonstrated pharmacokinetic similarity and bioequivalence between HS628, a proposed tocilizumab biosimilar to Genentech’s Actemra®.  The safety and immunogenicity profiles of HS628 were also found to be similar to the reference product in healthy Chinese male subjects.  Actemra® is approved in the US for the treatment of rheumatoid arthritis (RA) and juvenile idiopathic arthritis patients.  The study also notes that a phase III clinical trial is currently underway to compare the efficacy and safety of HS628 and Actemra® in patients with moderate to severe RA.

On 5 June 2023, Dr Reddy’s announced a successful phase I study of its biosimilar to Actemra®.

July 4, 2023

Aurobindo Pharma announced that CuraTeQ Biologics’ BP02 showed equivalence to Genentech’s Herceptin® in its phase III clinical trial.  The study’s results indicated that BP02 has clinical response equivalence (pharmacokinetics and immunogenicity) and comparable safety profiles to the originator product.

On 26 June 2023, CuraTeQ Biologics withdrew its EMA MA applications for biosimilars ZEFYLTI® (filgrastim) and DYRUPEG® (pegfilgrastim) after receiving guidance from the EMA.

July 4, 2023

Samsung Biologics announced it has reached two agreements with Pfizer to manufacture its biosimilar products for oncology, inflammation and immunotherapy until 2029 in new South Korean Plant 4.

These announcements include a $704M contract and an additional $193M agreement (a follow-up to a $183M manufacturing deal previously announced on 2 March 2023).

July 1, 2023

Organon and Samsung Bioepis announced that Hadlima®, biosimilar to AbbVie’s Humira® (adalimumab), is now available in the US.  Hadlima® is available at a list price of $1,038, an 85% discount in comparison to the list price of Humira®.  Samsung Bioepis announced a global settlement with AbbVie in April 2018, under which Samsung Bioepis was licensed to supply biosimilar adalimumab in the US from 30 June 2023, and in EU from 16 October 2018. 

On 1 July 2023, the following biosimilar entities are licensed to launch: Alvotech, Celltrion, Boehringer Ingelheim, Coherus before Fresenius Kabi  in July (on an unspecified date), Mylan/Viatris on 31 July 2023, Sandoz on 30 September  2023,  Momenta and Pfizer on 20 November 2023.

July 1, 2023

Seven biosimilars to AbbVie’s Humira® (adalimumab): Coherus Biosciences’ Yusimry®, Organon and Samsung Bioepis’ Hadlima®, Sandoz’s Hyrimoz®, Celltrion’s Yuflyma®, Fresenius Kabi’s Idacio®, Biocon Biologics’ Hulio® and Boehringer Ingelheim’s Cyltezo® are now commercially available in the US.

Each became authorised for supply in the US in July 2023 following their respective settlements with AbbVie. Samsung Bioepis settled with AbbVie on 5 April 2018, Viatris settled on 17 July 2018 (Biocon Biologics acquired Viatris’ global biosimilars business in November 2022), Sandoz settled on 11 October 2018, Fresenius settled on 18 October 2018, Boehringer settled on 14 May 2019, and Coherus settled on 27 November 2019, and Celltrion obtained a licence from AbbVie on 27 April 2022.

AbbVie entered into other deals with biosimilar entrants enabling US market entry, including: Alvotech (market entry on 1 July 2023, which has been delayed by a recent CRL from the FDA), Momenta (market entry on 20 November 2023), and Pfizer (market entry on 20 November 2023).

June 30, 2023

The Korea Biomedical Review reported that Celltrion has filed an NDA with the FDA for CT-P42 (aflibercept), biosimilar to Regeneron’s Eylea®.  Based on its phase III trials which demonstrated equivalence and similarity to Eylea®, Celltrion is seeking approval for all adult indications (including wet age-related macular degeneration and diabetic macular edema).  Celltrion will seek marketing authorisation for CT-P42 in key markets including Europe.

June 30, 2023

Kashiv Biosciences has completed a Phase I study comparing ADL-018, its omalizumab biosimilar, to Xolair® as marketed in the US by Genentech and in Europe by Novartis.  The study was a randomized, double blind, three-arm, single dose, parallel group, PK, PD and safety and immunogenicity study following single subcutaneous dosing in 306 healthy, adult subjects.

No results have been posted.

Amneal Pharmaceuticals and Kashiv Bioscience developed Fylnetra™ (biosimilar pegfilgrastim), which was approved by the FDA on 27 May 2022 to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.

June 29, 2023

The US District Court of Delaware has denied Biogen’s motion for preliminary injunction in its proceedings against Sandoz which were commenced in September 2022 regarding Sandoz’s natalizumab biosimilar.  Biogen and Sandoz filed a joint stipulation and proposed schedule, seeking a preliminary injunction after 07 April 2023.   Biogen filed a sealed complaint against Sandoz and Polpharma in September 2022, alleging infringement of 28 Biogen patents. Oral argument was heard on 17 May 2023.  The Court held that Biogen failed to demonstrate that it would suffer irreparable harm in the absence of an injunction and that it would likely succeed on the merits.  Interestingly, the Court confirmed in a footnote of the orders that it will ‘try its best to schedule a trial before April 2025’.

June 29, 2023

Express Pharma reported that Enzene Biosciences announced its launch of bevacizumab, biosimilar to Genentech’s Avastin®, in India to treat metastatic colorectal cancer, non-squamous non-small cell lung cancer and glioblastoma.

This news comes after Lupin and Enzene announced on 30 May 2023 a strategic collaboration to launch Cetuxa®, the first Indian biosimilar cetuximab for Eli Lilly and Merck’s Erbitux®.

June 29, 2023

Formycon and Klinge Biopharma announced that its BLA for FYB203 (biosimilar to Regeneron’s Eylea® aflibercept) has been submitted to the FDA. A response from the FDA is expected by the end of August 2023.  FYB203 is being developed by Formycon, and will be commercialised by Klinge Biopharma.

June 28, 2023

Alvotech provided an update about its high concentration adalimumab (AVT02) application in the US.  Alvotech has announced that the FDA issued a complete response letter (CRL) for its second BLA for AVT02 (high-concentration adalimumab, biosimilar to AbbVie’s Humira®, with interchangeability designation).   The CRL highlighted certain deficiencies found during the FDA’s reinspection of Alvotech’s facility in Reykjavik, Iceland must be resolved before the AVT02 application can be approved. Alvotech will now submit a new BLA for AVT02, with data supporting its interchangeability designation. Alvotech is exploring options to raise additional capital “due to the expected delay in the potential approval of AVT02 in the US”.

On 13 April 2023, Alvotech announced that had received and responded to the first CRL from the FDA regarding AVT02.   From 1 July 2023, Alvotech is licensed to supply AVT02 in the US from 01 July 2023 in accordance with its licence agreement with AbbVie.

June 28, 2023

Bloomberg reported that the Complete Response Letter (CRL) issued by the FDA in relation to Regeneron’s BLA for aflibercept 8mg identified deficiencies at Catalent Inc.’s facility in Bloomington, Indiana.  On 27 June 2023, Regeneron announced that that the FDA had issued a CRL in relation to inspection findings at a third-party filler, and that no issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.

June 27, 2023

Regeneron announced that the FDA has issued a Complete Response Letter (CRL) in relation to the Regeneron BLA for aflibercept 8 mg.  Aflibercept 8mg is being jointly developed by Regeneron and Bayer AG as a higher dose formulation of aflibercept (compared to the currently approved 2mg Eylea®) with the aim of extending treatment intervals.

Regeneron reported that the CRL was issued in relation to inspection findings at a third-party filler, and that no issues with clinical efficacy or safety, trial design, labeling or drug substance manufacturing were identified in the CRL.  Regeneron reported that it will work with the FDA and the third-party filler to obtain approval as soon as possible.

The BLA for aflibercept 8mg for was accepted by the FDA for priority review in February 2023, and has not yet been approved by any regulatory authority.

June 26, 2023

UCB announced that its Biologics License Application (BLA) for bimekizumab to treat moderate to severe plaque psoriasis remains under review with the FDA.  The FDA acceptance was expected in Q2, 2023, however it is not anticipated that the FDA will do so in Q3 2023.  Bimekizumab is an IL-17A and IL-17F inhibitor, is currently approved for moderate to severe psoriasis by 10 regulatory authorities and in 39 countries worldwide.

In June 2023, bimekizumab was approved for two additional indications in Europe – the treatment of adults with active psoriatic arthritis, and for the treatment of adults with active axial spondyloarthritis (axSpA), including non-radiographic axSpA and ankylosing spondylitis, also known as radiographic axSpA.

June 26, 2023

Aurobindo Pharma subsidiary CuraTeQ Biologics informed stock exchanges that it has withdrawn marketing authorisation applications to the EMA for biosimilars ZEFYLTI®, biosimilar to Amgen’s Neupogen® (filgrastim) and DYRUPEG®, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  The withdrawal was made after guidance was received from EMA, which advised the Company it will not obtain EU-GMP certification of its biosimilars manufacturing facility within the current Day 180 clock stop period, which would not be extended.  CuraTeQ confirmed it will work with the EMA to re-submit the applications as soon as possible.

On 11 January 2022, Orion Corporation and CuraTeQ Biologics announced an expansion to their biosimilar distribution agreement in Europe.

June 26, 2023

AstraZeneca announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended the MA for Astra Zeneca’s Soliris® (eculizumab) be expanded to include the treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor antibody-positive.  AZ confirmed that regulatory submissions for Soliris® for the treatment of paediatric patients with gMG are pending or planned with multiple health authorities.

On 13 June 2023 the Chinese NMPA approved Soliris® for treatment of gMG in adults who are anti-acetylcholine receptor antibody-positive.

June 24, 2023

Ocuphire announced its phase II clinical trial poster was presented at the 83rd Scientific Sessions of the American Diabetes Association, titled “Oral APX3330 Reduces the DRSS Worsening after 24-weeks of Daily Treatment—Efficacy and Safety Results of the ZETA-1 Phase 2 Trial in Diabetic Retinopathy”.  APX3330 is a first-in-class, small molecule oral drug, and is seeking to provide an alternative to intravitreal injection treatments.  The clinical trial demonstrated that APS3330 reduced clinically meaningful progression of diabetic retinopathy (DR), as measured by the DR severity scale (DRSS).

Ocuphire is meeting with the FDA for its End of Phase 2 meeting to confirm the Phase 3 study design.

June 23, 2023

Boehringer Ingelheim announced that Optum Rx, pharmacy benefit manager, will place Cyltezo® (adalimumab-adbm), the FDA-approved Interchangeable biosimilar to AbbVie’s Humira® on its commercial formulary as a preferred brand.  Optum Rx covers more than 66 million members in the US.

Optum Rx will also supply two other adalimumab biosimilars, Sandoz’s Hymiroz® and Amgen’s Amjevita®

Cyltezo® became authorised for supply in the US on 1 July 2023 following the Boehringer and AbbVie settlement  of their patent dispute on 14 May 2019.

June 22, 2023

ASLAN Pharmaceuticals announced that it entered an exclusive licence with Zenyaku Kogyo to develop and commercialise eblasakimab (a first-in-class monoclonal antibody) to treat atopic dermatitis in Japan.  ASLAN will receive an upfront payment of $12M from Zenyaku and is eligible for an extra $3M if it meets specific conditions relating to phase IIb trial data and delivery of the clinical study report.  ASLAN can potentially earn up to $29.5M in development milestones and up to $94M in commercial milestones.

Zenyaku will conduct a phase I study of eblasakimab in Japan during the first half of 2024 and will make royalty payments to ASLAN based on net sales of eblasakimab.  ASLAN retains an option to reacquire the rights to eblasakimab in Japan at any time in the future.

June 21, 2023

Samsung Bioepis has filed an IPR in the US against Alexion’s Soliris® (eculizumab) patent 10,703,809 (’809 patent) advocating that all claims of the ‘809 patent are obvious in light of the prior art (including patent applications, a granted patent, manuscripts and a journal article).

On the same day, Samsung Bioepis also filed an IPR against Janssen’s Stelara® (ustekinumab) patent no. 10,961,307 (‘307 patent), addressed here

June 21, 2023

Samsung Bioepis has filed an IPR against Janssen’s US patent no. 10,961,307 (‘307 patent) relating to Stelara® (ustekinumab).  Samsung Bioepis argues that all claims of the ‘307 patent are invalid. Claims 1-4, 6-22, and 24-34 allegedly lack novelty and are anticipated by a Janssen clinical overview summary for a phase III clinical trial of ustekinumab (NCT-236).   All claims (1-34) are allegedly obvious in light of NCT-236 combined with a journal article and the Stelara® Prescribing Information.

On the same day, Samsung Bioepis filed an IPR against Alexion’s US patent no. 10,703,809 (’809 patent) relating to Soliris® (eculizumab).

On 12 June 2023 Alvotech and Teva announced they reached a settlement and licence agreement with J&J for AVT04 (Alvotech’s biosimilar to Stelara®) providing a licensed US launch date of no later than 21 February 2025, and on 22 May 2023 Amgen settled its Stelara® patent invalidity suit with Janssen in the US with a licensed US launch date of no later than 1 January 2025.

June 21, 2023

Xbrane Biopharma announced the FDA has accepted a supplemental Biologics License Application (sBLA) for its biosimilar to Genentech’s Lucentis® (ranibizumab) to treat serious eye diseases such as wet age-related macular degeneration, macular edema following retinal vein occlusion and myopic choroidal neovascularization.  The Biosimilar User Fee Amendment goal date is 21 April 2024.

Xbrane entered into a co-development agreement with STADA Arzneimittel AG in 2018, and subsequently, in May 2020, the two companies signed an exclusive licensing agreement with Bausch + Lomb to bring the biosimilar candidate to market in the United States and Canada.

On 25 April 2023, STADA and Xbrane together announced the supply of Ximluci® (ranibizumab) on the NHS in England.

June 20, 2023

LOTTE Biologics announced it has signed a memorandum of understanding with LOTTE Corporation, Incheon Metropolitan City and the Incheon Free Economic Zone to establish biologics production facilities in the area.  LOTTE Biologics plans to construct three mega plants by 2030, that can produce 360,000L of biologic therapeutics.

On 8 June 2023, Samsung Biologics and Pfizer announced a US$411M collaboration to manufacture biosimilars in Korea.

June 16, 2023

BusinessWire reports that Bio-Thera Solutions and Biomm SA have reached a licensing and supply agreement for BAT2206 (ustekinumab biosimilar).  Under the agreement, Biomm will have exclusive rights to distribute and market the product in Brazil.

We previously reported that Bio-Thera has previously entered into a licence agreement with Hikma for the US (with option to add Europe) and with Pharmapark for Russia and other CIS countries.

June 16, 2023

Merck announced that it has acquired Prometheus Biosciences, Inc. which is now a wholly-owned subsidiary of Merck.  Prometheus’ leading candidate product PRA-023 (now known as MK-7240), is a humanized monoclonal antibody being developed to treat immune-mediated diseases such as autoimmune disease, ulcerative colitis and Crohn’s disease.

This news comes shortly after the FDA accepted sBLA for Merck’s KEYTRUDA® (pembrolizumab) plus chemotherapy for advanced or unresectable biliary tract cancer on 8 June 2023.

June 15, 2023

The Economic Times in India reported that Glenmark provided a drastic price drop in India for Trumab® (trastuzumab), biosimilar to Genentech’s Herceptin®.  Glenmark reduced the cost of its 440mg vial from ₹54,000 down over 70% to ₹15,749 in a market supplying the medicine for between Rs 40,000 and Rs 50,000 per vial.

June 15, 2023

Genentech announced that the FDA approved Columvi® (glofitamab-gxbm) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) not otherwise specified or large B-cell lymphoma (LBCL) arising from follicular lymphoma, after two or more lines of systemic therapy.  The FDA approved Columvi® under the accelerated approval pathway based on a phase I/II clinical trial.  Genentech confirmed that Columvi® will be available in the US in the coming weeks.

On 26 April 2023, the EMA’s Committee for Medicinal Products for Human Use recommended approval of Columvi® for R/R DLBCL.

June 15, 2023

Sandoz announced its new Act4Biosmilars Action Plan as part of its Act4Biosimilars initiative that aims to increase the adoption of biosimilars in over 30 countries by 30% by 2030.  The Plan features 12 initiatives to help accelerate biosimilar uptake, examining accessibility, affordability, approvability and acceptability.

The Plan will be supported by reports analysing challenges for biosimilar uptake across jurisdictions.  Sandoz confirmed that it will first report on issues in the Americas, including the complex interchangeability guidelines in the US, the risk to patients in Colombia and Ecuador where biosimilars may not meet appropriate WHO guidelines, lack of consistency in educational materials across Canada, the US and Brazil, and supply chain risks in Mexico and Brazil.

The Act4Biosimilars Impact Index will measure and assess progress for 30 initiative-tracked countries in relation to the favourability of the local environment towards biosimilars.

Sandoz initially launched its Act4Biosimilars campaign in May 2022.

June 14, 2023

Coherus has confirmed in a Form 8-K filed with the SEC that it has resolved its recent dispute with AbbVie relating to a potential breach of its settlement and licence agreement entered into in late 2019, under which Coherus received a royalty bearing non-exclusive licence to commercialise its biosimilar adalimumab YUSIMRY® from 1 July 2023.

According to the SEC disclosure, in a letter from AbbVie Coherus received on 6 June 2023, AbbVie claimed that Coherus breached its obligations under the agreement by announcing an 85% discount for its US launch of YUSIMRY® and its partnership with Mark Cuban on 1 June 2023.

Coherus responded to AbbVie on 11 June 2023 denying the allegation and requesting more information. On 13 June, it also filed a motion for a temporary restraining order in the District Court of Delaware against AbbVie to prevent it from terminating the license, and AbbVie filed for preliminary injunction on the same day

After negotiations the next day, 14 June 2023, Coherus agreed to resolve its motion for a temporary restraining order against AbbVie, and AbbVie agreed not to terminate the licence agreement relating to the commercialisation of YUSIMRY®, adalimumab biosimilar to AbbVie’s Humira®.  AbbVie will only be entitled to terminate if it serves a new notice of breach and affords Coherus an opportunity to cure any alleged breach.

June 14, 2023

Seagen’s SEC filing has disclosed that Pfizer withdrew its notification to the Federal Trade Commission (FTC) and Department of Justice (DOJ) to acquire Seagen for US$43B.  The filing also notes that the companies expect to complete the acquisition in late 2023 or early 2024.

On 12 March 2023, Seagen and Pfizer entered into an agreement to merge, in which Seagen would become a wholly-owned subsidiary of Pfizer.  On 12 May 2023, Seagen and Pfizer each filed a Notification and Report Form relating to the merger with the FTC and DOJ as required under the Hart-Scott-Rodino Antitrust Improvements Act of 1976 (Act). Only a few days later, the FTC brought proceedings to block Amgen’s US$27.8B acquisition of Horizon Therapeutics.  On 30 May 2023, Seagen shareholders approved the acquisition by Pfizer.

By withdrawing the form, the statutory waiting period under the Act will now expire on 14 July 2023 (which can be extended if the FTC requests additional information / documents).  Whilst it is possible that Pfizer’s notification withdrawal is in response to FTC proceedings against Amgen, it has not yet been confirmed by either Pfizer or Seagen.

Pfizer also filed the requisite documentation with the European Commission pursuant to Article 4(5) of the EU Merger Regulation, alerting it of the intended merger on 1 June 2023.

June 13, 2023

The Korea Economic Daily reports that Celltrion announced it intends to apply for regulatory approval of five new biosimilars before the end of 2023. Celltrion intends to offer more than 10 biosimilars by 2025, of which it currently offers six.  Celltrion also confirmed that its biosimilar to Amgen’s Prolia® (denosumab) and Genentech’s Actemra® (tocilizumab) are in phase III clinical trials and it intends to apply for their approval by the end of 2023.

Since April 2023, Celltrion has filed MAAs with the EMA for its biosimilar to Janssen’s Stelara® (ustekinumab) and its biosimilar to Genentech/Novartis’ Xolair® (omalizumab), has submitted a phase III IND plan to the FDA for its biosimilar to Genentech’s Ocrevus® (ocrelizumab), and announced positive phase III trials for its biosimilar to Regeneron’s Eylea® (aflibercept).

June 13, 2023

AstraZeneca announced that the Chinese NMPA has approved Soliris® (eculizumab) for treatment of refractory generalised myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AChR) antibody-positive. This is the third approved indication approved for Soliris® in China, and is the first and only complement inhibitor approved to treat gMG in China.  The NMPA’s approval was based on results of the Phase III REGAIN trial in which Soliris® demonstrated clinical benefit for patients with anti-AChR antibody-positive gMG who had previously failed immunosuppressive treatment and suffered significant unresolved disease symptoms.

Biosimilars to Soliris® are in the pipeline: on 30 May 2023 Samsung Bioepis’ Epysqli® (eculizumab) was approved in Europe to treat paroxysmal nocturnal hemoglobinuria, and on 23 February 2023 the CHMP recommended MA for Amgen’s Bekemv® for the same condition.

June 12, 2023

Alvotech and Teva announced they have reached a settlement and license agreement with Johnson & Johnson for AVT04, Alvotech’s biosimilar to Stelara® (ustekinumab).  J&J have granted a license entry date for AVT04 in the US no later than 21 February 2025. This is seven weeks after the reported date by which Amgen will be able to enter the market (1 January 2025) pursuant to its recent settlement with J&J.

On 6 January 2023, the FDA accepted the BLA for AVT04.

June 9, 2023

Biogen announced that the FDA’s Peripheral and Central Nervous System Drugs Advisory Committee (PCNS) unanimously voted that the results of a specific Eisai phase III clinical trial verified the clinical benefit of LEQEMBI® (lecanemab) for the treatment of Alzheimer’s disease.  The Committee also confirmed the overall benefit-risk profile and the clinical meaningfulness of the data.  The FDA released a briefing document on 7 June 2023 outlining its views ahead of the PCNS meeting on 9 June 2023.

On 5 March 2023, Biogen and Eisai Co announced that the FDA has accepted their sBLA and granted priority review for traditional approval of LEQEMBI™ (lecanemab) for treatment of Alzheimer’s disease.  It was approved under the Accelerated Approval Pathway on 6 January 2023 (approval based on ‘surrogate’ marker or endpoint).

June 8, 2023

JAMA Ophthalmology published the results of Ph III trials of Samsung Bioepis’ SB15 (aflibercept biosimilar).  Researchers reported that SB15 showed equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to reference aflibercept in participants with neovascular age-related macular degeneration.  In April 2023, Samsung Bioepis announced 1-year outcomes of its Ph III study of SB15 at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.

June 8, 2023

Samsung Biologics and Pfizer announced that they have entered a new long-term strategic partnership for manufacturing of Pfizer’s biosimilars portfolio.  According to a Samsung Biologics company filing, the contract is worth US$411M.  Using its newest facility, Plant 4, Samsung Biologics will provide Pfizer with additional capacity for large-scale manufacturing of biosimilars covering oncology, inflammation, and immunology.

This news comes only days after Samsung Biologics announced it will accelerate the timeline for construction and operations of its new, fifth manufacturing plant.

June 8, 2023

Merck announced the US Food and Drug Administration (FDA) has accepted for review a new supplemental Biologics License Application (sBLA) seeking approval for KEYTRUDA®, Merck’s anti-PD-1 therapy, in combination with gemcitabine and cisplatin chemotherapy for the treatment of patients with locally advanced unresectable or metastatic biliary tract cancer (BTC).

June 7, 2023

Eisai and Biogen announced that Eisai filed a marketing authorisation application (MAA) for LEQEMBI® (lecanemab) for treatment of early Alzheimer’s disease (mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD dementia) with confirmed amyloid pathology in the brain.  The submission for the investigational anti-amyloid beta antibody was made to the Ministry of Food and Drug Safety in South Korea based on positive results from Phase III and Phase IIb studies

Eisai submitted an MAA to the MHRA in the UK for LEQEMBI® only a few weeks ago.

June 6, 2023

Samsung Biologics announced that it will accelerate the construction and completion of Plant 5, which will now be in operation by April 2025.  The plant will add 180,000L capacity to Samsung Biologics’ capabilities, so it will maintain the world’s largest biomanufacturing capacity at 784,000L upon completion.  Samsung Biologics CEO John Rim announced at BIO2023 that completion of the fifth plant was initially expected in September 2025.

This week Samsung Biologics and Pfizer announced a collaboration to manufacture biosimilars.

June 6, 2023

The US District Court for the Northern District of West Virginia has granted Regeneron’s motion for judgment dismissing Mylan’s inequitable-conduct counterclaims regarding two Eylea® (aflibercept) patents (US patent nos. 10,888,601 and 11,235,572).  Chief Judge Thomas Kleeh also dismissed Mylan’s  second motion to amend its answer, defences, and counterclaims.   The case is set down for an expedited two-week trial on 12 June 2023.

In a separate judgment, the Court also denied motions for summary judgment filed by each of Regeneron and Mylan in April.  Regeneron requested summary judgment of non-obviousness in relation to its US patent no. 11,084,865.  Mylan sought summary judgment or partial summary judgment in its favour in relation to counts 12, 17, 18, and 21 of the complaint filed by Regeneron.  In relation to both requests, Chief Judge Kleeh found that genuine disputes regarding material facts existed to the extent that summary judgment for either party would be inappropriate.

Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of various patents relating to Eylea®.  On 23 May 2023, Amgen filed a motion to intervene in the proceedings.

June 5, 2023

Dr Reddy’s Laboratories announced completion of a successful phase I clinical trial of DRL_TC, its biosimilar to Genentech’s Actemra® (tocilizumab) by intravenous route.  The study demonstrated the pharmacokinetic equivalence, safety, and immunogenicity of DRL_TC compared to the reference products (US sourced Actemra® and EU sourced RoActemra®), confirming similarity in pharmacodynamic parameters and no notable differences in safety and immunogenicity.

In December 2022, Dr Reddy’s announced successful phase I trial of DRL_TC by subcutaneous route.

June 5, 2023

Rani Therapeutics announced that it has expanded its partnership with Celltrion to develop an orally administered adalimumab biosimilar RT-105, following their previous collaboration on an ustekinumab biosimilar.  The partnership allows Rani to use Celltrion’s adalimumab biosimilar drug substance (CT-P17) exclusively for the development and commercialisation of RT-105.   Celltrion will have the option to acquire worldwide rights to RT-105 after a phase I study.

Rani developed the RaniPill® capsule, an oral delivery technology which intends to replace subcutaneous or intravenous injection of biologics and drugs.  This is the first announced partnership for a program involving the RaniPill® HC, a high-capacity device in preclinical testing that delivers 20mg of payload with high bioavailability.

June 5, 2023

Samsung Biologics revealed in a regulatory filing with Korea Exchange that it has signed a US$81M CMO contract with a ‘European pharmaceutical company’.  The contract amount is 3.58% of sales and is binding on the two companies.  Samsung said that when the main contract is concluded in the future, the confirmed details will be disclosed.  The EU pharma company name must be disclosed by 1 January 2024 according to the corporate filing.

In March 2023, Samsung Biologics announced it will begin construction of its fifth plant in Korea.

June 3, 2023

Merck announced positive results in two studies evaluating Keytruda®, its anti-PD-1 therapy.   

Merck reported that its Phase 3 KEYNOTE-671 trial evaluating Keytruda® plus chemotherapy before surgery and continued as a single agent after surgery showed reduced risk of disease recurrence, progression or death by 42% versus pre-operative chemotherapy in resectable Stage II, IIIA or IIIB non-small cell lung cancer (NSCLC).  Merck previously announced that, based on these results, the U.S. Food and Drug Administration (FDA) accepted a new supplemental Biologics License Application (sBLA) for Keytruda® for the treatment of these patients in combination with platinum-containing chemotherapy as neoadjuvant treatment, and then continued as a single agent as adjuvant treatment, with a target action date of October 16, 2023.  

Merck also reported that its Phase 3 KEYNOTE-483 trial evaluating Keytruda® plus chemotherapy as first-line treatment for patients with unresectable advanced pleural mesothelioma showed significantly improved overall survival chemotherapy alone.   

June 2, 2023

Sanofi-Aventis filed one of the earliest UPC revocation cases against Amgen’s Repatha® (evolocumab) patent EP3666797 in Munich on 2 June 2023, the day after the UPC’s commencement. Evolocumab is a human monoclonal antibody that inhibits proprotein convertase subtilisin/kexin type 9 (PCSK9).  To date, this is the only UPC case relating to a monoclonal antibody.

On 18 May 2023, the US Supreme Court invalidated genus claims in two Amgen patents relating to Repatha® (evolocumab).

June 1, 2023

Innovent announced that it has entered into a clinical trial collaboration and supply agreement with Merck for a combination therapy of IBI351 (GFH925) with cetuximab (ERBITUX®).  Innovent says the therapy is a potential treatment for non-small cell lung cancer (NSCLC) which will be tested in a phase Ib clinical trial in Chinese patients with advanced or metastatic NSCLC harbouring KRASG12C mutation. 

In October last year, Merck entered a clinical trial collaboration with Jacobio Pharma to investigate a combination therapy of JAB-21822 (KRAS G12C inhibitor) with ERBITUX® to treat KRAS G12C-mutated colorectal cancer. 

June 1, 2023

Novartis announced that the European Commission (EC) has approved its Cosentyx® (secukinumab) for a new indication to treat active moderate to severe hidradenitis suppurativa (HS) in adult patients who have had an inadequate response to conventional systemic HS therapy.  This is the first biologic treatment approved for HS in nearly a decade.  Novartis said a decision from the FDA for this indication is expected later this year.  

This approval follows the CHMP recommendation last month. 

June 1, 2023

Coherus announced it is launching YUSIMRY® (adalimumab-aqvh) biosimilar to AbbVie’s Humira®, in July 2023 with a list price of $995 per carton.  This is the lowest price announced of any adalimumab product in the US, and represents an 85% discount on the originator product.   

On the same day, Coherus also announced a partnership with Mark Cuban Cost Plus Drug Company (MCCPDC) to offer MCCPDC customers YUSIMRY® in July 2023 for $569.27 plus dispensing and shipping fees. 

YUSIMRY® was approved by the FDA in December 2021 indicated for plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis.  As the AbbVie global Humira® (adalimumab) empire crumbles, Samsung Bioepis/Merck has the next licensed launch date in the US on 30 June this year, and the next day (1 July) the following  biosimilar entities are licensed launch: Alvotech, Celltrion, Boehringer Ingelheim, Coherus before Fresenius Kabi in July (on an unspecified date), Mylan/Viatris on 31 July 2023, Sandoz on 30 September  2023,  Momenta and Pfizer on 20 November 2023. 

June 1, 2023

Celltrion has received marketing authorization from the New Zealand Medicines and Medical Devices Safety Authority (MEDSAFE) for Remsima® SC, biosimilar to Janssen’s Remicade® (infliximab). It has been approved for the full range of indications previously approved for Remicade®, namely rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, adult Crohn’s disease, and adult ulcerative colitis.

This news comes as Celltrion launched Remsima® SC in Brazil on 22 May 2023, and has received approval in several other jurisdictions (EuropeKorea and Canada) for treatment of various inflammatory conditions.

May 31, 2023

The FDA announced that it has approved AstraZeneca’s Lynparza® (olaparib) with abiraterone and prednisone (or prednisolone) for patients with deleterious or suspected deleterious BRCA-mutated metastatic castration-resistant prostate cancer, as determined by an FDA-approved companion diagnostic test.  Following this approval, AstraZeneca announced that it will receive a regulatory milestone payment from MSD, anticipated to be confirmed in Q2 2023 results. 

This news follows the FDA’s Oncologic Drugs Advisory Committee vote to support FDA approval of Lynparza® with abiraterone and prednisone (or prednisolone) for the above indication in April 2023.  

May 31, 2023

Celltrion has released its clinical phase I data for its tocilizumab product CT-P47, biosimilar to Roche’s Actemra® which it announced at the 2023 European Congress of Rheumatology (2023 EULAR).  Celltrion has successfully demonstrated pharmacodynamic equivalence and safety comparable to Actemra®.  

Last week Celltrion filed MAA with EMA for biosimilar to Janssen’s Stelara® (ustekinumab).  

May 30, 2023

BMS announced that the FDA accepted its New Drug Application for repotrectinib, a tyrosine kinase inhibitor for the treatment of ROS1-positive locally advanced or metastatic non-small cell lung cancer (NSCLC).  The FDA granted the application Priority Review and a decision is expected by 27 November 2023.  If approved, it could potentially be a best-in-class option for TKI-naïve patients and a first-in-class option for previously treated patients with ROS1-positive NSCLC.   

BMS recently announced that the FDA has accepted its sBLA, and the EMA has validated its Type II Variation Application, for Reblozyl® (luspatercept-aamt). 

May 30, 2023

Lupin announced a strategic collaboration with Enzene Biosciences (Aklem Laboratories’ biological arm) to launch Cetuxa®, the first Indian biosimilar cetuximab for Eli Lilly and Merck’s Erbitux®.  Cetuximab is approved by Drug Controller General of India for treating head and neck cancer, particularly Squamous Cell Carcinoma of the Head and Neck (SCCHN).  

In February 2023, Enzene Biosciences began supply of its Humira® (adalimumab) biosimilar in India for the treatment of ankylosis spondylitis and rheumatoid arthritis.   

May 30, 2023

The European Commission (EC) has granted Marketing Authorisation for Samsung Bioepis’ Epysqli® (eculizumab), biosimilar to Alexion’s Soliris®.  Epysqli® is approved for the treatment of adult and children patients with paroxysmal nocturnal hemoglobinuria (PNH), and is Samsung Bioepis’ first hematology biosimilar. 

The EMA Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for Epysqli® on 30 March 2023. 

May 30, 2023

Chia Tai Tianqing announced that it received a drug registration certificate from China’s National Medical Products Administration for DELITUO® biosimilar to Roche’s Mabthera® (rituximab). It is indicated for treatment of non-Hodgkin’s lymphoma (follicular lymphoma, CD20-positive diffuse large B-cell lymphoma, chronic lymphoma Tumor cell leukemia).

In March 2022, Henlius obtained NMPA approval of its rituximab biosimilar (汉利康®).

May 29, 2023

Roche has announced that it has successfully concluded meetings with pan-Canadian Pharmaceutical Alliance (pCPA) regarding Vabysmo® (faricimab).  The company said that it secured a letter of intent with the pCPA for Vabysmo®, a treatment indicated for neovascular age-related macular degeneration and diabetic macular edema.  The pCPA’s mandate is to enhance patient access to clinically relevant and cost-effective drug treatment options by conducting collective, expert-informed negotiations for drugs. 

Roche Canada intends to work with other provincial jurisdictions to make Vabysmo® available as soon as possible through public drug plans. 

This news comes a few weeks after the FDA accepted Roche’s sBLA for Vabysmo® to treat macular edema following retinal vein occlusion.  

May 26, 2023

The EMA’s Committee for Medicinal Products for Human Use (CHMP) has recommended that Adakveo® (crizanlizumab) should no longer be used to prevent painful crises in patients aged 16 years and older with sickle cell disease This follows a review by the CHMP, which concluded that the benefits of the medicine did not outweigh its risks The CHMP reviewed a clinical trial study which compared the effectiveness and safety of Adakveo® with placebo, and demonstrated that Adakveo® did not lead to a decrease in painful crises when compared to the placebo.  

May 26, 2023

Alnylam commenced  proceedings in the US District Court of Delaware on 26 May 2023 against both Moderna and Pfizer alleging patent infringement over Alnylam’s RNA Lipid Particle Technology encompassed in United States Patent Nos. 11,590,229, 11,633,479, 11,633,480 and 11,612,657.  Alnylam claims that its patented technology is ‘foundational to the success of the recently-developed messenger RNA (mRNA) based COVID vaccines’.    

Alnylam alleges that Moderna: 

  • infringes Alnylam’s ’479 patent and ’480 patent by using SM102, a protonatable biodegradable lipid formulated into lipid particles that protect and deliver the vaccine’s mRNA;  
  • infringes Alnylam’s ’229 patent by using Alnylam’s patented lipid particles that protect and deliver Moderna’s COVID-19 Vaccine’s mRNA (comprising four lipids: SM-102, polyethylene glycol [PEG] 2000 dimyristoyl glycerol [DMG], cholesterol, and 1,2-distearoyl-sn-glycero-3- phosphocholine [DSPC]); and 
  • used confidential information presented to it in discussions between Alnylam and Moderna in 2013/2014 about a potential license Alnylam’s IP along with a potential business relationship or a collaboration. 

Alnylam alleges that Pfizer infringes: 

  • Alnylam’s ’479 patent through the use of ALC-0315, a lipid compound used in Pfizer’s COVID-19 Vaccine; 
  • the ’480 patent through the use of ALC-0315, which is formulated into a lipid particle that protects and delivers the vaccine’s mRNA; and 
  • Alnylam’s ’657 and ’229 patents through the use of Alnylam’s patented lipid particles that protect and deliver Pfizer’s COVID-19 Vaccine’s mRNA (comprising four lipids: ALC-0315 (a protonatable biodegradable lipid), 2-(polyethylene glycol 2000)-N,N-ditetradecylacetamide (a PEG-modified lipid), 1,2-distearoyl-sn-glycero-3-phosphocholine (DSPC), and cholesterol).  

Alnylam is seeking to recovery monetary compensation for Moderna and Pfizer’s unlicensed use of Alnylam’s patents.  Alnylam is not seeking injunctive relief. 

May 26, 2023

The Medicines and Healthcare products Regulatory Agency (MHRA) announced the establishment of new regulatory recognition routes for medicines, utilising approvals from Australia, Canada, the EU, Japan, Switzerland, Singapore, and the US to expedite new product approvals This framework will leverage the expertise and decision-making of regulatory partners to expedite the assessment of specific products, resulting in faster access to medicines in the UK and reducing costs and streamlining regulatory processes for the industry.  The UK regulator will remain responsible for approving and/or rejecting applications under the new framework.  The MHRA expects the framework will be in place by Q1 2024.  

May 26, 2023

Korea Biomed has reported that Celltrion filed a marketing authorisatn application with the EMA for CT-P43, its biosimilar to Janssen’s Stelara® (ustekinemab).  Based on its phase III clinical trial in plaque psoriasis patients, which demonstrated similar efficacy, pharmacokinetic, and safety results between CT-P43 and Stelara®, Celltrion’s MAA sought approval for all Stelara® indications.  Celltrion confirmed it intends to seek approval in other key countries.

May 26, 2023

The Pharma Letter has reported that the STADA-controlled Norbitec biologics facility in Uetersen, Germany, has been approved by the FDA to manufacture and store Pfizer’s Retacrit® (epoetin alfa-epbx), biosimilar to Amgen’s Epogen®/Procrit®.  The approval followed a six-day FDA inspection of the German site.

May 26, 2023

Astrazeneca announced that it has received approval in Japan for Ultomiris® (ravulizumab).  Ultomiris is  the first and only long-acting C5 complement inhibitor approved for preventing relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica.  The approval was based on positive results from the CHAMPION-NMOSD Phase III trial, which demonstrated the efficacy of Ultomiris® in preventing relapses.  

Ultomiris was also recently approved in the EU for NMOSD treatment, and regulatory reviews are ongoing in other countries including the US.  

May 26, 2023

Bristol Myers Squibb announced that the EMA CHMP recommended the approval of Opdivo® (nivolumab) in combination with platinum-based chemotherapy for the neoadjuvant treatment of resectable non-small cell lung cancer (NSCLC) with a high risk of recurrence in adult patients whose tumor cells express PD-L1 at a level of 1% or higher.  The recommendation is based on positive results from the CheckMate-816 trial, which demonstrated significant improvement in event-free survival and pathologic complete response when Opdivo® was combined with chemotherapy compared to chemotherapy alone prior to surgery.   

Opdivo® is already approved to treat melanoma, as an adjuvant treatment of melanoma, treat non-small cell lung cancer (with ipilimumab), malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell cancer of the head and neck, urothelial carcinoma, as an adjuvant treatment of urothelial carcinoma, treat mismatch repair deficient or microsatellite instability-high colorectal cancer, oesophageal squamous cell carcinoma, as an adjuvant treatment of oesophageal or gastro-oesophageal junction cancer and treat gastric, gastro-oesophageal junction (GEJ) or oesophageal adenocarcinoma.  

In April 2023 BMS brought proceedings against AstraZeneca in the US District Court of Delaware claiming AstraZeneca’s Imfinzi® (durvalumab) infringed its patent encompassing Opdivo® 

May 26, 2023

AstraZeneca announced that its Ultomiris® (ravulizumab) has a new indication approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) as the first and only long-acting C5 complement inhibitor for the prevention of relapses in patients with anti-aquaporin-4 (AQP4) antibody-positive (Ab+) neuromyelitis optica spectrum disorder (NMOSD), including neuromyelitis optica.  The approval was based on AZ’s phase III clinical trial where Ultomiris® was compared to an external placebo arm from the Alexion Soliris® (Eculizumab) PREVENT clinical trial. 

Two weeks ago the European Commission approved Ultomiris® for the same condition above.  

May 26, 2023

A study published in JAMA Network Open has found in a systematic review and meta-analysis that biosimilars of adalimumab, etanercept, and infliximab were associated with clinically equivalent effects in patients with rheumatoid arthritis compared with their reference biologics (AbbVie’s Humira®, Amgen’s Enbrel® and J&J’s Remicade® respectively).  The authors assessed 25 head-to-head trials (including 10,642 randomised participants) and found the biosimilars were associated with similar rates of adverse events, study discontinuation, and immunogenicity responses compared with reference biologics.

Only two weeks ago on 8 June 2023, the Ph III results of Samsung Bioepis’ SB15 (aflibercept biosimilar) published in JAMA Ophthalmology showed equivalent efficacy and comparable safety, pharmacokinetics and immunogenicity to reference aflibercept.

May 25, 2023

Takeda and HUTCHMED announced that the FDA granted priority review for the NDA of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2, and -3, for the treatment of previously treated metastatic colorectal cancer.  The Prescription Drug User Fee Act goal date for the FDA’s decision is set for 30 November 2023.  The NDA submission includes data from the Phase 3 FRESCO-2 trial, which demonstrated significant improvements in overall survival and progression-free survival.  Fruquintinib is currently approved in China under the brand name ELUNATE®.

May 25, 2023

Sandoz announced that the European Medicines Agency (EMA) has accepted marketing authorisation applications (MAA) for its proposed biosimilar denosumab, for regulatory review. The two applications include the approved indications for the originator drugs Prolia® and Xgeva®, including osteoporosis in postmenopausal women and in men at increased risk of fractures, treatment-induced bone loss, prevention of skeletal related complications in cancer that have spread to the bone, and giant cell tumor of the bone.

This week Mitsubishi and GlycoNex announced Japanese approval of their phase I clinical trial of SPD8, a denosumab biosimilar to Prolia®

May 25, 2023

Daiichi Sankyo announced that VANFLYTA® (quizartinib) has been approved in Japan for a new indication: the treatment of FLT3-ITD mutation positive acute myeloid leukemia (AML)VANFLYTA® is now approved to treat these patients in combination with standard cytarabine and anthracycline induction and standard cytarabine consolidation chemotherapy and as maintenance monotherapyThis is the first and only FLT3 inhibitor in Japan approved for newly diagnosed AML treatment. The existing approval from June 2019 covers relapsed or refractory FLT3-ITD mutation-positive AML.  

May 24, 2023

As previously reported, on 22 May 2023 the US District Court of Delaware dismissed Janssen’s patent infringement case against Amgen pertaining to its Stelara® (ustekinumab) biosimilar with prejudice on the basis that each party bears its own costs. The proposed orders made it clear that the parties had settled.

Reuters has since reported a statement by Amgen that the ustekinumab settlement will permit Amgen to sell its biosimilar “no later than January 1st, 2025”, suggesting the permitted launch date may be earlier than 1 January 2025.  As the API patent, one of six patents Janssen asserted in the proceedings, expires on 25 September 2023, we speculate that the agreed launch date is some time between 25 September 2023 and 1 January 2025.

May 23, 2023

Celltrion announced that its Yuflyma® (adalimumab) product, a high-concentration formulation and biosimilar to AbbVie’s Humira®, has obtained FDA approval.  According to Celltrion, Yuflyma® will be available in the US from July for the key indications of Humira®, including rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, plaque psoriasis, and Hidradenitis Suppurativa.

Celltrion’s announcement came only three days after Boehringer Ingelheim announced its Humira® biosimilar Cyltezo® autoinjector pen obtained FDA approval.

May 23, 2023

Mitsubishi Gas Chemical Company, Inc. and GlycoNex announced approval to commence a phase I clinical trial of SPD8 denosumab, biosimilar to Amgen’s Prolia®, from the Japanese Pharmaceuticals and Medical Devices Agency (PMDA).  The companies announced that the first patient has now been enrolled.  The double-blind trial will compare SPD8 with Prolia® in healthy postmenopausal women, who will undergo pharmacokinetic and safety assessments.

This month Boan Biotech commenced its phase III clinical trial for its Prolia® denosumab biosimilar.

May 23, 2023

The National Institute for Health and Care Excellence (NICE) has issued a final appraisal document recommending Merck’s Keytruda® (pembrolizumab) combined with Eisai’s Lenvima® (lenvatinib) as an option for treating advanced or recurrent endometrial cancer in adults whose cancer has progressed on or after platinum-based chemotherapy who cannot have curative surgery or radiotherapy, in the NHS in England and Wales.

In March 2023, NICE recommended the use of Keytruda® for advanced cervical cancer in the NHS, funded by the Cancer Drugs Fund.

May 23, 2023

Amgen filed a motion to intervene in the proceedings on foot between Regeneron and Mylan in West Virginia relating to aflibercept, and has sought to unseal certain documents. Amgen argued that the sealing of the documents blocked the public’s right of access to Court documents, and that the Court has provided no justification for sealing a number of documents.

Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea (including the ‘601 patent), and a 10 day trial has been set down for June 2023, which is 10 months after Regeneron filed its complaint.

May 22, 2023

Alvotech announced that it has entered into a master license and supply agreement with Advanz to commercialise and supply in Europe AVT05 (biosimilar to Janssen’s Simponi® and Simponi Aria® (golimumab)), AVT16 (biosimilar to Takeda’s Entyvio® (vedolizumab)), and three additional early-stage, undisclosed biosimilar candidates.

Under this agreement:

  • Alvotech will develop the products and provide the dossiers.
  • Advanz has an exclusive right to obtain and maintain regulatory approvals for the products and to commercialize them in the European Economic Area, the United Kingdom and Switzerland
  • Advanz will make upfront payments of €56M
  • Advanz will make additional milestone payments for an aggregate amount of up to €264
  • Alvotech will manufacture, supply and deliver the product to Advanz
  • Advanz will exclusively buy the relevant biosimilar candidate from Alvotech at a royalty of approximately 40% of the estimated net selling price or an agreed-upon floor price

On 19 May 2023, Alvotech and STADA entered into three termination agreements to terminate the license and supply agreements between Alvotech and STADA pertaining to Alvotech’s product candidates AVT03 (biosimilar candidate to Prolia®/Xgeva® (denosumab)), AVT05 and AVT16.  Alvotech will repay €17.4M it received from STADA under the (now terminated) agreement.

On 19 May 2023, Alvotech also disclosed the reference products for two product candidates in its pipeline: AVT16 (above) and the reference product for AVT33 is Merck’s Keytruda® (pembrolizumab).

This comes after Alvotech announced in February 2023 that it entered an exclusive agreement with Advanz Pharma regarding   for EU, UK CA, CH and ANZ.

May 22, 2023

The Korea Herald has reported that Celltrion has launched its Remsima® SC (infliximab, bio-better to Janssen’s Remicade®) in Brazil, the largest pharmaceutical market in South America.  Celltrion is also selling Remsima® and Truxima® (rituximab, biosimilar to Biogen’s Rituxan®) in Brazil and plans to introduce Remsima SC in Mexico, Colombia and Peru during the second half of 2023.

Celltrion recently presented its positive phase III results for Remsima® SC as a sub-cutaneous maintenance therapy for IBD patients.

May 22, 2023

Coherus BioSciences announced that its single-dose prefilled autoinjector of UDENYCA® (pegfilgrastim-cbqv), biosimilar to Amgen’s Neulasta®, is now available in the US.  UDENYCA® is administered after chemotherapy to decrease the incidence of infection as manifested by febrile neutropenia.

The FDA approved Udenyca® as a single-dose, prefilled autoinjector in March 2023.

May 22, 2023

The US District Court of Delaware has dismissed with prejudice Janssen’s patent infringement case against Amgen pertaining to its Stelara® (ustekinemab) biosimilar.  The parties agreed to dismiss the action with prejudice and each party will bear its own costs, expenses and attorney’s fees, and the proposed orders state the parties have agreed to settle the litigation.

Janssen commenced these proceedings against Amgen in November 2022 in relation to the API and MOT (UC) patents, and filed a motion for preliminary injunction in March 2023 (following dismissal of an earlier application due to non-compliance with the Court’s page limit requirements).

May 21, 2023

Boehringer Ingelheim announced that the FDA has approved an autoinjector pen presentation of its Cyltezo® (adalimumab-adbm), an FDA-approved interchangeable biosimilar to AbbVie’s Humira® (adalimumab). Cyltezo® is indicated for multiple chronic inflammatory diseases.  The autoinjector pens will be available in the US from 1 July 2023.

Boehringer is licensed to supply its adalimumab biosimilar in the US from 1 July 2023.  In total, AbbVie entered into numerous deals with biosimilar entrants enabling US market entry as follows: Samsung Bioepis/Merck (30 June 2023),  Alvotech (1 July 2023), Coherus (1 July 2023),  Celltrion (July 2023),  Fresenius Kabi (July 2023),  Mylan/Viatris (31 July 2023), Sandoz (30 September 2023), Momenta (20 November 2023), and Pfizer (20 November 2023).

May 21, 2023

Biogen and Eisai announced that Eisai submitted a marketing authorisation application (MAA) for LEQEMBI® (lecanemab) to the UK Medicines and Healthcare products Regulatory Agency (MHRA).  LEQEMBI® is an investigational anti-amyloid beta protofibril antibody indicated for the treatment of early Alzheimer’s disease (AD) with confirmed amyloid pathology in the brain.  Lecanemab has been designated by the MHRA for the Innovative Licensing and Access Pathway.

Last week Health Canada accepted a new drug submission for LEQEMBI® to treat early AD and mild AD dementia with confirmed amyloid pathology in the brain.

May 21, 2023

A study published in the New England Journal of Medicine has found that patients with chronic obstructive pulmonary disease (COPD) and type 2 inflammation who received Dupixent® (dupilumab) had fewer exacerbations, better lung function and quality of life, and less severe respiratory symptoms than those who received the placebo.  The results of this phase III, double-blind randomised trial were simultaneously announced at the 2023 American Thoracic Society (ATS) International Conference.

The study was sponsored by Sanofi with Regeneron as collaborator.

May 19, 2023

Alvotech has provided updates on some of its biosimilar products in its report on its financial results for the first 3 months of 2023.

  • As previously reported, Alvotech initiated a confirmatory patient study for AVT05, its proposed biosimilar to Simponi® and Simponi Aria® (golimumab).
  • In March 2023, Alvotech provided Biosana Pharma a notice of termination for the licensing agreement between the two companies relating to AVT23, biosimilar to Xolair® (omalizumab). The deal was announced in February 2022.

May 18, 2023

The US Supreme Court handed down its decision in Amgen v Sanofi, relating to the enablement requirement.  Amgen filed the Supreme Court petition in response to a Federal Court decision which invalidated genus claims in two Amgen patents relating to Repatha® (evolocumab) which it asserted against Sanofi/Regeneron regarding Praluent® (alirocumab).  A unanimous Supreme Court affirmed the Federal Circuit’s ruling that the Amgen patent claims were not enabled.

On 3 November 2022, the Supreme Court granted Amgen’s petition for certiorari in relation to ‘whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort’”.

The patents in suit relate to engineered antibodies that reduce levels of low-density lipoprotein (LDL) cholesterol.  In 2011, both Amgen and Sanofi obtained patents covering the antibody used in their respective drugs.  The dispute concerned two additional patents Amgen obtained in 2014 claiming  “the entire genus” of antibodies that “bind to specific amino acid residues on PCSK9” and “block PCSK9 from binding to [LDL receptors].”

The Supreme Court emphasised that to satisfy the enablement requirement, it may be sufficient to provide “an example if the specification also discloses ‘some general quality . . . running through’ the class that gives it ‘a peculiar fitness for the particular purpose’”.

The Court held that Amgen’s patents only describe 26 antibodies but claim “a vast number of additional antibodies,” and opined that Amgen “offers persons skilled in the art little more than advice to engage in “trial and error” to make every embodiment within a broad claim.

May 18, 2023

Teva announced its new strategic framework and “Pivot to Growth” strategy which aims to bolster the Company’s strong commercial portfolio with products including biosimilars. Biosimilars are part of Teva’s ‘accelerate growth’ stage between 2025-2027.  The company intends to focus on biosimilar launches, and has near-term biologics products targeting >US$40B that are in late stage development.

On 6 January 2023, the FDA accepted the BLA for Alvotech and Teva’s AVT04 Stelara® (biosimilar) ustekinumab.

May 18, 2023

The National Institute for Health and Care Excellence (NICE) has issued final draft guidance recommending AbbVie’s Rinvoq® (upadacitinib) as an option for eligible adults with moderate to severe active Crohn’s disease (CD) on the NHS in England and Wales.  It is the first janus kinase inhibitor available for treatment CD in England and Wales, where patients have had an inadequate response, lost response or were intolerant to conventional therapy or a biological agent.

This news was announced on the same day the FDA approved RINVOQ® for this same indication for CD.

May 18, 2023

The FDA has approved AbbVie’s RINVOQ® (upadacitinib) for adults with moderately to severely active Crohn’s disease (CD) who have had an inadequate response or intolerance to one or more tumor necrosis factor blockers.  RINVOQ® is the first oral treatment approved to this indication.  The approval was based on efficacy and safety in two randomized induction trials NCT03345836 and NCT03345849. 

On the same day, the National Institute for Health and Care Excellence issued final draft guidance recommending Rinvoq® as an option for eligible adults with moderate to severe active CD on the NHS in England and Wales. 

May 16, 2023

Amneal announced it has launched FLYNETRA™ (pegfilgrastim) in the US, biosimilar to Amgen’s Neulasta®.  FLYNETRA™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.

FLYNETRA™ was approved by the FDA in May 2022.  This is Amneal’s third biosimilar approved in the US (following its filgrastim and bevacizumab biosimilars).

May 15, 2023

Boan Biotech announced that it has completed patient enrolment in its phase III clinical trial for BA5101, its proposed biosimilar to Eli Lilly’s Trulicity® (dulaglutide) used in patients with insufficiently controlled type 2 diabetes mellitus.  Boan’s clinical trial will compare the clinical efficacy, safety, immunogenicity and pharmacokinetics of BA5101 with Trulicity® in Chinese adult patients with type 2 diabetes.  

Two weeks ago, Boan’s parent company Luye Pharma announced that it commenced a phase III clinical trial for its Prolia®/Xgeva® (denosumab) biosimilar. 

May 15, 2023

The US Supreme Court denied Teva’s petition for certiorari to review the August 2021 decision of the US Court of Appeals for the Federal Circuit in relation to skinny label carve-outs and Teva’s US$235M loss in its patent dispute with GSK.   The issue that Teva sought to put before the Supreme Court was whether a generic manufacturer of an FDA-approved label which excludes the originator’s patented uses constitutes encouragement of patent infringement by the carved-out uses.   According to Teva’s petition, the lower Court held that even though Teva’s skinny label carved out GSK’s sole patented indication for its product Coreg® (carvedilol), Teva could nonetheless be held liable for inducement of patent infringement based on other sections of the label.

Many brief amici curiae were filed, including a brief from 42 professors of law, economics, business and medicine pharmaceutical companies Alvotech and Mylan, the Association for Accessible Medicines and the Solicitor-General of the US (the only party specifically invited to file a brief).  The Solicitor-General’s brief quoted the lower court’s dissenting judgment that “the carved-out labelling is more naturally viewed as evidence of the generic manufacturer’s ‘inten[t] not to encourage infringement’” and concluded that the petition for a writ of certiorari should be granted.

May 15, 2023

Korea Biomed reported that Celltrion submitted a phase III investigational new drug (IND) plan to the FDA for its CT-P53, biosimilar to Genentech’s Ocrevus® (ocrelizumab), used to treat multiple sclerosis.  The phase III global clinical trial will be a comparative study on the effectiveness, pharmacokinetics, and safety between CT-P53 and Ocrevus® on patients with recurrent palliative multiple sclerosis.

Celltrion recently reported US$126M profit in Q1 2023, and increased its operate profit for Q1 by 41.1% on-year.

May 15, 2023

Biogen and Eisai Co., Ltd announced that Health Canada has accepted a new drug submission (NDS) for LEQEMBI® (lecanemab) to treat early Alzheimer’s disease (AD) and mild AD dementia with confirmed amyloid pathology in the brain.  LEQEMBI® is an investigational anti-amyloid beta protofibril antibody.   The NDS is based on a Phase III study and Phase IIb clinical study which demonstrated that lecanemab treatment showed a reduction of clinical decline in early AD.

On 5 March 2023 the FDA accepted the sBLA and granted priority review for traditional approval of LEQEMBI™ (lecanemab), and the FDA is discussing the full approval on 9 June 2023.

May 15, 2023

Byondis announced that the FDA has issued a complete response letter (CRL) for its Biological License Application (BLA) for [vic-]trastuzumab duocarmazine (SYD985).  Byondis sought approval for its anti-HER2 antibody-drug conjugate in HER2-positive unresectable locally advanced or metastatic breast cancer.  The CRL confirmed that the FDA has suspended its decision on SYD985’s approvability, requesting extra information.  Byondis said that it cannot respond to the request within the current evaluation period.

May 12, 2023

Viatris investor Jason Taylor has brought proceedings on behalf of a class of Viatris shareholders against the company and its executive officers and directors, seeking remedies under the Securities Exchange Act of 1934 including damages, interest, costs, and equitable, injunctive, or other relief as the Court sees fit.  The class includes all persons or entities who purchased or acquired Viatris stock between 1 March 2021 and February 25, 2022 (Period).  At the beginning of the Period, Viatris announced a plan, relying on its strong pipeline of new products (including biosimilars) that would create a stable revenue base, realise US$1B in cost synergies by 2024, and improve cash conversion and free cash flow generation.  Taylor alleges that the Defendants made false representations, inter alia, including that 2021 was a “trough year” for Viatris and its biosimilars business was a core part of the Company’s long-term investment strategy.   Contrary to the Defendants representations, Viatris was allegedly experiencing significantly more competition in its US complex generics business than disclosed, and it was not able to create a stable revenue base.  Throughout 2021, Viatris’ total revenues were declining quarter-over-quarter.  In February 2022, Viatris entered into an agreement to sell its biosimilars business to Biocon Biologics Ltd.  After announcing fiscal results, Viatris’ stock declined by 24% between 25 February and 28 February 2022.

Interestingly, the US Magistrate Judge Patricia Dodge recused herself on 17 May 2023 and the case will be re-assigned.

May 12, 2023

A Senju study has shown that its ranibizumab biosimilar (biosim to Roche/Genentech’s Lucentis®) is more cost-effective in treat-and-extend (TAE) regimens compared to aflibercept based on higher quality-adjusted life-years (QALYs) and lower cost in treating neovascular age-related macular degeneration (nAMD).  The biosim was also cost-saving compared to Lucentis® for both TAE and pro re nata regimens. Senju’s ranibizumab biosimilar was the first ranibizumab biosim in Japan, which demonstrated comparable quality, efficacy, and safety for the treatment of nAMD.

On 25 April 2023, STADA and Xbrane announced they are supplying Ximluci® (ranibizumab) in England under a NHS England Framework Agreement.

May 11, 2023

Korea Biomed has reported that Celltrion Healthcare has won bids to supply Vegzelma®, biosimilar to Genentech’s Avastin® (bevacizumab), in Italy and Belgium to treat metastatic colorectal and breast cancer.  Celltrion says that it will supply three Italian provinces (Lombardy, Emilia Romagna, and Toscana), which make up ~40% of the market in Italy, for two to three years.  It will supply two Belgian hospital groups (Brugge Regional Hospital Group and Onze LIeve Vroiw General Hospital) for two years.

Celltrion launched Vegzelma® in the US (April 2023), and despite being “the latecomer”, Celltrion says it has achieved “significant results in key European countries since its launch, thanks to a flexible pricing strategy implemented”.

May 10, 2023

Alvotech announced that an exclusive agreement with Polifarma for the commercialisation of AVT06 (aflibercept, biosimilar to Bayer/Regeneron’s Eylea®) in Turkey.  Alvotech announced the initiation of ALVOEYE clinical trials for AVT06 in July 2022 in (wet) age-related maculation degeneration (AMD).

May 10, 2023

AstraZeneca announced that the European Commission has approved its Ultomiris® (ravulizumab) for an additional indication, the treatment of adults with anti-aquaporin-4 antibody-positive neuromyelitis optica spectrum disorder (NMOSD).  According to AstraZeneca, Ultomiris® is the first and only long-acting C5 complement inhibitor treatment for the above form of NMOSD in the EU, and EU is the first region in which this new indication has been approved.

This follows the positive opinion of the CHMP in April 2023 based on results from the CHAMPION-NMOSD Phase III trial.  Ultomiris® was previously approved in the US, EU and JP for the treatment of certain myasthenia gravis, paroxysmal nocturnal haemoglobinuria (PNH), atypical haemolytic uraemic syndrome to inhibit complement-mediated thrombotic microangiopathy.

May 9, 2023

Zion Pharma announced that Roche has acquired the global rights to ZN-A-1041, an orally administered selective tyrosine kinase inhibitor targeting the Human Epidermal Growth Factor Receptor 2 (HER2).  ZN-A-1041 has the potential to treat or prevent the onset of brain metastases in patients with HER2- positive metastatic breast cancer.  Zion will receive up to US$70 million in upfront and near-term milestone payments, and will be eligible for up to US$610 million in additional payments following achievement of certain development, regulatory, and sales-based milestones events, as well as tiered royalties on sales.

The current phase I trial is being conducted across the US and China, and details will be presented at the American Society of Clinical Oncology Annual Meeting in June 2023.

May 9, 2023

AbbVie announced that Health Canada has approved its Rinvoq® (upadacitinib, 15mg), an oral once-daily selective and reversible JAK inhibitor for the treatment of Active Non-Radiographic Axial Spondyloarthritis (nr-axSpA) in adult patients with objective signs of inflammation who have had an inadequate response to a biologic disease modifying anti-rheumatic drug or when use of those therapies is inadvisable.  It is the first and only JAK inhibitor approved for the full spectrum of axial spondyloarthritis.

This comes only a few weeks after the EC approved Rinvoq® for Chron’s disease in Europe.

May 9, 2023

Sandoz announced that it has partnered with Just-Evotec Biologics (subsidiary of Evotec SE) to develop and manufacture multiple biosimilar medicines (with an option for expansion).  The deal will utilise Just-Evotec Biologics’ AI driven drug substance development platform and continuous manufacturing technology to expand Sandoz’s pipeline from 15 to 24 assets, and integrate development and manufacturing.  Sandoz highlighted that a mutual commitment to “use disruptive technology with lower operational costs” underpins the deal, and that development of biosimilars will ramp-up in the next 12-18 months.

This news comes only a few weeks after Sandoz signed an MOU to build a USD$400M biologics facility in Slovenia in March 2023.

May 9, 2023

Roche announced that the FDA has accepted its sBLA for Vabysmo® (faricimab) to treat macular edema following retinal vein occlusion.  The sBLA is based on results from the phase III BALATON and COMINO studies which met primary endpoint of non-inferior visual acuity gains at 24 weeks compared to aflibercept.

Last year, Health Canada approved Vabysmo® for the treatment of neovascular (wet) age-related macular degeneration and diabetic macular edema.

May 9, 2023

Innovent Biologics and Eli Lilly announced that the Chinese NMPA has approved the sNDA for TYVYT® (sintilimab injection) in combination with bevacizumab and chemotherapy (pemetrexed and cisplatin) in patients with epidermal growth factor receptor (EGFR)-mutated non-squamous non-small cell lung cancer (NSCLC) who progressed after EGFR tyrosine kinase inhibitor therapy.  TYVYT® is globally the first approved PD-1 inhibitor for this indication.  This is the seventh NMPA-approved indication of TYVYT®.

This comes a day after Innovent Biologics announced dosing of the first participant in its phase III study of IBI311 (Anti-IGF-1R Monoclonal Antibody).

May 8, 2023

AstraZeneca announced Koselugo® (selumetinib) has been approved in by the Chinese NMPA for the treatment of symptomatic, inoperable plexiform neurofibromas in patients with neurofibromatosis type 1 aged three years and above.  The NMPA relied on results of the SPRINT Stratum 1 trial, published in the New England Journal of Medicine.  The study was sponsored by the National Institutes of Health’s National Cancer Institute Cancer Therapy Evaluation Program.

May 8, 2023

The Korea Times has reported Celltrion has reported a Q1 2023 net profit of ₩167.1B (US$126.4 million).  Celltrion said in a regulatory filing that operating profit for Q1 rose 41.1% on-year to ₩182.4B, and revenue increased 12.4% to ₩597.5B.

In April 2023, Celltrion launched Vegzelma® (bevacizumab), biosimilar to Genentech’s Avastin®, in the US, and in May 2023 Celltrion won bids to supply Vegzelma in Italy and Belgium.

May 8, 2023

Amgen announced new data from a real-world study of nearly half of a million postmenopausal women with osteoporosis in the US showing Prolia® (denosumab) injection reduced fracture risk in patients versus oral alendronate, a frequently prescribed bisphosphonate treatment. Treatment with Prolia® was also associated with greater reductions in fracture risk over time.

The data were presented during an oral presentation at the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO), in Barcelona, May 4-7, 2023.

May 8, 2023

Innovent Biologics announced that the first patient with thyroid eye disease (TED) has been dosed in the phase III study (RESTORE) for IBI311.  IBI311 is a recombinant anti-insulin-like growth factor-1 receptor monoclonal antibody.   The study (CTR20223393) will evaluate the efficacy of IBI311 in improving proptosis in TED subjects to support the potential new drug application of IBI311.

In June last year the Chinese NMPA approved Innovent’s TYVYT® (sintilimab injection), and Innovent’s Bevagen® (bevacizumab) was approved in Indonesia.

May 6, 2023

A Regeneron-sponsored study presented at Digestive Disease Week 2023 in Chicago concluded that Regeneron/Sanofi’s Dupixent® (dupilumab) improves histologic, symptomatic, and endoscopic aspects of eosinophilic esophagitis (EoE).  Dupilumab was effective regardless of whether adolescent and adult patients had a history of dilation, and improved outcomes for primary and key secondary efficacy endpoints.

Last week Health Canada issued a Notice of Compliance for Sanofi’s Dupixent® (dupilumab) for the treatment of patients over 12 with EOE.

May 5, 2023

A study published in the Journal of Allergy and Clinical Immunology: In Practice reports that Dupilumab holds promise for adults and adolescents with moderate to severe atopic hand and foot dermatits.

This comes 6 years after the FDA approved Dupixent® (dupilumab) for atopic dermatitis.

May 4, 2023

Sanofi announced that Health Canada has issued a Notice of Compliance for Dupixent® (dupilumab) for the treatment of patients over 12 with eosinophilic oesophagitis (EOE).  EoE is a chronic, progressive inflammatory disease that damages the oesophagus.  This is the eighth indication for Dupixent® on label in Canada and the first in gastroenterology.

Two weeks ago Sanofi and Regeneron announced that Health Canada issued a Notice of Compliance for Dupixent® as a treatment of patients 6 months to 5 years with moderate-to-severe atopic dermatitis.

May 4, 2023

Regeneron published its Q1 2023 financial results, reporting a 5% drop in US Eylea® sales from the previous quarter. The FDA accepted for priority review Regeneron’s BLA for higher dose aflibercept 8mg for treatment of patients with wet age-related macular degeneration in February 2023, with a target action date of 27 June 2023.

May 4, 2023

Organon has published its results for Q1 2023, demonstrating biosimilars revenue increased 18% and 20% ex-FX.  The results indicate that this increase was primarily driven by Renflexis® (biosimilar to Janssen’s Remicade® infliximab-abda) which grew 34% ex-FX due to continued demand growth in the United States and Canada as well as Brenzys™ (biosimilar to Amgen’s Enbrel® etanercept) which grew 36% ex-FX as a result of timing of tenders in Brazil.  The report confirms that the ongoing competitive pressures in Europe more than offset strong US growth in Ontruzant®(biosimilar to Genentech’s Herceptin® trastuzumab-dttb).

Organon only launched Ontruzant® and Aybintio® (biosimilar to Genentech’s Avastin® bevacizumab) in Canada in November 2022.

May 4, 2023

Alvotech announced that it has initiated a confirmatory patient study to compare the efficacy, safety, and immunogenicity of AVT05, its golimumab biosimilar, and Simponi® in adult patients with moderate to severe rheumatoid arthritis.

In January 2023, Alvotech announced the initiation of a pharmacokinetic study for AVT05.

May 4, 2023

Luye Pharma announced that it has enrolled its first subject in an international multi-center Phase 3 clinical study for its internally developed denosumab products (BA6101 and BA1102) to be carried out in Europe, the United States, and Japan. BA6101 and BA1102 are biosimilars to Amgen’s Prolia® and Xgeva®, respectively.   Prolia® is indicated for the treatment of osteoporosis, and Xgeva® is indicated for the prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumours, and treatment of giant cell tumour of bone.

BA6101 (Boyoubei®) was approved for marketing in China in November 2022, as the first approved Prolia® biosimilar in the world, and China’s NMPA has accepted Boan’s BLA for approval as an Xgeva® biosimilar.

May 1, 2023

Bristol Myers Squibb announced that the FDA has accepted its sBLA, and the EMA has validated its Type II Variation Application, for Reblozyl® (luspatercept-aamt) to include treatment of anaemia (without previous use of erythropoiesis-stimulating agents in adults with very low- to intermediate-risk myelodysplastic syndromes who may require red blood cell transfusions).  The FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act goal date of 28 August 2023.

In August 2021, the TGA approved Reblozyl® for transfusion dependent anaemia.

May 1, 2023

A study published in Health Affairs has suggested the US 340B Drug Pricing Program has reduced biosimilar uptake in hospitals that participate in the Program.  The 340B Program offers eligible safety-net hospitals (almost one third of US hospitals) to purchase originator medicines at a significant discount.  The authors analysed figures on filgrastim and infliximab and estimated that 340B program eligibility was associated with a 22.9% reduction in biosimilar adoption.

The research was sponsored by the Commonwealth Fund.

May 1, 2023

On 1 May 2023, Amgen instigated proceedings in the US District Court of New Jersey against Sandoz, Novartis and Lek, alleging infringement of 21 patents relating to Amgen’s Prolia® and Xgeva® (denosumab) products.  Sandoz submitted its aBLA to the FDA in December 2022 (which was accepted on 6 February 2023) seeking approval of its anti-RANKL mAb Prolia® and Xgeva® biosimilar.

Amgen is asserting that Sandoz/Novartis/Lek failed to comply with the BPCIA 42 U.S.C. § 262(l)(2)(A) “patent dance” requirements, and is seeking declaratory judgement under § 262(l)(9)(C).

Interestingly, of the 21 patents in suit, there are 2 product patents, and 19 process patents including many to media related “inventions”.

The asserted patents (and the nature of the patent, according to Amgen) are:

  • 7,364,736 (“the ’736 Patent”) – denosumab sequence patent
  • 7,928,205 (“the ’205 Patent”) – process (reduction/oxidation reagent + (optionally) a chaotopric agent)
  • 8,058,418 (“the ’418 Patent”) – product patent;
  • 9,012,178 (“the ’178 Patent”) – methods of culturing mammalian cells to express protein in a serum free media
  • 9,133,493 (“the ’493 Patent”) – methods of culturing mammalian cells (tyrosine and cysteine feeds)
  • 9,228,168 (“the ’168 Patent”) – methods of stabilizing feed media (pyruvate)
  • 9,320,816 (“the ’816 Patent”) – methods of treating cell culture media (UV C light and filtration)
  • 9,328,134 (“the ’134 Patent”) – methods of making proteins with modified glycosylation profile
  • 9,359,435 (“the ’435 Patent”) – methods of modulating glycoform content (mannose)
  • 9,481,901 (“the ’901 Patent”) – methods of influencing high mannose glycoform content (mannose sugars)
  • 10,167,492 (“the ’492 Patent”) – methods of influencing fucosylated glycan content
  • 10,513,723 (“the ’723 Patent”) – methods of influencing high mannose glycoform content
  • 10,583,397 (“the ’397 Patent”) – systems and methods to control filtration
  • 10,822,630 (“the ’630 Patent”) – methods of influencing fucosylated glycan content
  • 10,894,972 (“the ’972 Patent”) – methods of influencing high mannose glycoform content (mannose sugars)
  • 11,077,404 (“the ’404 Patent”) – systems and methods to control filtration
  • 11,098,079 (“the ’079 Patent”) – methods of using a charged depth filter
  • 11,130,980 (“the ’980 Patent”) – methods of regulating high mannose glycoform content (monensin)
  • 11,254,963 (“the ’963 Patent”) – methods of influencing high mannose glycoform content
  • 11,299,760 (“the ’760 Patent”) – methods of regulating high mannose glycoform content (monensin)
  • 11,434,514 (“the ’514 Patent”) – methods of influencing high mannose glycoform content (mannose sugars).

Given the timing of Sandoz’s submission, in the ordinary course of events its approval will precede expiry of US patent no. 7364736 to the denosumab antibody in February 2025.

Prolia® is indicated for the treatment of osteoporosis, and Xgeva® is indicated for the prevention of skeletal-related events in patients with multiple myeloma and bone metastases from solid tumours; and treatment of giant cell tumour of bone.

 

April 28, 2023

Merck announced that the FDA’s Oncologic Drugs Advisory Committee (ODAC) has voted to support FDA approval of Lynparza® (olaparib) plus abiraterone and prednisone or prednisolone for the first-line treatment of BRCA-mutated metastatic castration-resistant prostate cancer (mCRPC).  ODAC voted against approval for the combination beyond this patient population.

Lynparza® is currently approved in the US for patients with homologous recombination repair gene-mutated mCRPC who have progressed following prior treatment with enzalutamide or abiraterone.  It is also approved for the treatment of ovarian, breast and pancreatic cancer.  The first line combination use is approved in Europe for mCRPC patients in whom chemotherapy is not clinically indicated.

April 27, 2023

Samsung Bioepis filed an IPR petition against Regeneron’s US patent no. 11,253,572directed to methods of treating an angiogenic eye disorder by intravitreal injection of aflibercept via a specified dosage regime, with a specified result.

Apotex (unsuccessfully) filed an IPR against claims 1-14 of the Patent on 10 March 2023, as the PTAB denied institution of Apotex’ petition in March 2023.  Conversely, Samsung is challenging all 30 claims of the Patent.   Samsung argues that a number of the claims are anticipated by press releases and a peer reviewed publication pertaining to phase III clinical trials for aflibercept.  It is also arguing that various claims are invalid for obviousness in light of those disclosures.

This comes only two days after Samsung released its new phase III trial data for its aflibercept (Eylea®) biosimilar.

April 26, 2023

Novartis announced that the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the grant of marketing authorization for Cosentyx® (secukinumab) in adults with active moderate to severe hidradenitis suppurativa, an inflammatory skin disease.  The recommendation was based on results from two phase III trials which showed that patients who received Cosentyx® continued to improve beyond the primary endpoint analysis at week 16, with more than 55% of patients achieving a Hidradenitis Suppurativa Clinical Response at week 52.

Last year BioThera began phase III trials of BAT2306, biosimilar to Cosentyx®,  in patients with moderate to severe plaque psoriasis.

April 26, 2023

Roche announced that the EU’s European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Columvi® (glofitamab) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL) as a third line therapy.  The recommendation was based on results from a phase I/II study, in which Columvi® was demonstrated to induce early and long-lasting responses in people with R/R DLBCL.

This news comes less than two weeks since the FDA approved Genentech/Roche’s Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab) for DLBCL.

April 26, 2023

The European Commission (EC) has adopted a proposal for a new Directive and a new Regulation which will revise and replace the existing pharmaceutical legislation, and amount to the largest regulatory reform in the EU in over 20 years.  The Directive and Regulation have been submitted to the European Parliament and the Council of the EU for discussion.  The EC confirmed that discussions will start as soon as possible, however it cannot predict the timing for adoption.  Both the Parliament and Council will need to approve the reforms.

The regulatory reforms aim at increasing patient access to affordable medicines and improving the security of supply.  EC Vice-President Margaritis Schinas has described the changes as “enormous”.

Key measures include:

  • A 2 year reduction of the baseline data protection period in order to encourage early market access of generics and biosimilars. However, additional periods of data protection may be available when certain conditions, potentially extending the period of regulatory protection beyond those currently available.
    • Companies marketing innovative medicines will have a minimum period of regulatory protection of 8 years, which includes 6 years of data protection and 2 years of market protection. However companies may benefit from additional periods of protection (total period up to 12 years, compared 11 years today).  These additional periods of protection can be obtained if the medicine is launched in all Member States (+2 years), if the medicine addresses an unmet medical need (+6 months), or if comparative clinical trials are conducted (+6 months).  A further year of data protection can be granted if the medicine can treat other disease(s) too.  The 2 year protection based on launch in all Member States is expected to increase access by 15%.
    • For rare disease medicines the standard market exclusivity will be set at 9 years. Companies may benefit from additional periods of market exclusivity if they launch in all Member States (+ 1 year), address a high unmet medical need (+1 year), or develop new therapeutic indications for an already authorised orphan medicine (up to 2 extra years). The total regulatory production periods can add to 13 years (today the maximum is 10 years).
  • Broader scope of the ‘Bolar exemption’: biosimilars will not need risk management plans as the originator will already have one.
  • An incentive for repurposing
  • Faster authorisation of new medicines:
    • The EMA will have 180 days instead of 210 to assess new medicines
    • If medicines are of major public health interest, the EMA will only take 150 days
    • The EC will have 46 days instead of 67 for authorisation
  • Regulatory ‘sandboxes’ to test new regulatory approaches for novel therapies under real world conditions.
  • The ability for governments to suspend data and market protection when a compulsory licence has been issued to tackle a public health emergency.

April 26, 2023

Regeneron listed additional aflibercept patents on the Purple Book patent list.  The Purple Book patent list records the patents exchanged between the originator and biosimilar applicant as part of the patent dance and suggests that another dance has begun with a second biosimilar applicant. There are now 46 aflibercept patents listed on the Purple Book, including the 24 asserted against Mylan in August 2022. 

April 25, 2023

BMS has brought proceedings against AstraZeneca in the US District Court of Delaware for infringement of alleging that AstraZeneca’s Imfinzi® (durvalumab) infringes the patent relating to anti-PD-L1 antibodies.  BMS also claims that ‘899 encompasses the BMS product Opdivo® (nivolumab).

The US District Court of Delaware has already set down BMS’ patent infringement case against AstraZeneca regarding Imfinzi® (durvalumab) as a jury trial in April 2024.  It is unclear whether BMS intends to seek to have the two matters heard together.

April 25, 2023

Korea BioMed reported that Celltrion has submitted its application in EMA for CT-P39 (omalizumab), a biosimilar to Genentech/Novartis’ Xolair®.  The reference product Xolair® is approved in Europe for the treatment of asthma, chronic spontaneous urticaria and severe chronic rhinosinusitis with nasal polyps, and in other markets.  On 10 April 2023, Celltrion announced its phase III safety and efficacy results for CT-P39.

April 25, 2023

Formycon AG announced the successful conclusion of its extended Phase I clinical study comparing the pharmacokinetics of FYB202 and the reference drug Stelara® (ustekinumab).  This follows Formycon’s report in August 2022 that its Phase III studies demonstrated the comparable efficacy of FYB202 and Stelara® in patients with moderate-to-severe psoriasis vulgaris (plaque psoriasis).  Formycon stated FYB202 was bioequivalent to the reference drug Stelara® sourced in the EU as well as in the U.S. for all primary endpoint parameters.

EU and US regulatory submissions are still planned for the third quarter of 2023.  The product will be sold by Fresenius Kabi in key global markets.

April 25, 2023

STADA and Xbrane announced they are supplying  Ximluci® (a biosimilar to Roche/Genentech’s Lucentis® (ranibizumab)) in England under a NHS England Framework Agreement.   Ximluci® is indicated for the treatment of retinal vascular disorders, including wet age-related macular degeneration, diabetic macular oedema, diabetic retinopathy, retinal vein occlusion and visual impairment due to choroidal neovascularization.  STADA is responsible for commercializing Ximluci® across Europe and Xbrane is responsible for commercial supply.

On 3 April 2023 Stada and Xbrane announced the continental European launch of Ximluci®.

April 25, 2023

Samsung Bioepis announced 1-year outcomes of its Ph III study of SB15 (biosimilar to Eylea® aflibercept) at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting.  Samsung Bioepis reported that the safety, immunogenicity and PK profiles of SB15 were comparable with those of aflibercept, and that no treatment-induced or treatment-boosted anti-drug antibodies developed in the switching group after week 32.

April 24, 2023

Xbrane has announced it has resubmitted its BLA for its investigational biosimilar to Genentech’s Lucentis® (ranibizumab) with FDA.  Xbrane expects that there will be a ten-month review process and its candidate could be approved during the first half of 2024.  In July 2022, Xbrane received a General Advice letter from the FDA with comments and recommendations for the resubmission of its BLA for a ranibizumab biosimilar.

April 20, 2023

Samsung Bioepis announced that it will present new data on its SB15 (proposed aflibercept biosimilar) at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting, on 23 and 24 April 2023, including 56-week results from its Ph III trials.

Samsung Bioepis and Biogen announced a partnership for the commercialisation of aflibercept and ranibizumab biosimilars in November 2019.

April 20, 2023

Sanofi and Regeneron announced that Health Canada issued a Notice of Compliance for Dupixent® (dupilumab) as a treatment of patients 6 months to 5 years with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or not advisable.

This comes weeks after Sanofi/Regeneron announced European Commission approval of Dupixent® on 21 March 2023 for the same age group.

April 19, 2023

The US District Court of West Virginia has issued a claim construction order pertaining to seven claims of the four patents asserted in Regeneron’s BPCIA case against Mylan.  The four patents in suit (US Patent Nos. 10,888,601, 11,084,865, 11,253,572, and 11,104,715) are directed to Regeneron’s Eylea® (aflibercept).  The Court only adopted one of Regeneron’s proposed constructions of the terms, and adopted the remaining six terms as proposed by Mylan.  On 20 April 2023, Mylan sought summary judgment of non-infringement or invalidity of particular claims in the above four patents.  The case is set down for an expedited two-week trial beginning 12 June 2023.

April 19, 2023

Genentech and Roche announced that the FDA approved Polivy® (polatuzumab vedotin-piiq) in combination with Rituxan® (rituximab), cyclophosphamide, doxorubicin and prednisone (R-CHP) for the treatment of adult patients who have previously untreated diffuse large B-cell lymphoma (DLBCL), not otherwise specified or high-grade B-cell lymphoma, and who have an International Prognostic Index score of two or greater.  This approval converts the FDA’s previous accelerated approval of Polivy® in combination with bendamustine and Rituxan® for relapsed or refractory DLBCL into a regular approval.

We recently reported that Dr. Reddy’s was preparing to file BLA/MAA dossiers for rituximab biosimilar against Rituxan®.

April 19, 2023

Taiho Oncology announced that the FDA accepted for Priority Review its supplemental new drug application (sNDA) for Lonsurf® (trifluridine/tipiracil) in combination with bevacizumab for metastatic colorectal cancer (mCRC).  The sNDA is based on results of a phase III clinical trial which combined Lonsurf® with Genentech’s Avastin® (bevacizumab), which saw improved survival and progression-free survival over Lonsurf® alone.  The FDA expects to decide on the sNDA by 13 August 2023.

Last year Genentech and Samsung Bioepis settled their US BPCIA Avastin® bevacizumab patent dispute.

April 18, 2023

Samsung Bioepis released its first US Biosimilar Market Report which found that biosimilars will save the US healthcare system $181B in the next five years.  The report will be published each quarter after the Center of Medicare, Medicaid Services publishes new data.  Key findings from the report include:

  • On average, biosimilars gained 53% market share in the three years after their initial launch. This was influenced by the faster acceptance (75%) for oncology compared to other therapeutic areas (25%) and for pegfilgrastim compared to other molecules
  • Average sales prices declined 41% on average three years after first biosimilar launch. The prices for oncology biosimilars experienced the steepest decline (each dropping >50% in the first three years after biosimilar launch)
  • Unbranded insulin glargines are discounted by up to 66% compared to Lantus® (Sanofi)
  • As of Q4 2022 the biosimilar share of the trastuzumab market has reached 82%

April 18, 2023

The US District Court of Delaware has ordered that Biogen Inc.’s and Biogen MA, Inc.’s Motion for Preliminary Injunction against Sandoz’s biosimilar natalizumab Tysabri® and the cross motions to strike is set down for an oral hearing on 17 May 2023 after the briefing on Biogen’s motion was completed in April 2023.

In September 2022, Biogen filed a sealed complaint in the District of Delaware against Sandoz and Polpharma for infringement of 28 Biogen patents relating to Tysabri®.  Biogen filed an amended complaint on 30 November 2022, in which it had to reduce the number of patents it relied upon for the preliminary injunction (up to 5 patents and up to 10 claims).

April 17, 2023

AbbVie announced that the European Commission has approved Rinvoq® (upadacitinib) for the treatment of adults with moderately to severely active Crohn’s disease who have had an inadequate response, lost response or areintolerant to either conventional therapies or biologic agents.  According to Abbvie, this is the seventh approved indication for Rinvoq® in the EU and is the only oral Janus Kinase inhibitor approved to treat adult patients with moderately to severely active Crohn’s disease.

The CHMP gave a positive opinion for Rinvoq® for the above indication on 27 February 2023.

April 17, 2023

The Korean Biomedical Review reported that Celltrion has launched Vegzelma®,  biosimilar to Genentech’s Avastin® (bevacizumab), in the US .

Celltrion received FDA approval for Vegzelma® in September 2022 for the treatment of six types of cancer.

April 14, 2023

The District Court of West Virginia denied Mylan’s emergency motion seeking orders which would require Regeneron to immediately narrow the scope of its infringement proceedings to 12 claims of 3 patents. As it currently stands, Regeneron is required to narrow the scope of the proceedings within seven days of the court making its Markman order, or seven days after the close of fact discovery, whatever is later.  The Court found that Mylan had not shown good cause for an emergency order status or a modification of the scheduling order.

Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea®, and a 10 day trial has been set down for June 2023, which is 10 months after Regeneron filed its complaint.

April 13, 2023

Alvotech announced that it received (in March) and responded to (in April) a complete response letter from the FDA regarding its BLA for high concentration (buffer free) formulation of AVT02, biosimilar to AbbVie’s Humira®, and is awaiting the FDA’s assessment of its response.

Alvotech has filed a second BLA for AVT02, which contains data to support approval as a biosimilar with interchangeability designation.  This remains under review by the FDA, with a BsUFA date of 28 June 2023.

Satisfactory outcome of the facility reinspection remains the key requirement for approval of both ABLAs.

April 12, 2023

Samsung filed a notice of opposition to the grant of Janssen’s Australian patent application AU2019346134 for the treatment of ulcerative colitis using an anti-IL12/IL23 antibody including Stelara® (ustekinumab).  Samsung’s Statement of Grounds and Particulars in support of the opposition are due to be filed with the Australian Patent Office by 12 July 2023.

We recently reported on Samsung’s Phase I clinical studies for SB17, its biosimilar to Janssen’s Stelara®.

April 10, 2023

The FDA has scheduled a meeting of its Peripheral and Central Nervous System Drugs Advisory Committee Meeting on 9 June 2023 to discuss full approval of Eisai Co and Biogen’s LEQEMBI™ (lecanemab) for the treatment of Alzheimer’s.

On 5 March 2023, Biogen and Eisai Co announced that the FDA has accepted their sBLA and granted priority review for traditional approval of LEQEMBI™ (lecanemab) for treatment of Alzheimer’s disease.  It was approved under the Accelerated Approval Pathway on 6 January 2023 (approval based on ‘surrogate’ marker or endpoint).

April 10, 2023

The Scottish Medicines Consortium (SMC) accepted Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) for restricted use within NHSScotland as a monotherapy for the treatment of unresectable or metastatic HER2 positive breast cancer when patients have received one or more prior anti HER2 based regimens.  The SMC relied on a phase III study in which trastuzumab deruxtecan was associated with significantly improved progression-free survival compared with an antibody-drug conjugate medication.

On 27 March 2023, Daiichi Sankyo announced that Enhertu® was approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of adults with HER2 low unresectable or recurrent breast cancer after prior chemotherapy.

April 10, 2023

The Korea Herald has reported that Celltrion has confirmed in a phase III study the safety and efficacy of CT-P39, a biosimilar to Genentech/Novartis’ Xolair® to treat asthma and urticaria.  The results indicate that CT-P39 prompted the same biological response in terms of efficacy, safety, immunogenicity and pharmacokinetics in patients with chronic spontaneous urticaria treated with Xolair®.

April 8, 2023

A study published in Clinical Ophthalmology has found that Intas’ Razumab® (ranibizumab) biosimilar to Genentech’s Lucentis® has similar efficacy and safety in Indian patients over 50 years old for treating neovascular age-related macular degeneration (nAMD).  The study provides retrospective analysis demonstrating that Razumab® improved visual acuity and reduced central macular thickness in nAMD patients over a one-year period, with similar efficacy to Lucentis®.   This study was sponsored by Intas.

April 6, 2023

Merck and Moderna announced that their joint investigational personalized mRNA cancer vaccine mRNA-4157/V940, in combination with Keytruda®, Merck’s anti-PD-1 therapy has been granted Priority Medicines (PRIME) scheme designation by the EMA for the adjuvant treatment of patients with high-risk stage III/IV melanoma following complete resection.  The designation was based on data from the Phase IIb KEYNOTE-942/mRNA-4157-P201 trial which will be presented at the American Association for Cancer Research (AACR) from April 14-19 2023.

In December 2022 we reported on the phase IIb KEYNOTE-942/mRNA-4157-P201 trial, and in October 2022 Merck announced that it had exercised its option to jointly develop and commercialise mRNA-4157/V940.

April 6, 2023

A Samsung Bioepis study published in JAMA Network Open has demonstrated that SB3, its proposed trastuzumab biosimilar is comparable to Genentech’s Herceptin®.   In their analysis of RCT outcomes of SB3 and Herceptin®, long term cardiac safety and efficacy were comparable after six years.

In February 2022, Samsung Bioepis announced that Health Canada has approved its Ontruzant® (biosimilar trastuzumab) for the treatment of adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer.

April 5, 2023

Accord BioPharma, the US speciality division of Intas, announced that the FDA has accepted its BLA for proposed trastuzumab biosimilar HLX02 for adjuvant treatment of HER2-overexpressing breast cancer, HER2-overexpressing metastatic breast cancer, and HER2-overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.  HLX02 was originally developed by Accord’s business partner Shanghai Henlius Biotech, Inc.  In 2021, Henlius granted Accord the exclusive rights to develop and commercialise HLX02 in North America.

Separately, on 15 February 2023 Henlius announced the FDA acceptance of Henlius’ BLA for HLX02.  It is unclear whether this is the same BLA as that which Accord has recently announced.

April 4, 2023

A study published in Frontiers in Pharmacology has found that the pharmacokinetic characteristics and immunogenicity of Livzon Mabpharm’s LZM008 were similar to Genentech’s ACTEMRA®.  The safety profiles of LZM008 were similar in two groups with mild–moderate adverse effects.  The study was a randomised, double-blinded, single-dose, parallel-group phase I clinical trial conducted in Huashan Hospital and Wuxi People’s Hospital in China.  The incidence of treatment emergent adverse events was comparable in LZM008 and ACTEMRA® groups (98% versus 100%).  The study was funded by the Livzon Mabpharm Inc. and the Ministry of Science and Technology of China.

In February 2023, Fresenius Kabi demonstrated bioequivalence for its tocilizumab biosimilar.

April 3, 2023

STADA announced the European launch of locally-manufactured Ximluci® (ranibizumab) biosimilar to Roche/Genentech’s Lucentis®.  Ximluci® is indicated for the treatment of visual impairment in all Lucentis® adult indications.

Ximluci® is the first product developed through a collaboration between STADA and Xbrane, and represents Xbrane’s first commercial launch.  Both companies are jointly responsible for development and manufacturing of Ximluci®, whilst STADA holds the marketing authorisations and commercial rights.

In January 2023, STADA and Xbrane announced that Ximluci® was granted marketing authorisation by the MHRA for UK supply.

April 3, 2023

Sandoz announced that the EC granted marketing authorisation in the EU for its citrate-free high concentration (100mg/ml) formulation of its Hymiroz® (adalimumab), biosimilar to AbbVie’s Humira®, for all indicates covered by Humira®.

On 21 March 2023, the Sandoz citrate-free high concentration formulation of adalimumab Hymiroz® was approved by the FDA.  Sandoz intends to launch in the US on 1 July 2023 pursuant to its 2018 settlement with AbbVie.

April 3, 2023

Korea Biomedical Review reported that the 24 week results from Celltrion’s Ph III trials of CT-P42 (aflibercept) demonstrate equivalence and similarity to Regeneron’s Eylea®.  CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regeneron’s Eyela®.  Celltrion intends to file an ABLA for CT-P42 in at least the US and Europe later in 2023.

We have previously reported on the Celltrion IPR challenges to Regeneron’s key aflibercept patents in the US.

April 3, 2023

AstraZeneca announced that the CHMP has recommended marketing authorisation for its Ultomiris® (ravulizumab) to treat patients with neuromyelitis optica spectrum disorder (NMOSD) who are anti-aquaporin-4 antibody positive.  If authorised, Ultomiris® would be the first and only approved long-acting C5 complement inhibitor for the treatment of the above condition in the EU.

CHMP based its positive opinion on results from the CHAMPION-NMOSD Phase III trial, in which Ultomiris® was compared to an external placebo arm from the Soliris® PREVENT clinical trial.

April 1, 2023

The PBS Catch-up Statutory Price Reductions have reduced the cost of AbbVie’s Humira® products by 24.39% to $618.90, with adalimumab biosimilars (Arrow Pharma’s Hadlima®, Apotex’ Amgevita®, Sandoz’ Hyrimoz® and Fresenius Kabi’s Idacio®) reduced by 6.91%.  Interestingly, this means that the originator AbbVie Humira® product will have a lower PBS reimbursement price than equivalent biosimilars.

As the AbbVie global Humira® empire crumbles, Samsung Bioepis/Merck has the next licensed launch date in the US on 30 June this year, and the next day (1 July) the following biosimilar entities are licensed to launch: Alvotech, Celltrion, Boehringer Ingelheim, Coherus before Fresenius Kabi in July (on an unspecified date) and, Mylan/Viatris on 31 July 2023.

Last week we reported the FDA approved Sandoz’ adalimumab biosimilar Hyrimoz®; and two weeks ago we noted that AbbVie owes US Medicare rebates to the Centers for Medicare & Medicaid Services for raising the price of Humira® faster than inflation.

April 1, 2023

Eli Lilly has launched its insulin glargine Rezvoglar®, biosimilar to Sanofi’s Lantus®, on the US market.  It will be offered at a 78% discount to Lantus®.  Rezvoglar® is the second insulin glargine biosimilar (following Viatris/Mylan’s Semglee®) to be supplied to the US.  Lilly received FDA approval for Rezvoglar® on 18 November 2022.

March 31, 2023

Mabwell announced that it received Chinese marketing approval for Mailishu® (denosumab), biosimilar to Amgen’s Xgeva®/Prolia®, from the National Medical Products Administration (NMPA) for the treatment of osteoporosis in postmenopausal women at high risk of fracture.  It is the world’s second approved denosumab biosimilar.  Mailishu was developed by Mabwell’s wholly-owned subsidiary T-mab.

This announcement comes only 10 days after the NMPA accepted Boan Biotech’s BLA for its denosumab BA1102, biosimilar to Amgen’s Xgeva®/Prolia®.

March 30, 2023

EMA recommended granting marketing authorisation for Samsung Bioepis’ Epysqli™ (eculizumab), biosimilar to Alexion’s Soliris®.  Epysqli is indicated for the treatment of adults and children with paroxysmal nocturnal haemoglobinuria.  According to Samsung Bioepis, Epysqli™ is Samsung Bioepis’ first haematology biosimilar to be recommended for approval in Europe.

On 23 February, EU’s CHMP recommended a grant of market authorisation for Bekemv®, Amgen’s eculizumab biosimilar.

March 30, 2023

A Takeda study published in the New England Journal of Medicine found that vedolizumab was more effective than a placebo at inducing remission in patients with chronic pouchitis after undergoing ileal pouch–anal anastomosis (IPAA) for ulcerative colitis (UC).  31% of patients who received Takeda’s Entyvio®/Kynteles®/MLN0002 (vedolizumab) were in remission after 14 weeks, compared to 10% who received the placebo.

In March 2023, Takeda received Japanese approval for subcutaneous Entyvio® as maintenance therapy for moderate to severe ulcerative colitis in patients with inadequate response to conventional treatment.

March 29, 2023

Two biosimilars are on the July 2023 PBAC meeting agenda seeking to be PBS reimbursed for Australia:

  • Cipla Australia has applied to list Ardalicip®, biosimilar to AbbVie’s Humira® (adalimumab), which was developed by Alvotech (AVT02)
  • Juno Pharmaceuticals has applied to list Exarane™ and Exarane Forte™ (Sanofi’s Lovenox®) (enoxaparin)

March 29, 2023

The UK’s National Institute for Heath Care and Excellence (NICE) has recommended the use of Merck’s Keytruda® (pembrolizumab) for advanced cervical cancer in the NHS, funded by the Cancer Drugs Fund.  This is the first immunotherapy drug for an advanced form of the disease, and Clinical Trials Arena reported that this is the first new treatment regime in this condition in 14 years.

March 27, 2023

Daiichi Sankyo announced that its Enhertu® (trastuzumab deruxtecan) has been approved by Japan’s Ministry of Health, Labour and Welfare for the treatment of adults with HER2 low unresectable or recurrent breast cancer after prior chemotherapy.  The approval was granted based on results of Daiichi’s DESTINY-BREAST04 phase III trials.  Enhertu® combines a biosimilar to Gententech’s Herceptin® (trastuzumab) with chemotherapy drug deruxteca.

In August 2022, the FDA provided accelerated approval of Enhertu® for metastatic non-small cell lung cancer where tumours have activating HER2 mutations.

March 27, 2023

Eli Lilly has announced a $1B investment to build a new biotech facility in Raheen (Ireland) for the manufacture of on-market monoclonal antibodies (mAbs).  The site is expected to start production of Lilly’s new clinical products in 2026.  The company said that this investment will expand Lilly’s manufacturing network for biologic active ingredients and support demand for existing products.

This news comes shortly after Samsung Biologics recently announced construction of its US$1.5B fifth plant in South Korea.

March 27, 2023

The Supreme Court heard the opening oral arguments in the Amgen v Sanofi case (2020-1074; No. 21-757) this week.  The case arises from a Federal Court decision which invalidated claims in two Amgen patents (8,829,165 and 8,859,741) relating to Repatha® (evolocumab) which it asserted against Sanofi/Regeneron regarding Praluent® (alirocumab).  Repatha® is a monoclonal antibody indicated for the treatment of hyperlipidemia that generated US$1.5B for Amgen in 2022.  Repatha® is a monoclonal antibody indicated for the treatment of hyperlipidemia that generated US$1.5B for Amgen in 2022.

In November 2022, the Supreme Court granted Amgen’s petition for certiorari in relation to ‘whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation.’ A decision is expected by the end of June 2023.

March 27, 2023

Takeda Pharmaceuticals announced that it received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market its subcutaneous (SC) formulation of vedolizumab, Entyvio®.  The approval covers both pens and syringes for SC injection.  The SC products were approved as maintenance therapy for moderate to severe ulcerative colitis in patients with inadequate response to conventional treatment.

March 25, 2023

A study published in Rheumatology and Therapy has found that Mabpharm’s infliximab biosimilar candidate CMAB008 was equivalent to Janssen’s Remicade® in patients with moderate-to-severe rheumatoid arthritis treated with basic MTX.  Remicade® is produced in mouse myeloma SP2/0 cells, but CMAB008 is produced in CHO cells.

This comes only weeks after Celltrion Healthcare presented its positive phase III results for its infliximab biobetter Remsima SC® as a sub-cutaneous maintenance therapy for patients with IBD.

March 24, 2023

Newfoundland and Labrador and Yukon each announced implementation of biosimilar switching policies consistent with Ontario and seven other provinces in Canada.  In Yukon from 3 April 2023, patients enrolled in the Pharmacare and the Chronic Disease and Disability Program will have six months to transition from certain biologic drugs to a biosimilar to maintain coverage.  In Newfoundland and Labrador, to maintain coverage, patients currently using Copaxone®, Enbrel®, Humalog®, Humira®, Lantus®, Lovenox®, NovoRapid®, Remicade® or Rituxan® will be transitioned to a biosimilar version on or before March 31, 2024.

We reported on previous Canadian announcements of Biosimilar switching initiatives, including Ontario’s announcement in December 2022, following British ColumbiaAlbertaNew BrunswickQuebec, Northwest Territories, Nova Scotia and Saskatchewan’s earlier announcements.

March 23, 2023

A study published in Clinical and Experimental Rheumatology found that patients with rheumatoid arthritis and psoriatic arthritis (PsA) experienced a worsening in the patient global assessment when they switched from AbbVie’s Humira® (adalimumab) to Samsung Bioepis’ Imraldi® for administrative/economic reasons.  Patients with PsA also reported a worsening in Health Assessment Questionnaires.  However, there were no differences found in other relevant scores (such as the disease activity score or Bath Ankylosing Spondylitis Disease Activity Index).   Interestingly, where patients switched (also for non-medical reasons) from Amgen’s biosimilar Amgevita® to Imraldi®, no differences were found in patient-reported outcomes.

The authors concluded that these results may be due to a possible nocebo response, and encouraged comprehensive communication with patients to prevent worse outcomes when switching from the originator product to a biosimilar.

March 22, 2023

PTAB instituted Celltrion’s IPR challenges to US 10,888,601 (decision here) and US 10,130,681 (decision here) and Samsung Bioepis’ IPR challenge to US 10,888,601 (decision here).  PTAB also granted Celltrion and Samsung Bioepis’ motions to join these IPRs with the earlier IPRs filed against the same Regeneron patents by Mylan in July 2022 which were instituted in January 2023.  Celltrion and Samsung Bioepis sought to join the Mylan IPRs in February 2023.

Note:

March 21, 2023

Regeneron and Sanofi announced European Commission approval of Dupixent® (dupilumab) for the treatment of children aged six months to five years old with severe atopic dermatitis.  Dupilumab is the only targeted medicine to treat this condition in young children approved in Europe and the US.  The approval was based on data from a phase III clinical trial published in the Lancet.

This comes after Regeneron and Sanofi recently announced that the FDA accepted their sBLA for Dupixent® (dupilumab) to treat chronic spontaneous urticaria.

March 21, 2023

Sandoz announced that it has received FDA approval for its Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira® in a citrate-free, high concentration formulation that it intends to launch in the US on 1 July 2023 pursuant to the licence granted in its settlement with AbbVie on 11 October 2018.  Hyrimoz® is approved for the same seven indications as the reference product, AbbVie’s Humira®.

This follows Amgen’s recent launch of Amjevita®, the first adalimumab biosimilar available in the US on 31 January 2023 pursuant to its AbbVie settlement dated 28 September 2017.  In total, AbbVie entered into 11 deals with biosimilar entrants enabling US market entry as follows: Amgen (31 January 2023), Alvotech (1 July 2023), Celltrion (July 2023), Mylan/Viatris (31 July 2023), Sandoz (30 September 2023), Momenta (20 November 2023), Pfizer (20 November 2023), Fresenius Kabi (July 2023), Samsung Bioepis/Merck (30 June 2023), Coherus (1 July 2023) and Boehringer Ingelheim (1 July 2023).

March 21, 2023

Luye Pharma Group announced that the Center for Drug Evaluation (CDE) of China’s National Medical Products Administration (NMPA) accepted the BLA submitted by Luye’s subsidiary Boan Biotech for denosumab (BA1102), biosimilar to Amgen’s Xgeva®. It is indicated for the treatment of bone metastases from solid tumors and patients with multiple myeloma, to delay or reduce the risk of skeletal-related events, and for the treatment of adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity.

In late 2022, Boan Biotech previously announced the apprA approval and launch of its Boyoubei® (denosumab, biosimilar to Amgen’s Prolia®), for the treatment of postmenopausal women with osteoporosis with high risk of fractures.

March 21, 2023

A new study published in Rheumatology has found that etanercept biosimilars (Biogen’s Benepali® and Novartis’ Erelzi®) demonstrated comparable efficacy to Pfizer’s Enbrel®.  The study is one of the largest to date, and showed that biologic-naïve rheumatoid arthritis patients had similar outcomes in terms of survival and disease activity whether they received the originator or biosimilar treatment.

The study was supported by the British Society for Rheumatology.

March 20, 2023

Coya Therapeutics, Inc. announced an exclusive worldwide licensing agreement with Dr Reddy’s Laboratories, Ltd for Coya to use the Dr Reddy’s abatacept biosimilar (to BMS’ Orenica®) to develop and commercialise its subcutaneous combination product COYA302 (abatacept with COYA 301), a dual biologic for neurodegenerative diseases.

COYA 301 is an investigational immunomodulatory cytokine for subcutaneous administration intended to enhance regulatory T cell (Treg) function in vivo, and Abatacept is a fusion protein that binds to antigen-presenting cells and downregulates T effector cells and other pro-inflammatory cells.

Coya retains exclusive rights to develop and commercialize COYA 302 across multiple neurodegenerative diseases in multiple territories, including North and South America, the EU, UK, and Japan.  Dr. Reddy’s obtains exclusive rights to commercialize COYA 302 elsewhere.

Coya expects to file an IND for COYA 302 in the second half of 2023 and intends to subsequently begin phase Ib/II trials for Amyotrophic Lateral Sclerosis.

March 17, 2023

Samsung announced that its Phase I clinical studies for SB17, biosimilar to Stelara® (ustekinumab), demonstrated pharmacokinetic bioequivalence and comparable safety, tolerability, and immunogenicity to reference ustekinumab in healthy volunteers.   Samsung will present these results at the 2023 American Academy of Dermatology (AAD) Annual Meeting held in New Orleans, March 17-21, 2023.

March 17, 2023

Samsung Biologics announced that it will commence construction of its fifth plant and its second Bio Campus to meet increased market demand.  Samsung Biologics will invest KRW 1.9T (~US$1.5B) to build the new facility with a 180,000L manufacturing capacity, bringing its total capacity to 784,000L.  It is expected that the site will commence operations in 2025.  Plant 4 started partial operations in October 2022 and is expected to commence full operations by mid-2023.

This announcement comes only weeks after Pfizer and Samsung Biologics entered into US$183M biologics CMO agreement.

March 17, 2023

Alvotech announced clinical studies support biosimilarity and comparability of its ATV04 (ustekinumab biosimilar) and Johnson & Johnson’s Stelara®.  The data will be presented at the American Academy of Dermatology Annual Meeting on 17-21 March in New Orleans.

EMA accepted Alvotech’s MAA for AVT04 in February 2023, and the FDA accepted a BLA for AVT04 in January 2023.

March 16, 2023

A study published in Rheumatology International has concluded that there was ‘high comparability’ between Sandoz’s Rixathon® (rituximab) and Roche’s Mabthera®.  The Norwegian participants included adults with rheumatoid arthritis who had a mandatory biosimilar switch from MabThera to Rixathon, and those who had only received Rixathon.  The authors found that a non-medical switch to the biosimilar Rixathon in those patients was largely effective, and drug survival was comparable to published data for the originator Mabthera.

No specific funding was received from any bodies in the public, commercial or not-for-profit sectors to carry out the study.

March 16, 2023

Sanofi announced that it will cut the list price of its Lantus® insulin by 78% and establish a US$35 cap on OOP costs for patients with commercial insurance, with effect from 1 January 2024.  This is in addition to Winthrop’s (a Sanofi company) launch of its unbranded Lantus® biologic (insulin glargine U-100) in June 2022, which is 60% cheaper than the Lantus® product.

March 15, 2023

Janssen Biotech, Inc. has filed a redacted, public version of its opening brief in support of its motion for a preliminary injunction in proceedings relating to Amgen’s Stelara® (ustekinemab) biosimilar.  Janssen is seeking to enjoin Amgen, Inc. from manufacturing and using in commercial quantities, offering to sell, selling within the United States, or importing for commercial purposes into the United States its ABP 654 biosimilar product.  We previously reported that Janssen initially asserted two patents: US Patent Nos 6,902,734 (API) and 10,961,307 (methods of treating ulcerative colitis).  In its redacted brief Janssen states that while it has also asserted four ‘manufacturing’ patents, it is seeking a preliminary injunction for the duration of the proceedings based on only two of these: US Patent Nos 9217168 and 9475858.  We also previously reported that Janssen refiled its preliminary injunction motion after its original motion was denied because it did not comply with the court’s page limit requirements.

March 15, 2023

The US District Court for Eastern Pennsylvania has made final orders to approve a US$25M settlement in the anti-trust class action lawsuit against Johnson & Johnson (J&J) and Janssen Biotech Inc relating to the supply of Remicade® (infliximab) between 5 April 2016 and 28 February 2022.  The Court also issued a Memorandum on Motion for Final Approval, finding that the Plaintiffs’ Motion for Final Approval of Settlement was appropriate.

The matter related to a class action alleging that J&J and Janssen engaged in anticompetitive conduct related to the supply of Remicade® in violation of federal and state antitrust laws and state consumer protection laws.  The action alleged that the two companies sought to block competition by new entrants in the infliximab market.

In July 2021, Pfizer and Johnson & Johnson settled antitrust litigation arising from the terms of J&J’s payer contracts which restricted reimbursement for Pfizer’s Inflectra® except if Remicade® was first proven ineffective for any particular patient.

March 15, 2023

The US Department of Health and Human Services and the White House have announced that AbbVie will be required to pay rebates to the Centers for Medicare & Medicaid Services for raising the price of Humira® (adalimumab) faster than inflation. This new mechanism was brought about by the Inflation Reduction Act 2022 through the Medicare Prescription Drug Inflation Rebate Program.  This new inflation rebate applies to Medicare Part B rebatable drugs: single source drugs, biological products and certain biosimilars.

March 14, 2023

The Veterans’ Health Administration (VHA) announced coverage of Esai’s LEQEMBI™ (lecanemab) for veterans with early stages of Alzheimer’s disease (AD), two months after the FDA approved LEQEMBI™ under the Accelerated Approval Pathway.  This Pathway requires Eisai to continue phase IV testing to confirm its clinical benefit, and therapies under this pathway are not fully covered by the Centers for Medicare & Medicaid Services.

We reported on 5 March 2023 that the FDA accepted Eisai/Biogen’s sBLA and granted priority review for traditional approval of LEQEMBI™ for treatment of AD. On 27 February 2023 the companies announced that LEQEMBI™ was designated for Priority Review by the NMPA in China.

March 14, 2023

Lupin Ltd announced that the FDA completed an inspection of its Bioresearch Centre in Pune, India, which was closed without any observation.  The Lupin share price increased by 1.4% on the day of the announcement.

March 13, 2023

A mAbxience study published in Pharmacology and Research Perspective has found in a randomised, double-blind phase I clinical trial that its MB02 (bevacizumab) is bioequivalent to Genentech’s Avastin®.  MB02 has previously been shown to be bioequivalent to the originator product, however this study was conducted after mAbxience optimised the MB02 manufacturing process using completely chemically defined growth and feed media.  The new process leads to increased purity and reduced levels of heavy–heavy–light fragment.  The authors of the study concluded that newly manufactured MB02 is comparable to the original, and that it is biosimilar to the reference product Avastin®.  

In March 2022 Fresenius Kabi obtained a majority (55%) stake in mAbxience. 

March 13, 2023

Luye Pharma Group announced that it has completed patient enrolment in Ph III trials of BA9101 (also known as OT-702), biosimilar to Regeneron’s aflibercept/Eylea®.  BA9101 was developed by Luye Pharma’s subsidiary Boan Biotech with clinical studies being conducted in conjunction with Boan’s partner Ocumension Therapeutics under an agreement announced in October 2020.

March 10, 2023

PTAB denied institution of the IPR filed by Apotex against Regeneron’s 11,253,572 patent relating to a method of treating an angiogenic eye disorder by administering a VEGF antagonist, including Eylea® (aflibercept).  Apotex filed the IPR in September 2022, challenging claims 1-5, 8-11, 14 and 26 for anticipation and 6, 7, 12 and 13 for obviousness.  PTAB found that Apotex had not demonstrated a reasonable likelihood that it would prevail in showing that any of the challenged claims of the ‘572 patent is unpatentable.

The ‘572 patent is one of the 24 patents included in the Regeneron suit against Mylan in West Virginia, filed in August 2022, and one of the six patents chosen by Regeneron to be determined at a 10 day trial in June 2023, 10 months after Regeneron filed its complaint.  No other application for IPR has been filed to date against the ‘572 patent, although there are currently 7 other applications against 3 patents pending: 10,130,681 (filed by Mylan, Celltrion and Samsung Bioepis), 10,888,601 (filed by Mylan, Celltrion and Samsung Bioepis) and 10,464,992 (filed by Celltrion).  Institution of Mylan’s challenge to 10,857,205 was recently denied after Regeneron disclaimed all claims of the patent. Last year PTAB invalidated Regeneron’s 9,254,338 and 9,669,069 for anticipation based on Mylan’s application for IPR.

In December 2022, we reported on Ontario’s biosimilar switching program which required patients to be transitioned to biosimilars (including infliximab) by 29 December 2023.

March 9, 2023

Novartis announced that Sandoz signed an MOU to build a new biologics production facility in Lendava, Slovenia.  The investment is expected to be worth at least USD$400M and is one of the largest international private sector investments in Slovenia.  Work on the new plant is set to begin in 2023, with full operations provisionally planned for late 2026. 

This comes only a few weeks after Roche’s Genentech announced it is investing US$280M to build a new biologics manufacturing facility in Oceanside California that will begin operations in 2025. 

March 7, 2023

Sanofi and Regeneron announced that the FDA has accepted their sBLA for Dupixent® (dupilumab) to treat chronic spontaneous urticaria.  The FDA’s decision is expected on 22 October 2023.  The sBLA relied on data from two phase III trials (LIBERTY-CUPID Studies A and B). 

Sanofi also recently announced that it received EC approval for Dupixent® as the first and only targeted medicine indicated for eosinophilic esophagitis in the EU.  

March 7, 2023

An Extrapolate Research report estimates that the biologics and biosimilars market is likely to upsurge by US$271.5 billion globally by 2028The report claims that monoclonal antibodies dominate the market.  

March 6, 2023

Coherus announced that the FDA has approved its single-dose, prefilled autoinjector presentation of Udenyca® (pegfilgrastim-cbqv) biosimilar to Amgen’s pegfilgrastim (Neulasta®) as an additional presentation on 3 March 2023.  This the only US approved PFS presentation of pegfilgrastim.   

March 6, 2023

Janssen Biotech, Inc. has filed another motion for a preliminary injunction against Amgen regarding its ustekinemab biosimilar, after its original motion was denied by US District Court Judge Noreika on 2 March 2023.  Janssen is seeking to enjoin Amgen, Inc. from manufacturing and using in commercial quantities, offering to sell, selling within the United States, or importing for commercial purposes into the United States its ABP 654 biosimilar product. 

As we previously reported, Judge Noreika had denied Janssen’s motion because it did not comply with the court’s page limit requirements.  Her Honour orally ordered that the motion could be re-filed in compliance with court requirements. 

March 6, 2023

MiGenTra, a German healthcare transforming company, announced the commencement of the German phase I trial of Minapharm Pharmaceuticals’ African developed adalimumab biosimilar (Adessia®) on 24 February 2023.  Results are expected at the end of 2023.

MiGenTra was founded in 2021 by ProBioGen (CMDO) and Minapharm Pharmaceuticals with management in Berlin and Cairo, to develop biosimilars, cell and gene therapies and vaccines.  MiGenTra and Minapharm Pharmaceuticals are jointly responsible for filing and commercialising Adessia® in Africa and the Middle East. 

March 6, 2023

A study published in BioDrugs found that there was no difference between rituximab biosimilars (Truxima® (Teva Pharmaceuticals), Rixathon® (Sandoz) and Ruxience® (Pfizer)) and the originator product (Roche’s MabThera®) for hypersensitivity reactions (at initiation, switch or over time).  The authors used data of 91,894 patients from the French National Health Data System over a five year period.  Further, no association was found between a switch to biosimilars and occurrence of hospitalization for anaphylactic shock or serum sickness after treatment.

This study comes after Dr Reddy’s also recently announced that it has successfully completed the full set of clinical studies of DRL_RI (proposed rituximab biosimilar) for filing in the US, EU and other regions.

March 5, 2023

Biogen and Eisai Co announced that the FDA has accepted their sBLA and has granted priority review for traditional approval of LEQEMBI™ (lecanemab) for treatment of Alzheimer’s disease.  It was approved under the Accelerated Approval Pathway on 6 January 2023 (approval based on ‘surrogate’ marker or endpoint). 

On 27 February 2023 the companies announced that LEQEMBI™ was designated for Priority Review by the NMPA in China. 

March 4, 2023

Janssen announced its positive long-term safety and clinical data for Stelara® (ustekinumab) in Chron’s disease and ulcerative colitis (five and four years respectively) at the ECCO CongressThe findings indicate that key safety events were similar between a placebo and Stelara®The data demonstrated that of the patients with moderate to severe ulcerative colitis who achieved clinical response and continued treatment with Stelara® for 200 weeks – 58% were in clinical remission and 80% were in clinical response.  

March 3, 2023

The Korea Biomedical Review has reported that Seo Jung-jin, founder and the honorary chairman of Celltrion Group, who left the company in March 2021, has been asked to return to management. He was asked to return to assist Celltrion’s reorganisation of future strategies given the instability of the global economy. Appointment of Seo will be finalised at the upcoming shareholders’ meeting on 28 March.

March 3, 2023

Celltrion Healthcare presented its positive phase III results for its infliximab biobetter Remsima SC® as a sub-cutaneous maintenance therapy for patients with IBD.  Remsima SC® (CT-P13 SC) is Celltrion’s subcutaneous re-formulation of Johnson & Johnson’s infliximab (Remicade®).  

Celltrion’s ABLA for Remsima SC® was filed with FDA on 22 December 2022 for use in ulcerative colitis  and Crohn’s disease.  Remsima SC® has been approved in several other jurisdictions (Europe, Korea and Canada) for treatment of various inflammatory conditions.  

March 3, 2023

The ‘Increasing Access to Biosimilar Act of 2023’ (HR 1352) was introduced into the US House of Representatives.  The bill, if passed by Congress, would ‘require the Secretary of Health and Human Services to establish a demonstration project to increase access to biosimilar biological products under the Medicare program’.  Its purpose is ‘to evaluate the benefits of providing a shared savings payment for biosimilar biological products’.  The bill has been praised by the Biosimilars Forum.

March 2, 2023

Biogen Canada Inc. announced that its Lucentis® (ranibizumab) biosimilar Byooviz™ is available in Canada following approval by Health Canada for treatment of serious eye disorders including neovascular (wet) age-related macular degeneration. On 2 June 2022, Byooviz™ was launched in the US.

 
 

March 2, 2023

On Thursday, US District Court Judge Noreika denied a motion filed by Janssen Biotech, Inc (a Johnson & Johnson subsdiary) for a preliminary injunction regarding Amgen’s ustekinemab biosimilar, because the motion did not comply with the court’s page limit requirements.  We previously reported that Janssen commenced proceedings against Amgen in the US District Court (District of Delaware) in November 2022, asserting infringement of two patents, US 6902734 (ustekinemab compound) and US 10961307 (use of ustekinemab for the treatment of ulcerative colitis).   Judge Noreika ordered that the motion may be refiled in compliance with court requirements, so the consequences of the denial may be short-lived.   Janssen’s original Complaint states that Amgen had notified Janssen of its intention to commence marketing its Stelara® biosimilar on 6 May 2023 or as soon as it received FDA approval thereafter.

March 2, 2023

Samsung revealed in a South Korean regulatory filing that it has entered into a KRW$241 billion (~USD$183M) contract with Pfizer. The ‘Biologics CMO Contract’ is effective between 28 February 2023 and 31 December 2029 and relates to the manufacture of unnamed biologics by Samsung Biologics on behalf of Pfizer.

March 2, 2023

The FDA provided an update on its collaboration with the Federal Trade Commission (FTC) which it announced in February 2020.  The FDA and FTC have been working together on issues including exchanging information about how to combat anti-competitive activities and those that harm public healthThe two agencies have developed an educational resource for consumers about biosimilars to address common community misconceptions. 

March 2, 2023

A Turgut İlaçları study published in the Turkish Journal of Pharmaceutical Sciences indicated that Turgut’s TUR01, biosimilar to Amgen’s Humira® (adalimumab), was stable when stored under long-term storage conditions at for at least 18 months and for 24 months.  In 2020, Turgut completed a phase I study to compare the pharmacokinetics, safety, tolerability, and immunogenicity of two formulations of adalimumab (TUR01 and EU Sourced Humira®).  The results have not been disclosed.

Despite eight adalimumab biosimilar products available in the US, on 3 August 2023 Teva confirmed its intention to launch its AVT02 adalimumab biosimilar in 2024.

March 1, 2023

The November 2022 PBAC meeting has recommended the following biologics for PBS listing:

  • Sanofi-Aventis’ dupilumab (Dupixent®) autoinjectors in two new forms for the same indications as the currently listed pre-filled syringe, to treat chronic severe atopic dermatitis and uncontrolled severe asthma in patients aged 12 years and older.
  • Merck’s pembrolizumab (Keytruda®) for the treatment of persistent, recurrent, or metastatic (Stage IVB) squamous cell carcinoma, adenocarcinoma and adenosquamous carcinoma of the cervix in patients whose tumours express PD-L1 combined positive score equal to or greater than 1. This is further to pre-existing listing for unresectable Stage III or Stage IV malignant melanoma, resected Stage IIIB, Stage IIIC or Stage IIID malignant melanoma, relapsed or refractory Hodgkin lymphoma, Stage IV (metastatic) non-small cell lung cancer, locally advanced (Stage III) or metastatic (Stage IV) urothelial cancer, relapsed or refractory primary mediastinal B-cell lymphoma, unresectable or metastatic deficient mismatch repair colorectal cancer and recurrent or metastatic squamous cell carcinoma of the oral cavity, pharynx or larynx.
  • Pfizer’s pneumococcal polysaccharide conjugate vaccine, for the prevention of pneumococcal disease in individuals with an at-risk condition (≥ 18 years), non-Indigenous adults aged ≥ 70 years and Aboriginal and Torres Strait Islander adults aged ≥ 25 years. This was the first submission of the vaccine for the proposed vaccination populations.
  • AbbVie’s risankizumab (Skyrizi®) (which was on the July 2022 PBAC meeting agenda but a decision was deferred to November 2022) to treat adults with severe Crohn’s disease, who have failed to achieve an adequate response, or are contraindicated, to prior systemic therapy, further to pre-existing listing for treatment for severe chronic plaque psoriasis

March 1, 2023

Alvotech announced its full financial results for 2022, highlighting its annual revenue increased by 114% to USD$85M, primarily driven by the commercialisation of AVT02 (adalimumab), biosimilar to AbbVie’s Humira® in 17 countries.  As of December 31, 2022, the company had cash and cash equivalents of US$66.4 million, and R&D expenses were US$180.6 million.  In addition, Alvotech highlighted recent corporate achievements, including its marketing applications for AVT04  (ustekinumab), a proposed biosimilar to Johnson & Johnson’s Stelara® in the US (FDA accepted BLA for review in January 2023 with a new goal date of 13 April 2023), and EU (expected EMA recommendation in the second half of 2023).

The company held a business update conference with the investment community on 2 March 2022.

Robert Wessman, Chairman and CEO of Alvotech said that “Looking ahead, 2023 is expected to be equally important.  We’re currently preparing for a reinspection of our Reykjavik facility by the FDA, which, if satisfactory, could pave the way for the approval and subsequent launch of our interchangeable, high concentration biosimilar to Humira® in the US market on July 1, 2023.”

March 1, 2023

PTAB denied institution of Mylan’s IPR challenge to US10,857,205 (relating to Regeneron’s Eylea® aflibercept), after Regeneron filed a disclaimer with the USPTO, disclaiming all claims of the patent  

March 1, 2023

A new study published in Gastroenterology Research and Practice has found that British Columbia’s 2019 ‘Biosimilars Initiative’ was not associated with harmful impacts on medications and health services use.  The Initiative required IBD patients to switch from Johnson & Johnson’s Remicade® to an infliximab biosimilar (Pfizer’s Inflectra® or Organon’s Renflexis®).

February 28, 2023

Biospectrum India reported that Enzene Biosciences has launched its adalimumab (biosimilar to AbbVie’s Humira®) in India for the treatment of ankylosis spondylitis and rheumatoid arthritis.  Enzene believes that this is the first commercial launch using continuous manufacturing technology, which will reduce COGS.  This is the fourth biosimilar launch for Enzene, following teriparatide (treatment for osteoporosis) approval on 4 February 2021, romiplostim (treatment for chronic Immune Thrombocytopenic Purpura) on 10 August 2021, and denosumab (treatment for osteoporosis) on 27 August 2021.

February 28, 2023

Celltrion filed an application for inter-partes review (IPR) against a fourth Regeneron US patent 10,406,226 relating to a method of making a VEGF antagonist fusion protein, including the fusion protein aflibercept supplied by Regeneron as Eylea®.    

Celltrion previously filed IPRs against Regeneron’s method of treatment patents 10,888,601 and 10,130,681 patents on 10 February 2023, as did Viatris (Mylan) on 11 January 2023 and Samsung Bioepis on 10 February 2023 and 6 January 2023 respectively.  Last month Celltrion and Samsung Bioepis separately sought joinder of their challenges to Regeneron’s ’601 and ’681 patents with Viatris’ IPR against the ‘601 and ‘681 patents, which were instituted in January 2023 

The Regeneron suit against Mylan in West Virginia, filed in August 2022, includes each of the ‘601, ‘681 and ‘226 patents.  The ‘601 patent is one of the six patents chosen by Regeneron to be determined at a 10 day trial in June 2023, 10 months after Regeneron filed its complaint.  

February 28, 2023

Genentech has filed separate complaints against Biogen (in the US District Court Northern District of California) and Millennium (in the Superior Court of State of California) alleging breach of their respective licences to the Cabilly patents.  The Cabilly patents related to methods of manufacturing antibodies, and was one of the most widely licensed patent families in the biotechnology industry.  The last of the US pre-GATT filed “submarine” patents counterparts expired on 18 December 2018. 

The Complaint against Millennium (23-CIV-00924) alleges that Millennium’s Entyvio® (vedolizumab) product was manufactured in accordance with the Cabilly patents and royalties were paid to Genentech until the Cabilly patent expired.  Genentech argue that Millennium’s stockpile of Entyvio® which was manufactured before the Cabilly patents expired, but would be sold after 18 December 2018, constituted a “licenced product” and royalties are owed based on the sales of those products.  

The Complaint against Biogen (3:23-cv-909) is similar, but pertains to Biogen’s Tysabri® (natalizumab) product.  Genentech allege that Biogen also owe royalties based on sales of Tysabri® that were manufactured before the Cabilly patents expired but sold after.   

Genentech is unaware of the size of Millennium and Biogen’s respective stockpiles, but claims that they each owe Genentech “tens of millions of dollars in unpaid royalties”. 

February 27, 2023

Eisai and Biogen announced that its BLA for LEQEMBI™ (in the US) (lecanemab) an investigational anti-amyloid beta (Aβ) protofibril antibody, has been designated for Priority Review by the National Medical Products Administration (NMPA) in China.  The assessment period for LEQEMBI™ is therefore expected to be shortened.  The NMPA reviewed data from the phase II clinical trial (Study 201) and the top-line data of the large global Phase III Clarity AD study in mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD with confirmed Aβ accumulation in the brain.

February 27, 2023

AbbVie announced that the EMA CHMP recommended approval of RINVOQ® (upadacitinib) for treatment of moderate to severe Chron’s disease when patients have not responded to conventional therapy or biologic.  The CHMP relied on three phase III trials, including two induction studies, U-EXCEED and U-EXCEL, and one maintenance study, U-ENDURE.

The CHMP recommend expanding the indications for RINVOQ® (upadacitinib) to treatment of moderate to severe atopic dermatitis (in addition to rheumatoid arthritis, psoriatic arthritis and ankylosing spondylitis)  on 24 June 2021.  On 19 May 2022, CHMP recommended it be further expanded to include moderate to severe active ulcerative colitis.

February 27, 2023

Korean Biomed has reported that Celltrion has entered into a joint R&D contract with GeneMedicine, a Korean anticancer virus development company, to develop CT-P6, biosimilar to Genentech’s Herceptin® (trastuzumab), in system administration form.  Celltrion will provide the raw material and GeneMedicine will apply its proprietary nanomaterial-based platform technology (that enables effective and tumor-targeted systemic administration of oncolytic viruses).  The companies plan to develop platform technology with the goal of completing the non-clinical parts of the development by the end of 2023.

February 26, 2023

The phase III trial LIBERTY-EoE-TREET examined eosinophilic esophagitis patients treated with duplimab. The authors found that patients had improved histologic, symptomatic, and endoscopic results and the treatment was well tolerated. One of the authors Professor Evan Dellon presented a subanalysis of the data at the American Academy of Allergy, Asthma & Immunology (AAAAI) 2023 Annual Meeting in San Antonio, Texas. Professor Dellon said in an interview that his research “suggests that the medication is biologically active and working on these mechanisms, or we think it would work.”

We have previously reported on the use of dipilumab for atopic dermatitis.

February 24, 2023

The Korea Biomedical Review has reported that Celltrion has explained to shareholders the delay in obtaining US approval for its Humira® adalimumab biosimilar Yuflyma®. Despite obtaining EMA approval in December 2020, Celltrion confirmed that FDA took issue with Celltrion’s overseas and end-product manufacturing plants. Celltrion has rectified the problems and the FDA will complete a final review by May 2023. We have previously reported on Yuflyma®’s progress and approvals including its EU approval in December 2020, in CA on 24 December 2021 and in AU on 28 February 2022.   Celltrion is licensed to supply Yuflyma® in the US from July 2023 pursuant to its settlement with AbbVie.

February 23, 2023

The Korea Herald has reported that Samsung Bioepis, through partner Biogen launched its Lucentis® (ranibizumab) biosimilar SB11 in February 2023 in Germany.   The product is sold as Byooviz™ in Europe and Ameliv™ in Korea Byooviz™ was launched in the US on 2 June 2022. 

February 23, 2023

Regeneron announced that the FDA has accepted for priority review its BLA for aflibercept 8mg for treatment of patients with wet age-related macular degeneration, diabetic macular edema and diabetic retinopathy.  The BLA was supported by two pivotal trials demonstrating non-inferior vision gains to EYLEA® (aflibercept) Injection, with vast majority of patients maintaining extended dosing regimens through 48 weeks.  The FDA target action date is 27 June 2023. Aflibercept 8mg is being jointly developed by Regeneron and Bayer A.G.

February 23, 2023

The EMA CHMP has recommended a grant of market authorization for Bekemv®, Amgen’s eculizumab biosimilar to Alexion’s Soliris® (eculizumab). Bekemv is indicated for the treatment of paroxysmal nocturnal haemoglobinuria in adults and children.

February 22, 2023

AstraZeneca has announced that its Imfinzi® (durvalumab) and Imjudo® (tremelimumab) immunotherapy combination has been approved in the EU for first-line treatment of advanced liver and lung cancers. The approval follows recommendations by the EMA human medicines committee in December 2022 based on positive results from their POSEIDON and HIMALAYA Phase III trials.

BMS has brought patent infringement proceedings against AstraZeneca for its Imfinzi® product, with a jury trial set down for April 2024.

February 22, 2023

Merck (known as MSD outside of the United States and Canada) and Moderna announced a new investigational mRNA cancer vaccine mRNA-4157/V940 combined with Keytruda® (pembrolizumab) has been granted Breakthrough Therapy Designation by the FDA for adjuvant treatment of patients with high-risk melanoma following complete resection. The designation will result in expedition of the FDA’s the  review of the combination treatment. According to the release, the companies will initiate a Phase 3 study in adjuvant melanoma in 2023, and rapidly expand to additional tumor types (including non-small cell lung cancer). Merck and Moderna exercised the option to jointly develop the treatment in October 2022.

February 22, 2023

Eli Lily has published its annual financial report, noting that the there was a 12% increase in revenue in the US, and 13% increase outside of the US, from sales of Taltz® ixekizumab. The annual report discloses that Eli Lily derived more than US$2.48 billion from the supply of Taltz® worldwide.

February 22, 2023

South Korea’s Alteogen announced that its subsidiary Altos Biologics has completed patient enrolment in its Ph III trials of ALT-L9 aflibercept (biosimilar to Regeneron’s Eylea®) in patients with neovascular  age-related macular degeneration.  Alteogen reported that it plans to submit the BLA in early 2024, with a European launch anticipated in the first half of 2025.

February 22, 2023

The Financial Times has reported that the Dutch Pharmaceutical Accountability Foundation (PAF), a public interest group, is suing Abbvie for allegedly overcharging citizens for Humira® (adalimumab) in Holland. PAF is arguing that the pricing of the drug is in breach of human rights.  AbbVie has rejected the allegations

February 20, 2023

Growth Plus Reports has reported that the adalimumab global biosimilars market (valued at US$3.53B in 2021) and is expected to reach US$18.53B by 2030.  The report notes that Europe is the key growth region for the adalimumab global biosimilars market, and Amgen’s Amjevita® to AbbVie’s Humira® has the largest market share.

Read our previous post about the short term US cost savings expected from Amjevita® here.

February 18, 2023

Takeda published the results of Ph III trials of vedolizumab in the prevention of intestinal acute graft-versus-host disease (aGvHD) in patients undergoing allogeneic hematopoietic stem cell transplantation (allo-HSCT).  Takeda reported that the study met its primary endpoint, with vedolizumab achieving a statistically significant improvement in intestinal aGvHD-free survival versus placebo by Day 180 after allo-HSCT.

February 17, 2023

A study published in the United European Gastroenterology Journal has found that multiple successive switches from Janssen’s Remicade® to biosimilars were effective and safe in IBD patients, regardless of   the number of switches.   The team performed a prospective observational cohort study of three switch programs, including Janssen’s Remicade® to CTP-13 (Pfizer’s Inflectra® in US/ Celltrion’s Remsima® in EU), CT-P13 to SB2 (Samsung Bioepis’ Flixabi® in EU, Renflexis® in the US and Remaloce® in Korea), and from SB2 to CTP-13.

The study was funded by UK Research and Innovation Grans, the Medical Research Council, The University of Edinburgh and the Wellcome Trust.

February 16, 2023

The Paris Court of Appeal (Cour d’Appel de Paris) has overturned the anti-trust fines implemented by Autorité de la Concurrence, France’s competition commission in 2020. The French competition commission claimed that Novartis and Roche abused their dominant market position to preserve the price of Lucentis® (ranibizumab) by “colluding in obstructive behavior” and spreading “alarmist” and “misleading” statements about the risks associated with a cheaper drug Avastin® (bevacizumab). However, the Appeal Court overturned the decision, finding no cartel conduct.

Novartis says that it “strongly contested these allegations from the outset and firmly believes the company has acted appropriately and in compliance with competition law and the interests of patients at all times”.

February 16, 2023

Fresenius Kabi launched Stimufend® (biosimilar to Amgen’s Neulasta® pegfilgrastim) in the US.  Stimufend is Fresenius Kabi’s first biosimilar launch in the US.  Fresenius Kabi also intends to launch Idacio® (biosimilar to AbbVie’s Humira® adalimumab) in the US in July 2023 pursuant to its settlement agreement with AbbVie.

February 16, 2023

Biora Therapeutics announced preliminary results from preclinical testing of PGN-0B1, reporting an average bioavailability greater than 50% for a variant of adalimumab. Biora’s systemic therapeutics platform uses an ingestible capsule for needle-free, oral delivery of biotherapeutics using liquid jet delivery.

February 16, 2023

Organon published its results for Q4 and full year ended 31 December 2022, reporting a second consecutive year of double-digit revenue growth in biosimilars. Organon reported that this growth was primarily drive by double-digit growth from Renflexis® (biosimilar to Johnson & Johnson’s Remicade® infliximab), Ontruzant® (biosimilar to Roche’s Herceptin® trastuzumab), Hadlima® (biosimilar to AbbVie’s Humira® adalimumab) and Aybintio® (biosimilar to Roche’s Avastin bevacizumab).

February 15, 2023

Coherus and Junshi Biosciences published the results of Ph III trials of toripalimab in JUPITER-02 (NCT03581786), a randomized, double-blind, placebo-controlled Phase 3 clinical trial evaluating toripalimab in combination with gemcitabine and cisplatin as the first-line treatment for patients with recurrent or metastatic nasopharyngeal carcinoma (“NPC”).  Coherus reported that final analysis demonstrated a statistically significant and clinically meaningful improvement in overall survival  in NPC patients treated with toripalimab plus chemotherapy compared to chemotherapy alone.  The FDA has granted Breakthrough Therapy designation (and associated regulatory expedition) for toripalimab for the indications relating to use in combination with gemcitabine and cisplatin as first-line treatment for patients with advanced recurrent or metastatic NPC and for toripalimab monotherapy for the second-line or later treatment of recurrent or metastatic NPC after platinum-containing chemotherapy.

February 15, 2023

Henlius announced that the FDA has accepted its BLA for HLX02 (trastuzumab, biosimilar to Roche’s Herceptin®). According to the release, this is the first Chinese biosimilar to be approved in both China and the EU and may be the first to be approved in the US.

February 14, 2023

JSR Life Sciences’ Similis Bio announced plans to enter into a partnership with Novel351K to co-develop three undisclosed biosimilar programs.  Under the initial agreement, Similis will be responsible for cell line development, analytics, process development, and cGMP production, leading to pharmacokinetics/pharmacodynamic clinical trials, while Novel351K will assist with accelerating the development of the programs to commercialisation.

February 13, 2023

A new Fresenius Kabi study published in the Expert Review of Clinical Immunity has confirmed pharmacokinetic bioequivalence between a tocilizumab biosimilar and a US-licensed tocilizumab (Actemra®). The authors also found that the safety profiles were similar. Tocilizumab is prescribed for autoimmune conditions including rheumatoid arthritis.

February 12, 2023

Biocon announced that the FDA has issued a Complete Response Letter for Viatris (Mylan)’s BLA regarding the bevacizumab jointly developed with Biocon Biologics (biosimilar to Genentech’s Avastin®).  Biocon Biologics said in the announcement that is has submitted a comprehensive Corrective and Preventative Action plan, and is confident of addressing the observations within the stipulated timeframe.

February 10, 2023

Celltrion and Samsung Bioepis each filed motions seeking joinder of their respective IPR challenges to Regeneron’s 10,888,601 and 10,130,681 patents for Eylea® (aflibercept) with Mylan’s, which was instituted in January 2023.

PTAB also instituted Mylan’s IPR against Regeneron’s US10,130,681.   A third Mylan IPR challenge against US10,857,205 remains pending and is likely to be initiated in April 2023.

Separately, Regeneron sued Mylan in West Virginia in August 2022, alleging infringement of 24 patents relating to Eylea (including the ‘601 patent), and a 10 day trial has been set down for June 2023, which is 10 months after Regeneron filed its complaint.

February 10, 2023

Samsung Bioepis filed a petition for inter partes review of Regeneron’s US 10,888,601, relating to Eylea® (aflibercept).  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the‘601 patent.

February 9, 2023

Alvotech and STADA announced that EMA has accepted the MAA for Alvotech’s AVT04 biosimilar to Janssen’s Stelara™.  The companies expect the EMA to recommend AVT04 for approval as early as the second half of 2023.  In January 2023, the FDA accepted for review the BLA for AVT04.

February 8, 2023

Regeneron announced that the FDA has approved Eylea® (aflibercept) for the treatment of preterm infants with retinopathy of prematurity.  Eylea is now approved in the US to treat five retinal conditions caused by ocular angiogenesis.

February 6, 2023

Sandoz announced that FDA accepted its BLA for anti-RANKL mAb, biosimilar denosumab.  The application includes all indications included in the Amgen reference products Prolia® and Xgeva®.

February 6, 2023

Alvotech announced that it has entered into an exclusive agreement with Advanz Pharma for the commercialisation of AVT23 (omalizumab, biosimilar to Novartis’ Xolair™).  The agreement covers the European Economic Area, UK, Switzerland, Canada, Australia and New Zealand.  Alvotech will be responsible for development and manufacture, while Advanz Pharma will handle registration and commercialisation of AVT23.

February 3, 2023

Merck announced that Ph III trials of Keytruda® (pembrolizumab) in combination with chemotherapy met its primary endpoint of progression-free survival for the treatment of stage III-IV or recurrent endometrial carcinoma.  Reportedly, the safety profile of Keytruda was consistent with that observed previously, with no new safety signals identified.

February 2, 2023

Fresenius Kabi and Formycon AG announced they have reached a global license agreement to commercialise FYB202, biosimilar to Johnson & Johnson’s Stelara®. Under the agreement, Fresenius will have the exclusive commercialisation rights in key global markets, whilst Formycon will be responsible for development and registration with health authorities.

On 19 September 2022, Formycon announced that it was developing a biosimilar to Merck’s Keytruda® (pembrolizumab).

February 2, 2023

Roche’s Genentech is investing US$450M in expanding its biologics capabilities at Oceanside California. Approximately US$280M will go toward building a new biologics manufacturing facility that will begin operations in 2025. The new facility will produce protein-based medicines and antibodies, and will have capacity to manufacture small batches of drugs including personalised medicines and treatments for patients with rare diseases.

January 31, 2023

Reuters reported that it expects only limited cost savings to result from Amgen’s launch of Amjevita® (biosimilar to AbbVie’s Humira® adalimumab) in the US in January this year.  Reuters reported that while Amgen launched Amjevita at two price points (one with a 5% discount to Humira, and one with a 55% discount to Humira), the more heavily discounted product is not expected to be as widely used.

Costs may ease later this year with the launch of biosimilars developed by Alvotech (1 July 2023), Celltrion (July 2023 – but Celltrion’s launch may be delayed as reported above), Mylan/Viatris (31 July 2023) Sandoz (30 September 2023), Momenta (20 November 2023) Pfizer (20 November 2023), Fresenius Kabi (July 2023), Samsung Bioepis/Merck (30 June 2023), Coherus (1 July 2023) and Boehringer Ingelheim (1 July 2023).

January 31, 2023

The much anticipated launch of the first US Humira biosimilar occurred with Amgen launching Amjevita® (adalimumab) on 31 January 2023, pursuant to its settlement agreement with AbbVie which was penned in September 2017.  Amjevita® is the first adalimumab biosimilar to be launched in the US and is available at a Wholesale Acquisition Cost 55% below the current Humira® list price.  Biosimilars developed by Alvotech, Celltrion, Mylan/Viatris, Sandoz, Momenta, Pfizer, Fresenius Kabi, Samsung Bioepis/Merck, Coherus and Boehringer Ingelheim are able launch in the US later this year, in accordance with their settlements with AbbVie.

On 16 September 2022 Pearce IP prepared a Vlog in its PiPCast® series on IP strategies to enable the launch of biosimilars around the world, with a particular focus on Australia.

January 31, 2023

A CVS report has predicated that interchangeability designations for adalimumab biosimilars will not primarily drive their adoption by prescribers.  This contradicts the Cardinal Health 2023 Biosimilars Report, which found that a majority of providers intended to only prescribe interchangeable adalimumab biosimilars, rather than AbbVie’s Humira®.

Earlier in January 2023, we reported that Samsung Bioepis was accelerating its interchangeability studies for Hadlima® (adalimumab biosimilar).  In December 2022, Alvotech announced that the FDA confirmed that data supplied for its AVT02 (adalimumab biosimilar) was sufficient to support a determination of interchangeability.

January 30, 2023

The EC approved Sanofi’s Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE).  Dupixent is the first medicine specifically indicated to treat EoE in Europe and the US.

January 30, 2023

The CHMP adopted a positive opinion recommending the approval of a citrate-free high concentration formulation of Hyrimoz® (adalimumab), biosimilar to AbbVie’s Humira®.  The positive opinion relates to all indications in the reference product, Humira®.  Hyrimoz was first approved in the EU in July 2018, and Sandoz is seeking to expand its approved indications to those of Humira.

January 27, 2023

Australia’s PBAC recommended amending the circumstances under which Roche’s Actemra® (tocilizumab) is available for reimbursement via the PBS.  The new PBS listing of Actemra includes ultrasound in the clinical criteria as a method for diagnosis of giant cell arteritis.

January 27, 2023

Korea IT Times reported that Celltrion Healthcare has launched Vegzelma™, bevacizumab, biosimilar to Roche’s Avastin™, in Japan.  Vegzelma received approval in Japan in September 2022.

January 24, 2023

Alvotech and Bioventure announced that the Saudi Food & Drug Authority has approved the manufacture and distribution of Simladi™ (AVT02, biosimilar adalimumab).  Bioventure, is a wholly owned subsidiary of GlobalOne Healthcare Holding LLC, the healthcare division of Yas Holding LLC, and is Alvotech’s exclusive strategic partner for the commercialisation of Simlandi in the Middle East and North Africa.

January 23, 2023

Alvotech announced the completion of a private placement of approximately USD$137 million of its ordinary shares, at a purchase price of $11.57 per share.  Alvotech reported that the shares are expected to be delivered from previously issued treasury shares held by Alovtech’s subsidiary, Alvotech Manco ehf.  The private placement was initiated on 19 January 2023 and completed on 22 January 2023.

January 20, 2023

Dr. Reddy’s announced that it has successfully completed the full set of clinical studies of DRL_RI (proposed rituximab biosimilar) for filing in the US, EU and other regions against Roche/Biogen’s Rituxan®. DRL_RI will be commercialised by Fresenius Kabi in the US, and by Dr. Reddy’s directly in other jurisdictions.

January 20, 2023

PTAB instituted two IPR petitions filed by Mylan challenging Regeneron’s US10,130,681 and US10,888,601 patents, which relate to Eylea® (aflibercept).  PTAB found that Mylan demonstrated a reasonable likelihood that at least claim 1 of the ‘681 patent and claim 34 of the ‘601 patent is unpatentable as being anticipated by the same piece of prior art.  A third Mylan IPR challenge, to Regeneron’s US10,857,205 is likely to be initiated in April 2023.

January 18, 2023

BeiGene announced that the National Reimbursement Drug List released by China’s NMPA has been updated to include four new indications for its PD-1 inhibitor tislelizumab.  BeiGene’s Xgeva® (denosumab) was also renewed in the NRDL.  These updates will take effect from 01 March 2023.

January 17, 2023

Celltrion filed a petition for inter partes review of Regeneron’s US 10,464,992, relating to Eylea® (aflibercept).  Celltrion has alleged the 992 patent is invalid on obviousness and anticipation grounds.  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the 992 patent.

January 16, 2023

Business Korea has reported that Regeneron has filed patent infringement and prevention claims against Samsung Biologics and its subsidiary Samsung Boepis relating to Eylea® (aflibercept).  Regeneron claims that the Samsung Bioepis’ aflibercept (biosimilar to Eylea®) infringes Regeneron’s Korean patents.   

This comes only a few days after Samsung Bioepis filed a petition for inter partes review of Regeneron’s US10,130,681, relating to Eylea® in the US.    

January 16, 2023

Korea Biomedical Review reported that Dong-A STl has published the results of its global Ph III trials of DMB-3115 (biosimilar ustekinumab).  Dong-A ST reported that the study confirmed the therapeutic equivalence and safety of DMB-3115 compared to Janssen’s Stelara®.  DMB-3115 will be commercialised by Intas Pharma in Japan, Korea and certain countries in Asia under a July 2021 agreement.

January 16, 2023

Bio-Thera Solutions announced that China’s NMPA has approved BAT1806 (biosimilar tocilizumab) for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.

January 16, 2023

STADA and Xbrane announced that Ximluci® (ranibizumab, biosimilar to Roche/Genentech’s Actemra®) has been granted marketing authorisation by the MHRA. Under a July 2018 agreement, STADA and Xbrane are jointly responsible for development and manufacturing of Ximluci, while STADA holds the marketing authorisations and commercial rights to the product across all territories included in the agreement.

January 13, 2023

Alvotech and Fuji Pharma announced an expansion to their existing exclusive commercialisation partnership in Japan, adding a new undisclosed biosimilar candidate.  The commercialisation agreement, which was first announced in 2018 and was most recently expanded in February 2022, now covers seven products.

January 11, 2023

Alvotech announced the initiation of a pharmacokinetic study for AVT05 (biosimilar golimumab candidate to Janssen’s Simponi® and Simponi Aria®).  Alvotech’s portfolio also includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar candidate to Stelara®) for which Alvotech recently announced positive topline results; AVT04 (aflibercept/biosimilar candidate to Eylea®) and omalizumab/biosimilar to Xolair®.

January 11, 2023

Merck announced that it has completed the cash tender offer for all of the outstanding shares of common stock of Imago BioSciences, Inc for $36 per share. Merck intends to complete the acquisition of Imago through a merger of Merck’s wholly owned subsidiary and the common stock of Imago will no longer be traded on the Nasdaq.

January 10, 2023

Luye Pharma announced that its subsidiary Boan Biotech has signed an agreement with CP Pharmaceutical Qingdao Co., Ltd. (CP Qingdao) to grant CP Qingdao the right to commercialise Boyoubei® (biosimilar denosumab) in mainland China.  Boyoubei was approved by China’s NMPA in November 2022.

January 9, 2023

Rani Therapeutics announced that it has partnered with Celltrion for the development of RT-111 (orally administered ustekinumab biosimilar).  Under the agreement, Celltrion will exclusively supply drug substance CT-P43 (biosimilar ustekinumab drug substance) to Rani.  Rani is granted an exclusive licence to use CT-P43 in the development and commercialisation of RT-111 and Celltrion has a right of first negotiation to acquire worldwide rights to RT-111 following Ph I trials.  The RaniPill™ capsule, is “intended to replace subcutaneous or intravenous injection of biologics and drugs with oral dosing”.

January 9, 2023

Coherus Biosciences announced that it has executed a binding term sheet with Klinge Biopharma granting Coherus the exclusive US commercialisation rights to Klinge’s FYB203 (biosimilar aflibercept, targeting Bayer’s Eylea®, developed by Regeneron).  Coherus expects to complete the transaction in Q1 2023, and to file a BLA later in 2023.  Coherus plans to launch the product at biosimilar market formation, currently expected to be in 2025.

January 7, 2023

Mylan filed a petition for inter partes review of Regeneron’s US 10,130,681 and US 10,888,601, relating to Eylea® (aflibercept).  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the ‘681 and ‘601 patents.

January 7, 2023

Biocon announced that its subsidiary Biocon Biologics has received a complete response letter (CRL) from the FDA in relation to its insulin-r product.  Biocon reported that the CRL cites additional data required and that it is in the process of addressing the CRL.

January 6, 2023

Samsung Bioepis filed a petition for inter partes review of Regeneron’s US10,130,681, relating to Eylea® (aflibercept).  In August 2022, Regeneron sued Viatris (Mylan) for infringement of 24 patents relating to Eylea, including the ‘681 patent.

January 6, 2023

Alvotech and Teva announced that the FDA has accepted for review a BLA for AVT04 (biosimilar ustekinumab). Alvotech reported that it expects the review to be completed in the second half of 2023.  AVT04 is being developed under a strategic agreement between Alvotech and Teva announced in August 2020.

January 6, 2023

Genentech and Tanvex BioPharma filed a joint notice of settlement in the District Court of the Southern District of California, notifying the court that they have reached an agreement-in-principle to resolve all pending claims in relation to their dispute over Tanvex’s BLA submission for a biosimilar trastuzumab.  The parties stated that they expect the final executed Joint Stipulation of Dismissal of all claims will be filed within 30 days.

 

January 5, 2023

Korea Biomedical Review reported that Celltrion has obtained approval from Health Canada for CT-P16/Vegzelma® (biosimilar bevacizumab) for the same indications as Avastin®.  Celltrion obtained approval for Vegzelma in the US in September 2022.  Vegzelma is Celltrion’s third anticancer drug, after Truxima® (biosimilar rituximab) and Herzuma® (biosimilar trastuzumab).

January 4, 2023

Lannett provided an update on its biosimilar insulin aspart and insulin glargine products. Lannett reported that its study of its biosimilar insulin aspart product indicated that the product was highly comparable with NovoLog®.  Lannett announced that it plans to file the BLA for its insulin aspart product by the end of 2024, with a potential launch in 2025, and plans to file the BLA for its insulin glargine product by mid-year 2023, with a potential launch late in the first half of 2024.

January 3, 2023

Hikma Pharmaceuticals announced that is has signed an exclusive licensing agreement with Celltrion for Vegzelma® (biosimilar bevacizumab CT-P16) for MENA (Middle East and North Africa) markets.  Vegzelma is approved in the US and CA, and is the seventh biosimilar to be licensed by Celltrion to Hikma, following Truxima® (rituximab), Remsima® (intravenous infliximab), Herzuma® (trastuzumab), Remsima® SC (subcutaneous infliximab), Yuflyma™ (adalimumab), and CT-P43 (ustekinumab). The deals regarding CT-P43 (biosimilar ustekinumab) and Yuflyma™ (biosimilar adalimumab) were announced in 2022.

January 2, 2023

Alteogen announced that it has entered into an exclusive licence agreement with Sandoz for the use of ALT-B4 (novel hyaluronidase derived using Alteogen’s Hybrozyme™ technology) to develop a subcutaneous version of an undisclosed Sandoz biosimilar product.  The agreement also includes an option for Sandoz to licence the Hybrozyme technology for two further products.  Alteogen will receive an upfront payment and is eligible to receive milestone payments and tiered royalties on sales of the commercialised products.  Alteogen will be responsible for the regulatory development and commercial supply of ALT-B4 to Sandoz.

January 1, 2023

Amgen’s Amgevita® is due to become the first biosimilar adalimumab in the US market, with a launch possible from 31 January 2023, in accordance with its settlement agreement with AbbVie.  Amgevita was launched in Europe in 2018, Canada in 2021 and Australia in 2021.

January 1, 2023

The Korea Herald reported that Samsung Bioepis has brought forward its interchangeability study of Hadlima® (biosimilar adalimumab). Samsung had previously announced that it would complete the study by September 2023, however now plans to complete the study in May 2023.  Samsung reported that Organon will launch in the US by July 2023 in accordance with its settlement agreement with AbbVie, without an interchangeable designation.

January 1, 2023

A new study published in the Journal of Orthopaedic Translation reported that LY06006 (biosimilar denosumab) might be an effective treatment for osteoporosis.  The study also reported that LY06006 was generally safe and well tolerated without unexpected reactions, similar to Prolia® (denosumab).

2022

December 30, 2022

OncoC4 announced that the first patient has been dosed in Ph II trials of ONC-392 (nextgen target-preserving anti-CTLA-4 antibody) and Keytruda® (pembrolizumab) in patients with platinum-resistant ovarian cancer.  The study is sponsored by OncoC4 in collaboration with Merck and GOG Foundation Inc.

December 22, 2022

Alvotech announced that the FDA has granted a new Biosimilar User Fee Amendment goal date of 13 April 2023 for its AVT02 (biosimilar adalimumab), and that FDA has confirmed that the data provided are sufficient to support a determination of interchangeability, subject to a site reinspection.  Alvotech is licensed to supply AVT02 in the US from 01 July 2023 in accordance with a licence agreement with AbbVie.

December 22, 2022

Celltrion announced that it has submitted a BLA for CT-P13 SC (subcutaneous biosimilar infliximab) with the FDA.  CT-P13 is the first and only known infliximab to have both intravenous and subcutaneous formulations.

December 20, 2022

Ontario announced that it will adopt a biosimilars switching program from 31 March 2023.  Patients currently treated with Copaxone® (glatiramer acetate), Enbrel® (etanercept), Humalog® (insulin lispro), Humira® (adalimumab), Lantus® (insulin glargine), NovoRapid® (insulin aspart), Remicade® (infliximab), and Rituxan® (rituximab) will be required to transition to the biosimilar version by 29 December 2023.  Ontario is the 8th jurisdiction to adopt a biosimilars switching program, following British Columbia, Alberta, New Brunswick, Quebec, Northwest Territories, Nova Scotia and Saskatchewan.

December 19, 2022

Dr Reddy’s announced that DRL_TC (biosimilar tocilizumab) met is primary and secondary endpoints in Ph I trials.  Dr Reddy’s is developing DRL_TC in both subcutaneous and intravenous formulations.

December 15, 2022

Regeneron and Sanofi announced that the EC has expanded  the marketing authorisation for Dupixent® (dupilumab) in the EU to include adults with moderate-to-severe prurigo nodularis who are candidates for systemic therapy.  Dupixent is the only targeted medicine to treat prurigo nodularis approved in Europe and the US.

December 15, 2022

Zhejiang Doer Biologics announced a clinical trial collaboration agreement with Merck to evaluate DR30303 (humanized anti-Claudin18.2 heavy chain antibody Fc fusion protein) in combination with Keytruda® (pembrolizumab).  Under the agreement, Doer Bio will conduct the clinical study in patients with Claudin18.2-positive, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GC/GEJ) cancer.

December 13, 2022

Fresenius Kabi announced that the FDA has approved its citrate-free biosimilar adalimumab (Idacio®) for all Humira® indications.  Idacio was approved in the EU 2019.  Fresenius intends to launch in the US in July 2023 pursuant to its settlement agreement with AbbVie.

December 12, 2022

Amgen announced that it will acquire Horizon Therapeutics for $27.8 billion.  Amgen reported that it expects the acquisition to strengthen its innovative therapeutic portfolio, adding a number of rare disease drugs to its portfolio, including Uplizna® (inebilizumab-cdon), Tepezza® (teprotumumab-trbw) and Krystexxa® (pegloticase)

December 12, 2022

The EMA reported that it is reviewing an application for biosimilar ustekinumab.  If approved, this will be the first ustekinumab biosimilar approved in the EU.

December 11, 2022

Finland’s Paras Biopharmaceuticals announced the split of its biologics and biosimilars business units, with the establishment of a new division “Paras Biologics” focussed on biosimilars co-development and licensing opportunities.  Paras Biopharma will continue to focus on new biologics activities.

December 11, 2022

A new Roche study published in the New England Journal of Medicine reported that first in class bispecific (anti-CD20/anti-CD3) antibody glofitamab [CD20-TCB, also known as RG6026] is effective in patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL).  Australia’s Peter MacCallum Cancer Centre played a major role in this study, treating the first patients in the world with glofitamab.  Roche’s glofitamab is yet to be approved, but it has received orphan drug status in Australia and the EU for DLBCL.

December 9, 2022

Biogen announced that the FDA accepted its aBLA for BIIB800 (biosimilar tocilizumab) referencing Genentech’s Actemra®.  This follows the EMA acceptance of Biogen’s MAA for BIIB800 in September 2022. Tocilizumab is an anti-interleukin-6 receptor monoclonal antibody which is indicated for various health conditions including moderate to severe RA in adults as well as juvenile idiopathic polyarthritis and systemic juvenile idiopathic arthritis.

December 8, 2022

Alvotech announced that its shares started trading on the Nasdaq Iceland Main Market in addition to the NASDAQ and NASDAQ first growth market, concluding its listing trilogy.  Alvotech announced that Nasdaq Iceland had approved its request for the admission of its shares on the Nasdaq Iceland Main Market under the ticket symbol ‘ALVO’ in early December 2022. Alvotech became the first dual US-Icelandic listed company on 23 June 2022.

December 7, 2022

Alvotech and STADA announced the launch of their high-concentration, citrate free biosimilar adalimumab Hukyndra® in Belgium, Bulgaria, Croatia, Czech Republic, Latvia, Romania, and Slovenia.  Hukyndra was first launched in Europe in June 2022, and in Switzerland in September 2022.  STADA has commercialisation rights to Hukyndra under a November 2019 strategic agreement with Alvotech.

December 6, 2022

In its aflibercept suit against Mylan in the Northern District of West Virginia Regeneron filed an expedited motion seeking to compel Mylan  to  redesignate its biosimilar regulatory file and regulator correspondence from “Outside Counsel’s Eyes Only” (“OCEO”) to enable Regeneron’s in-house Counsel to access the materials.    Regeneron has asked the court to de-designate Mylan’s aBLA immediately to confidential, and to correct the remainder of its designations.  Regeneron asserts that its in-house Counsel has already seen a substantial portion of the materials in the patent dance.

December 3, 2022

Reuters reported that Merck hopes to patent subcutaneous formulations of Keytruda® (pembrolizumab).  Merck has several studies evaluating subcutaneous pembrolizumab planned or underway, according to a search of clinicaltrials.gov and a previous press release.  A subcutaneous formulation may be more convenient for patients and healthcare providers, and therefore has the potential to replace the current infusion regime in many settings.  Reuters reported that Merck CFO Caroline Litchfield stated that Merck believes such a formulation would be patentable, which could mean Merck’s patent protection for its blockbuster is extended for a considerable period of time.  The report states that Merck is anticipating biosimilar competition for the infusion product by 2028.

December 3, 2022

Alvotech announced that Nasdaq Iceland has approved its request for the admission of its shares on the Nasdaq Iceland Main Market under the ticket symbol ‘ALVO’. Alvotech became the first dual US-Icelandic listed company on 23 June 2022.  Alvotech also announced changes to its leadership team, with CEO Mark Levick stepping down.  Executive Chairman and founder, Robert Wessman will replace Mark Levick as CEO, with former Executive VP and Head of Global R&D at Teva, Dr Hafun Fridriksdottir to become Chief Operating Officer.

November 30, 2022

Erasca announced it has signed a clinical trial collaboration and supply agreement with Pierre Fabre for BRAFTOVI (encorafenib) within key international territories.  Erasca reported that this agreement will support a clinical proof-of-concept trial evaluating ERAS-007 (oral ERK1/2 inhibitor) in combination with encorafenib and cetuximab for the treatment of BRAF V600E-mutant metastatic colorectal cancer (mCRC).

November 30, 2022

Janssen sued Amgen in the District Court of Delaware in relation to Amgen’s ABP654 (biosimilar ustekinumab).  Janssen alleges that Amgen’s product will infringe US patent Nos 6,902,734 (API) and 10,961,307 (methods of treating ulcerative colitis).  Amgen released preliminary results from its Ph III trials of ABP654 in April 2022, and it has not yet been approved by the FDA.

November 29, 2022

Biocon announced that its subsidiary Biocon Biologics completed its multi-billion dollar (part equity, part cash) acquisition of Viatris’ global biosimilars business on 29 November 2022.  With the closing of the deal, Biocon Biologics has full ownership of collaboration assets, including biosimilar trastuzumab, pegfilgrastim, bevacizumab, insulin glargine, insulin aspart, and pertuzumab, as well as Viatris’ rights to adalimumab, etanercept and aflibercept.  Biocon announced that Biocon Biologics would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.

November 29, 2022

The MHRA updated its guidance on Dupixent® (dupilumab), warning of the risk of ocular adverse reactions.  The MHRA reported that the potential for ocular adverse reactions was established during clinical trials, however further ocular adverse reactions have been identified during post-marketing clinical use.

November 29, 2022

Merck has filed a complaint in the United States District Court (District of Maryland) against The Johns Hopkins University in relation to certain patents of the university relating to Keytruda® (pembrolizumab).  Based on the wording of the complaint, the dispute arose out of a contract between Merck and the university to design and conduct a clinical trial on administration regimes for Keytruda® in cancer patients with certain genetic biomarkers.  The complaint alleges that the university was issued four US patents in 2021 and 2022 that cite the joint study but that the university claimed the inventions arose prior to the study, and that it exclusively licensed the patents to others, demanding payment from Merck for use of Keytruda®.  Merck is seeking from the court a declaration that the university breached the contract for the clinical trial, damages for breach of contract and declarations that Merck’s manufacture, use, sale offer for sale and/importation of Keytruda® do not infringe any of the patents in question.

 

November 29, 2022

Hikma Pharmaceuticals announced that it has signed an exclusive licence agreement with Celltrion for CT-P43 (biosimilar ustekinumab).  Under the agreement, Hikma will receive exclusive rights to market Celltrion’s product in all of Hikma’s MENA markets.

November 23, 2022

AbbVie announced that Skyrizi® (risankizumab) has been approved for the additional indication of Crohn’s disease by EMA.  This is the first specific interleukin-23 inhibitor to be approved for Crohn’s disease.

November 22, 2022

Merck announced positive results from the Phase 3 KEYNOTE-859 trial investigating KEYTRUDA® (pembrolizumab), Merck’s anti-PD-1 therapy, in combination with chemotherapy for the first-line treatment of patients with human epidermal growth factor receptor 2 (HER2)-negative locally advanced unresectable or metastatic gastric or GEJ adenocarcinoma. Merck reported that the treatment showed significant and clinically meaningful improvement in the trial’s primary endpoint of overall survival (OS), and that significant and clinically meaningful improvement in progression-free survival (PFS) and overall response rate (ORR) were also observed.  Keytruda is already approved by the FDA and elsewhere for other gastric and GEJ tumours.

November 22, 2022

Reuters reported that Teva and Sandoz are planning a significant ramp-up in production of biosimilars.

According to Reuters:

  • More than 55 blockbuster biologics will come off patent protection over the next decade, and account for more than $270 billion in expected peak annual sales;.
  • The value of the global biosimilar market could more than triple to an estimated $74 billion by 2030.
  • Sandoz is currently the second biggest player after Pfizer in the biosimilar market by gross sales globally. Amgen is in third place).
  • Sandoz has launched eight biosimilar drugs, has 15 products in development, and in the next five years would like to double the value of its marketed portfolio
  • Teva has 3 approved biosimilars and 13 in development.
  • EMA has approved more than 50 biosimilars, and biosimilars have taken the majority of market share from brand-name biologics in Europe and resulted in savings between 75% to 90% off the reference product prices.
  • FDA has approved 39 biosimilars and 22 products have been launched as of October 2022.

November 22, 2022

Junshi Biosciences announced today that China’s NMPA has approved its supplemental application for additional indications for 君邁康® (biosimilar adalimumab) for the treatment of Crohn’s disease, uveitis, polyarticular juvenile idiopathic arthritis, plaque psoriasis in children and Crohn’s disease in children.

November 22, 2022

Amneal announced the launch of Releuko® (biosimilar filgrastim) for the treatment of neutropenia. Amneal and Amgen settled their patent dispute in November 2019.  This is the second biosimilar product to be launched by Amneal this year, following the US launch of Alymsys® (biosimilar bevacizumab) in October 2022.

November 22, 2022

The FDA announced that it is investigating the risk of severe hypocalcemia with serious outcomes in patients with advanced kidney disease on dialysis treated with Amgen’s Prolia® (denosumab).  According to the announcement, FDA’s review of interim results of ongoing safety studies suggested an increased risk of hypocalcemia in patients with advanced kidney disease, and a substantial risk with serious outcomes including hospitalization and death.

November 18, 2022

Korea Biomedical Review reported that Celltrion has obtained approval from South Korea’s Ministry of Food and Drug Safety for a domestically manufactured Yuflyma® (biosimilar adalimumab).

November 18, 2022

The FDA approved Eli Lilly’s Rezvoglar® (biosimilar insulin glargine) as an interchangeable biosimilar to Lantus®.  Rezvoglar was approved as a biosimilar in December 2021.

November 17, 2022

A Chinese study by Innovent Biologics, Inc. has demonstrated that the combination therapy of sintilimab and bevacizumab biosimilar provided better quality of life for the treatment of hepatocellular carcinoma, albeit at a higher cost ($33,102 vs $21,037 (2021 USD)), compared with lenvatinib.

November 17, 2022

Senator Mike Lee (R-UT) introduced the Biosimilars Red Tape Elimination Bill into the US Senate, which – if implemented, will prohibit the FDA from requiring biosimilars to undergo switching studies to obtain ‘interchangeable’ designation.  Unlike small-molecule drugs, biosimilars cannot be substituted at the pharmacy level without this interchangeability designation.

November 17, 2022

Korea Biomedical Review reported that Dong-A ST has completed Ph III trials of DMB-3115 (biosimilar ustekinumab).  Dong-A ST reported that it plans to file for regulatory approval in the US and Europe in the first half of 2023.  DMB-3115 has been jointly developed by Dong-A ST and Meiji Seika Pharma.  Intas Pharma and Meiji/Dong-A ST signed a commercialisation agreement in July 2021 for DMB-3115.

November 16, 2022

Alvotech reported its financial results for the first nine months of 2022, reporting revenue of $59.2 million compared to $2.0 million for the same period in 2021.  Alvotech also announced financing facilities securing gross proceeds of approximately $136 million.

November 14, 2022

Strides’ biologics arm Stelis Biopharma announced that it has obtained a positive CHMP recommendation for its first biosimilar product Kauliv™ (teriparatide, biosimilar to Eli Lily’s Forsteo®) for the treatment of osteoporosis.

Kualiv is the first biosimilar product developed in house by Stelis.  Stelis will make Kualiv, which it has already licensed across 20 countries, in Bangalore.  According to the announcement, the product “will generate incremental revenues for the Company starting FY24”.

Stelis is developing teriparatide, insulin glargine (biosimilar to Sanofi’s Lantus®), insulin lispro (biosimilar to Eli-Lilly’s Humalog®), insulin aspart (biosimilar to NovoNordisk’s Novolog®) and another “recently filed peptide for diabetes”.

November 14, 2022

Alvotech announced the Australian approval for AVT02 (biosimilar adalimumab).  Cipla will supply Alvotech’s product in Australia and New Zealand under a partnership first announced in July 2019 for adalimumab, which was expanded in March 2021 to include 4 additional biosimilars: aflibercept, ustekinumab, denosumab and golimumab biosimilars.

November 14, 2022

Biocon announced its financial results for Q2 2022, reporting consolidated revenue growth of 23% year on year.  Biocon subsidiary Biocon Biologics’ acquisition of Viatris’ global biosimilars business is expected to close “soon”.  Biocon announced that its subsidiary Biocon Biologics would acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash in February 2022.

November 14, 2022

Organon launched Ontruzant® (biosimilar trastuzumab) and Aybintio® (biosimilar bevacizumab) in Canada. Ontruzant and Aybintio were developed and manufactured by Samsung Bioepis, under a February 2013 agreement.

November 11, 2022

TME Pharma announced the publication of interim data from Ph I/II clinical trials of NOX-A12 (PEGylated L-stereoisomer RNA aptamer that targets CXCL12) combined with radiotherapy and bevacizumab biosimilar in first-line MGMT unmethylated brain cancer.  A poster presentation containing additional and updated data will be presented at the Society for Neuro-Oncology Annual Meeting on 18 November 2022.

November 11, 2022

The CHMP recommended the approval of Dupixent® (dupilumab) for the treatment of moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

November 11, 2022

Janssen published data from Ph III trials of Tremfya® (guselkumab) for the treatment of psoriatic arthritis.  Janssen reported that early skin and enthesitis responses predicted longer-term clinical response, including disease remission at week 52.

November 10, 2022

Alvotech announced that it will present two posters (and will be featured in an Ignite Talk) related to its switching study for ATV02 (100mg/mL citrate-free biosimilar adalimumab) at the American College of Rheumatology (ACR) Convergence Conference, in Philadelphia on November 10-14, 2022.  Alvotech is the only known company that has both developed a high-concentration biosimilar candidate to Humira and completed a switching study to support potential regulatory approval as an interchangeable product.  Alvotech’s application for AVT02 was accepted in February 2022.

November 10, 2022

China’s NMPA approved Luye Pharma subsidiary Boan Biotech’s Boyoubei® (denosumab biosimilar) for the treatment of postmenopausal women with osteoporosis at high risk of fractures.  Boyoubei® is the first biosimilar to Prolia® (the originator of denosumab) approved for marketing anywhere in the world.  Boan Biotech is developing Boyoubei for global sale.

November 9, 2022

PTAB issued decisions in Mylan’s IPR challenges relating to Regeneron’s 9,254,338 and 9,669,069 relating to Eylea® (aflibercept),  invalidating all claims the subject of the Mylan challenge, for anticipation.  Mylan’s IPRs were heard by PTAB in August 2022.  Regeneron filed a complaint against Mylan in West Virginia on 03 August 2022, alleging infringement of twenty-four patents – including the 2 subject patents – relating to Eylea® (aflibercept).

November 8, 2022

Coherus Biosciences provided a business update, announcing that Cimerli™ (biosimilar ranibizumab) has achieved leading biosimilar market share in the US within the first four weeks of launch, with 2023 net sales expected to exceed $100 million.  Coherus’ net revenue for the quarter ending September 2022 was $45.4 million, down from $82.5 million for the quarter ending September 2022.  Coherus attributed this decline to a decrease in the sales of Udencya® (pegfilgrastim biosimilar) as well as a lower net realized price due to increased competition.

November 8, 2022

NICE published final draft guidance recommending Keytruda® (pembrolizumab) for the treatment of triple-negative breast cancer.  NICE expects to publish its final guidance on pembrolizumab for treating early or locally advanced triple-negative breast cancer next month (December 2022).

November 7, 2022

The MHRA has updated its guidance on the licensing of biosimilars to allow interchangeability between biosimilars to the same reference product at the prescriber level.  The MHRA’s position on pharmacy substitution (not allowed) remains unchanged.  This follows a similar move by the EMA in September 2022.

November 7, 2022

Amgen announced that it will present data across its portfolio at the American College of Rheumatology Convergence on 10-14 November 2022, including data for Amgevita® (biosimilar adalimumab), Enbrel® (biosimilar etanercept) and Prolia® (biosimilar denosumab).

November 4, 2022

A new study involving 295 patients with AD published in JAMA reported that there is no association between serum dupilumab and treatment response and adverse effects in atopic dermatitis during the first year of treatment.

November 3, 2022

On Friday, the US Supreme Court granted Amgen’s petition for certiorari in relation to ‘whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort,’”. This petition was filed in response to the Federal Court decision which invalidated genus claims in two Amgen patents relating to Repatha® (evolocumab) which it asserted against Sanofi/Regeneron regarding Praluent® (alirocumab).

November 2, 2022

Accord Healthcare was the clear winner at the Global Generics and Biosimilars Awards which were presented on 2 November in Frankfurt, achieving “Biosimilar Initiative of the Year”, “Company of the Year”, “Value Added Medicine Initiative of the Year”, and “Regulatory Achievement of the Year”.  Dr Reddy’s, Samsung Bioepis, Stada and Shanghai Henlius Biotech were also winners in the following categories:

  • Dr Reddy’s Laboratories: Company of the Year, Americas;
  • Samsung Bioepis: Company of the Year, Asia-Pacific;
  • Stada: Intellectual Property Strategy of the Year; and
  • Shanghai Henlius Biotech: BD of the year.

November 1, 2022

Bio-Thera Solutions announced that it has commenced Ph III trials of BAT2306, biosimilar to Novartis’ secukinumab (Cosentyx®) in patients with moderate to severe plaque psoriasis.

November 1, 2022

Australia’s PBAC reversed the temporary COVID measures put in place in response to drug shortages during the COVID pandemic allowing patients to transition off tocilizumab during the shortage period to another biological disease modifying drug (bDMARD) claiming that “as of 15 July 2022, the supply shortage of tocilizumab has resolved”.  From 01 December 2022, these items will move to a ‘Supply Only’ state for six months (allowing patients to fill outstanding repeats on prescriptions), before being completely removed from the PBS.

October 28, 2022

The Australian Pharmaceutical Benefits Advisory Counsel (PBAC) published the public summary documents from its July 2022 meeting.  Among the updates were:

  • Yuflyma® (adalimumab): recommended with ‘a-flagged’ status for the same indications as Humira®.
  • Tysabri® (natalizumab): amended listings (removing a requirement for neurologists prescribing natalizumab to be registered with the Tysabri Australian Prescribing Program) recommended by PBAC.
  • Epidyolex® (cannabidiol): not recommended for the treatment of Lennox-Gastaut syndrome, as the incremental cost effectiveness ratio was deemed to be unacceptably high at the price proposed.
  • Keytruda® (pembrolizumab): amended listings (increasing the max number of repeats, and maximum number of cycles in a lifetime) recommended by PBAC.
  • Stelara® (ustekinumab): vial for IV infusion and PFS recommended for the treatment of moderate to severe ulcerative colitis. 90mg/1mL PFS recommended for the treatment of Crohn disease and severe chronic plaque psoriasis.

October 28, 2022

Roche Canada announced that Health Canada has approved Actemra® IV (tocilizumab) for the treatment of hospitalised adult patients with COVID-19 who are receiving systemic corticosteroids, and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.

October 28, 2022

Outlook Therapeutics announced that the FDA has accepted its BLA for ONS-5010 (ophthalmic bevacizumab biosimilar) for the treatment of wet age-related macular degeneration. The FDA has set a PDUFA goal date of 29 August 2023.

October 27, 2022

Merck announced its third quarter 2022 financial results on 27 October.  Worldwide sales for the quarter were $15.0 billion, an increase of 14% from third quarter 2021.  $5.4 billion of this was attributable to KEYTRUDA® (pembrolizumab), sales for which had grown 20% over third quarter 2021.

October 27, 2022

Biogen is seeking a preliminary injunction in its proceedings against Sandoz commenced in September 2022 relating to natalizumab.  Biogen and Sandoz filed a joint stipulation and proposed schedule, seeking a preliminary injunction after 07 April 2023.  Biogen filed a sealed complaint against Sandoz and Polpharma in September 2022, alleging infringement of 28 Biogen patents.

October 27, 2022

Alvotech announced that it will release financial results for the first nine months of 2022 on 15 November 2022.  Following the release, Alvotech will conduct a business update conference call and live webcast.

October 27, 2022

In October 2022, Fresenius Kabi entered into a confidential settlement agreement with Chugai and Roche, which resulted in the termination of seven Inter Partes Review proceedings in relation to tocilizumab patentsThe IPRs were commenced by Fresenius in 2021 and 2022.  At the time of settlement, the PTAB had instituted six of the IPRs, with one pending institutionThe IPRs were IPR2021-01024, IPR2021-01025 , IPR2021-01288, IPR2021-01336, IPR2021-01542, IPR2022-00201 and IPR2022-01065. 

October 25, 2022

A trial date of 12 – 23 June 2023 has been set in the Regeneron v Mylan aflibercept District Court (NDWV) BPCIA dispute.  Regeneron has identified 6 patents (10,888,601, 11,053,280, 11,084,865, 11,104,715, 11,253,572 and 11,299,532) from 3 patent families for initial proceedings, and has stipulated that it will not seek injunctive relief on the other 18 patents asserted in its complaint.  This hearing date will be a mere ten months after Regeneron filed a complaint against Mylan in August 2022. Mylan filed it’s a-BLA for biosimilar aflibercept in October 2021, and received FDA notification that the application was accepted on 28 December 2021.

October 25, 2022

JSR Life Sciences announced that its recently launched biosimilars business Similis Bio has entered into a development and licence agreement with Blau Farmaceutica for four biosimilar products targeting oncology, inflammation and blood disorders.  Under the agreement, Similis Bio will provide full processes and associated IP for tech transfer to Blau; and Blau will use the licensed IP for GMP manufacturing and clinical development, and seek regulatory approval.  JSR disclosed the global market value of these 4 products is USD 42B.

October 24, 2022

Rani Therapeutics announced that it has commenced preclinical development of RT-111 a RaniPill GO capsule containing an ustekinumab biosimilar.  BioFactura and Rani Therapeutics entered into an agreement in September 2021 to assess Bio-Thera’s BFI-751 (ustekinumab biosimilar) in combination with Rani’s RaniPill® platform.

October 21, 2022

Regeneron announced that the FDA has granted paediatric exclusivity for Eylea® (aflibercept), extending market exclusivity in the US to 17 May 2024. Paediatric exclusivity was granted on the basis of Ph III trials of Eylea as a treatment for retinopathy of prematurity in preterm infants.

October 21, 2022

Spectrum Pharmaceuticals announced the US launch of Rolvedon™ (eflapegrastim-xnst), a market which is estimated to be valued at over US$2B.  Rolvedon was FDA approved in September 2022 to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

October 20, 2022

AbbVie announced the acquisition of DJS Antibodies, a UK-based biotechnology company.  DJS’ lead program is DJS-002, a lysophosphatidic acid (LPA) receptor 1 (LPAR1) antagonist antibody currently under investigation for the treatment of Idiopathic Pulmonary Fibrosis (IPF) and other fibrotic diseases.

October 19, 2022

Alvotech announced that it has expanded its exclusive partnership with JAMP for Canada, adding AVT16 (immunology biosimilar) and AVT33 (oncology biosimilar) to their existing partnership.  Under the agreement, Alvotech will be responsible for the development and commercial supply of the products, in exchange for milestone payments and future sales royalties.  Alvotech and JAMP previously entered into a biosimilar commercialisation agreement for five biosimilar products in January 2020.

October 19, 2022

Lupin disclosed that the FDA has issued 17 observations in relation to its biotech manufacturing facility in Pune, India.  Lupin announced that it is committed to addressing the concerns raised by the FDA, and that it does not expect the observations to impact on the existing revenues raised through this facility.

October 18, 2022

Former Genentech scientist Xanthe Lam and her husband Allen Lam were each sentenced to six months imprisonment and fines of over $10,000 for their role in the Genentech/JHL Biotech trade secrets scandal.  The Lams plead guilty to stealing confidential intellectual property relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab) and Avastin® (bevacizumab), passing the information onto JHL Biotech to aid in its biosimilar development.

 

October 17, 2022

Biocon Biologics announced that it will license its ustekinumab and denosumab biosimilars to Yoshindo for Japan.  Yoshindo will pay an upfront licence fee and further payments over the next few years as certain development milestones are achieved. Biocon Biologics estimates the market opportunity for the two biosimilars in Japan to be US$700m.

October 17, 2022

Alvotech announced that Fuji Pharma has submitted a marketing authorisation application to Japan’s Ministry of Health, Labor and Welfare for an undisclosed product.  This is the first MAA to be submitted under the exclusive partnership agreement between Alvotech and Fuji Pharma.  In February 2022, Alvotech and Fuji Pharma announced an expansion to their strategic partnership  for Japan.

October 14, 2022

BioFactura has announced successful completion of its Ph I trials relating to biosimilar ustekinumab candidate BFI-751.  The trial in Australia and New Zealand involved 226 subjects and demonstrated bioequivalence of BFI-751 to the US and EU versions of Janssen’s Stelara.  BioFactura now intends to conduct a Ph III confirmatory safety and efficacy trial in patients.

October 13, 2022

Prestige Biopharma announced that it has submitted a request to the FDA for a pre-submission meeting to discuss the planned BLA for Tuznue® (biosimilar trastuzumab).  Prestige announced that it plans to submit the BLA by the end of the year.

October 12, 2022

Amgen published its 9th Biosimilars Trends Report, reporting on the current and future state of the US biosimilars market.  Among Amgen’s findings were the following:

  • Trends show an increase in savings per quarter, and in Q2 alone, savings in drug spend due to biosimilar availability are estimated to be $3.2 billion.
  • Biosimilars primarily covered under the medical benefit have typically launched at a wholesale acquisition cost (WAC) that is generally 10% to 57% lower than that of the reference product.
  • Seven or more launches of Humira® (adalimumab) biosimilars are possible in 2023. The entry of biosimilars is expected to lead to price declines across all products within the class.

October 12, 2022

Jacobio Pharma announced it has entered into a clinical trial collaboration agreement with Merck to study Jacobio’s JAB-21822 (KRAS G12C inhibitor) in combination with Erbitux® (cetuximab) for the treatment of KRAS G12C-mutated colorectal cancer.

October 12, 2022

Regeneron announced that the FDA has accepted for Priority Review the sBLA for Eylea® (aflibercept) to treat retinopathy of prematurity in preterm infants.   The target action date for the FDA decision is 11 February 2023.

October 12, 2022

Merck announced that it has exercised its option to jointly develop and commercialise the personalised cancer vaccine mRNA-4157/V940 under the terms of the Collaboration and License Agreement originally signed by Merck and Moderna in 2016.  Moderna is conducting a Phase 2 clinical trial evaluating mRNA-4157/V940 in combination with Merck’s KEYTRUDA® as adjuvant treatment for patients with high-risk melanoma. Primary data are expected in Q4 2022.

October 10, 2022

Janssen published data from its Ph IIa clinical trials of guselkumab with golimumab in the treatment of ulcerative colitis.  Janssen reported that adults with moderately to severely active ulcerative colitis (UC) who received 12 weeks of combination induction therapy with guselkumab and golimumab, followed by a transition to guselkumab alone for maintenance, achieved a higher clinical remission rate than induction and maintenance treatment with either guselkumab alone or golimumab alone.

October 9, 2022

India’s Central Drug Standard Control Organisation granted permission to IQVIA to conduct Ph III clinical trials of Alvotech’s AVT06 (biosimilar aflibercept) for the treatment of retinal vascular diseases.

October 8, 2022

In an interview with Managed Healthcare, Samsung Bioepis’ head of US market access Tom Newcomer announced that Samsung Bioepis will pursue interchangeability for Hadlima® (biosimilar adalimumab) in 2024.  Hadlima was approved in the US in July 2019 and is expected to launch in the US from July 2023 pursuant to an agreement with AbbVie.

October 5, 2022

Celltrion announced the commencement of Ph III clinical trials regarding Yuflyma® (biosimilar adalimumab) in Estonia.  This trial will run for 13 months and will be used to support Celltrion’s application for interchangeability in the US.  Yuflyma was approved in the EU in February 2021, and in Canada in December 2021.

October 3, 2022

A temporary increase in medicare payments for qualifying biosimilars commenced under section 11403 of the Inflation Reduction Act.  This temporary increase applies to biosimilars whose average sales price is not more than the price of the reference product. This provision is intended to increase competition in the marketplace and to improve access to medicines.

October 3, 2022

Amneal Pharmaceuticals announced the launch of Alymsys® (biosimilar bevacizumab) in the US on 03 October 2022. Alymsys was developed by mAbxience and was approved by the FDA in April 2022.

October 3, 2022

The FDA announced that it will pilot a regulatory science program to advance the development of interchangeable products and improve the efficiency of biosimilar product development.  The program, set out briefly in the FDA’s Biosimilar User Fee Act (BsUFA) reauthorization commitment letter for fiscal years 2023 to 2027 (BsUFA III), will comprise two demonstration projects.  The first will evaluate the data required to meet safety standards for interchangeability, and may include researching approaches other than switching studies to meet the interchangeability standard.   The second, evaluating opportunities to streamline biosimilar product development,  will take into account scientific advancements in analytical and pharmacological assessments, as well as experience with prior product development and marketed biosimilar products.  Both will investigate methodologies, such as in vitro and in silico methods, to predict immunogenicity.

The BsUFA provides a framework for the FDA to collect user fees from companies developing biosimilar and interchangeable biological products in return for committing to certain performance goals, which are periodically refreshed and reauthorised.  BsUFA III comprises the second reauthorisation under this framework, and commences in October 2022, running until September 2027.   As well as the science program, BsUFA III sets out a number of performance goals for the FDA, including review response times; procedures relating to clinical protocol evaluation, facilities inspection, FDA-sponsor meetings and human factors validation studies for biosimilar-device combination products;  and timeframes for the publication of a range of new or revised draft guidance documents.

September 30, 2022

Biogen announced that the EMA has accepted the MAA for BIIB800 (biosimilar tocilizumab).  Biogen holds the rights to commercialise Bio-Thera’s product in all countries excluding China under an April 2021 agreement.

September 28, 2022

A new study reported that Intas Pharmaceuticals’ Razumab® (biosimilar ranibizumab) achieved comparable visual acuity outcomes to Lucentis® in patients with polypoidal choroidal vasculopathy.

September 28, 2022

Korea Biomedical Review reported that Samsung Bioepis will present on three scientific abstracts on its ophthalmology biosimilars, aflibercept and ranibizumab, at the American Academy of Ophthalmology 2022 between 30 September – 03 October.  Samsung Bioepis reported that interim analysis of SB15 (biosimilar aflibercept) indicated an equivalence in efficacy of SB15 and Eylea® in terms of best-corrected visual acuity at 8 weeks in patients with neovascular age-related macular degeneration. This is the first time that Samsung Bioepis has disclosed data on its aflibercept biosimilar.

September 27, 2022

BioNTech and Pfizer have filed suit in the Patents Court of England and Wales seeking to invalidate two Moderna patents relating to COVID vaccine technology.  Moderna sued Pfizer and BioNTech for patent infringement in the US District Court for the District of Massachusetts and the Regional Court of Dusseldorf in August 2022.

September 27, 2022

Merck announced that Japan’s Ministry of Health has granted approval of Keytruda (pembrolizumab) for four new indications: in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy as adjuvant treatment, for patients with hormone receptor-negative and human epidermal growth factor receptor 2 (HER2)-negative breast cancer; as monotherapy for the adjuvant treatment of certain patients with renal cell carcinoma (RCC); in combination with chemotherapy, with or without bevacizumab, for the treatment of patients with advanced or recurrent cervical cancer; and as monotherapy for the adjuvant treatment of patients with stage IIB or IIC melanoma after complete resection.  With these new approvals, Keytruda is now approved for 23 uses in 13 different types of cancer in Japan.

September 27, 2022

Pulse News reported that Celltrion has received approval for Vegzelma™ (biosimilar bevacizumab) in Japan for the treatment of a number of indications including colorectal cancer, non-small cell lung cancer and metastatic breast cancer.

September 27, 2022

Celltrion announced that the FDA has approved Vegzelma™ (biosimilar bevacizumab) for the treatment of metastatic colorectal cancer; recurrent or metastatic non-squamous non-small cell lung cancer (nsNSCLC); recurrent glioblastoma; metastatic renal cell carcinoma; persistent, recurrent, or metastatic cervical cancer; and epithelial ovarian, fallopian tube, or primary peritoneal cancer.

September 26, 2022

The Australian Department of Health and Aged Care announced that from 1 October 2022 Keytruda (pembrolizumab) will be included in the Australian Pharmaceutical Benefits Scheme (PBS) for the treatment of squamous cell carcinoma of the head and neck.   The Health Minister reported that without subsidy patients can pay more than AUD $135,000 per course of treatment, but with the PBS listing, this treatment will cost patients less than AUD $50 per prescription.   Keytruda is already PBS-listed for a range of cancers including malignant melanoma, Hodgkin’s lymphoma, non-small cell lung cancer (NSCLC), urothelial cancer, B-cell lymphoma and colorectal cancer.

September 22, 2022

AstraZeneca and Merck (“MSD” outside North America) announced that China’s NMP has approved Lynparza® (olaparib) as first-line maintenance treatment for adult patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer who are in complete or partial response to first-line platinum-based chemotherapy in combination with bevacizumab and whose cancer is associated with homologous recombination deficiency (HRD)-positive status.

September 22, 2022

Alvotech and STADA announced the launch of Hukyndra® (100mg/mL, citrate free biosimilar adalimumab) in Switzerland.  Alvotech reached a settlement with AbbVie in April 2022, enabling the launch of adalimumab across Europe, and STADA has since launched Hukyndra in several European countries from June 2022.  Alvotech and STADA announced an exclusive partnership in November 2019 relating to six biosimilars, including adalimumab.

September 20, 2022

Korea Biomedical Review reported that Celltrion has successfully invalidated a Taiwanese Roche rituximab patent relating to the treatment of rheumatoid arthritis.  Celltrion reported that it will now expand its label in Taiwan to include all indications of Rituxan®.

September 20, 2022

AVEO Oncology announced that the FDA has granted fast track designation to ficlatuzumab (its investigational humanized IgG1 mAb targeting hepatocyte growth factor) for the treatment of relapsed or recurrent head and neck squamous cell carcinoma.

September 19, 2022

Korea Biomedical Review reported that the UK’s MHRA has approved Celltrion’s Vegzelma™ (biosimilar bevacizumab) for the same indications as Avastin®.  The EMA approved Vegzelma in August 2022.

September 19, 2022

Formycon disclosed that it is developing a biosimilar of Keytruda® (pembrolizumab), referred to as FYB206.  The project is at an advanced preclinical stage, with GMP manufacturing planned for the end of 2022.

September 19, 2022

Coherus Biosciences announced that it will launch Cimerli™ (interchangeable biosimilar ranibizumab) in the US on 03 October 2022.  Cimerli was approved by the FDA as interchangeable with Genentech/Roche’s Lucentis® and the EMA in August 2022.

September 19, 2022

The EMA’s Biosimilar Medicines Working Party and the Heads of Medicines Agencies Biosimilars Working Group issued a joint statement (which was endorsed by the CHMP and the Biologics Working Party), confirming that biosimilar medicines approved in the EU are interchangeable with the reference product or with an equivalent biosimilar.  Previously, interchangeability was permitted if the national regulatory agency allowed it, and EMA had not previously issued an official position on interchangeability.  EMA confirmed that substitution at the pharmacy level will remain a matter for national governments.  It is hoped that this harmonised approach will provide clarity for healthcare professionals prescribing biologics.

September 19, 2022

Sandoz announced the results of its Ph I/III trials of its biosimilar denosumab.  Sandoz reported that the results confirm that the biosimilar matches the pharmacokinetics, pharmacodynamics, efficacy, safety and immunogenicity of the reference product.

September 16, 2022

Pearce IP’s Naomi Pearce speaks to Kate Legge about the key IP strategies to enable the launch of biosimilars around the world, with a particular focus on Australia.  Offering practical tips to success for biosimilar companies, this 14 minute PiPCast touches on:

  • biosimilar FTO/clearance strategies, litigation, and settlement strategies;
  • key lessons learned from the 11 AbbVie global royalty bearing deals relating to adalimumab (Humira®); and
  • Australian biosimilar litigations.

September 16, 2022

Korea Biomedical Review reported that Prestige Biopharma has voluntarily withdrawn its EMA application for the HD201 (Tuznue®, biosimilar trastuzumab).  Prestige received a negative opinion from the CHMP in May 2022, with the CHMP taking the view that the manufacturing process used for the commercial production of these medicines differed from that used during clinical testing.  Prestige reportedly was not able to establish equivalence in a requested re-examination by CHMP.  Prestige has represented that following withdrawal, it will supplement its data and resubmit with EMA this year.

September 16, 2022

STADA and Xbrane Biopharma announced that the CHMP provided a positive opinion for Ximluci® (biosimilar ranibizumab).  If approved, ranibizumab will be the sixth biosimilar approval for STADA, following adalimumab, bevacizumab, epoetin zeta, pegfilgrastim and teriparatide.

September 15, 2022

Apotex filed an IPR against Regeneron, seeking revocation of Regeneron’s method of treatment (MOT) patent US 11,253,572, relating to the sequential administration of 2mg doses of aflibercept (Eylea®) on the grounds of anticipation and obviousness.

September 13, 2022

Merck announced that Health Canada has granted approval for KEYTRUDA® (pembrolizumab), for the adjuvant treatment of adult and paediatric (12 years and older) patients with stage IIB or IIC melanoma following complete resection.

September 13, 2022

Lupin announced that Health Canada has approved Rymti® (biosimilar etanercept) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, axial spondylarthritis (including ankylosing spondylitis and non-radiographic axial spondylarthritis), plaque psoriasis and paediatric plaque psoriasis.

September 12, 2022

Novartis announced that it will invest USD300 million in the creation of a fully integrated, dedicated facility for early development of biotherapeutics.  The investment will be used to strengthen Novartis’ existing campuses in Basel and Schaftenau, and to create a dedicated biologics campus in Menges, Slovenia.

September 12, 2022

President Biden has made an Executive Order to advance “biotechnology and biomanufacturing innovation for a sustainable, safe, and secure American bioeconomy”, including in relation to “health, climate change, energy, food security, agriculture, supply chain resilience, and national and economic security.”  The Order states that it is the policy of the Biden Administration to, amongst other things: “(a) bolster Federal investment in key research and development areas of biotechnology and biomanufacturing; (b) foster a biological data ecosystem that advances biotechnology and biomanufacturing innovation; and (c) improve and expand domestic biomanufacturing production capacity and processes, while also increasing piloting and prototyping efforts to accelerate the translation of basic research results into practice.”  The Order provides details of how the policy objectives will be achieved and the timescales involved.

September 10, 2022

Merck reported that it presented data at the European Society for Medical Oncology (ESCO) Congress in Paris on 11 September, including:

  • in patients with metastatic nonsquamous NSCLC, data from KEYNOTE-189 demonstrating KEYTRUDA plus pemetrexed (ALIMTA®) and platinum chemotherapy (cisplatin or carboplatin) had a five-year overall survival (OS) rate of 19.4% versus 11.3% for chemotherapy alone; and
  • in patients with metastatic squamous NSCLC, results from KEYNOTE-407 showing the five-year OS rate for KEYTRUDA plus carboplatin-paclitaxel or nab-paclitaxel was 18.4% versus 9.7% for chemotherapy alone.

Separately, Eisai reported that would be presenting data on several trials on the combination of lenvatinib and pembrolizumab at the conference, including a late-breaking oral presentation of detailed results from the LEAP (Lenvatinib And Pembrolizumab) clinical program including the final analysis of the Phase 3 LEAP-002 trial as a first-line treatment for patients with unresectable hepatocellular carcinoma, as well as two mini-oral presentations with updated efficacy and safety data from the pivotal Phase 3 CLEAR (Study 307)/KEYNOTE-581 trial evaluating the combination in patients with advanced renal cell carcinoma, and Phase 3 Study 309/KEYNOTE-775 trial evaluating the combination in patients with advanced endometrial carcinoma.

September 9, 2022

Spectrum Pharmaceuticals announced that the FDA has approved its novel long-acting GCSF (LA-GCSF) ROLVEDON™ (eflapegrastim-xnst) to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with clinically significant incidence of febrile neutropenia.

September 9, 2022

AstraZeneca published the results of a 5-year follow up study of Lynparza® (Olaparib) with or without bevacizumab in newly diagnosed patients with advanced ovarian cancer. AstraZeneca reported that Olaparib with bevacizumab reduced the risk of death by 38% in HRD-positive patients compared to bevacizumab alone.

September 9, 2022

Biogen filed a sealed complaint against Sandoz and Polpharma for infringement of 28 Biogen patents in the District of Delaware relating to Sandoz’s biosimilar natalizumab (Tysabri®).  Whilst the complaint was accepted under seal, Biogen was ordered to file a redacted complaint by 19 September 2022. Sandoz and Polpharma announced that they had entered into a licensing deal for Polpharma’s natalizumab biosimilar in September 2019, and the FDA accepted Sandoz’s ABLA for biosimilar natalizumab in July 2022.

September 8, 2022

Regeneron announced that the primary endpoints were met in two pivotal trials evaluating aflibercept 8mg with 12 and 16 week dosing regimes in diabetic macular edema and wet age-related macular degeneration.

September 7, 2022

Organon announced the release of the ‘Biosimilars: A global roadmap for policy sustainability’ setting out a number of priorities to achieve long-term sustainability of biosimilars in Australia, including:

  • Ensuring alignment of financial incentives that benefit all key stakeholders, including physicians, pharmacists and patients
  • Decreasing patient co-payments applied for biosimilars to enable cost savings not only for payers but for a broader range of stakeholders including patients
  • Increasing multi-disciplinary decision-making regarding dispensing of biosimilars to ensure the best outcomes for the patients and best value for the healthcare system.
  • Optimising existing pricing and reimbursement policy to mitigate the impact of erosion driven by mandatory discounts and considers the differences across therapeutic areas, the number of competitors and population size.

September 7, 2022

Lupin and DKSH announced that they have signed an exclusive licensing and supply agreement to market five of Alvotech’s biosimilar products in the Philippines.  The biosimilars include AVT03 (biosimilar denosumab – Prolia® and Xgeva®), AVT05 (biosimilar golimumab/Simponi®) and AVT06 (biosimilar aflibercept/Eylea®) as well as two undisclosed proposed biosimilars for immunology and oncology.

September 7, 2022

Genentech and Samsung Bioepis filed a joint stipulation of dismissal in the District Court of Delaware in the bevacizumab BPCIA dispute, settling all claims and counter-claims.  Genentech filed the suit against Samsung Bioepis in June 2020, alleging infringement of 14 patents relating to bevacizumab (Avastin®).  No further details about the settlement agreement have been disclosed.

September 7, 2022

Yonhap News Agency reported that Celltrion’s ustekinumab biosimilar CT-P43 Ph III trials demonstrated comparable efficacy and safety to Janssen’s Stelara®.  Data from the global 28-week study in 509 plaque psoriasis patients was presented at the European Academy of Dermatology and Venereology Congress 2022 in Milan, Italy.

September 6, 2022

Australia’s TGA approved Cipla/Alvotech’s 100mg/mL adalimumab biosimilar AVT02 (Ciptunec®/Ardalicip®) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, polyarticular juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis, ulcerative colitis, hidradenitis suppurativa and uveitis.  Cipla will supply Alvotech’s product in Australia and New Zealand under a partnership first announced in July 2019, which was expanded in March 2021 to include aflibercept, ustekinumab, denosumab and golimumab biosimilars.

September 6, 2022

German based biosimilars focussed company Formycon published its preliminary and unaudited financial results for the first half of 2022.  Formycon reported a turnover of Euro 17.6 million in the first six months of 2022.  The preliminary report does not include the purchase price allocation effects from the ATHOS transaction reported in May 2022 under which Formycon acquired rights to FYB202 (biosimilar Stelara®), 50% of the rights to FYB201 biosimilar Lucentis® and the operational development unit Bioeq GmbH.  Formycon has six biosimilars in development, and is also working on the development of a COVID-19 drug FYB207.

September 5, 2022

Alvotech announced that it has received a complete response letter from the FDA in relation to its BLA for AVT02 (biosimilar adalimumab).  Alvotech anticipates being launch ready by the expected US launch date of 1 July 2023 .

September 1, 2022

The FDA approved Fresenius Kabi’s Stimufend® (biosimilar pegfilgrastim).  Stimufend is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia.

August 31, 2022

Prestige Biopharma announced that it will acquire more shares of Prestige Biologics, to secure a total of 24.88% of the CDMO company.  Prestige Biopharma reported that the new structure will allow the group to establish a full value chain with a 154,000 L, global-scale production facility.

August 31, 2022

Alvotech published its first half 2022 financial results, reporting a revenue growth to over $40 million compared to $2.0 million in the first half of 2021 due to recent launches of adalimumab (AV02) in Canada and Europe.  The company has $128.4Min cash/equivalents and has current borrowings of $120.8M.  Its R&D costs in the same period were 86.9M.

Alvotech “pipeline highlights” includes (amongst other things) an exclusive global licence agreement with BiosanaPharma regarding biosimilar omalizumab/to Xolair®, expanded partnership with Fuji Pharma, the completion and US submission of interchangeability studies for its high concentration adalimumab biosimilar, a US settlement with AbbVie relating to adalimumab and positive results from clinical studies on AVT04 (biosimilar ustekinumab/Stelara®).  Alvotech also secured funding of approximately $185M through the OACB merger and PIPE financing.

August 31, 2022

Biocon Biologics announced that the FDA has issued 17 observations following its inspection of Biocon’s manufacturing facilities in Bengalaru, India (11 observations) and Johor, Malaysia (6 observations) relating to pre-approval inspections for bevacizumab, rh-Insulin and insulin aspart and a capacity expansion inspection for biosimilar trastuzumab.  Biocon Biologics reported that the observations relate to the need for improving strategies for microbial control, enhancing quality oversight, augmenting the use of software applications and computerised tools to aid risk assessment and investigations, and other procedural and facility upgrades.  Reportedly, Biocon Biologics does not expect the observations to impact current supply.

August 31, 2022

The PTAB instituted Celltrion’s two inter partes reviews (IPRs) of Chugai and Roche’s tocilizumab patents 8,580,264 and 10,874,677.  The IPRs were instituted on each of the grounds in Celltrion’s petition.

August 30, 2022

Outlook Therapeutics announced that it has re-submitted its BLA for ONS-5010 LYTENAVA™ (bevacizumab-vikg, ophthalmic formulation) for wet AMD to the FDA.  Outlook first submitted its BLA in March 2022, however withdrew it in May 2022 following requests from the FDA for additional information.  Outlook reported that it has now provided the additional required information and is confident in the new application.

August 29, 2022

Merck announced that it will present data on several oncology medicines at the European Society for Medical Oncology (ESCO) Congress in Paris from 9-13 September, including relating to KEYTRUDA® (pembrolizumab) and PADVEV® (enfortumab vedotin).

August 26, 2022

Moderna has announced that it commenced proceedings against Pfizer and BioNTech in both the U.S. District Court for the District of Massachusetts and the Regional Court of Düsseldorf in Germany last Friday seeking damages for patent infringement relating to the Pfizer/BioNTech COVID vaccine.  Interestingly, Moderna is not seeking injunctions.

The lawsuit is reported to be based on three patent families Moderna filed between 2011 and 2016.  The Moderna press release says:

“Moderna believes that Pfizer and BioNTech’s COVID-19 vaccine Comirnaty® infringes patents Moderna filed between 2010 and 2016 covering Moderna’s foundational mRNA technology. This groundbreaking technology was critical to the development of Moderna’s own mRNA COVID-19 vaccine, Spikevax®. Pfizer and BioNTech copied this technology, without Moderna’s permission, to make Comirnaty®.”

This lawsuit is despite Moderna’s October 2020 pledge to not to enforce its COVID-19 related patents while the pandemic continued. This pledge was updated in March 2022, when “the collective fight against COVID-19 entered a new phase and vaccine supply was no longer a barrier to access in many parts of the world”.  Moderna’s position is now that “while it would never enforce its patents for any COVID-19 vaccine used in the 92 low- and middle-income countries in the GAVI COVAX Advance Market Commitment (AMC 92), Moderna expected companies such as Pfizer and BioNTech to respect its intellectual property rights and would consider a commercially reasonable license should they request one for other markets. Pfizer and BioNTech have failed to do so.

August 26, 2022

Merck & Co is reportedly in negotiations to acquire Seagen Inc (previously known as Seattle Genetics, Inc), with negotiations presently having stalled due to a failure to agree on price.  The acquisition could give Merck access to Seagen’s pipeline of antibody-drug conjugates (ADCs).  Merck has previously announced strategic oncology collaborations with Seagen for two of its ADCs as well as Merck taking a USD1B equity stake in Seagen.   Neither Merck nor Seagen have made any formal announcement about the purported acquisition.

August 26, 2022

Formycon announced that the European Commission has approved Ranivisio®, biosimilar to Lucentis®/ranibizumab developed by Bioeq (which is a joint venture between Formycon and Polpharma Biologics).  Ranivisio is EC approved for the treatment of neovascular (wet) age-related macular degeneration (nAMD), the treatment of visual impairment due to diabetic macular oedema (DME) or choroidal neovascularization (CNV), the treatment of proliferative diabetic retinopathy (PDR) as well as the treatment of visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO).

Earlier this month, Coherus announced the US approval of Cimerli™ with interchangeability designation, which Bioeq licensed to Coherus for the US.  The Bioeq product was also approved in the UK in May 2017 as Teva’s Ongavia®.

August 25, 2022

Alvotech announced that it has commenced a confirmatory patient study for AVT03 (biosimilar to Prolia® and Xgeva®, denosumab).  The objective of the study is to demonstrate clinical similarity of AVT03 to Prolia® in terms of efficacy, safety, immunogenicity and pharmacokinetics in postmenopausal women with osteoporosis.  The results from this trial will be used to extrapolate to additional Xgeva® indications.  Alvotech commenced phase I trials for denosumab in July 2022.

August 25, 2022

Novartis announced that it will spin off Sandoz into a new publicly traded standalone company.  The new company will be headquartered in Switzerland and will be listed on the SIX Swiss Exchange, with an American Depositary Receipt program.  Novartis reported that this separation will allow it to build a focused innovative medicines company.  Novartis first announced that it would undertake a strategic review of the Sandoz division in October 2021, and in July 2022 confirmed that a decision on Sandoz’s future would be made by the end of 2022.

August 25, 2022

STADA published its first half 2022 financial results, reporting a 15% increase in adjusted group sales.  Adjusted for currency fluctuations and special effects, earnings before interest, tax, depreciation and amortisation (EBITDA) improved by 23% to €386.5 million.  STADA currently markets five biosimilar products, including Hukyndra® (biosimilar adalimumab) and Oyavas® (biosimilar bevacizumab).

August 25, 2022

Lupin announced that it has entered into an exclusive licensing agreement with I’rom Group for biosimilar denosumab in Japan.  Under the agreement, I’rom and Lupin will together conduct clinical trials and obtain registration, and I’rom will then exclusively distribute and market the product in Japan.

August 24, 2022

Samsung Bioepis’ Byooviz® (biosimilar ranibizumab) was approved in Australia for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular oedema (DME), proliferative diabetic retinopathy (PDR), visual impairment due to choroidal neovascularisation (CNV) or choroidal neovascularisation (CNV) secondary to pathologic myopia (PM), and visual impairment due to macular oedema secondary to retinal vein occlusion (RVO).  Byooviz was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019.

Samsung Bioepis obtained marketing approval for Byooviz in the US and EU in September 2021, Canada in March 2022, and in Korea in May 2022.  It was reported in September 2021 that Samsung Bioepis took a licence for ranibizumab from Genentech from June 2022.

August 23, 2022

Amgen announced the results of a Ph III study evaluating the efficacy and safety of ABP959 (proposed eculizumab biosimilar) compared with Soliris® in adult patients with paroxysmal nocturnal haemoglobinuria.  Amgen reported that the study met its primary endpoints and that the safety and immunogenicity profile of ABP 959 was comparable to Soliris.

August 23, 2022

Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved an expanded indication for Novartis’ Beovu® (brolucizumab).  The approved indications now include diabetic macular oedema.

August 19, 2022

AU’s TGA approved Cipla’s FILPEGLA® (biosimilar pegfilgrastim) for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infection, as manifested by febrile neutropenia.

August 18, 2022

Fresenius Kabi announced that the EMA has accepted its MAA for MSB11456 (biosimilar tocilizumab).  The application includes clinical data for both subcutaneous and IV administrations.

August 18, 2022

Celltrion announced that the EC approved Vegzelma™ (biosimilar bevacizumab) for the treatment of metastatic breast cancer, non-small cell lung cancer, advanced and/or metastatic renal cell cancer, metastatic carcinoma of the colon or rectum, ovarian cancer and cervical cancer.  The CHMP recommended the approval of Vegzelma in June 2022.

August 17, 2022

Samsung Bioepis and Organon announced that the FDA has approved the citrate-free, high-concentration (100mg/mL) formulation of Hadlima™ (biosimilar adalimumab).  The Hadlima 50mg/ml formulation was FDA approved in July 2019.  Hadlima is expected to be launched on or after 1 July 2023, in accordance with its settlement with AbbVie announced in April 2018.

August 16, 2022

Formycon has reported that its ustekinumab biosimilar candidate FYB202 showed comparable efficacy and safety to Janssen’s Stelara in a Ph III clinical trial in plaque psoriasis patients.  Formycon’s extended pharmacokinetics Ph I study has commenced.  This follows Formycon’s acquisition of 100% of the rights to FYB202 from Athos, as previously reported.

August 16, 2022

Merck and Orna Therapeutics announced that they have entered into a collaboration agreement to discover, develop and commercialise multiple RNA programs, including vaccines and therapeutics in the areas of infectious diseases and oncology.

August 15, 2022

Merck’s PD-1 receptor blocker Keytruda is approved in the US and Europe for the treatment of a range of tumours, including melanoma, non-small cell lung cancer, head and neck squamous cell cancer, classical Hodgkin Lymphoma, urothelial carcinoma, oesophageal cancer, cervical cancer, renal cell carcinoma and triple negative breast cancer.  Merck has now reported updates on several clinical trials, in which treatment with Keytruda® did not reach its primary endpoints:

  • Phase 3 LEAP-002 trial investigating Keytruda® plus Eisai’s Lenvima® (lenvatinib), compared to Lenvima® monotherapy as a first-line treatment for patients with unresectable hepatocellular carcinoma (uHCC). See the Merck update of 3 August here.
  • Phase 3 KEYNOTE-921 trial evaluating Keytruda® in combination with chemotherapy (docetaxel) compared to chemotherapy alone for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). See the Merck update of 3 August here
  • Phase 3 KEYNOTE-412 trial evaluating Keytruda®with concurrent chemoradiation therapy (CRT) followed by Keytruda® as maintenance therapy for the treatment of patients with unresected locally advanced head and neck squamous cell carcinoma (HNSCC). See the Merck update of 20 July here

In each trial clinical improvements were shown but they did not meet pre-specified statistical significance.  The safety profile from each trial was consistent with earlier studies.

August 14, 2022

Opthea announced a non-dilutive financing transaction for up to US$170 million from investment funds working with Launch Therapeutics to finance and advance the ongoing Ph III clinical trials and pre-commercialisation activities of OPT-302 (VEGF-C/-D ‘trap’ inhibitor) for wet age-related macular degeneration (wet AMD).  Under the agreement, the funds will commit US$120 million in three instalments at fixed time points, with an option to commit an additional US$50 million.  In exchange, Opthea will make a milestone payment after regulatory approval in a major market, followed by six annual fixed payments and variable success payments of 7% of net sales, with cumulative payments capped at four times the amount funded to Opthea.

August 12, 2022

Alvotech announced that its Board of Directors has approved to move its share listing from the First North Growth Market to the Nasdaq Main Market in Iceland.

Alvotech became the first dual US-Icelandic listed company on 23 June 2022.

August 12, 2022

Alvotech, Mylan, the Association for Accessible Medicines, and 42 professors of law, economics, business and medicine filed amicus curiae briefs in the US Supreme Court in support of Teva’s petition for a writ of certiorari.  Teva is seeking review of the controversial divided panel of the Court of Appeal for the Federal Circuit decision in August 2021 in which Teva was found to have induced infringement of a narrow GSK method of treatment (MOT) patent relating to the use of Coreg® (carvedilol) to treat congestive heart failure, despite Teva’s CHF indication carve out.  Teva and other companies have argued that this decision will threaten the future of ‘skinny-label’ for small molecules and large molecules.

August 11, 2022

Daiichi Sankyo and AstraZeneca announced that the FDA has offered accelerated approval to Enhertu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic non-small cell lung cancer whose tumours have activating HER2 mutations.  Continued approval for this accelerated indication may be contingent upon verification in a confirmatory trial.

August 11, 2022

Roche announced that the FDA has approved the use of its Ventana® MMR RxDx Panel as the first immunohistochemistry companion diagnostic test to aid in identifying patients who may be eligible for treatment with Keytruda®.  The panel is used to identify patients whose solid tumours are deficient in DNA mismatch repair (dMMR), and endometrial cancer patients whose tumours are proficient in DNA mismatch repair (pMMR).

August 11, 2022

ALX Oncology announced the initiation of Ph II trials of evorpacept (CD47 blocker) in combination with Erbitux® (cetuximab) and Keytruda® (pembrolizumab) for the treatment of refractory microsatellite stable metastatic colorectal cancer following at least two lines of systemic therapy.

August 10, 2022

The IPRs (inter-partes reviews) commenced by Mylan against Regeneron’s Eylea® patents 9,669,069 and 9,254,338 (instituted in December 2021) were heard by the PTAB together on 10 August 2022.  The patents relate to Regeneron’s blockbuster product Eylea® (aflibercept) and analysts have reported that (at least) the ‘338 patent is likely to be invalidated, based on comments made by the PTAB during the proceedings.

August 4, 2022

Amgen announced that it has agreed to acquire ChemoCentryx, a biopharmaceutical company focused on auto-immune diseases, inflammatory disorders and cancer, for around $3.7 billion.  ChemoCentryx markets Tavneos® (avacopan), a first-in-class treatment for multi-system autoimmune diseases involving small vessel inflammation.

August 4, 2022

In its earnings call on 4 August 2022, Coherus announced that it is developing a high concentration adalimumab formulation, which it intends to market following launch of its 50mg/ml citrate-free Yusimry™ formulation in July 2023.  Coherus also shared its plans to capture “at least 10%” of the Humira® market in its first year of sales, which is capped by its current manufacturing capacity, although Coherus says it “has the potential to triple that capacity”.

August 3, 2022

Regeneron has filed a complaint against Mylan in West Virginia under the BPCIA alleging infringement of twenty-four patents relating to Eylea® (aflibercept).  This follows the FDA’s acceptance for review of Mylan’s aBLA for its aflibercept biosimilar.  Regeneron recently listed twenty-four patents in the Purple Book as part of its patent dance with Mylan.  Mylan previously sought IPR of several aflibercept patents.

August 2, 2022

Coherus Biosciences announced that the FDA has approved Coherus’ Cimerli™, a biosimilar to Genentech’s Lucentis® (ranibizumab).  Cimerli is the third approved US biosimilar, but is the first to be approved for all five of Lucentis’ indications and to receive the interchangeable designation, resulting in twelve months interchangeability exclusivity.

August 1, 2022

Fresenius Kabi announced that the FDA has accepted for review Fresenius’ biosimilar candidate MSB11456 to Chugai’s Actemra® (tocilizumab).  Actemra is presently the only tocilizumab product on the market in the US.

August 1, 2022

Janssen announced that the FDA has approved Stelara® (ustekinumab) for the treatment of paediatric patients aged six and over with active psoriatic arthritis (PsA).  As there were insufficient paediatric patients with PsA to conduct clinical trials, the FDA based its approval on phase III trials in adults and children with plaque psoriasis and adults with PsA.

August 1, 2022

The Court of Appeals for the Seventh Circuit has agreed with the District Court, finding that AbbVie holding 132 US patents relating to Humira®, and settling litigation regarding the same, was not anti-competitive.  The decision rejected the appeal filed by welfare benefit payors.  The Court commented that there is no cap on the number of patents any one person can hold pertaining to a single subject, that every patent is presumed to be valid, that the appellants have not proved that AbbVie was using invalid patents to protect its monopoly, and that the settlements did not amount to cartel conduct.

July 29, 2022

A third revocation proceeding was commenced by Samsung Bioepis against a Fresenius Kabi adalimumab 50 mg/mL formulation patent AU2020204269 (‘269).  The ‘269 patent covers a specific formulation of adalimumab with a specific buffer, sugar, surfactant and pH.  These proceedings were commenced a day after the patent was granted (28 July 2022), following Samsung withdrawing its pre-grant opposition on 27 July (which it filed in December 2020).

Samsung commenced a revocation proceeding in June 2022 against a second, related 50 mg/mL adalimumab formulation patent.  In 2019, Samsung also sought revocation of a first Fresenius adalimumab formulation patent, which resulted in Fresenius surrendering the patent in November 2019, the proceedings being dismissed by consent, and a costs order against Fresenius being made against Fresenius.

July 29, 2022

Celltrion Healthcare has reportedly filed an IND application to the FDA for a phase III clinical trial to demonstrate the interchangeability of its Yuflyma® (adalimumab) biosimilar and AbbVie’s Humira®.  The trial will involve 366 patients with plaque psoriasis.  Following Celltrion’s aBLA filing in late 2020 and its settlement with AbbVie in Q1 of 2021, Celltrion plans to launch in the US on 1 July 2023.

July 27, 2022

It has been reported that a Ph III clinical trial of Qilu Pharmaceutical’s biosimilar denosumab, QL1206, showed beneficial effects in post-menopausal Chinese women with osteoporosis and high fracture risk.  After twelve months, subjects who received QL1206 showed significantly improved bone mineral density in the lumbar spine, total hip, femoral neck and trochanter compared to placebo.

July 27, 2022

Biocon announced that its Q1 2022 revenue for biosimilars was up 29%.  This comes in advance of Biocon’s subsidiary Biocon Biologics’ acquisition of Viatris’ biosimilars business, expected to close later in 2022.

July 27, 2022

Alphapharm (Viatris’ Australian subsidiary) has its etanercept biosimilar, Nepexto®, on the agenda for the November PBAC meeting.  If the PBAC recommends that Nepexto is PBS-listed, it will become the third PBS-listed etanercept product after Pfizer’s Enbrel® and Arrow’s Brenzys®.

July 26, 2022

Prestige Biopharma announced an exclusive partnership with Intas and its affiliate Accord Healthcare to commercialise Prestige’s biosimilar bevacizumab in US, Europe, Canada, MENA, Brazil, Mexico, South Africa, Thailand, Vietnam, Philippines, Malaysia, Singapore, Indonesia, Kyrgyzstan and Tajikistan.  Prestige´s bevacizumab (HD204) is a biosimilar to Roche’s Avastin®.  US and EU regulatory filings are expected in 2023.

July 25, 2022

Henlius Biotech announced that the TGA has approved Henlius’ trastuzumab biosimilar, which will be marketed in Australia by Cipla.  The 150mg/vial product HANQUYOU has been sold as Zercepac™ in Europe and will be offered under trade names Tuzucip and Trastucip in Australia, covering all indications of the reference product.

July 25, 2022

Sandoz announced that the FDA has accepted its ABLA for a natalizumab biosimilar developed by Polpharma Biologics for all indications covered by the reference medicine Tysabri® including relapsing forms of multiple sclerosis (MS) – clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS) and active secondary progressive disease in adults – and Crohn´s Disease.  The EMA accepted a MAA for the same product earlier this month.

July 21, 2022

Sandoz announced that the FDA has accepted its sBLA for a high-concentration citrate-free formulation (100mg/mL) of Hyrimoz® (biosimilar adalimumab).  The 50mg/mL formulation of Hyrimoz® was approved by the FDA in 2018 for the treatment of rheumatoid arthritis, juvenile idiopathic arthitis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

July 20, 2022

Alvotech announced that it has initiated a pharmacokinetic study for AVT03 (denosumab, biosimilar to Prolia®/Xgeva®).  The study will assess the pharmacokinetics, safety and tolerability of AVT03 compared to Prolia® in healthy adult male subjects.

Alvotech’s portfolio also includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar candidate to Stelara®) for which Alvotech recently announced positive topline results; AVT04 (aflibercept/biosimilar candidate to Eylea®), golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.

July 19, 2022

Novartis published its financial results, reporting a 1% decrease USD (5% increase cc) in Q2 2022 sales over Q2 2021, and 3% decrease USD (5% increase cc) for Sandoz sales.  Novartis confirmed that its strategic review of Sandoz is on track, and that it would provide an update at the latest, by the end of 2022.

July 19, 2022

Korea Biomedical Review reported that Celltrion has received approval from Poland’s Pharmaceutical and Medical Equipment Registration Office (URPL) for its IND for Ph III trials of CT-P47 (biosimilar to Actemra®, tocilizumab).

July 19, 2022

Johnson & Johnson reported a 53% YoY decrease in exports of Remicade® (infliximab) from the US suggesting a very significant decline in global Remicade sales since the first approved biosimilar in 2013.

July 18, 2022

Erasca and Eli Lilly announced that they have entered into a clinical trial collaboration and supply agreement for Erbitux® (cetuximab).  This agreement will support Erasca’s ongoing Ph I trials evaluating ERAS-601, its SHP2 inhibitor, with cetuximab for the treatment of triple wildtype metastatic colorectal cancer and HPV-negative advanced head and neck squamous cell carcinoma.  Lilly will supply cetuximab to Erasca at no cost.

July 18, 2022

Hikma Pharmaceuticals announced that it has entered into a commercialisation agreement with Celltrion in relation to Celltrion’s YuflymaTM (biosimilar citrate-free adalimumab).  Under the agreement, Hikma will gain exclusive commercialisation rights to YuflymaTM in all of its Middle East and North Africa (MENA) markets.  Hikma has launched a number of Celltrion biosimilars: Truxima® (rituximab), Remsima® (infliximab) and Herzuma® (trastuzumab), with the launch of Remsima® SC (subcutaneous infliximab) in progress.

July 15, 2022

Polpharma Biologics announced that the EMA has accepted its MAA for its biosimilar natalizumab for highly active relapsing-remitting multiple sclerosis with the same dosing, presentation and indication as Tysabri®.  Polpharma granted Sandoz commercialisation rights to Polpharma’s biosimilar under a global agreement announced in September 2019.

July 14, 2022

Roche reported that eight-year data from its Ph III trials of Perjeta® (pertuzumab) in combination with Herceptin® (trastuzumab) and chemotherapy in HER2-positive early breast cancer demonstrates continued benefit of the combination in comparison to trastuzumab and chemotherapy alone.  Roche reported a 28% reduction in the risk of recurrence or death in patients with lymph node-positive disease, and a safety profile consistent with previous studies.

July 14, 2022

Alvotech announced the expansion of its board of directors as part of its transition from private to publicly traded company in June 2022.  Alvotech has welcomed four new board members, Lisa Graver, Arni Hardarson, Linda McGoldrick and Ann Merchant, joining existing board members Robert Wessman (founder and Executive Chairman), Richard Davies, Tomas Ekman and Faysal Kalmoua.

July 12, 2022

Byondis B.V. announced that the FDA has accepted its BLA for [vic-] trastuzumab duocarmazine (SYD985), a HER2-directed antibody-drug conjugate, for the treatment of patients with HER2-positive unresectable locally advanced or metastatic breast cancer (MBC), with a PDUFA action date of 12 May 2023.  This is Byondis’ first regulatory submission for SYD985 which is its lead program.  In January 2018, the FDA granted fast track designation for SYD985, based on promising Phase I data for pretreated last-line HER2-positive MBC patients.

July 11, 2022

Overland ADCT BioPharma announced the dosing of the first patient in China in its second phase III clinical trials regarding Zynlonta® (loncastuximab tesirine-lpyl, a CD19-directed antibody drug conjugate), this time with rituximab  in second-line or later, transplant ineligible patients with diffuse large B-cell lymphoma (DLBCL).  The studies are intended to support sBLA filings in US and the PRC.  Zynlonta® was granted accelerated approval by the FDA in April 2021.

July 7, 2022

Alvotech announced the initiation of its ALVOEYE clinical trials for AVT06, biosimilar to Eylea® (aflibercept) which is indicated for the treatment of adult patients with neovascular (wet) age-related macular degeneration (AMD).  AVT06 is the third Alvotech biosimilar product to enter the clinic, and is one of eight products under development.

Alvotech’s portfolio also includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar to Stelara®) for which Alvotech recently announced positive topline results; denosumab/biosimilar to Prolia®, golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.

July 6, 2022

Janssen’s Stelara® (ustekinumab): requesting a General Schedule Authority Required listing of a new form for the treatment of patients with Crohn disease and chronic plaque psoriasis

July 6, 2022

AstraZeneca’s Enhertu® (trastuzumab deruxtecan): requesting a Section 100 Authority Required listing for the treatment of human epidermal growth factor receptor 2 positive (HER2) metastatic breast cancer in patients whose disease has progressed following treatment with at least one prior HER2-directed regimen in the metastatic setting or whose disease has progressed during or within 6 months following HER2-directed adjuvant treatment

July 6, 2022

AbbVie’s Skyrizi® (risankizumab): requesting General Schedule Authority Required listings for the treatment of severe Crohn’s disease and for complex refractory fistulising Crohn’s disease

July 6, 2022

BMS’ Opdivo® (nivolumab): requesting a s100 Authority Required listing for adjuvant treatment of patients who have undergone radical resection of muscle invasive urothelial carcinoma originating in the bladder or upper urinary tract and are at high risk of recurrence

July 6, 2022

Biogen’s Tysabri® (natalizumab):  requesting removal of the clinical criterion which requires neurologists prescribing natalizumab under the PBS to be registered with the Tysabri Australian Prescribing Program

July 6, 2022
  • Pfizer’s Zirabev® (biosimilar bevacizumab): reviewing positive recommendations not accepted by Pfizer

July 6, 2022

At the PBAC meetings 6 – 8 July, Australia’s PBAC considered a number of applications for biologic and biosimilar products, including:

Celltrion’s Yuflyma® (biosimilar adalimumab): requesting listing under the same conditions as Humira®

July 6, 2022

Roche announced that the FDA has accepted the BLA and granted priority review for Roche’s Lunsumio® (mosunetuzumab) (potential first-in-class CD20xCD3 T-cell engaging bispecific antibody) for the treatment of adults with relapsed or refractory follicular lymphoma who have received at least two prior systematic therapies.  The FDA is expected to a make a decision by 29 December 2022.

July 5, 2022

Following Alvotech’s listing on the NASDAQ and NASDAQ First North growth market last month, the board of directors has approved an increase in its share capital by an amount of $270,721.67 through the issuance of 27,072,167 ordinary shares.  The share capital increase was executed to facilitate the Company’s obligations (a) in relation to the public and private warrants assumed as a consequence of the business combination with Oaktree Acquisition Corp announced in December 2021, (b) under its management incentive plan.

July 5, 2022

Viatris announced that it was voluntarily recalling one batch of insulin glargine 100 units/mL, 3mL prefilled pens (batch BF21002895) due to the potential for the label to be missing on some pens.  This recall pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens.  The batch was manufactured by Biocon Sdn Bhd, and sold in the US between 4 April 2022 and 5 May 2022.

July 4, 2022

Xbrane Biopharma confirmed that it will resubmit a BLA for its biosimilar to Lucentis® (ranibizumab) this year.  Xbrane previously announced that it would withdraw the BLA after receiving feedback from the FDA in May that additional information was required for the FDA to accept the BLA and initiate a review.

July 2, 2022

PDS Biotechnology announced that the FDA has granted fast-track designation to PDS0101 (novel T-cell HPV-specific immunotherapy) in combination with Keytruda® (pembrolizumab) for the treatment of recurrent or metastatic HPV16-positive head and neck cancer.

June 30, 2022

The results of a phase III study of Iranian biopharmaceutical company AryoGen Pharmed’s denosumab biosimilar Arylia in osteoporosis patients showed that its efficacy and safety were not inferior to Amgen’s Prolia®.

June 30, 2022

Shanghai Henlius Biotech announced that the IND for HLX53 (anti-TIGIT Fc fusion protein) has been accepted by China’s NMPA.  HLX23 is being developed for the treatment of patients with advanced/metastatic solid tumours or lymphomas.

June 29, 2022

Regeneron announced that the FDA has accepted for review the sBLA for Eylea® (aflibercept) for a 16-week 2mg dosing regimen (after initial monthly doses) in patients with diabetic retinopathy.  The FDA has set a target action date of 28 February 2023.

June 27, 2022

Daiichi Sankyo announced that it has submitted a sNDA to Japan’s Ministry of Health, Labour and Welfare for trastuzumab deruxtecan for the treatment of adult patients in Japan with HER2 low unresectable or recurrent breast cancer after prior chemotherapy.

June 24, 2022

Merck announced that the EC has approved Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment of adults and adolescents aged 12 years and older with stage IIB or IIC melanoma and who have undergone complete resection, as well as expanding the indications for Keytruda® in advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) in adolescent patients aged 12 years and older.

June 24, 2022

EU’s CHMP adopted a positive opinion recommending a change to the existing indication for Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) to ‘Enhertu as monotherapy is indicated for the treatment of adult patients with unresectable or metastatic HER2 positive breast cancer who have received two one or more prior anti HER2 based regimens’.

June 24, 2022

Samsung Bioepis filed a suit against Fresenius Kabi in the AU Federal Court, seeking to revoke AU2020201090 ‘Liquid pharmaceutical composition’ (‘090 patent) which was granted 2 days earlier, on the grounds of novelty, obviousness, lack of utility, lack of best method, lack of clarity and lack of support.

The ‘090 patent is related to Fresenius Kabi’s AU 2015263246 (‘246 patent), which Samsung sought to revoke in 2019.  The proceedings were discontinued in early 2020 after Fresenius Kabi surrendered the patent, with Fresenius ordered to pay Samsung’s costs.

The recently granted ‘090 patent, like the earlier granted ‘246 patent, relates to a specific composition of adalimumab, including a histidine buffer, specified sugar and polysorbate.

There is a third granted family member (AU2018222887), which Samsung has not sought to revoke to date, nor has Fresenius asserted it against Samsung.

June 23, 2022

The CHMP recommended the approval of Celltrion’s Vegzelma® (bevacizumab/biosimilar to Avastin®) for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

June 23, 2022

The CHMP recommended the approval of Midas Pharma’s 10mg/ml Ranivisio® (ranibizumab/biosimilar to Lucentis®) for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular oedema or choroidal neovascularisation, and proliferative diabetic retinopathy.

June 22, 2022

AVEO Oncology announced that it has entered into a clinical trial collaboration and supply agreement with Eli Lilly to evaluate ficlatuzumab in combination with ERBITUX® (cetuximab) in the US and Canada in patients with recurrent or metastatic head and neck squamous cell carcinoma.  This follows a similar engagement with Merck earlier in 2022 regarding Aveo’s clinical development plan for ficlatuzumab.

June 22, 2022

Following its 16 June 2022 listing of warrants and shares on the NASDAQ Alvotech debuted on the NASDAQ First North growth market on 23 June 2022, becoming the first dual US-Icelandic listed company.  Alvotech’s current portfolio of eight products and product candidates represent an estimated total addressable market of over US$85 billion, based on estimated peak sales of the reference products.

Alvotech’s portfolio includes AVT02 (high concentration adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022 and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar to Stelara®) for which Alvotech recently announced positive topline results; aflibercept/biosimilar to Eylea®, denosumab/biosimilar to Prolia®, golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.

Alvotech has signed commercialisation agreements with CiplaStadaFuji Pharma, BiosanaPharma, Teva, JAMP/BIOJAMP, DKSH and Yangtze River Pharmaceuticals.

June 21, 2022

Formycon published its Q1 2022 financial results, reporting sales and other earnings of EUR 8.2 million.  Formycon also announced the addition of two biosimilar projects to its pipeline, FYB208 and FYB209, for undisclosed products.  Late stage Formycon development programs include biosimilars to Lucentis® (ranibizumab), Stelara® (ustekinumab) and Eylea® (aflibercept). Formycon plans to launch its biosimilar to Lucentis® (ranibizumab) in the second half of 2022.

June 21, 2022

Korea Biomedical Review reported that Samsung Bioepis and Samil Pharmaceutical have signed a commercialisation agreement for Amelivu®,biosimilar to Lucentis® (ranibizumab).  Under the agreement, Samil is licenced to sell Amelivu® in Korea.  Samsung Bioepis signed a settlement with Genentech in 2021 allowing it to market its ranibizumab biosimilar from June 2022.  Amelivu®/Byooviz® has been approved in the EU, US, Canada and Korea, and was launched in the US in June 2022.

June 20, 2022

Innovent Biologics and Eli Lilly announced that the CDE of China’s NMPA has approved the sNDA for TYVYT® (sintilimab injection) in combination with cisplatin plus paclitaxel or cisplatin plus 5-FU chemotherapy for the first-line treatment of unresectable, locally advanced, recurrent or metastatic esophageal squamous cell carcinoma (ESCC).

June 17, 2022

Sandoz announced that the EMA has accepted its application for high concentration (100mg/mL) citrate-free product Hyrimoz® (biosimilar adalimumab).  Sandoz’s application seeks approval for all AbbVie Humira® indications.

June 16, 2022

Alvotech announced that its shares and warrants began trading on the Nasdaq on 16 June under the new ticker symbols ‘ALVO’ and ‘ALVOW’ respectively, following the completion of the company’s business combination with Oaktree Acquisition Corp. II.  The transaction was supported by a PIPE totalling approximately $175M, backed by top-tier investors.

Ordinary shares are also expected to commenced trading on the Nasdaq First North Growth Market in Iceland from 23 June 2022.  Alvotech is expected to be the first dual-listed Icelandic company listed on both a US and Icelandic stock exchange.

Alvotech’s portfolio includes AVT02 (adalimumab/biosimilar to Humira®) which launched in Canada in April 2022 and Europe in June 2022  and is expected to launch in the US from July 2023; AVT04 (ustekinumab/biosimilar to Stelara®) for which Alvotech recently announced positive topline results; aflibercept/biosimilar to Eylea®, denosumab/biosimilar to Prolia®, golimumab/biosimilar to Simponi® and omalizumab/biosimilar to Xolair®.

June 13, 2022

Innovent Biologics and PT Etana Biotechnologies announced that the Indonesian Food and Drugs Authority has approved Bevagen® (bevacizumab biosimilar) for metastatic colorectal cancer (mCRC); locally recurrent or metastatic triple negative breast cancer (mTNBC); advanced, metastatic, or recurrent non-small cell lung cancer (NSCLC); epithelial ovarian, fallopian tube, and primary peritoneal cancer (OC); and cervical cancer (CC).  According to Innovent and Etana, Bevagen® may be “the first Chinese antibody drug to be marketed and locally produced in Southeast Asia”.

June 13, 2022

Merck announced that the FDA has accepted its sBLA for Keytruda® (pembrolizumab) as adjuvant therapy for stage IB-IIA non-small cell lung cancer following complete surgical resection.

June 13, 2022

Organon announced that it has entered into a licence agreement with Shanghai Henlius Biotech regarding biosimilars to Perjeta® (pertuzumab, HLX11) and Prolia®/Xgeva® (denosumab, HLX14).  Under the agreement, Organon has exclusive global commercialisation rights “except for China; including Hong Kong, Macau and Taiwan”.  The agreement also includes an option for an exclusive licence for global commercialisation rights to a biosimilar to BMS’ Yervoy® (ipilimumab).

June 11, 2022

Samsung Bioepis presented data from its Ph III trials of SB12 (eculizumab biosimilar) in paroxysmal nocturnal hemoglobinuria at the European Hematology Association 2022, reporting that SB12 is bioequivalent to Alexion’s Soliris®.

June 9, 2022

Alvotech announced the launch of Hukyndra® (citrate-free 100mg/ml biosimilar adalimumab) in Europe by its partner STADA.  The initial launch regions include France, Germany, Finland, and Sweden, with further launches scheduled “over the coming months”.  Whilst Hukyndra® is the fifth biosimilar to be marketed by STADA, it is the first arising from its partnership with Alvotech which covers seven biosimilar products.

June 6, 2022

A new study sponsored by GSK presented at the ASCO annual meeting reported on a small trial of 14 patients with locally advanced mismatch repair-deficient rectal cancer.  The researchers reported that 6 months of treatment with dostarlimab led to clinical complete responses in 100% of the patients, removing the need for chemotherapy, radiation or surgery.

June 6, 2022

Amgen announced that the FDA has approved a new indication for Riabni™ (biosimilar rituximab) – in combination with methotrexate, for adults with rheumatoid arthritis who have had an inadequate response to TNF antagonist therapies.  Riabni™ is Amgen’s fifth approved US biosimilar, and was  approved in December 2020 for the treatment of non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis.

June 3, 2022

The PTAB instituted an inter partes review filed by Fresenius Kabi against US Patent 9,750,752 (‘752 patent) owned by Chugai Seiyaku Kabushiki Kaisha and Hoffman-La Roche.  The ‘752 patent is directed at methods of treating giant cell arteritis by subcutaneously administering tocilizumab.  This is the sixth IPR instituted by PTAB regarding tocilizumab patents arising from Fresenius Kabi challenges.

June 2, 2022

Biogen and Samsung Bioepis announced the launch of Byooviz™ (biosimilar ranibizumab) in the US.  Biogen announced that Byooviz will be available at a discount of 40% compared to Lucentis®.  Byooviz was developed under a partnership between Biogen and Samsung Bioepis, and this launch is the first US biosimilar arising from the partnership.

June 2, 2022

Civica announced that is has selected Profil as its clinical trial partner to support the development of its affordable insulin initiative.  In March 2020, Civica announced its plan to manufacture biosimilar insulins glargine, lispro and aspart.  Civica plans to set a maximum recommended consumer price of no more than $30 per vial, or $55 for a box of five pen cartridges.

June 1, 2022

Roche announced that Health Canada has approved Vabysmo® (faricimab) for the treatment of neovascular (wet) age-related macular degeneration (AMD) and diabetic macular edema (DME).  This is the first approved treatment in Canada for wet AMD and DME that targets both VEGF-A and Ang-2.

June 1, 2022

Lannett provided an update on its pivotal clinical trials of biosimilar insulin glargine.  Lannett announced that half of the subjects have received the first two doses in healthy volunteer pharmacokinetics (PK) and pharmacodynamics (PD) study.  No serious adverse events have been reported, with the study due to finish at the end of 2022.  Lannett also announced that it plans to submit its BLA for the project in early 2023, with a potential launch in the first half of 2024.

June 1, 2022

Novartis announced that the FDA has approved Beovu® (brolucizumab) for the treatment of diabetic macular edema (DME).  Beovu® is also indicated for the treatment of wet age-related macular degeneration.

May 31, 2022

Sandoz launched Act4Biosimilars a new initiative aimed at improving patient access to biosimilars by facilitating greater approvability, accessibility, acceptability and affordability.  The mission of Act4Biosimilars is to increase biosimilar use by 30% in 30+ countries by 2030.

May 31, 2022

Outlook Therapeutics announced that it has voluntarily withdrawn its BLA for ONS-5010/LYTENAVA™ (proposed biosimilar bevacizumab) after the FDA requested additional information.  Outlook Therapeutics announced that it is actively working to respond to the FDA’s request and plans to re-submit a revised BLA by September 2022.

May 30, 2022

Australia’s Generic and Biosimilar Medicines Association hosts 2022 Biosimilar Awareness Week with the key focus on delivering equitable access to affordable medicines to all Australians.

May 27, 2022

Amneal Pharmaceuticals announced that the FDA has approved its ABLA for Fylnetra™ (biosimilar pegfilgrastim).  Fylnetra™ is indicated to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with nonmyeloid malignancies receiving myelosuppressive anti-cancer drugs.  This is Amneal’s third biosimilar approved in the USA (following its filgrastim and bevacizumab biosimilars), which was developed in collaboration with Chicago based Kashiv Biosciences.

May 24, 2022

Alpine Immune Sciences announced that the FDA has removed the partial clinical hold placed on its NEON-2 trial evaluating davoceticept (first-in-class conditional CD28 costimulator and dual checkpoint inhibitor) in combination with pembrolizumab in adults with advanced malignancies.   The partial clinical hold (now lifted) was implemented in March 2022 after a grade 5 serious adverse event leading to a patient’s death occurred.

May 24, 2022

The UK’s NICE published final draft guidance recommending Vabysmo® (faricimab) for the treatment of adult patients with wet age-related macular degeneration (AMD) or diabetic macular oedema (DMO).

May 24, 2022

Shanghai Henlius Biotech announced that it has entered into a semi-exclusive license agreement with Abbott Operations Uruguay for the commercialisation of Hanlikang® (biosimilar rituximab) and Hanquyou® (biosimilar trastuzumab) in Brazil.

May 23, 2022

Biond Biologics announced the first patients have been dosed in its Ph I trials of BND-22 (an Ig-Like Transcript 2 (ILT2) receptor blocking antibody) in combination with pembrolizumab or cetuximab being conducted in Israel and the US.  BND-22 is being developed under an exclusive world wide licence with Sanofi.

May 23, 2022

The US District Court of Delaware has set down BMS’ patent infringement case against AstraZeneca regarding Imfinzi® (durvalumab) as a jury trial in April 2024.  BMS filed a complaint against AstraZeneca in March 2022, alleging that AstraZeneca’s Imfinzi® (durvalumab) infringes eight of its patents relating to anti-PD-L1 antibodies.

May 20, 2022

Merck announced that it has received a positive opinion from the CHMP for its  anti-PD-1 therapy Keytruda® (pembrolizumab) as monotherapy for the adjuvant treatment for adult and adolescent patients with stage IIB or IIC melanoma following complete resection.  CHMP additionally recommended expansion of the Keytruda indications into advanced (unresectable or metastatic) melanoma and stage III melanoma (as adjuvant treatment following complete resection) to include adolescent patients (12 years and older).

Days later Merck announced that the EC has approved Keytruda® (pembrolizumab) with chemotherapy as neoadjuvant treatment, then continued as adjuvant monotherapy after surgery for locally advanced or early-stage triple-negative breast cancer at high risk of recurrence.  Merck says this is the fifth approval for Keytruda in a breast or gynecologic cancer in the EU in less than a year.

May 20, 2022

The CHMP recommended refusing the marketing authorisations for Prestige Biopharma’s applications for trastuzumab biosimilars Tuznue® and Hervelous®.  The CHMP stated that the manufacturing process used for the commercial production of these medicines differed from that used during clinical testing, and considered that ”the studies presented did not provide enough evidence to show that the commercially produced medicine will be biosimilar to the reference medicine”.  Korea Biomedical Review reported that Singapore based, Kosdaq-listed Prestige Biopharma will appeal the decision.

May 19, 2022

Biocon Biologics and Viatris announce the launch of Abevmy® (biosimilar bevacizumab) in Canada.  Abevmy® was jointly developed by Biocon Biologics and Viatris, and is indicated for metastatic colorectal cancer, locally advanced, metastatic or recurrent non-small cell lung cancer, platinum-resistant recurrent epithelial ovarian, fallopian tube and primary peritoneal cancer and malignant glioma-glioblastoma.  This is the fourth Canadian biosimilar launched by Viatris.

Under the portfolio development agreement (which includes a “broad portfolio of biosimilars and insulin analogs”), Viatris has exclusive commercialisation rights in the U.S., Canada, Australia, New Zealand, EU and the European Free Trade Association countries, whilst Biocon Biologics has them in certain emerging markets.  They share co-exclusive commercialisation rights in the rest of the world.

May 17, 2022

Korea Biomedical Review reported that Celltrion has submitted a global Ph III clinical trial plan for CT-P47 (biosimilar tocilizumab) to Poland’s Office for Registration of Medicinal Products, Medical Devices and Biocidal Products.  The global Ph III trial commenced in May 2022, and follows the phase 1 trial which commenced in July 2021.

May 17, 2022

Teva announced that the UK’s MHRA has granted marketing approval for Ongavia® (biosimilar ranibizumab), making the UK the first country in Europe to approve the product for the treatment of (wet) AMD.  Ongavia® will be Teva’s first biosimilar commercialised in Europe, and the UK’s first Lucentis® biosimilar.  The product is the result of a strategic agreement between Teva and Bioeq AG.  Ongavia® is approved for the treatment of: neovascular (wet) age-related macular degeneration; visual impairment due to diabetic macular oedema (DME); proliferative diabetic retinopathy (PDR); visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO); and visual impairment due to choroidal neovascularisation (CNV).

May 16, 2022

Korea Biomedical Review reported that Samsung Bioepis has received marketing approval for Amelivu® (biosimilar ranibizumab) in Korea.  Amelivu® will be launched in Korea after June 2022 in accordance with Samsung Bioepis’ licence from Lucentis® developer Genentech.  The Korean Biomedical Review reports that Samsung Bioepis may launch in other licensed regions (which includes the USA) following “after Genentech’s SPC expires”.

May 16, 2022

Alvotech announced positive top-line results from a 3 arm, parallel design study conducted in Australia and New Zealand regarding AVT04 (ustekinumab biosimilar), reporting that the study results demonstrate bioequivalence between AVT04 and Janssen’s Stelara®.  Teva and Stada are Alvotech’s exclusive strategic partners for commercialising AVT04 in the US and EU respectively.

May 11, 2022

Alvotech announced that it will hold an Extraordinary General Meeting of shareholders to approve the pending business combination with Oaktree Acquisition Corp. II. (Oaktree) on 07 June 2022.  Alvotech has filed the proxy statement/prospectus with the US SEC and the SEC has declared the Registration Statement on Form F-4 effective.  On 7 December 2021, Alvotech and Oaktree announced that they had entered into a merger agreement for the creation of a publicly-traded global biopharmaceutical company.

May 10, 2022

JSR Life Sciences announced the launch of a new business division, Similis Bio.  Similis Bio plans to operate a partnering program to help biopharmaceutical companies improve the efficiency and cost of biosimilar development programs.

May 10, 2022

Merck announced that it will present data from studies of six medicines and pipeline candidates in more than 25 cancers at the 2022 American Society of Clinical Oncology Annual Meeting in June.  This will include data on Keytruda® (ustekinumab), Lenvima® (lenvatinib) and its investigational anti-LAG-3 therapy favezelimab.

May 10, 2022

Formycon and Athos KG announced closing of the acquisition by Formycon of 50% of the rights to FYB201 (biosimilar ranibizumab), 100% of the rights to FYB202 (biosimilar ustekinumab), together with Bioeq GMBH, which is described as its “long-time partner”.  The total value of the deal is €650M.

May 6, 2022

Pfizer commenced patent infringement proceedings in the Federal Court of Australia against Samsung Bioepis, Merck, Organon and Arrow Pharmaceuticals in relation to AU2005280034 and the supply of etanercept.

May 5, 2022

AstraZeneca announced that the FDA has approved Enhertu® (trastuzumab deruxtecan) a HER2-directed antibody drug conjugate jointly developed and commercialised by AZ and Daiichi Sankyo, for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received a prior anti-HER2-based regimen either in the metastatic setting, or in the neoadjuvant or adjuvant setting and have developed disease recurrence during or within six months of completing therapy.

May 5, 2022

Opthea Limited presented data for OPT-302 (VEGF-C/-D ‘trap’ inhibitor) in combination with ranibizumab for polypoidal choroidal vasculopathy at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting.  Opthea reported that OPT-302 used in combination with ranibizumab achieved superior visual acuity gains and anatomic improvements compared to monthly ranibizumab monotherapy.

May 5, 2022

Korea Biomedical Review reported that Boditech Med has obtained approval in Korea for its AFIAS infliximab system. AFIAS infliximab is a therapeutic drug monitoring device used to measure infliximab levels in the blood and check for adverse reactions.

May 3, 2022

The Kennedy Institute (Oxford University) published the results of Ph IIb trials of adalimumab in Dupuytren’s disease.  The researchers reported no related serious adverse events, and that the treatment was effective.  Although the half-life of adalimumab is two or three weeks, researchers saw continued effects nine months after the last injection.

April 29, 2022

Merck announced that the EC has approved Keytruda® (pembrolizumab) in combination with chemotherapy (with or without bevacizumab) for the treatment of persistent, recurrent or metastatic cervical cancer in adults whose tumours express PD-L1.

April 27, 2022

Korea Biomedical Review reported that Celltrion has a licence from AbbVie enabling the launch of Yuflyma® (Celltrion’s biosimilar adalimumab) in the US from July 2023.  Celltrion expects to receive approval for Yuflyma® this year.  Celltrion previously announced in February 2021 that it had completed patent settlements in the US and was approaching settlements in Europe.

April 27, 2022

Amgen released its Q1 2022 financial results, reporting a 6% increase in YoY revenues. Amgen reported a 12% increase in Prolia® (denosumab) sales, a 7% decrease in Enbrel® (etanercept) sales, a 2% increase in Amgevita™ (biosimilar adalimumab) sales and a 40% decrease in Kanjinti® (biosimilar trastuzumab) sales.

April 25, 2022

Merck announced that it received a positive CHMP opinion for its anti-PD-1 therapy Keytruda® (pembrolizumab) in combination with chemotherapy as neoadjuvant treatment, and then continued as monotherapy in adjuvant treatment after surgery for adults with locally advanced, or early-stage triple-negative breast cancer (TNBC) at high risk of recurrence.

April 22, 2022

Biogen announced that it has withdrawn the MAA for aducanumab for the treatment of the early stages of Alzheimer’s disease, following feedback from the CHMP suggesting the data provided would not be sufficient to support a positive opinion.

April 21, 2022

Australia’s TGA granted orphan drug designation to Roche’s glofitamab.  The TGA also provided approval for Roche to apply for registration using the provisional approval pathway, an expedited approval process.  Roche has until 21 October 2022 to make an application through this pathway.

April 20, 2022

Biogen reported that it has completed the sale of its stake in the Samsung Bioepis joint venture to Samsung Biologics.  In January 2022 Biogen announced that it would sell its stake in Samsung Bioepis for an aggregate consideration of up to USD $2.3 billion.

April 18, 2022

Amgen released preliminary results from its Ph III study of ABP654 (proposed ustekinumab biosimilar) in adults with severe plaque psoriasis.  Amgen reported that the study met the primary efficacy endpoint, and that the safety profile of ABP654 was comparable to STELARA®.

April 14, 2022

Cancer Network reported that initial data from AstraZeneca’s Ph II trial of durvalumab and tremelimumab in combination with chemotherapy as neoadjuvant therapy for patients with advanced-stage ovarian cancer was presented at the AACR meeting.  The results suggest that more than 80% of all patients had at least had a partial response to treatment, and five patients (11.11%) had a pathologic complete response.

April 14, 2022

BIOJAMP announced the launch of SIMLANDI™/AVT02 (high-concentration, low volume, citrate-free biosimilar adalimumab) in Canada.  JAMP Pharma has exclusive commercialisation rights to Alvotech’s AVT02 in Canada in accordance with their January 2020 agreement.

April 13, 2022

Korea Biomedical Review reported that Celltrion released the results of its Ph III trials of CT-P16 (biosimilar bevacizumab candidate) at the American Association for Cancer Research 2022.  Celltrion said that CT-P16 demonstrated equivalence in efficacy with Avastin®.  Based on these results, Celltrion has completed an application for CT-P16 product approval in Korea, the U.S., and the EU seeking approval for a full label.

April 13, 2022

Amneal Pharmaceuticals announced that the FDA has approved its BLA for Alymsys® (biosimilar bevacizumab) marking the second of three oncology biosimilar approvals Amneal expects to receive in 2022.  Alymsys® was developed by mAbxience, and its approval is the third biosimilar bevacizumab approved in the US.

April 11, 2022

Celltrion announced the launch of Yuflyma® (high-concentration, low-volume, citrate-free and latex-free biosimilar adalimumab) in Canada.  Yuflyma® is approved in Canada for ten indications: rheumatoid arthritis, polyarticular juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn’s disease, adult ulcerative colitis, hidradenitis suppurativa, plaque psoriasis, adult uveitis, and paediatric uveitis.

April 6, 2022

Alvotech announced that it has resolved its patent disputes with AbbVie in Europe and selected markets elsewhere relating to Alvotech’s citrate free, high concentration adalimumab (AVT02, biosimilar to Humira®).  This follows the resolution of the US litigation between AbbVie and Alvotech last month and paves the way for Stada to commercialise adalimumab in Europe under the Hukyndra® brand name.  AbbVie has granted Alvotech a non-exclusive royalty bearing license to AbbVie’s Humira® patents in Europe and selected markets elsewhere.

April 4, 2022

Intas announced that it has signed an exclusive license and supply agreement with Axantia, a Middle Eastern pharmaceutical company, for the commercialisation of ranibizumab (biosimilar Lucentis®) in territories including Saudi Arabia, Jordan, Iraq and Lebanon.

April 4, 2022

Regeneron announced that the FDA has accepted for Priority Review the sBLA for Dupixent® (dupilumab) for the treatment of eosinophilic esophagitis (EoE).

March 31, 2022

31 March 22 | Fresenius Kabi announced that it has bought a majority stake (55%) in mAbxience, a company specialising in biosimilars, for an upfront EUR 495 million plus milestone payments, and Ivenix, which has a leading infusion therapy platform, for an upfront US$ 240 million plus milestone payments.  These transactions are expected to close in mid-2022.

March 29, 2022

Telix Pharmaceuticals announced that the FDA has designated Telix’s monoclonal antibody TLX66 (90Y-besilesomab) an orphan drug for use in conditioning treatment of bone marrow prior to hematopoietic stem cell transplant.

March 29, 2022

Formycon and Athos KG announced that they have agreed to enter into a long-term strategic partnership regarding biosimilars.  As part of this agreement, Formycon will acquire 100% of the rights in FYB202 (biosimilar ustekinumab candidate) and a 50% stake in FYB201 (biosimilar ranibizumab candidate) in exchange for EUR 650 million.

March 29, 2022

Lannett announced that it has commenced dosing in its pivotal trial of biosimilar insulin glargine.

March 28, 2022

Medical Xpress reports on an Institute of Cancer Research, London, study showing that levels of the protein PD-L1 detected in head and neck tumours can be used to personalise medicine.  Depending on PD-L1 levels, patients should receive personalised medicine of either chemotherapy with or without cetuximab, pembrolizumab in combination with chemotherapy, or pembrolizumab alone.

March 28, 2022

Aurobindo announced that it will acquire certain business assets from Veritaz (the supplier of branded generic formulations and other health care products) for Rs 171 crore on a debt free basis.  The acquisition will support Aurobindo’s plans to manufacture biosimilars and other products in India.

March 25, 2022

The Office of the Assistant Secretary for Preparedness and Response has announced that it will pause the distribution of sotrovimab in certain US states in which the BA.2 variant has become the dominant COVID-19 strain.  This announcement follows FDA advice which indicates that sotrovimab is not effective against the BA.2 variant.

March 25, 2022

Australia’s TGA approved Celltrion’s Yuflyma® (biosimilar to AbbVie’s Humira® adalimumab) for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, enthesitis-related arthritis, psoriatic arthritis, ankylosing spondylitis. Crohn’s disease, ulcerative colitis, psoriasis, hidradenitis suppurativa and uveitis.

March 22, 2022

The FDA hosted a public meeting entitled ‘Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act’, in line with its previously stated commitment to do so no later than 30 September 2022.

March 22, 2022

The Government of British Columbia announced an expansion of its biosimilars switching program to include blood thinner enoxaparin.  This change took effect on 22 March 2022, with all new PharmaCare approvals to be for biosimilar enoxaparin only.

March 21, 2022

Merck announced that the FDA has approved Keytruda® (pembrolizumab) (anti-PD-1 therapy) as a single agent for the treatment of patients with advanced endometrial carcinoma that is microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR).  Keytruda® is also indicated in combination with Lenvima® (lenvatinib) for the treatment of patients with advanced endometrial carcinoma that is not MSI-H or dMMR.

March 21, 2022

Henlius Biotech published the results of Ph II trials of novel anti-PD-1 monoclonal antibody serplulimab (novel anti-PD-1 mAb) in the treatment of advanced cervical cancer.  Henlius reported that the study demonstrated a manageable safety profile and encouraging efficacy.  Serplulimab is stated to be the first innovative mAb developed by Henlius.

March 19, 2022

Amgen and Pfizer settled their pegfilgrastim (Neulasta®) dispute Amgen Inc v Hospira Inc (D. Del., No. 20-201) which has been on foot since February 2020.  No further details about the settlement agreement have been published to date.

March 17, 2022

Merck announced results from Ph III trials of Keytruda® (pembrolizumab) in patients with Stage IB-IIIA non-small cell lung cancer, reporting that Keytruda® significantly improved disease-free survival.

March 16, 2022

Prestige BioPharma published preclinical data on its first-in-class pancreatic cancer treatment PBP1510 (ulenistamab).  PBP1510 is being developed as a potential treatment for pancreatic cancer and is currently in Ph 1/2a trials in France and Spain.

March 15, 2022

Merck announced that it will discontinue Ph III trials of Keytruda® (pembrolizumab) in combination with Lynparza® (olaparib) in patients with metastatic castration-resistant prostate cancer following the recommendation of an independent Data Monitoring Committee.  Merck said that interim analysis indicated that the combination treatment did not demonstrate a benefit in overall survival.

March 15, 2022

The Centre for Biosimilars reported on a study on Celltrion’s CT-39 (biosimilar omalizumab) presented at the American Academy of Allergy Asthma and Immunology annual meeting.  Celltrion reported that the study demonstrated equivalence with Xolair® (omalizumab).

March 15, 2022

Evio Pharmacy announced a roll-out of a biosimilar strategy to help make medicines affordable.  Evio announced that it has contracted directly with biosimilars manufacturers for autoimmune disease and cancer therapeutics.

March 14, 2022

OcyonBio announced that it has entered into a manufacturing and operations agreement with Biosimilar Solutions Inc. to create a contract biosimilars development/manufacturing organisation (including process development, plasmid, vectors, cell banks, processing and testing facilities) in Puerto Rico.  Biosimilar Solutions expects to manufacture recombinant proteins and monoclonal antibodies from 2022.

March 10, 2022

Samsung Bioepis and Biogen announced that Health Canada approved Byooviz™ (biosimilar ranibizumab) on 8 March for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment due to diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (RVO), choroidal neovascularization (CNV) secondary to pathologic myopia (PM) and choroidal neovascularization (CNV) secondary to ocular conditions other than AMD or PM.  This is the first Health Canada approval of a biosimilar ranibizumab to date, and whilst is it Samsung’s 6th Canadian biosimilar, it is Biogen’s first.  Byooviz™ was approved in the US in September 2021, and in the EU and the UK in August 21.

March 8, 2022

Alvotech announced that it has settled all pending US disputes with AbbVie, including the ITC case brought by AbbVie in December 2021.  Under the settlement Alvotech will receive non-exclusive rights to market AVT02 (high-concentration, citrate-free biosimilar adalimumab) in the United States from 1 July 2023.  This date is the same US license date AbbVie granted to Coherus and Boehringer Ingelheim in their respective settlements with AbbVie, which follows Amgen’s US license date of 31 Jan 23 and Samsung’s 30 June 2023.  Alvotech is the only known company that has both developed a high-concentration biosimilar adalimumab and conducted switching studies to enable the launch of what is expected to be the first high concentration interchangeable biosimilar adalimumab in the US.  Teva is Alvotech’s strategic partner for the US commercialisation of AVT02.  AVT02 is already approved in Europe, Canada and the UK.

March 7, 2022

Merck published interim results from its Ph III trial of Keytruda® (pembrolizumab) as an adjuvant treatment for patients with stage IIB and IIC melanoma.  According to the announcement, the trial met its key secondary endpoint and showed an improvement in recurrent-free survival compared to placebo.

March 3, 2022

Shanghai Henlius Biotech announced that China’s NMPA has approved its biosimilar rituximab (汉利康®)), as the first biosimilar approved in combination with methotrexate for the treatment of adult patients with rheumatoid arthritis  who have inadequate response to one or more TNF-alpha antagonist therapies.  Additional approved indications include NHL (mono therapy) and CLL in combination with fludarabine and cyclophosphamide.

March 3, 2022

The Juvenile Diabetes Research Foundation (JDRF) announced that it has entered into a partnership with not-for-profit generic manufacturing company Civica to manufacture biosimilar insulins, including biosimilars to glargine (Lantus®), lispro (Humalog®), and aspart (Novolog®).   Biosimilar insulins are to be developed for the US market so that low-cost insulin is supplied irrespective of insurance status from 2024.  JDRF is underwriting the initial development costs of the project, and Civica will manufacture and distribute biosimilar insulin for less than USD$30/vial, or $55/box of five pen cartridges.

March 3, 2022

FDA announced a new funding opportunity for the BsUFA III Regulatory Science Program to support research projects that “enhance biosimilar and interchangeable biological product development and regulatory science”.

March 2, 2022

Shanghai Junshi Biosciences announced that China’s NMPA has approved its biosimilar adalimumab product (50mg/ml) for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.  The product was jointly developed by Shanghai Junshi Biosciences and Jiangsu T-mab BioPharma (T-mab Bio), a subsidiary of Mabwell (Shanghai) Bioscience Co (Mabwell Bio).

March 2, 2022

Celltrion launched Yuflyma® (high concentration citrate-free biosimilar adalimumab) in Korea.

March 1, 2022

AbbVie announced that is has completed its acquisition of Syndesi Therapeutics SA for $1B, including up front payment of $130M, with a further $870M in milestone payments.  This acquisition will expand AbbVie’s neuroscience portfolio, giving AbbVie access to Syndesi’s portfolio, including lead molecule SDI-118, a small molecule which is currently in Ph Ib studies.

March 1, 2022

Amneal announced that the FDA has approved Amneal’s first biosimilar product Releuko™ (biosimilar filgrastim), a product developed by Kashiv Speciality Pharmaceuticals (which was acquired by Amneal in April 2021).  Amneal also disclosed that US applications for biosimilar pegfilgrastim and bevacizumab are under FDA review, and Amneal plans to launch both products in 2022.

February 28, 2022

The Korea Herald reported that Samsung Bioepis has secured a total of 10 biosimilar products on its 10th year anniversary.  Six biosimilars have been approved globally: infliximab, etanercept, adalimumab, trastuzumab, bevacizumab and ranibizumab.  Eculizumab has recently completed its Ph III clinical trial, and three other biosimilar candidates are under Ph III trials.

February 28, 2022

Biocon announced that its subsidiary Biocon Biologics will acquire Viatris’ biosimilar assets for USD 3.335 billion in stock and cash to create a vertically integrated biosimilars leader.  The transaction is expected to close in the second half of 2022, subject to conditions including certain regulatory approvals.  The subject business revenues are expected to be USD1billion in 2023 alone.

February 28, 2022

Alvotech announced that the FDA has accepted the BLA including data supporting interchangeability for AVT02, Alvotech’s high-concentration (100mg/ml) biosimilar adalimumab.  The Biosimilar User Fee Act goal date for FDA decision is December 2022.

February 25, 2022

Pfizer announced that the FDA has accepted its sBLA seeking interchangeability for Abrilada™ (biosimilar adalimumab).  The Biosimilar User Fee Act goal date for FDA decision is Q4 2022.

February 23, 2022

Alvotech and Fuji Pharma announced that they have expanded their strategic partnership for Japan to include an undisclosed biosimilar currently in early phase development.  This brings the total number of products covered by the partnership to six.  Fuji will receive exclusive commercial rights to this biosimilar in Japan in exchange for upfront and milestone payments tied to development progression.  Alvotech will also receive a share of the in-market sales.

February 22, 2022

Bio-Thera provided an update on its pipeline at the BioPharmaSynergy conference in Amsterdam, reporting that its dupilumab, secukinumab, mepolizumab and vedolizumab biosimilars are in preclinical development.

February 21, 2022

Prestige BioPharma announced that the manufacturing facility for Tuznue® (biosimilar trastuzumab) has received EUGMP certification.  Tuznue® is under Marketing Authorisation Application review in the EU, Canada and South Korea.

February 19, 2022

Janssen released data from a Ph 2a clinical trial of guselkumab and golimumab in ulcerative colitis.  Janssen reported that the combination induced higher rates of clinical response, clinical remission, endoscopic improvement and a composite histologic-endoscopic endpoint at 12 weeks that either treatment alone.

February 18, 2022

Australia’s TGA provided a safety update for BMS’ Yervoy® (ipilimumab), resulting in a warning on the PI that ipilimumab has been linked to serous retinal detachment, a rare but serious adverse event.

February 18, 2022

Celltrion released two data sets on the subcutaneous (SC) form of Remsima® (biosimilar infliximab).  Celltrion reported that switching from IV to SC infliximab leads to higher infliximab trough levels and a lower risk of relapse in patients with IBD.

February 17, 2022

Coherus BioSciences published its Q4 2021 financial results, reporting a net loss of $45.7 million.  Coherus attributed this net loss to a decrease in the number of units of Udenyca® (biosimilar pegfilgrastim) sold, as well as a decline in net realised price due to increased competition and COVID-19 impacts.

February 16, 2022

The Korea Times reported that Celltrion’s net profit has grown 20% year-over-year.  Celltrion has reported significant market shares in the US for its infliximab and rituximab biosimilars.

February 14, 2022

New Zealand’s Pharmac requested feedback on a proposal to provide access to Riximyo® (biosimilar rituximab) for patients with pemphigus.  Riximyo® is not approved for pemphigus in New Zealand and would need to be prescribed by an authorised prescriber in accordance with section 25 of the Medicines Act.  The consultation period closes on 1 March 2022.

February 14, 2022

The FDA awarded Medscape Education a contract for the development of an education curriculum and outreach program on the use of biosimilars in medical practice.  The program will include accredited continuing education courses for physicians, pharmacists, and nurses.

February 14, 2022

The Korea Herald reported that Celltrion’s Remsima® (biosimilar infliximab) has captured 33.7% of the US market for infliximab since its approval in April 2016.

February 10, 2022

A real-world study of Pfizer’s Zirabev® (biosimilar bevacizumab) indicates that Zirabev® has been well adopted in US oncology practice.

February 10, 2022

Sanofi announced that the FDA has accepted for Priority Review the sBLA for Dupixent® (dupilumab) as an add-on maintenance treatment for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis.  Dupixent was first approved by the FDA in March 2017.

February 9, 2022

Selexis SA and Generium JSC announced the launch of Genolar® (biosimilar omalizumab) in Russia.

February 8, 2022

Pfizer published its Q4 2021 financial results, reporting a 30% growth in biosimilars revenues year-over-year.

February 8, 2022

South Africa’s Competition Commission filed a referral with the Competition Tribunal for prosecution of Roche for alleged excessive pricing of trastuzumab.

February 7, 2022

Cardinal Health published its 2022 Biosimilars Report: The US Journey and Path Ahead.  Cardinal predicted that 2022 is set to be a turning point for biosimilars in the US, reporting that most healthcare providers have a strong interest in using biosimilars to broaden patient access and drive more affordable care for their patients.

February 7, 2022

Biogen and Xbrane Biopharma announced that they have entered into a commercialisation and license agreement to develop, manufacture and commercialise Xcimzane™ (proposed biosimilar certolizumab pegol).

February 7, 2022

The International Generic and Biosimilar medicines Association (IGBA) announced that it has established a CEO Advisory Committee.  Committee members represent Amneal Pharmaceuticals, Apotex, Cadila Healthcare, Cipla, Dr Reddy’s Laboratories, Insud Pharma, Lupin, Sandoz, STADA, Sun Pharmaceutical, Teva Pharmaceuticals, Towa Pharma and Viatris.  IGBA announced that the Committee will provide a forum for industry leaders to discuss broad, strategic issues and to engage and position the industry on a range of critical issues.

February 7, 2022

Bloomberg reported that the potential sale of Novartis’ Sandoz division has drawn a lot of interest from private equity as well as from other generics manufacturers.  Bloomberg reported that Blackstone Inc and Carlyle Group Inc are in talks to potentially team up on an offer, with other companies such as Advent International, Hellman & Friedman and KKR & Co said to be considering offers.  Novartis announced the potential sale of its Sandoz division in its Q3 2021 financial results and a decision on the future of Sandoz is expected by the end of 2022.

February 4, 2022

Nova Scotia launched a biosimilars switching program.  The program applies to certain insulins and products used for arthritis, IBD and psoriasis and pharmacare beneficiaries will have 12 months to apply the switch to biosimilars.  Similar programs have already been introduced in British Columbia, Quebec, Alberta and New Brunswick.

February 3, 2022

Dr Reddy’s announced that it has entered into an agreement to acquire privately owned German medical cannabis company Nimbus Health GmbH.  Dr Reddy’s said that the acquisition will allow it to introduce medical cannabis-based medicines as a promising treatment option for patients.

February 2, 2022

Australia’s National Medicines Policy Review Committee published a draft National Medicines Policy (NMP).  The original NMP was established in 2000, with the stated aim of achieving both ‘optimal health outcomes and economic objectives’.  The scope of the new NMP is proposed to be broadened to encompass biologic medicines, gene therapies, cell and tissue engineered products, and vaccines.

February 2, 2022

Samsung Bioepis announced that Health Canada has approved Ontruzant® (biosimilar trastuzumab) for the treatment of adults with early breast cancer, metastatic breast cancer and metastatic gastric cancer.

February 2, 2022

Alvotech announced that it has entered into an exclusive global licensing agreement with BiosanaPharma for the co-development of AVT23(BP001), a biosimilar omalizumab candidate.

February 1, 2022

Lupin announced that it has entered into a license, supply and technology sharing agreement with Axantia Holding for biosimilar pegfilgrastim in certain territories, including Saudi Arabia, Jordan, Lebanon, Iraq, Sudan, Libya and Algeria.

February 1, 2022

JAMP Pharma announced the creation of a new division BIOJAMP™ dedicated to biosimilars.  The creation of this division was primarily made possible through JAMP’s exclusive agreement with Alvotech.  Through the creation of the BIOJAMP™ division, JAMP Pharma plans to establish itself as a Canadian leader in biosimilars.

January 28, 2022

Genentech announced that the FDA has approved Vabysmo™ (faricimab) for the treatment of people with wet age-related macular degeneration and diabetic macular edema.

January 27, 2022

Biogen announced that Samsung Biologics will acquire Biogen’s equity stake in the Samsung Bioepis joint venture for an aggregate consideration of up to USD $2.3 billion.

January 27, 2022

MSD announced that the EC has approved Keytruda® (pembrolizumab) for the adjuvant treatment of adults with renal cell carcinoma at increased risk of recurrence following nephrectomy, or following nephrectomy and resection of metastatic lesions.

January 26, 2022

Vizient announced that remdesivir has replaced Humira® (adalimumab) as the most expensive drug by total member spend in its Winter 2022 Market Outlook.  Pembrolizumab, ustekinumab, ocrelizumab, denosumab, infliximab, nivolumab and tocilizumab also featured in the top 10 most expensive drugs by member spend.

January 26, 2022

The US International Trade Commission instituted AbbVie’s complaint relating to Alvotech’s adalimumab candidate.

January 24, 2022

Bio-Thera Solutions announced that it has commenced Ph I studies regarding BAT6021 (a monoclonal antibody with enhanced ADCC targeting TIGIT in cancer cells).

January 21, 2022

Innovent and Eli Lilly announced the results of Phase Ib trials of Tyvyt® (sintilimab) plus biosimilar bevacizumab for advanced hepatocellular carcinoma.  Innovent says that the safety profile is consistent with that observed in previously reported studies, without new or unexpected safety signals.

January 20, 2022

MSD and Eisai announced the publication of results from Ph III studies of Keytruda® (pembrolizumab) in patients with advanced endometrial carcinoma.

January 20, 2022

Biocon announced its Q3FY22 financial results, reporting a 28% year over year growth in biosimilars revenues from their subsidiary Biocon Biologics.

January 18, 2022

Alvotech announced $21 million in additional commitments for private placement (PIPE) of Oaktree II common stock.  Alvotech and Oaktree Acquisition Corp. II previously announced in December 2021 that they had entered into a pre IPO merger agreement.  According to the announcement, the business combination is expected to deliver gross proceeds to Alvotech in excess of $475M.

January 14, 2022

MoneyControl reported that Biocon is in the final stages of announcing the deal to buy Mylan’s biosimilar business.  In December 2021 MoneyControl reported that Biocon and Mylan were in advanced talks for the creation of a biosimilars spin-off, however neither party has confirmed this speculation.

January 12, 2022

The International Generics and Biosimilar Medicines Association (IGBA) announced the appointment of Vivian Fritelli as IGBA Chair for 2022.

January 11, 2022

Orion Corporation and CuraTeQ Biologics announced an expansion to their biosimilar distribution agreement in Europe to include the Baltic countries.  All products under the agreement are still in development or regulatory phases, with launches estimated to take place in 2023-2026.

January 10, 2022

Alvotech and JAMP Pharma announced that Health Canada has approved Simlandi (high-concentration, citrate-free biosimilar adalimumab).

January 7, 2022

Coherus Biosciences announced that it has entered into a loan agreement with investment funds managed by Pharmakon Advisors, LP.   The agreement will provide Coherus with up to $300 million committed across four tranches.  The third and fourth tranches are conditional upon Coherus receiving approval of the BLA for its toripalimab and its biosimilar ranibizumab, respectively.

January 5, 2022

Amneal Pharmaceuticals and Saol Therapeutics announced that Amneal will acquire Saol’s Baclofen franchise.  This acquisition is expected to bolster Amneal’s commercial infrastructure in advance of its planned launches of biosimilar filgrastim, biosimilar pegfilgrastim and biosimilar bevacizumab in 2022.

January 5, 2022

Samsung Bioepis and Organon announced that the FDA has accepted for review the supplemental Biologics License Application for a citrate-free, high-concentration formulation of SB5 (biosimilar adalimumab).  Organon expects to launch this product in the US on or after 1 July 2023, in accordance with a licensing agreement with AbbVie.

2021

December 30, 2021

Biocon Biologics announced that the US Court of Appeals for the Federal Circuit Court has upheld the US Patent and Trademark Appeal Board’s decisions of unpatentability for five device patents for Sanofi’s Lantus® (insulin glargine) SoloSTAR® as well as a district court decision on one of these patents.  Biocon Biologics and Viatris launched Semglee® (interchangeable biosimilar insulin glargine) in November 2021.

December 24, 2021

Innovent Biologics announced that China’s NMPA has accepted the supplemental New Drug Application for sintilimab plus biosimilar bevacizumab injection and chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung-cancer who progressed after EGFR-TKI therapy.

December 24, 2021

Health Canada approved Celltrion’s Yuflyma® (100mg/mL biosimilar adalimumab) for all indications as Humira®.

December 23, 2021

Theramex and Enzene Biosciences announced that they have entered into an agreement for the development and commercialisation of biosimilar tocilizumab.  The product will be available in parenteral vials, PFS and autoinjectors from 2026 in Europe, the UK, Switzerland and Australia.

December 22, 2021

Sandoz announced that it has submitted a BLA to the EMA for a proposed biosimilar trastuzumab.

December 20, 2021

Coherus announced that the FDA has approved Yusimry™ (biosimilar adalimumab).  Coherus plans to launch Yusimry™ in the US on or after 1 July 2023 in accordance with a 2019 agreement with AbbVie.

December 20, 2021

Sandoz announced that it has submitted a BLA to the FDA for a proposed biosimilar trastuzumab.

December 17, 2021

AbbVie filed a complaint with the US International Trade Commission in relation to Alvotech’s AVT02, alleging the misuse of trade secrets.  The US District Court dismissed the trade secrets lawsuit brought by AbbVie against Alvotech also relating to AVT02 in October 2021.

December 17, 2021

Alvotech announced that the EC has approved AVT02 (100mg/mL biosimilar adalimumab), following the positive recommendation made by the CHMP in September 2021.

December 17, 2021

The FDA approved Eli Lilly’s Rezvlogar® (biosimilar insulin glargine).

December 14, 2021

Hyphens Pharma announced that it has signed an exclusive license and supply agreement with DKSH’s subsidiary Favorex Pte Ltd for the commercialisation of Alvotech’s proposed biosimilar ustekinumab in Singapore, Malaysia and the Philippines.

December 13, 2021

Xbrane Biopharma announced it is developing two new biosimilar candidates referencing Keytruda® (pembrolizumab) and Darzalex® (daratumumab).

December 11, 2021

Samsung Bioepis announced that SB12 (proposed eculizumab biosimilar) met all the endpoints in a Ph I study.

December 10, 2021

Novartis CEO Vas Narasimhan announced that the potential sale of Sandoz has attracted interest from potential buyers.  Novartis is expected to decide the future of Sandoz by the end of 2022.

December 9, 2021

Dr Reddy’s and Prestige BioPharma announced that they have entered into an exclusive partnership for the supply and commercialisation of Prestige BioPharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia.

December 9, 2021

Hikma Pharmaceuticals and Gedeon Richter announced that they have entered into an exclusive license agreement to commercialise Gedeon Richter’s proposed denosumab biosimilar in the United States.

December 9, 2021

MoneyControl reported that Biocon and Mylan are in advanced talks for the creation of a biosimilars spin-off. To date neither party has confirmed this speculation.

December 8, 2021

Samsung Bioepis announced that its Ontruzant® (biosimilar trastuzumab) demonstrated comparable long-term survival results with reference trastuzumab in five-year follow-up results.

December 7, 2021

Prestige BioPharma announced that its Ph I study of PBP1502 (proposed adalimumab biosimilar) has been registered with the US National Institute of Health.  Prestige disclosed that it plans to file marketing authorisation applications with the EMA and FDA in 2023.

December 7, 2021

Alvotech and Oaktree Acquisition Corp. II announced that they have entered into a merger agreement for the creation of a publicly-traded global biopharmaceutical company. Alvotech is led by a team of highly experienced biopharma leaders, including Mark Levick as CEO, Anil Okay as CCO, and Philip Caramanica as Chief IP Counsel and Deputy General Counsel. The merger is expected to deliver gross proceeds to Alvotech in excess of USD$450 million.  Alvotech currently has seven products in its pipeline, including a biosimilar candidate to Humira® (adalimumab), Stelara® (ustekinumab), Eylea® (aflibercept), Prolia®/Xgeva® (denosumab) and Simponi®/Simponi ARIA® (golimumab).

December 6, 2021

Australia’s TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) for the treatment of adults with coronavirus who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.

December 3, 2021

Shanghai Henlius Biotech announced that China’s NMPA has approved Hanbeitai® (biosimilar bevacizumab) for the treatment of metastatic colorectal cancer and unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer.

December 3, 2021

Lupin and Biomm announced that they have entered into an exclusive distribution and marketing agreement for biosimilar pegfilgrastim in Brazil.

December 1, 2021

British Columbia announced that it has expanded its biosimilar program to include insulin.  About 30,000 patients will now have six months to transition to Admelog® (biosimilar insulin lispro) and Trurapi® (biosimilar insulin aspart).

December 1, 2021

Tot Biopharm announced that China’s NMPA has approved Pusintin® (biosimilar bevacizumab) for the treatment of patients with advanced, metastatic or recurrent non-squamous non-small cell lung cancer and patients with metastatic colorectal cancer.

November 25, 2021

Mochida Pharmaceutical and Ayumi Pharmaceutical announced the launch of high-dose 100mg/mL Adalimumab BS MA (adalimumab biosimilar) in Japan.

November 24, 2021

A new study of belimumab after rituximab reported a reduction of serum IgG anti-double-stranded DNA antibody levels and the risk for severe flare in systemic lupus erythematosus refractory in comparison to conventional therapy.

November 22, 2021

Korea Biomedical Review reported that Dong-A ST has completed patient enrolment for Ph III trials of DMB-3115 (proposed denosumab biosimilar) in patients with moderate to severe chronic plaque psoriasis.

November 21, 2021

Innovent released the results of a Ph III study of sintilimab and BYVASDA® (bevacizumab biosimilar) combined with chemotherapy in patients with EGFR-mutated non-squamous non-small cell lung cancer who progressed after EGFT-TKI therapy.

November 19, 2021

Merck announced that it has successfully completed the cash tender offer for all of the outstanding shares of common stock of Acceleron Pharma through its subsidiary Astros Merger Sub, Inc.  Merck announced that it intends to complete the acquisition through a merger of Astros Merger Sub with and into Acceleron, with Acceleron being the surviving corporation.

November 17, 2021

Samsung Bioepis launched a new white paper entitled ‘Improving the Understanding and Acceptance of Biosimilars in the United States’. In particular, the paper discusses the need to reduce information gaps, incentivise different stakeholders and practical considerations for implementation.

November 17, 2021

Pharmac announced that it will transfer Principal Supply status from Humira® (adalimumab) to Amgevita® (biosimilar adalimumab) from 01 March 2022.

November 16, 2021

Viatris and Biocon Biologics announced the US launch of Semglee® (interchangeable biosimilar insulin glargine) and Insulin Glargine.

November 15, 2021

Celltrion announced that the EC has approved Regkirona® (regdanvimab, CT-P59) for adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

November 12, 2021

AU’s PBAC published the outcomes from its July 2021 meeting. PBAC recommended listing:

  • Pfizer’s Abrilada® (50mg/mL adalimumab biosimilar) in 20mg/0.4mL syringe, 40mg/0.8mL syringe and 40mg/0.8mL pen for all indications as Humira®.
  • Janssen’s Darzalex SC® (daratumumab) for all indications for which the intravenous form of daratumumab is currently listed.
  • Pfizer’s Enbrel® (etanercept) in 50mg/1mL single use dose-dispenser cartridges under the same conditions as existing listings for etanercept.
  • BMS’ Opdivo® (nivolumab) for the treatment of patients with advanced or metastatic oesophageal squamous cell carcinoma who have disease progression following treatment with a fluoropyrimidine and platinum (FP)-based chemotherapy regimen.

November 12, 2021

RegenXBio announced additional interim data from its Ph II trials of RGX-314 (proposed one-time gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases). RGX-314 is a recombinant adeno-associated virus (AAV) gene therapy vector carrying a coding sequence for a soluble anti-VEGF protein.

November 12, 2021

The CHMP recommended approval of Celltrion’s Regkirona® regdanvimab for the treatment of adults with COVID-19 who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19.

November 10, 2021

Celltrion announced its Q3 2021 financial results. Celltrion reported that Remsima® (infliximab biosimilar) has obtained a 53% market share in Europe and 21% market share in Japan. Celltrion reported that Truxima® (rituximab biosimilar) has obtained a 40% market share in Europe and Herzuma® (trastuzumab biosimilar) has obtained a 14% market share in Europe. Celltrion also reported that it expects to launch biosimilar bevacizumab in 2022, biosimilar ustekinumab in 2023, biosimilar omalizumab and aflibercept in 2024 and biosimilar denosumab in 2025.

November 9, 2021

Coherus BioSciences reported its Q3 2021 financial results. Coherus announced that FDA review of CHS-201 (proposed adalimumab biosimilar) is advancing towards the target action date in December 2021. Coherus also disclosed that the FDA has accepted the BLA for its proposed toripalimab biosimilar for advanced nasopharyngeal carcinoma, with a target action date of April 2022.

November 4, 2021

Novartis announced that it will sell its stake in Roche for a total of USD 20.7 billion, stating that it no longer views its financial stake in Roche as part of its core business. This follows the announcement by Novartis that it would undertake a strategic review of the Sandoz division.

November 3, 2021

Pharmacy benefit manager Prime Therapeutics announced that it will add Semglee® (interchangeable biosimilar insulin glargine) to its preferred national formularies.

November 2, 2021

Fresenius Kabi released its Q3 2021 financial results. Fresenius Kabi confirmed that despite delays due to COVID-19, it expects to launch its pegfilgrastim biosimilar candidate in the EU in 2022.

November 2, 2021

Pfizer released its Q3 2021 results, reporting a 34% increase operationally in biosimilars. Pfizer announced that it plans to launch citrate-free Abrilada® (biosimilar adalimumab) in the US as early as 1 July 2023 in accordance with its agreement with AbbVie. Pfizer disclosed that it plans to seek interchangeable status for Abrilada® in December 2021.

November 1, 2021

The International Generic and Biosimilar Medicines Association called on all stakeholders ahead of its second Global Biosimilars Week to join the Biosimilars Movement on Advancing Access. The campaign seeks to gather useful ideas, experience, information and resources for and from patients, doctors and all other stakeholders across the healthcare community.

October 27, 2021

Teva released its Q3 2021 financial results, reporting a 2% decrease in revenues compared to Q3 2020. Teva disclosed that it does not expect to launch any new biosimilars in 2022.

October 27, 2021

Korea Biomedical Review announced that Samsung Bioepis has completed Ph III trials of SB12 (proposed eculizumab biosimilar) for the treatment of paroxysmal nocturnal hemoglobinuria.

October 26, 2021

Novartis disclosed in its Q3 2021 earnings announcement that it will undertake a strategic review of the Sandoz division. Novartis stated that this review will explore all options ranging from retaining the business to separation.

October 25, 2021

Janssen announced data from two new analyses of Stelara® (ustekinumab) for the treatment of adults with Crohn’s disease and ulcerative colitis. Janssen reported that the data from these analyses provides additional support for Stelara® as a first-line option for Crohn’s disease and ulcerative colitis.

October 22, 2021

Chugai Pharmaceutical announced that it will construct a new manufacturing facility in Tokyo to produce biopharmaceuticals for early clinical trials.

October 22, 2021

Biocon released its Q2 2022 financial results, reporting a 10% increase in biosimilars revenue from its subsidiary Biocon Biologics year on year.

October 22, 2021

Genentech announced that the FDA has approved Susvimo™ (ranibizumab) for intravitreal use via ocular implant for the treatment of patients with wet age-related macular degeneration who have previously responded to at least two anti-VEGF injections.

October 21, 2021

BMS announced that the EMA has approved Opdivo® (nivolumab) in combination with fluoropyrimidine- and platinum-based combination chemotherapy for the first-line treatment of adult patients with HER2-negative advanced or metastatic gastric, gastroesophageal junction (GEJ), or esophageal adenocarcinoma (EAC) whose tumors express PD-L1 with a combined positive score (CPS) ≥ 5.

October 21, 2021

Kintor Pharmaceutical announced that China’s NMPA has approved clinical trials for GT90008 (PD-L1/TGF-β dual-targeting antibody) for the treatment of advanced solid tumours.

October 21, 2021

The NSW State Government pledged $96 million towards a RNA pilot manufacturing facility, to be established in partnership with NSW universities. The facility is expected to house laboratories and pre-clinical trial spaces to enable early-stage RNA-based drug development.

October 21, 2021

Biocon Biologics announced that pharmacy benefit management company Express Scripts will list Semglee® (interchangeable biosimilar insulin glargine) as a preferred insulin brand on its National Preferred Formulary.

October 20, 2021

MorphoSys announced that the first patient has been dosed in its Ph II trials evaluating felzartamab for patients with Immunoglobulin A Nephropathy.

October 20, 2021

HepaRegeniX announced a new collaboration with the Netherlands Cancer Institute to investigate HRX-0233 (MKK4 inhibitor candidate) in preclinical in vivo models with Kirsten rat sarcoma virus (KRAS) mutant tumours.

October 19, 2021

Opthea announced that the first clinical trial sites in the Asia-Pacific region are now open for patient enrolment in its Ph III trials of OPT-302 (VEGF-C/-D ‘trap’ inhibitor).

October 18, 2021

Australia’s TGA provisionally approved Roche’s Ronapreve™ (casirivimab and imdevimab) for two indications relating to COVID-19. Ronapreve™ is indicated for the treatment of COVID-19 in adults and adolescents who do not require supplemental oxygen and who are at increased risk of progressing to severe COVID-19, and for the prevention of COVID-19 in adults and adolescents who have been exposed to SARS-CoV-2 and who either have a medical condition making them unlikely to respond to or to be protected by vaccination or are not vaccinated against COVID-19.

October 16, 2021

Bio-Thera Solutions announced it has reached a licensing and supply agreement with Pharmapark for BAT2206 (proposed ustekinumab biosimilar). Under the agreement, Pharmapark will have exclusive rights to distribute and market the product in Russia and other CIS countries.

October 15, 2021

Merck and Eisai announced that the CHMP has adopted positive opinions recommending the approval of the combination of Keytruda® (pembrolizumab) plus Lenvima®/Kisplyz® (lenvatinib) for the first-line treatment of adults with advanced renal cell cancer and for the treatment of adults with advanced or recurrent endometrial carcinoma.

October 15, 2021

Boehringer Ingelheim announced that FDA has approved Cyltezo® (biosimilar adalimumab) as the first biosimilar designated as interchangeable with Humira® (adalimumab).   Cyltezo® is a 50 mg/mL “citrate free” (ie acetate buffered) product, and the “interchangeable” designation will be limited to only some of the Humira® products, unless FDA responds favourably to the citizen petition lodged by Boehringer Ingelheim in December 2020 requesting FDA to interpret the term “strength” in legislation in section 351(k) of the Public Health Service Act (42 U.S.C. 262(k) in a manner which would extend BI’s interchangeability designation to all formulations delivering the same amount of active (irrespective of concentration).  The FDA stated in a May 2021 interim response that it has been unable to made a decision on the CP to date “because it raises complex issues requiring extensive review and analysis by Agency officials”.

October 15, 2021

Roche announced that the FDA has approved Tecentriq® (atezolizumab) as adjuvant treatment, following surgery and platinum-based chemotherapy, for adults with Stage II-IIIA non-small cell lung cancer whose tumours express PD-L1≥1%.

October 14, 2021

Gan & Lee Pharmaceuticals announced the completion of two Ph III studies of its proposed insulin glargine biosimilar.

October 13, 2021

Merck announced that the FDA has approved Keytruda® (pembrolizumab) plus chemotherapy, with or without bevacizumab, as a treatment for patients with persistent, recurrent or metastatic cervical cancer whose tumours express PD-L1.

October 12, 2021

The Korea Herald announced that Celltrion has submitted a Marketing Authorisation Application to the EMA for CT-P16 (proposed bevacizumab biosimilar).

October 9, 2021

The Australian reported that Australian pharmacists have raised concerns over proforma letters provided by AbbVie to prescribing doctors (specialist rheumatologists and gastroenterologists) and public hospital clinics instructing chemists to only dispense Humira® branded adalimumab rather than biosimilar adalimumab.

October 8, 2021

A new study published in Stat News reported that the aggregate savings enabled by biosimilars in the US was 4.3 times higher than that of generics.

October 8, 2021

Janssen announced the submission of a sBLA to the FDA seeking expanded approval of Stelara® (ustekinumab) to treat paediatric patients aged 5 years and older with juvenile psoriatic arthritis.

October 8, 2021

Australia’s TGA approved AstraZeneca’s Enhurtu® (trastuzumab deruxtecan) for the treatment of adult patients with unresectable or metastatic HER2-positive breast cancer who have received two or more prior anti-HER2-based regimens.

October 8, 2021

The US District Court for the Northern District of Illinois dismissed the Humira® trade secrets lawsuit brought by AbbVie against Alvotech for lack of jurisdiction.

October 7, 2021

Xbrane Biopharma and AGC Biologics entered into an agreement to manufacture Xcimzane™ (certolizumab pegol) for clinical development.

October 5, 2021

Celltrion announced that it has submitted a Marketing Authorisation Application to the EMA seeking approval of regdanvimab for the treatment of COVID-19 in adults who do not require supplemental oxygen therapy and who are at increased risk of progressing to severe COVID-19.

October 5, 2021

Coherus Biosciences announced positive results from a randomised, open-label, crossover study assessing the pharmacokinetic and pharmacodynamic bioequivalence of Udencya® (biosimilar pegfilgrastim) administered via an on-body injector device compared to the currently marketed Udencya® pre-filled syringe. Coherus plans to submit its application to the FDA in 2022 and expects to launch directly post approval.

October 4, 2021

Opthea announced the enrolment for its Ph III trials of OPT-302 (VEGF-C/-D ‘trap’ inhibitor) in the treatment of wet (neovascular) age-related macular degeneration has opened in Europe.

October 3, 2021

Celltrion presented two new data sets on the use of Remsima® SC (biosimilar infliximab) in inflammatory bowel disease in a poster presentation at United European Gastroenterology Week 2021.

October 2, 2021

A new study published in Cancer Communications reported that Boan Biotechnology’s LY01008 (proposed bevacizumab biosimilar) demonstrated similarity to Avastin® in patients with advanced or recurrent non-squamous NSCLC.

October 1, 2021

Coherus Biosciences announced that the FDA has accepted for review the BLA for CHS-201 (proposed biosimilar ranibizumab).

October 1, 2021

Korea Biomedical Review reported that Celltrion has submitted an application for CT-P16 (proposed biosimilar bevacizumab) in the US and Korea.

September 30, 2021

Xbrane Pharma and STADA announced that the MAA for Xlucane™ (proposed biosimilar ranibizumab) has been submitted to the EMA.

September 29, 2021

The US House Judiciary Committee voted in favour of the Preserve Access to Affordable Generics and Biosimilars Act. If passed, this act would allow the FTC to initiate proceedings against parties to any agreement resolving or settling a patent infringement claim in connected with the sale of a drug or biological product.

September 28, 2021

Eli Lilly announced that the FDA has approved Erbitux® (cetuximab) in combination with Braftovi® (encorafenib) for the treatment of metastatic colorectal cancer with a BRAF V600E mutation.

September 27, 2021

Apobiologix announced that Health Canada has approved Bambevi® (biosimilar bevacizumab) in combination with chemotherapy to treat specific types of colorectal, lung, brain and ovarian cancer.

September 27, 2021

A new study published in Annals of Internal Medicine reported that a live virus Varicella-Zoster vaccine in immunosuppressed patients receiving biologic therapies may be a reasonable option if no alternative vaccine is available.

September 27, 2021

AbbVie, Eisai Co and EA Pharma announced Humira® (adalimumab) has received additional approvals in Japan for its high-dose regimen in adults with ulcerative colitis and in a new regimen in paediatric patients.

September 27, 2021

JW Therapeutics announced that China’s NMPA has approved the IND for a clinical trial of BCMA-targeted Chimeric Antigen Receptor (CAR) T cell JWCAR129 in treating relapsed or refractory multiple myeloma.

September 27, 2021

Hikma Pharmaceuticals announced that it will acquire Custopharm for an initial cash consideration of USD $375 million with a further USD $50 million in contingent consideration payable upon the achievement of certain commercial milestones.

September 23, 2021

Korea Biomedical Review reported that Samsung Bioepis and Genetech have signed a licence agreement for ranibizumab.  Under the terms of the agreement, Samsung Bioepis can market its biosimilar ranibizumab from June 2022.

September 23, 2021

PharmGene Science and Access Bio announced that they have signed a Memorandum of Understanding for the joint development and commercialisation of a biosimilar mRNA COVID-19 vaccine.

September 23, 2021

Business Standard reported that Aurobindo Pharma (through the subsidiary CuraTeQ Biologics) has submitted a Marketing Authorisation Application to the EMA for BP14 (proposed biosimilar pegfilgrastim).

September 22, 2021

Syneos Health and CuraTeQ Biologics (a subsidiary of Aurobindo) are recruiting participants for a comparative trial to be conducted in New Zealand to assess the pharmacokinetics, pharmacodynamics, safety and immunogenicity of 3 different products (BP11, US-Xolair and EU-Xolair) containing 150mg of omalizumab as subcutaneous injection in healthy male volunteers.  The estimated study completion date is October 2022.

September 20, 2021

180 Life Sciences and Celltrion announced that they have entered into a Memorandum of Understanding for the supply of an anti-TNF biosimilar drug to be used for new indications with significant unmet medical needs.

September 20, 2021

AbbVie announced it has submitted the regulatory application for Skyrizi® (risankizumab) to the FDA for the treatment of patients 16 years and older with moderate to severe Crohn’s Disease.

September 20, 2021

Samsung Bioepis and Biogen announced that the FDA has approved Byooviz® (biosimilar ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration, macular edema and myopic choroidal neovascularisation.

September 18, 2021

Henlius announced that it will present the results of new studies on serplulimab (anti-PD-1 mAb) and HLX04 (bevacizumab biosimilar) at the 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO).

September 18, 2021

Celltrion announced that South Korea’s MFDS has approved regdanvimab for the extended use in elderly patients aged 50 years and over, or with at least one underlying medical condition with mild symptoms of COVID-19, and in adults patients with moderate symptoms of COVID-19.

September 18, 2021

Merck announced that the first results from Ph III trials of Keytruda® (pembrolizumab) showed a statistically significant and clinically meaningful improvement in recurrence-free survival compared to placebo in patients with resected high-risk stage II melanoma.

September 17, 2021

Alvotech announced that the EU’s CHMP has adopted a positive opinion recommending the approval of AVT02 (proposed adalimumab biosimilar).

September 13, 2021

AbbVie and RegenXBio announced a partnership to develop and commercialise RGX-314 (proposed one-time gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases).

September 13, 2021

Samsung Bioepis reported on a five-year follow-up study comparing ONTRUZANT® (trastuzumab biosimilar) with reference trastuzumab in early or locally advanced HER2 positive breast cancer. Samsung Bioepis reported that five year survival rates were 93.1% in the biosimilar trastuzumab group compared with 86.7% in the reference medicine group.

September 10, 2021

Australia’s TGA approved Kyowa Kirin’s Crysvita® (burosumab) for the treatment of X-linked hypophosphataemia.

September 10, 2021

Alvotech announced positive top-line results from its switching study between AVT02 (proposed adalimumab biosimilar) and Humira®. Alvotech reported that no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference cohort.

September 9, 2021

BioFactura announced it has reached an agreement with Rani Therapeutics to assess BFI-751 (proposed ustekinumab biosimilar) in combination with the RaniPill® platform. The RaniPill® capsule is intended to replace subcutaneous or IV injection of biologics with oral dosing.

September 9, 2021

Samsung Bioepis announced results from a post-hoc and subgroup analysis of a Ph III clinical study of Byooviz® (ranibizumab biosimilar). Samsung Bioepis reported that the data supports biosimilarity between Byooviz® and reference ranibizumab.

September 8, 2021

Bio-Thera Solutions announced that it has entered into a commercialisation and license agreement with Sandoz to commercialise BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Sandoz will commercialise the product in the US, Europe, Canada and other international markets in exchange for an upfront payment, potential milestone payments and royalties on product sales.

September 8, 2021

The EMA approved Samsung Bioepis and Biogen’s Byooviz® (biosimilar ranibizumab) for the treatment of neovascular (wet) age-related macular degeneration, diabetic macular oedema, proliferative diabetic retinopathy, macular edema and choroidal neovascularisation.

September 7, 2021

Adaptimmune Therapeutics announced it has entered into a strategic collaboration and license agreement with Genentech to develop and commercialise allogeneic cell therapies for multiple oncology indications.

September 7, 2021

Fresenius Kabi announced that its biosimilar tocilizumab candidate MSB11456 successfully met its primary and secondary endpoints in Ph I trials of both subcutaneous and intravenous formulations.

September 6, 2021

Australia’s TGA approved Gilead Sciences’ Trodelvy® (sacitizumab) for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer.

September 6, 2021

Australia’s TGA approved Mylan/Alphapharm’s Abevmy® (biosimilar bevacizumab) for the treatment of colorectal cancer, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube, peritoneal cancer and cervical cancer.

September 6, 2021

Hetero announced that it has received emergency use approval from India’s DCGI to market its biosimilar tocilizumab for the treatment of COVID-19.

September 4, 2021

Dr Reddy’s announced that it has sold all of its rights to E7777 (an engineered IL-2-diptheria toxin fusion protein) to Citius Pharmaceuticals. Under the agreement, Dr Reddy’s will receive $40 million upfront, and milestone payments of up to $40 million (related to the cutaneous T-cell lymphoma indication) and $70 million (additional indication approvals).

September 3, 2021

China’s NMPA approved JW Therapeutics’ Relma-cel (relmacabtagene autoleucel) for the treatment of large B-cell lymphoma.

September 3, 2021

The UK’s NICE recommended Novartis’ Cosentyx® (secukinumab) as a treatment for plaque psoriasis in children aged 6-17 years.

September 2, 2021

Amgen and Hospira appear ready to settle the ongoing dispute relating to Neupogen® (filgrastim). The matter was due to go to a jury trial on 20 September 2021.

September 1, 2021

The UK’s NICE recommended UCB Pharma’s Bimzelx® (bimekizumab) as a treatment for plaque psoriasis in adults.

August 30, 2021

Australia’s TGA approved Celgene’s Reblozyl® (luspatercept) for the treatment of transfusion-dependent anaemia.

August 27, 2021

India’s DCGI granted marketing authorisation for Enzene Bioscience’s biosimilar denosumab.

August 27, 2021

Bio-Thera Solutions and Hikma Pharmaceuticals announced that they have signed an exclusive commercialisation and license agreement for BAT2206 (proposed ustekinumab biosimilar). Under the agreement, Hikma will gain exclusive commercialisation rights in the US with a first-right-to-negotiate to add Europe (excluding CIS countries) to the agreement.

August 26, 2021

Two former executives of JHL Biotech plead guilty to conspiracy to steal trade secrets and commit wire fraud exceeding $101 million in the US District Court for the Northern District of California. The written plea agreements disclosed that the executives used confidential, proprietary and trade secret information from Genentech to accelerate the timeline and reduce the costs of JHL Biotech’s development and production of Genentech biosimilars.

August 26, 2021

The US District Court for the Northern District of Illinois refused to dismiss AbbVie’s Humira® (adalimumab) infringement suit against Alvotech hf. The court found that AbbVie is not required to sue the US based subsidiary listed on the aBLA form, but could sue Icelandic company Alvotech hf.

August 26, 2021

NZ’s Pharmac announced that it is considering awarding Principal Supply to Amgevita® (biosimilar adalimumab). Pharmac is seeking feedback on the proposed changes to the funding arrangements.

August 26, 2021

The US Federal Circuit reversed an infringement judgement against Kite Pharma (part of Gilead Pharma) of a patent relating to CAR-T therapies on the basis of lack of written description.  The Sloan Kettering Institute for Cancer Research owned patent at issue was licenced exclusively to Juno Therapeutics (now part of BMS).  Kite Pharma’s CAR-T therapy is Yescarta® (axicabtagene ciloleucel), which competes with Juno’s Breyanzo® (lisocabtagene maraleucel).

August 25, 2021

Cipla and Kemwell Biopharma announced that they have executed a joint venture agreement to develop, manufacture and commercialise biosimilars, with an aim to enter the respiratory biosimilars space.

August 24, 2021

UCB announced that it has gained EU marketing approval for Bimzelx® (bimekizumab), an IL-17A and IL-17F inhibitor indicated for the treatment of adults with moderate to severe plaque psoriasis.

August 20, 2021

The UK’s MHRA granted conditional marketing authorisation for REGEN-COV®/Ronapreve® (casirivimab and imdevimab antibody cocktail) to prevent and treat acute COVID-19 infection.

August 19, 2021

Australia’s TGA granted approval for AbbVie’s Skyrizi® (risankizumab) in a higher, 150mg/mL  concentration formulation. Skyrizi® is indicated for plaque psoriasis in adults.

August 17, 2021

Novartis announced that China’s NMPA has expanded its approval of Cosentyx® (secukinumab) to include the treatment of plaque psoriasis in paediatric patients.

August 17, 2021

Novartis announced the results of its Ph III trials of Beovu® (brolucizumab) versus aflibercept in patients with diabetic macular edema, reporting that Beovu® demonstrated superiority versus aflibercept in key endpoints.

August 17, 2021

The FDA announced the Biosimilar User Fee Act rates for the 2022 fiscal year. The new rates will apply from 01 October 2021.

August 13, 2021

Roche notified Australia’s TGA of shortages of multiple presentations of Actemra® (tocilizumab). Tocilizumab has been used off-label for COVID-19, driving global demand. The TGA made a number of recommendations for patients currently treated with Actemra®, including switching to alternative biological disease modifying drugs.

August 12, 2021

Progenity released its Q2 2021 financial results. Progenity disclosed that it has recently produced a GMP drug substance batch for its adalimumab oral biotherapeutics delivery system (PGN-0B1).

August 12, 2021

Brazil’s ANVISA granted emergency use authorisation (EUA) for Celltrion’s COVID‑19 treatment regdanvimab. 

August 11, 2021

Celltrion announced that Herzuma® (biosimilar trastuzumab) gained 51% of the market share in Japan in June.

August 10, 2021

Enzene Biosciences announced that India’s DCGI has approved its biosimilar romiplostim for the treatment of chronic Immune Thrombocytopenic Purpura (ITP) in adults.

August 10, 2021

A new study published in the The Lancet reported that the safety and efficacy of Boehringer Ingelheim’s BI695501 (adalimumab biosimilar) in patients with Crohn’s disease is similar to reference adalimumab.

August 9, 2021

Viatris released its Q2 2021 financial results, reporting 8% growth in operational change for net sales of biosimilars and complex generics.

August 9, 2021

Opthea commenced recruitment for its Ph III trials of OPT-302 (VEGF-C/-D ‘trap’ inhibitor) in the treatment of wet (neovascular) age-related macular degeneration.

August 5, 2021

Formycon and Bioeq announced that the BLA for FYB201 (proposed ranibizumab biosimilar) has been submitted to the FDA.

August 5, 2021

Coherus Biosciences released its Q2 2021 financial results. Coherus announced that its partner, Junshi Biosciences plans to submit the BLA for toripalimab for a number of indications later this quarter. Coherus also disclosed that it anticipates a mid-2022 target action date for its BLA for biosimilar ranibizumab, and confirmed it plans to launch its biosimilar adalimumab on or after 1 July 2023.

August 5, 2021

A new study reported that the safety profiles and pharmacokinetic parameters of Amgen’s ABP980 (biosimilar trastuzumab) and pertuzumab administered as an admixture in a single infusion bag is consistent with what is known for reference trastuzumab and pertuzumab.

August 3, 2021

Outlook Therapeutics reported positive efficacy and safety data from Ph III trials of ONS-5010 (proposed bevacizumab biosimilar) for the treatment of neovascular age-related macular degeneration.

August 3, 2021

Amgen released its Q2 2021 financial results, reporting double digit volume growth for Prolia® (denosumab), Repatha® (evolocumab), Mvasi® (biosimilar bevacizumab) and Kanjinti® (biosimilar trastuzumab).

August 3, 2021

Celltrion announced it has won a tender to supply the Brazilian market with Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab).

July 30, 2021

AbbVie released its Q2 2021 financial results, reporting US Humira® (adalimumab) net revenues increased 7.1%, but decreased internationally 12.6% on an operational basis. AbbVie attributed this decrease to biosimilar competition.

July 29, 2021

The American Academy of Ophthalmology pushed back against insurance company pressure to use new bevacizumab biosimilars off-label in eye treatment as alternatives to Avastin® (bevacizumab) in the absence of supporting studies.

July 29, 2021

A new study published in Lancet Oncology reported that pembrolizumab in combination with cetuximab shows promise as a treatment for patients with recurrent or metastatic head and neck squamous cell carcinoma.

July 29, 2021

The FDA announced it has approved the first interchangeable biosimilar insulin product. Semglee® (biosimilar insulin glargine) has been approved as an interchangeable biosimilar to Lantus® and is indicated for adults and paediatric patients with Type 1 diabetes and in adults with Type 2 diabetes.

July 28, 2021

Prestige BioPharma announced that HD201 (proposed trastuzumab biosimilar) demonstrated an equivalent pharmacokinetic and safety profile to reference trastuzumab in a bridging study completed last year.

July 27, 2021

Abenza and BioXpress Therapeutics announced they have formed a new partnership to support biosimilar development and manufacturing.

July 26, 2021

Teva is recruiting participants for a US study to compare the safety and efficacy of TEV-45779 compared to XOLAIR in patients with Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) who remain symptomatic on H1 antihistamine treatment.  The estimated study completion date is May 2024.

July 23, 2021

Pfizer and Johnson & Johnson (J&J) settled the antitrust litigation relating to Pfizer’s Inflectra® (infliximab biosimilar). Pfizer had alleged that J&J’s payer contracts restricted the use of Inflectra® by denying reimbursement unless Remicade was first proven ineffective for patients, causing a reluctance among pharmacies to stock Inflectra®. Details of the settlement have not been published.

July 22, 2021

A new study published in Rheumatology reported that the safety and efficacy of Celltrion’s CT-P17 (biosimilar adalimumab) were comparable after one year of treatment, including for patients who switched from reference adalimumab after 24 weeks.

July 22, 2021

Intas Pharma announced it has signed a commercialisation agreement with Meiji and Dong-A St for DMB-3115 (proposed ustekinumab biosimilar). Under the agreement, Intas will receive exclusive licensing rights to DMB-3115 worldwide excluding Japan, Korea and certain countries in Asia.

July 22, 2021

Inhalon Biopharma announced it will partner with Celltrion to develop IN-006, an inhaled form of regdanvimab for the treatment of COVID-19. It is hoped that the product will be able to reach the virus in the airways and allow patients to self-administer treatment at home. Last week we reported that regdanvimab demonstrated strong neutralising activity against the Delta variant of COVID-19 in pre-clinical studies.

July 20, 2021

Sorrento announced that China’s NMPA has granted marketing approval for Mabpharm’s infliximab ‘biobetter’. Sorrento holds exclusive commercial rights to the product outside of China and disclosed that it plans to file a BLA in the EU and US in 2021.

July 19, 2021

Samsung Bioepis announced that it has commenced Ph III trials of SB17 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.

July 19, 2021

Shanghai Henlius Biotech announced that the first patient has been dosed in its Ph I clinical trial of HLX04-O (proposed bevacizumab biosimilar) in the treatment of wet age-related macular degeneration.

July 16, 2021

Celltrion announced pre-clinical in vivo studies of CT-P59 (regdanvimab) demonstrated strong neutralising activity against the Delta variant of COVID-19. Celltrion reported a 100% survival rate after a clinically relevant dose compared to 0% for the placebo group, with significant protection against body weight loss after viral challenge. A therapeutic dosage of CT-P59 also significantly reduced the viral load and inflammation in the lungs compared to non-treated controls.

July 15, 2021

Bio-Thera Solutions announced that the first patient has been dosed in its Ph III trials of BAT206 (proposed ustekinumab biosimilar).

July 14, 2021

The UK’s NICE finalised its guidance on the treatment of moderate rheumatoid arthritis, recommending the use of adalimumab, etanercept, infliximab and abatacept for patients with moderate rheumatoid arthritis which is inadequately controlled on conventional therapies.

July 14, 2021

The FDA notified Amgen of its concerns relating to potential false or misleading promotional communications about Neulasta® (pegfilgrastim). The FDA alleged that promotional materials released by Amgen made false or misleading claims and representations about the benefit of Neulasta® when administered through the Onpro injection compared to a prefilled syringe. Amgen must provide a written response within 15 working days from the date of receipt of the letter.

July 12, 2021

Boditech Med announced it has obtained export approval for AFIAS Adalimumab, a diagnostic kit which measures adalimumab levels in blood. The test is able to return a result within 10 minutes using whole blood on-site.

July 9, 2021

US President Biden signed an executive order aimed at promoting competition in the US economy. The order directs the Health and Human Services Administration (HHS) to increase support for generic and biosimilar drugs, and encourages the FTC to ban ‘pay for delay’ agreements.

July 6, 2021

Australia’s PBAC recommended the listing of Amgen’s Mvasi® (biosimilar bevacizumab). The PBAC also recommended listing Keytruda® (pembrolizumab) for the first line treatment of unresectable or metastatic mismatch repair deficient colorectal cancer and recommended listing Stelara® (ustekinumab) for the treatment of paediatric patients with severe chronic plaque psoriasis.

July 6, 2021

Opthea announced the FDA has granted fast track designation for OPT-302 (VEGF-C/-D ‘trap’ inhibitor). OPT-302 (a soluble form of vascular endothelial growth factor receptor 3 (VEGFR-3)) is intended to treat neovascular (wet) age-related macular degeneration in combination with anti-VEGF-A therapy.

July 6, 2021

India’s Central Drugs Standard Control Organisation granted marketing authorisation for Lupin’s ranibizumab biosimilar.

July 6, 2021

The Government of Quebec released the details of its biosimilars switching program. Under the new program, patients will continue to be reimbursed for biologics for ongoing treatment until 13 April 2022. After this date, patients will only be reimbursed for biologics for which there is no covered biosimilar version, the request is for a pregnant woman or child, or there is a case of a therapeutic failure.

July 6, 2021

Merck announced that the FDA has approved an expanded label for Keytruda® (pembrolizumab). Keytruda® is now also approved for the treatment of patients with recurrent of metastatic or locally advanced cutaneous squamous cell carcinoma that is not curable by surgery or radiation.

July 6, 2021

Alvotech announced that the first patient has been dosed in the comparative, confirmatory efficacy and safety clinical study for AVT04 (proposed ustekinumab biosimilar). The trial is being conducted in Central and Eastern Europe and approximately 530 patients are expected to be enrolled in the study.

July 5, 2021

Chong Kun Dang announced it has signed a commercialisation agreement with Menagen for Nesbell® (biosimilar darbepoetin alfa). Under the agreement, Chong Kun Dang will receive a down payment and milestone payments in exchange for exclusive commercialisation rights in Oman, Saudi Arabia, UAE, Kuwait Qatar and Bahrain.

July 2, 2021

Gan & Lee Pharmaceuticals announced positive Ph I results for its three proposed insulin analog biosimilars (insulin aspart, insulin lispro and insulin glargine). Gan & Lee announced that all three Ph I studies met their primary PK and primary PD analyses.

June 29, 2021

STADA and XBrane BioPharma announced that Xlucane™ (proposed ranibizumab biosimilar) met its primary endpoint in a pivotal comparability trial. STADA disclosed that it plans to submit the MAA and BLA for Xlucane™ to the EMA and FDA respectively in the second half of 2021.

June 29, 2021

A new study published in Cancer Communications concluded that Luye Pharmaceuticals’ LY01008 (proposed bevacizumab biosimilar) demonstrated similarity to reference Avastin® in terms of efficacy and safety in patients with advanced or recurrent non-squamous non-small cell lung cancer

June 29, 2021

Bioeq announced that it has submitted the MAA for FYB201 (proposed ranibizumab biosimilar) to the EMA. Under the agreement announced on 28 June 2021, FYB201 will be marketed in the EU by Teva.

June 28, 2021

Teva and Bioeq announced they have entered into a strategic partnership for the exclusive commercialisation of Bioeq’s FYB201 (proposed ranibizumab biosimilar). Under the agreement, Bioeq will be responsible for the development, registration and supply of the product, while Teva will gain commercialisation rights in Europe, Canada, Israel and New Zealand.

June 27, 2021

Innovent Biologics announced China’s National Medical Products Administration has approved its supplemental New Drug Application for Tyvyt® (sintilimab) in combination with Byvasda® (biosimilar bevacizumab) as a first-line treatment for people with advanced or unresectable hepatocellular carcinoma.

June 25, 2021

UCB announced that the CHMP has recommended BIMZELX® (bimekizumab) for the treatment of plaque psoriasis.

June 25, 2021

Samsung Bioepis and Biogen announced that the CHMP has recommended BYOOVIZ™/SB11 (proposed ranibizumab biosimilar) for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to diabetic macular oedema, proliferative diabetic retinopathy, visual impairment due to macular oedema secondary to retinal vein occlusion (branch RVO or central RVO) and visual impairment due to choroidal neovascularization.

June 24, 2021

The CHMP recommended granting conditional marketing authorisation for Minjuvi® (tafasitamab) for the treatment of relapsed or refractory diffuse large B-cell lymphoma, and Abecma® (idecabtagene vicleucel) for the treatment of relapsed and refractory multiple myeloma.

June 24, 2021

The Committee for Medicinal Products for Human Use (CHMP) recommended expanding the indications for Opdivo® (nivolumab) and Rinvoq® (upadacitinib). If approved, Opdivo® will also be indicated for oesophageal or oesophageal junction cancer. If approved, Rinvoq® will also be indicated for atopic dermatitis.

June 24, 2021

Health insurance provider Cigna announced it will offer a one-time US$500 payment to patients who switch to a biosimilar or another preferred medication. This payment will be provided in a debit card and can be spent on health care services and products.

June 23, 2021

Innovent Biologics announced its Ph III trials of sintilimab in combination with chemotherapy met the overall survival primary endpoint.

June 23, 2021

Genentech announced that the FDA has accepted the BLA for its Port Delivery System (PDS) with ranibizumab under Priority Review. Genentech is seeking approval for its PDS for the treatment of wet, or neovascular, age-related macular degeneration (AMD).

June 18, 2021

Taiwan-based Synermore Biologics is recruiting participants for a study to be conducted in Europe and Russia to compare SYN008 and Xolair for the treatment of chronic urticaria not well controlled by antihistamines.

June 17, 2021

Nichi-Iko announced it has entered a licence and supply agreement with Laboratorio Elea Phoenix for a biosimilar infliximab product. Under the agreement Nichi-Iko will supply the product to Elea for the Argentine market.

June 17, 2021

Amneal announced the FDA has accepted the BLA for Alymsys™ (proposed bevacizumab biosimilar). Alymsys™ was developed in collaboration with mAbxience.

June 15, 2021

Alvotech announced it has reached the primary completion date in its switching study for AVT02 (proposed adalimumab biosimilar). Alvotech hopes to list AVT02 as an interchangeable adalimumab biosimilar in the US, which would allow for pharmacy substitution.

June 12, 2021

Celltrion presented data for Truxima® (biosimilar rituximab) in patients with diffuse large B-cell lymphoma at the EHA 2021 Virtual Congress. Celltrion reported that the response rates, survival rates and overall safety profile of Truxima® appeared consistent with those reported for the reference product.

June 10, 2021

Theramex UK announced it has entered into an agreement with Enzene Biosciences for the commercialisation of a biosimilar denosumab. Under the agreement, Enzene will supply Theramex with the product for commercialisation in Europe, the UK, Switzerland and Australia.

June 10, 2021

The UK’s NICE published final draft guidance recommending adalimumab, etanercept and infliximab for the treatment of moderate rheumatoid arthritis on the NHS. Previously, biologics had been recommended only for severe rheumatoid arthritis.

June 9, 2021

Magellan Rx Management announced that its oncology biosimilar medical benefit drug management solution has saved customers over US$40 million, with greater savings expected as the market shift to biosimilars accelerates.

June 8, 2021

Bio-Thera announced it has initiated Ph III trials of BAT2506 (golimumab biosimilar).

June 7, 2021

Merck released new data on Keytruda® (pembrolizumab) in combination with Lenvima® (levatinib) versus sunitinib in patients with advanced renal cancer. Merck said that the results reinforced the combination of pembrolizumab and levatinib as a potential new treatment option for renal cancer.

June 7, 2021

Celltrion launched Remsima SC® (subcutaneous infliximab biosimilar) in Canada.  Remsima SC® is indicated for the treatment of rheumatoid arthritis.

May 31, 2021

The Korea Herald has reported that Celltrion will launch Yuflyma® in the EU in June.  Citing ‘industry sources’ and a Celltrion official, the article discloses that Celltrion will initially launch Yuflyma® in six EU countries including Spain, before launching in an additional 7 EU countries in Q3 2021, and 3 more in Q4 2021.

May 28, 2021

The UK’s NICE recommended Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis and psoriatic arthritis.

May 28, 2021

Sun Pharma announced in its Q1 2021 earnings call that it will develop biosimilar products which have ‘significant future expiry dates’, aiming to be among the first approvals of ‘third wave’ biosimilar products.

May 25, 2021

AbbVie announced it will present new data from a number of studies on its immunology products including Rinvoq® (upadacitinib), Skyrizi® (risankizumab) and Humira® (adalimumab) at the EULAR 2021 Virtual Congress of Rheumatology.

May 25, 2021

BioFactura announced the initiation of Ph I trials of BFI-751 (proposed ustekinumab biosimilar). The trial is being conducted across three sites in Australia and New Zealand.

 

May 24, 2021

Zydus Cadila announced it has launched Ujvira (trastuzumab emtansine) in India. Ujvira is an antibody drug conjugate biosimilar and is available in 100mg and 160mg vials at a considerable discount to the reference product.

May 20, 2021

Meiji Seika Pharma announced its Ph I trials of DMB-3115 (proposed ustekinumab) biosimilar demonstrated the bioequivalence of its product to the reference product.

May 20, 2021

The US House of Representatives Committee on Oversight and Reform published a Drug Pricing Investigation Staff Report which was scathing regarding AbbVie’s conduct regarding the sale of its blockbuster drugs Humira® (adalimumab) and Imbruvica® (ibrutinib) in pursuing ‘a variety of tactics to increase drug sales while raising prices for Americans, including exploiting the patent system to extend its market monopoly, abusing orphan drug protections to further block competition, and engaging in anti-competitive pricing practices.’. 

May 18, 2021

The US Supreme Court declined to hear Novartis’ appeals against a lower court decision which upheld two Amgen patents relating to Enbrel® (etanercept).  Keren Haruvi, President of Sandoz US and Head of North America estimates that a biosimilar etanercept in the US could have saved payees USD$1 billion annually.

May 18, 2021

Prestige BioPharma announced it has entered into a memorandum of understanding with the Busan City Government for the establishment of a R&D centre in Busan, South Korea.  Prestige announced that the 45,000 m2 centre will house 209 new R&D personnel for the next five years.  Prestige also announced that it has completed Ph III trials of its proposed trastuzumab biosimilar, and an application is currently under EMA review.

May 18, 2021

The Government of Quebec announced it would introduce a biosimilar switching program which is expected to generate annual savings of more than CAD$100 million.  All patients in Quebec currently on biologics must switch to a biosimilar by April 12, 2022.  This follows similar moves from Alberta, New Brunswick and British Columbia.

 

May 17, 2021

Sandoz Canada launched Inclunox® (biosimilar enoxaparin sodium) in Canada.

May 14, 2021

Sarcoidosis News reported a new study demonstrates that patients with sarcoidosis can safely switch from Remicade® (infliximab) or Inflectra® (biosimilar infliximab) to Flixabi® (biosimilar infliximab) and maintain similar clinical benefits.  Infliximab is not indicated for sarcoidosis, but is commonly used off-label and has been shown to improve lung function in refractory patients.

May 14, 2021

Alphapharm received approval for Hulio® (biosimilar adalimumab) in Australia.  Hulio® was approved in a 20mg/0.4mL solution for pre-filled syringe, 40mg/0.8mL solution for pre-filled syringe, and 40mg/0.8mL solution for pre-filled pen.  Viatris launched Hulio® in Canada and Japan in February this year.

May 12, 2021

Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%.  Celltrion announced that it is planning to complete Ph III trials of biosimilar bevacizumab in the first half of 2021, and that ustekinumab, aflibercept, omalizumab and denosumab candidates remain in Ph III trials.

May 12, 2021

The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) finalised its ‘Guidance on the licensing of biosimilar products‘, outlining the licensing requirements for biosimilars in the post-Brexit UK.  The MHRA had previously foreshadowed in its draft guidance that comparative efficacy/safety trials would not be necessary for most biosimilars.  The MHRA has maintained its position in this finalised guidance, stating that ‘Although each biosimilar development needs to be evaluated on a case by case basis, it is considered that, in most cases, a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach.‘.

May 11, 2021

Alvotech filed a federal lawsuit against AbbVie in the US District Court of the Eastern District of Virginia, seeking to clear patent barriers relating to proposed biosimilar adalimumab, AVT02.  Alvotech alleges that AbbVie has sought to protect its product monopoly by ‘overwhelming’ Alvotech with 60+ patent claims with questionable validity.  Specifically, Alvotech alleges that AbbVie has acted improperly by:

  • patenting purported inventions that it does not use in the production of Humira®
  • seeking multiple patents on the same invention but as part of different patent families in a manner designed to cause confusion;
  • obtaining patents through inequitable conduct;
  • by seeking patents that cover Humira® already in the prior art; and
  • obtaining patents on purported inventions that AbbVie did not invent.

AbbVie’s Humira® still holds a monopoly in the US, despite biosimilars being available in the EU, Japan, Canada and Australia.

May 6, 2021

Coherus BioSciences reported its Q1 2021 financial results.  Coherus disclosed that it has commenced the rolling submission of the BLA for toripalimab and that it expects to file the BLA for CHS-201 (proposed ranibizumab biosimilar) mid-2021.

May 6, 2021

The Government of Alberta announced it has expanded its biosimilars switching program to include adalimumab for all originator indications except pediatric juvenial idiopathic arthritis. All adult patients on Humira® will be switched to Amgevita®, Hadlima®, Hulio®, Hyrimoz® or Idacio® by 01 May 2022.  This follows extensions made to biosimilar switching programs by British Columbia and New Brunswick last month.

May 5, 2021

ThePrint reported that Hetero Labs has submitted an application to start clinical trials and manufacture of biosimilar tocilizumab in India. Tocilizumab has been recommended for off-label use in the treatment of COVID-19 by the Indian Government, but has been subject to extreme shortages.  The product is manufactured by Roche and distributed in India by Cipla pharmaceuticals. It is not known whether Hetero has reached a licensing agreement with Roche.

May 4, 2021

Amgen launched Amgevita® (biosimilar adalimumab) in Canada. Amgevita® is available in 50mg/mL PFS and pen presentations and is citrate-free. Amgevita® will be reimbursed on the public drug plans in BC, Alberta, Ontario, Quebec, New Brunswick and Newfoundland.

May 3, 2021

Merck reported the vision, focus and business model for its new standalone company, Organon.  Merck disclosed that Organon with have a direct sales presence in 58 markets, with key growth drivers in Organon’s biosimilars portfolio expected to be Renflexis® (biosimilar infliximab), Aybintio® (biosimilar bevacizumab) and Hadlima® (biosimilar adalimumab).

May 3, 2021

Sandoz announced it will commence enrolling patients in MYLIGHT, its Ph III efficacy and safety study of its proposed aflibercept biosimilar.  MYLIGHT will assess the efficacy and safety of the biosimilar candidate in comparison to Eylea® in patients with neovascular age-related macular degeneration.

May 1, 2021

Samsung Bioepis announced a new study demonstrating the structural, physicochemical and biological similarity between its SB11 (proposed ranibizumab biosimilar) and Lucentis®.  The BLA and MA for SB11 are currently before the FDA and EMA respectively.

April 29, 2021

Biocon reported its Q1 2021 financial results.  Biocon reported its biosimilars revenues from its subsidiary Biocon Biologics increased 53% year-on-year.  Biocon identified its pegfilgrastim and trastuzumab biosimilars as key growth drivers.

April 28, 2021

Biocon Biologics announced it has received the 2021 Facility of the Year Award from the International Society for Pharmaceutical Engineering for its new monoclonal antibody manufacturing facility at Biocon Park, Bengaluru.

April 28, 2021

Teva reported its Q1 2021 financial results.  Teva’s overall year-on-year revenues decreased 10% in local currency terms, but its generic and biosimilar revenues increased 11% year-on-year.  In particular, Truxima® (biosimilar rituximab) was recognised as a key growth driver.

April 27, 2021

Biocon Biologics announced it has received EC marketing authorisation for Abevmy® (biosimilar bevacizumab).  This follows the positive recommendation made by the CHMP for Abevmy® on 01 March 2021.

April 26, 2021

President Biden signed into law the Advancing Education on Biosimilars Act of 2021. As we previously reported, this bill was introduced to the Senate in March 2021, and was passed by the House of Representatives on 14 April.  The Advancing Education on Biosimilars Act aims to improve confidence in the safety and effectiveness of biosimilars by providing patients and providers with educational materials.

April 26, 2021

Australia’s PBAC published the outcomes of its March 2021 meeting. The recommendations include:

  • Mvasi® (Amgen’s biosimilar bevacizumab): the PBS listing has been changed to an unrestricted benefit to allow access to combination treatment with atezolizumab.
  • Beovu® (brolucizumab): Beovu® was recommended for subfoveal choroidal neovascularisation due to AMD.
  • Keytruda® (pembrolizumab): PBAC recommended Section 100 Authority Required listing for the treatment of metastatic colorectal cancer.

April 23, 2021

A new study sponsored by UCB Biopharma SPRL indicates that bimekizumab is noninferior and superior to adalimumab at 16 weeks in the treatment of plaque psoriasis.

April 23, 2021

Samsung Bioepis released its Q1 2021 financial results.  Global sales for Benepali® (biosimilar etanercept), Flixabi® (biosimilar infliximab) and Imraldi® (biosimilar adalimumab) increased 3.9% quarter-on-quarter, with Benepali® accounting for the largest share of those sales.

April 23, 2021

Boehringer Ingelheim announced results from a Ph III switching study of Cyltezo® (biosimilar adalimumab) with Humira® produced similar clinical outcomes in terms of pharmacokinetics, efficacy, immunogenicity and safety.

April 21, 2021

New Brunswick announced it has introduced a biosimilar switching program, expected to save the province $10 million once fully implemented. New Brunswick reported that government spending on biologics accounted for 29.4% of drug costs but only represented 1.5% of the total number of prescriptions paid. British Columbia, which operates a similar program, recently expanded its switching program to include adalimumab and etanercept.

April 21, 2021

Roche published its Q1 2021 earnings report, noting significant impacts from biosimilars. In particular, Roche attributed a combined sales reduction of CHF 1.6 billion to the impact of rituximab, bevacizumab and trastuzumab biosimilars.

April 20, 2021

Luye Pharma announced its marketing authorisation application for LY01008 (proposed bevacizumab biosimilar) has been accepted by China’s National Medical Products Administration.

April 20, 2021

Huons Lab announced it has reached an agreement with PanGen Biotech for the development of biosimilar denosumab. Under the agreement, Huons Lab will gain access to PanGen Biotech’s cell line manufacturing and purification technology.

April 15, 2021

Prestige Biopharma and Pharmapark announced they have reached an agreement for the commercialisation of Prestige Biopharma’s proposed bevacizumab biosimilar in the Russian Federation.

April 15, 2021

Shanghai Henlius Biotech announced China’s NMPA has approved its investigational new drug (IND) application of its HLX26 (recombinant anti-LAG-3 human monoclonal antibody) for treatment of solid tumors and lymphomas. Currently, there are no LAG-3 targeted products on the market.

April 15, 2021

The Centre for Biosimilars reported a poster presented at AMCP 2021 shows a New York state Medicaid biosimilar preference initiative was successful in increasing biosimilar use in 2019. Biosimilar substitution is not permitted at the pharmacy level in New York, and provider prescriptions are required. The switching program was supported by months of biosimilar promotion and education among plan beneficiaries who were receiving originator biologics.

April 14, 2021

Two bills aimed at lowering the cost of prescriptions were passed by the House of Representatives. As we previously reported, the Advancing Education on Biosimilars Act and Ensuring Innovation Act were introduced to the Senate in March 2021.

April 13, 2021

NKMax and Merck KGaA announced an expansion of its clinical trial and supply agreement to include a Ph I/IIa trial of SNK01 in combination with Erbitux® (cetuximab) in patients with locally advanced or metastatic non-small cell lung cancer.

April 13, 2021

Purple Biotech announced it presented further preclinical data supporting the mechanism of action of NT219 at the American Association of Cancer Research 2021 Annual Meeting. NT219 is being developed as a treatment for recurrent and/or metastatic solid tumors and squamous cell carcinoma of the head and neck cancer.

April 8, 2021

Alteogen announced it has completed Ph I trials of its proposed aflibercept biosimilar ALT-L9. Alteogen reported that the trial confirmed the safety and efficacy of ALT-L9 were similar to that of Eylea®.

April 8, 2021

Biogen announced it has reached an agreement with Bio-Thera for the development, manufacture and commercialisation of BAT1806 (proposed tocilizumab biosimilar). Under the agreement, Biogen will gain exclusive rights to BAT1806 in all countries excluding China.

April 7, 2021

Biogen announced the EC has granted marketing authorisation for Tysabri® (natalizumab) in a subcutaneous presentation. Tysabri® SC is approved for the treatment of relapsing-remitting multiple sclerosis.

April 7, 2021

British Columbia expanded its biosimilars switching program to include adalimumab, and expanded coverage of etanercept. BC announced that almost 6,000 patients currently treated with Humira® will be switched to either Amgevita® (Amgen), Hadlima® (Merck/Samsung), Hulio® (Mylan), Hyrimoz® (Sandoz) or Idacio® (Fresenius Kabi) over a 6 month period. New and existing plaque psoriasis patients currently being treated by Enbrel® will also be transitioned to Brenzys® (Samsung Bioepis/Merck) or Erelzi® (Sandoz) over the same period.

April 6, 2021

The FDA approved a new dosage regimen for Erbitux® (cetuximab) for patients with K-RAS wild-type, EGFR-expressing metastatic colorectal cancer or squamous cell carcinoma of the head and neck. The new dosage regimen allows for fortnightly dosing.

April 6, 2021

PlantForm announced it has reached a collaborative research and development agreement with Bio-Manguinhos/Fiocruz to develop a biosimilar pembrolizumab for the Brazilian market.

March 31, 2021

A new AbbVie study published in the NEJM reports a 30mg dose of upadacitinib is superior to adalimumab in DMARD-refractory psoriatic arthritis (PsA). The percentage of patients with PsA who achieved an ACR20 response at week 12 was 78.5% of patients treated with 30 mg upadacitinib, compared to 65% of patients treated with adalimumab.

March 31, 2021

Celltrion received a positive CHMP opinion for Remsima® subcut (subcutaneous infliximab). Remsima® SC was recommended for the direct use without IV loading in patients with rheumatoid arthritis.

March 30, 2021

STADA launched Oyavas® (biosimilar bevacizumab) in the Netherlands and Germany. Oyavas® is indicated for carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

March 29, 2021

Samsung Bioepis announced on 29 March 2021 that it has launched Hadlima®, its 50mg/mL biosimilar adalimumab in Australia and Canada. Australia’s PBAC previously confirmed that Hadlima® would be PBS listed from 01 April 2021.

March 26, 2021

Alvotech has disputed AbbVie’s claim filed in the Northern District of Illinois last week relating to AbbVie’s allegations of wrongdoing in the development of Alvotech’s biosimilar adalimumab product.  Alvotech notes “AbbVie waited over three years from the purported date of the alleged wrongdoing to file its case, doing so after the ex-AbbVie employee had already left Alvotech and without naming the ex-AbbVie employee as a defendant”, suggesting that these latest accusations may be part of AbbVie’s broader strategy to delay biosimilar competition.

March 26, 2021

A number of changes have been made to the PBS listings of adalimumab. From 1 April:

  • The Amgen, Merck/Samsung, Sandoz and Fresenius 50mg/ml products will be PBS listed and A flagged against the 50mg/ml Humira formulations for all approved indications; and
  • Humira 100mg/ml 20mg and 40mg products will be listed and A flagged against the 50mg/ml Humira formulations, and the 50mg/ml Humira product will be phased out over 12 months but cannot be prescribed after 1 April (ie the pharmacies will honour scripts written prior to 1 April).
  • Humira 100mg/ml 80mg syringe and pen products will be PBS listed but will not be A flagged as they are not considered equivalent to the “original” Humira formulation/product.

March 25, 2021

Korea Biomedical Review reported that LG Chem has received approval from Japan’s Health Ministry for its biosimilar adalimumab. The product will be commercialised by Mochida Pharmaceuticals.

March 25, 2021

mAbxience announced it will install an ABEC 4,000L CSR bioreactor at its site in Leon, Spain. The system is expected to be installed within months, and will boost mAbxience’s biosimilar and CDMO manufacturing capacity.

March 24, 2021

EirGenix announced that its Ph III clinical trial of EG12014 (proposed trastuzumab biosimilar) has met its primary endpoint. EirGenix announced that EG12014 has shown equivalent efficacy to Herceptin®, and demonstrated a comparable safety profile.

March 17, 2021

The Korea Herald reported that Celltrion’s Herzuma® (biosimilar trastuzumab) reached a 44% market share in Japan last year.

March 15, 2021

Alvotech announced it has completed a second round of its US$100 million private placement.  In the first round, Alvotech raised US$65 million, including investments from Korea’s Shinhan, US’ Baxter Healthcare SA, and Germany’s ATHOS.

March 15, 2021

Korea Biomedical Review reported that Samsung Bioepis has entered an agreement with Yuhan Corp for the commercialisation of Adalloce™ (biosimilar adalimumab) in South Korea. Adalloce™ is marketed in Europe as Imraldi®.

March 14, 2021

The US Senate unanimously passed the Ensuring Innovation Act and the Advancing Education on Biosimilars Act.

The Ensuring Innovation Act aims to stop ‘evergreening’ by preventing pharmaceutical companies from claiming new innovations when they make insignificant modifications to their products. Under the current system, innovators are able to extend patent exclusivities by 5 years when one of these modifications is made.

The Advancing Education on Biosimilars Act aims to improve confidence in the safety and effectiveness of biosimilars by providing patients and providers with educational materials. These materials would include information about the standards for review and licensing of biosimilar products, relevant considerations for prescribers and the process of reporting adverse events for biological products. This material could be presented in webinars, videos, fact sheets and stakeholder toolkits.

March 10, 2021

Lannett announced it had received comments from the FDA related to the pivotal trial protocol and statistical analysis plan for its biosimilar insulin glargine program. Lannett said that it was comfortable with the feedback, and remains on track to submit an IND to the FDA later this calendar year. The pivotal trial is expected to commence in early 2022, with the BLA to be filed later in 2022 and launch expected in 2023.

March 5, 2021

Korea Biomedical Review reported that Alteogen has completed Ph I trials of ALT-L9 (proposed aflibercept biosimilar).

March 3, 2021

The EMA published the EPAR for Celltrion’s Yuflyma®. The EPAR revealed that Celltrion’s product is citrate-free, but is not buffer-free, with other ingredients including ‘acetic acid, sodium acetate trihydrate, glycine, polysorbate 80 and water for injections’.

March 2, 2021

Cipla and Alvotech announced that they have expanded their partnership for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. The agreement includes biosimilar aflibercept, ustekinumab, denosumab and golimumab candidates. This agreement is in addition to the previous agreement between Alvotech and Cipla for the commercialisation of AVT02 (biosimilar adalimumab candidate).

March 1, 2021

Pharmaceutical Technology reported AbbVie’s intended Humira® follow on Rinvoq® (upadacitinib) may face questions on class safety after a safety signal emerged in a postmarketing trial of Pfizer’s Xeljanz® (tofacitinib). Tofacitinib and upadacitinib are both JAK inhibitors, and this safety signal could hamper the movement to JAK inhibitors.

March 1, 2021

Samsung Bioepis commenced Ph I trials for SB11 (proposed ustekinumab biosimilar).

March 1, 2021

Biocon Biologics and Viatris announced that the CHMP has adopted a positive opinion recommending the marking authorisation of Abevmy® (biosimilar bevacizumab). If approved, Abevmy® will be available for the treatment of metastatic colorectal carcinoma, metastatic breast cancer, non-small-cell lung carcinoma, glioblastoma, ovarian, cervical and renal cancer in 100mg and 400mg injections. The decision of the EC is expected in May 2021.

February 25, 2021

The FDA extended the indications of Simponi Aria® (golimumab) to include fatigue in patients with psoriatic arthritis and rheumatoid arthritis. This is the first TNF inhibitor approved to include fatigue improvement in its labeling.

February 24, 2021

Coherus released its Q420 and Full Year 2020 financial results. Coherus reported it has captured 21% of the pegfilgrastim market and nearly 50% of the pre-filled syringe segment in the US. Additionally, Coherus announced it plans to file its BLA for its ranibizumab biosimilar mid-year 2021. Coherus also confirmed that it plans to launch its adalimumab biosimilar in the US on or after July 1, 2023.

February 24, 2021

Minnesota State Senator Carla Nelson (R-Rochester) and State Representative Jennifer Schultz (DFL-Duluth) announced the introduction of a new bill which would require health plans and pharmacy benefit managers to cover all versions of biosimilars.

February 23, 2021

In its Q4 2020 investor presentation, Fresenius Kabi announced it will launch its biosimilar adalimumab in Australia in Q2 2021 and in Brazil in Q3 2021. Additionally, Fresenius Kabi announced it will launch its biosimilar pegfilgrastim in the US and the EU in Q3/4 2021. Fresenius Kabi’s biosimilar tocilizumab candidate is planned for launch in the US and the EU in 2023. An undisclosed autoimmune biosimilar is planned for a 2024 launch, and an oncology biosimilar in 2025.

February 18, 2021

Viatris announced it has launched Hulio® (biosimilar adalimumab) in Canada. Hulio® is available in a 50mg/ml formulation (40mg/0.8mL) and is approved for all adalimumab indications.

February 18, 2021

Fresenius Kabi announced it has launched Idacio® (biosimilar adalimumab) in Canada. Idacio® is available in 50mg/ml formulation (40mg/0.8mL syringe, vial and pen presentations) and is approved for all Humira® indications.

February 17, 2021

Sandoz announced that it has launched Hyrimoz®, its 50mg/mL biosimilar adalimumab in Canada. Hyrimoz® was approved by Health Canada in November 2020 with a full label. It was also previously launched in Europe in 2018.

February 17, 2021

Coherus Biosciences announced the FDA has accepted the BLA for its biosimilar adalimumab candidate (CHS-1420). Coherus also announced that it plans to launch its product in the US on or after 01 July 2023. Coherus had previously disclosed that its license with AbbVie would commence in the US in December 2023.

February 15, 2021

Fujifilm Kyowa Kirin Biologics and Mylan announced the launch of Hulio® in Japan. Hulio® is available in a 40mg/0.8mL syringe and pen presentation (indicated for rheumatoid arthritis, juvenile idiopathic arthritis, psoriasis, ankylosing spondylitis, Entero-Behcet’s Disease and Crohn’s Disease), and a 20mg/0.4mL syringe (indicated for juvenile idiopathic arthritis). This is the first adalimumab biosimilar to be launched in Japan.

February 15, 2021

Celltrion announced it received EC marketing authorisation for Yuflyma® (biosimilar adalimumab) across all indications. This is the first approval of a high concentration, low-volume biosimilar adalimumab. The EPAR is yet to be published by EMA.

February 13, 2021

Saudi Arabia’s Tabuk Pharmaceuticals announced it has reached an exclusive licensing and distribution agreement with Korea’s Prestige Biopharma for the commercialisation of Tuznue® (biosimilar trastuzumab). Under the agreement, Tabuk will receive exclusive rights to commercialise and distribute Tuznue® in the Middle-East and North Africa region.

February 12, 2021

Biocon Biologics and Viatris announced Kixelle® (biosimilar insulin aspart) has received marking authorisation approval in the EU.

February 12, 2021

Roche announced new Ph III data shows faricimab (given at intervals of up to four months) is non-inferior compared to aflibercept (given every two months). This may reduce the treatment burden for patients suffering from diabetic macular edema and neovascular age-related macular degeneration.

February 9, 2021

Lannett announces it has entered into an agreement with the HEC Group of companies for biosimilar insulin aspart. Under the agreement, Lannett will be responsible for funding most of the clinical development requirements, while HEC will continue to develop the product and manufacturing infrastructure.

February 8, 2021

Celltrion announces it has commenced Ph III trials of its proposed aflibercept biosimilar.

February 4, 2021

Roche reports a huge erosion of its year on year CER growth in key areas, attributing this decline to COVID-19 impacts and biosimilars. Roche reported the YoY CER growth of Avastin (bevacizumab) was -25%, with the hematology franchise (including rituximab) at -22% and HER2 franchise (including trastuzumab and pertuzumab) at -8%.

February 4, 2021

In an interview with the Centre for Biosimilars the head of Celltrion’s Medical and Marketing Division, HoUng Kim PhD, discussed its high concentration, citrate-free adalimumab biosimilar. Kim announced that Celltrion has completed patent settlements in the US and is approaching settlements in Europe. Kim also revealed that the application for Celltrion’s US biosimilar adalimumab product was filed in November 2020.

February 4, 2021

Enzene Biosciences announces it has received marketing authorisation for its biosimilar teriparatide in India.

February 1, 2021

Coherus Biosciences announces it has reached an agreement with Junshi Biosciences for the development and commercialisation of toripalimab (anti-PD-1 antibody) in the United States and Canada. Toripalimab has received breakthrough therapy designation by the FDA for nasopharyngeal carcinoma and the first BLA is expected to be filed later this year.

February 1, 2021

Celltrion announces it has received a notice of compliance from Health Canada for Remsima® SC (subcutaneous infliximab). Remsima® has been approved for the treatment of rheumatoid arthritis.

January 29, 2021

The CHMP recommends13 medicines for approval. Among the recommendations were two bevacizumab biosimilars, Mabxience’s Alymsys® and STADA’s Oyavas®.

January 28, 2021

Bio-Thera Solutions announces the FDA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).

January 27, 2021

Health care performance improvement company Vizient releases its Winter 2021 Pharmacy Market Outlook. Vizient projected that the greatest price increases to members would occur in Humira® (adalimumab), with a 7.5% price increase predicted over the next 18 months. Adalimumab also topped the list of greatest total spend by product among Vizient members, followed by pembrolizumab, rituximab, infliximab, ustekinumab, nivolumab and denosumab. New figures also showed trastuzumab biosimilars have captured a significant market share, contributing to 39% of cost to members in September 2020.

January 20, 2021

Targeted Oncology interviews Mark J. Roschewski MD about the preliminary results of Ph II trials of copanlisib and rituximab as treatment of patients with untreated follicular lymphoma. Roschewski reported that all the patients responded and at least had a tumour reduction.

January 19, 2021

Pharm-Olam announces it has been selected by the US Department of Defense to lead and provide full service clinical trial support of Ph II/III clinical trials of adalimumab as a COVID-19 therapeutic.

January 18, 2021

Innovent announces it has signed a licensing agreement with PT Etana Biotechnologies for Byvasda® (biosimilar bevacizumab). Under the agreement, Etana will receive commercialisation rights in Indonesia in exchange for milestone payments and double-digit royalties on net sales.

January 15, 2021

Celltrion announces it has submitted an investigational new drug application for Ph III trials of CT-P41 (proposed denosumab biosimilar).

January 8, 2021

A new study reviews the use of rituximab as an alternative treatment option for the management of multiple sclerosis (MS). While not approved for MS, there is evidence of significant off-label usage of rituximab for the treatment of MS in some Northern European countries.

January 5, 2021

The Centre for Biosimilars reported a study presented at the 2020 San Antonio Breast Cancer Symposium found strong uptake of Amgen’s Kanjinti® (biosimilar trastuzumab) in Europe.

2020

December 27, 2020

Innovent announced China’s NMPA has approved Byvasda® (biosimilar bevacizumab) for the additional indication of adult recurrent glioblastoma.

December 25, 2020

Biocon announced that its subsidiary Biocon Biologics has been informed by the FDA of a deferred action on the BLA for its proposed bevacizumab biosimilar. This deferral was attributed to COVID-19, as the FDA was unable to conduct the required inspection of the manufacturing facility. Biocon Biologics is now awaiting dates for the inspection to occur.

December 24, 2020

The Centre for Biosimilars interviews Christophe Bourdon, senior VP and general manager of US Oncology at Amgen following FDA approval of Riabni® (biosimilar rituximab). Bourdon stated that Riabni® will be made available through speciality and wholesale distribution, and that Amgen is confident it will be able to support a quick uptake of this biosimilar.

December 23, 2020

Roche announces results for its investigational bispecific antibody faricimab in patients with diabetic macular edema. Roche announced that the candidate was generally well-tolerated with no new safety signals identified. This product is being developed as a replacement for Lucentis® (ranibizumab), which lost patent protection in the US this year.

December 21, 2020

Bio-Thera Solutions announces it has reached a licensing agreement with Biomm SA for BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Biomm will have exclusive rights to distribute and market the drug in Brazil. Bio-Thera has filed license applications for BAT1706 in the US, EU and China.

December 21, 2020

Celltrion announces Ph III trials of its proposed ustekinumab biosimilar CT-P43 will be completed by the second half of 2022. Celltrion also announced plans to launch the product when the API patents expire in the EU in September 2023 and in the US in July 2024.

December 17, 2020

Amgen announces it has received FDA approval for Riabni® (biosimilar rituximab) for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia, Granulomatosis with Polyangiitis and Microscopic Polyangiitis. Riabni® will be launched in the US in January 2021.

December 16, 2020

The Centre for Biosimilars reports a new study indicates dramatically increased usage of trastuzumab biosimilars in the US. The study presented at the San Antonio Breast Cancer Symposium indicated that biosimilar use increased based on payer policies that favored biosimilars.

December 14, 2020

Samsung Bioepis announces it has commenced Ph III trials of SB16 (proposed denosumab biosimilar) in women with postmenopausal osteoporosis.

December 12, 2020

Biopharma supplier Alexion announces it will be acquired by AstraZeneca. The acquisition is expected to close in Q3 2021 for total consideration to Alexion shareholders of $39bn. Under the deal, AstraZeneca will acquire Alexion’s pipeline of 11 molecules, as well as Alexion’s blockbuster products Soliris® (eculizumab) and Ultomiris® (ravulizumab).

December 11, 2020

Innovent announces the first patient has been dosed in its Ph II trials of IBI310 (anti CTLA-4 monoclonal antibody) in combination with Tyvyt® (sintilimab) for the treatment of second-line or above advanced cervical cancer.

December 11, 2020

A new long-term efficacy and safety study demonstrated the biosimilarity of Celltrion’s CT-P10/Truxima® (infliximab) to Rituxan® at 27 months in patients with low-tumor burden follicular lymphoma.

December 10, 2020

Merck receives a positive opinion from the EU’s CHMP for an extended indication set for Keytruda® (pembrolizumab). If approved, Keytruda® will also be indicated for metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

December 10, 2020

Celltrion receives a positive opinion from the EU’s CHMP for its proposed 100mg/mL adalimumab biosimilar Yuflyma® for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis, psoriatic arthritis, psoriasis, paediatric plaque psoriasis, hidradenitis suppurativa, Crohn’s disease, ulcerative colitis and uveitis. If approved, this will be the first registered high concentration, citrate-free adalimumab biosimilar anywhere in the world.

December 9, 2020

A new study indicates Intas Pharma’s romiplostim biosimilar Romy® has demonstrated a high overall response rate without adverse events in patients with immune thrombocytopenic purpura. Romy® has been approved in India.

December 7, 2020

Shanghai Henlius Biotech announces its adalimumab biosimilar HLX03 has been approved by China’s NMPA for rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

December 2, 2020

Boehringer Ingelheim filed a Citizen Petition asking the Commissioner of Food and Drugs to interpret the term ‘strength’ in s 351(k) of the PHS Act for parenteral solutions to mean ‘total drug content’. The current interpretation does not allow a biological product to be licensed as a biosimilar and/or interchangeable product if there is any variation in inactive drug volume. BI has argued that the proposed interpretation may increase access to more affordable biosimilar and interchangeable biological products.

December 1, 2020

US District Court Judge Leonard Stark refuses to grant costs in the Coherus/Amgen (pegfilgrastim) matter. Coherus argued that fees were warranted because Amgen had pursued a baseless claim and appeal, intending to thwart competition.

November 26, 2020

Bio-Thera Solutions announced it has submitted a marketing authorisation application for BAT1706 (proposed bevacizumab biosimilar) in EU.

November 25, 2020

Janssen announced that the European Commission has approved Tremfya® (guselkumab) for the treatment of adult patients with active psoriatic arthritis.

November 24, 2020

Novartis released its annual report ‘Meet Novartis Management 2020‘. In the report, Novartis announced that GP2411 (biosimilar denosumab candidate) has commenced Ph III trials. Novartis has also indicated it  has planned launches for biosimilar adalimumab and natalizumab in 2021-2023 and denosumab in 2024-2026.

November 24, 2020

Alvotech and Alvotech & CCHT Biopharmaceutical announced they have partnered with Yangtze River Pharmaceutical Group to form an exclusive strategic partnership for the commercialisation of eight biosimilar medicines in China.  Alvotech and Alvotech & CCHT will be jointly responsible for the development, registration, and supply of biosimilars in China, while Yangtze River Pharmaceutical will exclusively commercialise them.  The products will be manufactured in a new biopharmaceutical facility currently being built in Changchun, China through the Alvotech & CCHT partnership.

November 24, 2020

BGP Pharma receives a NOC from Health Canada for Hulio® (biosimilar adalimumab).

November 22, 2020

Innovent releases results of Ph III trials of Tyvyt® (sintilimab) with Byvasda® (biosimilar bevacizumab) as first-line treatment in patients with Advanced Hepatocellular Carcinoma (HCC).

November 20, 2020

Shanghai Henlius Biotech reports positive results from Ph III trials of its biosimilar bevacizumab candidate.

November 19, 2020

Korean Biomedical Review reports Samsung Biologics and AstraZeneca will liquidate their joint venture Archigen Biotech and discontinue the development of SAIT101, a rituximab biosimilar. The project was discontinued due to a perceived lack of commercial viability.

November 19, 2020

Alvotech announces the FDA and EMA have accepted its regulatory submissions for AVT02 (proposed adalimumab biosimilar). Approval is expected in the US in September 2021 and Q4 2021 in the EU.

November 18, 2020

Samsung Bioepis and Biogen announce the FDA has accepted for review the BLA for SB11 (proposed ranibizumab biosimilar).

November 18, 2020

The EMA approved Pfizer’s Nyvepria® (biosimilar pegfilgrastim).

November 16, 2020

CSL’s Sequiris announced it will build a next-generation $800 million influenza vaccine manufacturing facility in Australia. The facility is expected to be operational by mid-2026 and will be the only cell-based influenza vaccine manufacturing facility in the Southern Hemisphere.

November 15, 2020
Genentech files a complaint against Centus Biotherapeutics, Fujifilm Kyowa Kirin Biologics, Fujifilm Corp and Kyowa Kirin relating to its proposed bevacizumab biosimilar. Genentech asserts that Centus failed to provide sufficient information for Genentech to complete an analysis of potential patent infringements.

 

November 13, 2020

PM Scott Morrison announced the National Cabinet has endorsed a national vaccination policy. The policy focusses on five key areas; R&D, purchase and manufacturing, international partnerships, regulation and safety and immunisation administration and monitoring.

November 12, 2020

The CHMP adopts a positive opinion for the marketing approval for Samsung Bioepis’ Onbevzi® (biosimilar bevacizumab). Onbevzi® will be available as a 25mg/mL concentrate for solution for infusion, and is indicated for the treatment of carcinoma or the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix.

November 12, 2020

The TGA approves Celltrion’s subcutaneous “biobetter” infliximab product Remsima® in auto-injection pen and PFS presentations. This is the first subcut infliximab product to be approved in Australia.

November 11, 2020

Samsung Bioepis announces one-year results from Ph III study of SB11 (proposed ranibizumab biosimilar) at the American Academy of Ophthalmology 2020 Virtual. Samsung reported the data confirms equivalence in efficacy and pharmocokinetics as well as a comparable safety and immunogenicity profile.

November 10, 2020

Prestige BioPharma and Teva Israel announce they have entered into an exclusive partnership and supply agreement for Prestige’s Tuznue® (trastuzumab biosimilar) in Israel. Under the agreement, Prestige is responsible for registration and commercial supply, and Teva Israel will be responsible for local registration, sales and marketing in Israel.

November 10, 2020

Samsung Bioepis announces it has commenced Ph I trials for SB16 (proposed denosumab biosimilar).

November 9, 2020

Formycon and Bioeq announce they have commenced dosing in Ph III trials of FYB202 (proposed ustekinumab biosimilar) in patients with moderate to severe plaque psoriasis.

November 9, 2020

Shanghai Henlius Biotech announces it has commenced Ph I trials for HLX14 (proposed denosumab biosimilar).

November 8, 2020

CSL confirmed it will commence manufacturing AZD1222 (AZ/Oxford vaccine) on 09 November 2020. The product will be manufactured at its facility in Broadmeadows, Victoria, in eight large scale batches over 2020-21.

November 7, 2020

Biocon Biologics announces it has approved a USD 150 million capital injection from Goldman Sachs. Dr Christiane Hamacher (CEO of Biocon Biologics) announced that this capital injection will enable Biocon Biologics to make prudent investments in R&D, high-quality manufacturing and establishing a global commercial footprint.

November 5, 2020

Formycon announces its BLA resubmission strategy for FYB201 (proposed ranibizumab biosimilar) has been adjusted. The approval will now be requested directly for a large commercial scale, which Formycon and Bioeq expect will simplify the approval procedure.

November 5, 2020

The Australian Government announced it has secured an additional 50 million potential COVID-19 vaccine doses through agreements with Novavax and Pfizer/BioNTech.

November 4, 2020

Alvotech announces it has entered into an exclusive partnership with Cipla for two oncology biosimilars and three auto-immune biosimilars in South Africa. Under the agreement, Alvotech will be responsible for the development and supply of the products, while Cipla will be responsible for registration and commercialisation.

November 4, 2020

Amgen receives three Notices of Compliance (NOC) from Health Canada relating to Amgevita® (50mg/mL biosimilar adalimumab).

November 3, 2020

Hindu Business Line reported Strides Pharma has filed a submission with the EMA for PTH® (proposed teriparatide biosimilar).

November 2, 2020

SBS News reported Federal Health Minister Greg Hunt announced the Government is close to securing two supply contracts for an additional two proposed COVID-19 vaccines. Additionally, Minister Hunt announced that PM Scott Morrison will present a plan for vaccine rollout to National Cabinet in the coming weeks.

November 2, 2020

Celltrion announces the results of Ph III studies of CT-P17 (proposed adalimumab biosimilar) demonstrate comparable efficacy and safety against reference adalimumab in rheumatoid arthritis.

October 31, 2020

Minister for Foreign Affairs Marise Payne announced the Australian Government has committed an additional $500 million over the next three years to supporting access to safe and effective COVID-19 vaccines for the Pacific and Southeast Asia region. This funding is additional to the $23.2 million committed in the Budget, the Government’s commitments to the COVAX facility and the existing Advance Purchase Agreements with Astra Zenexa-Oxford and CSL-University of Queensland.

October 30, 2020

Ocumension Therapeutics announces it has reached an agreement with Shandong Boan Biological Technology to jointly develop OT-702, a proposed aflibercept biosimilar. Under the agreement, Ocumension has been granted an exclusive license to promote and commercialise the product in mainland China. OT-702 is currently in Ph III trials.

October 30, 2020

Ocumension Therapeutics announces it has reached an agreement with Shandong Boan Biological Technology to jointly develop OT-702, a proposed aflibercept biosimilar. Under the agreement, Ocumension has been granted an exclusive license to promote and commercialise the product in mainland China. OT-702 is currently in Ph III trials.

October 30, 2020

Fresenius Kabi receives a Notice of Compliance relating to its biosimilar adalimumab (50mg/mL), Idacio®.

October 29, 2020

SomaLogic announces it has signed an agreement with the FDA for the large-scale analysis of proteins for the identification of biomarkers that may be useful in demonstrating biosimilarity of a proposed biosimilar and a reference product. It is hoped that the five year collaboration will streamline the development of biosimilars by reducing the need for comparative clinical studies, thus accelerating the delivery of safe, effective and affordable biosimilar treatments.

October 28, 2020

In its Q3 2020 financial results, Amgen announces that it is moving ABP 654 (proposed ustekinumab biosimilar) into Ph III development.

October 27, 2020

Alvotech announces that its parent company, Alvotech Holdings SA, has successfully completed a $65 million private placement round, which will further finance the development and release of its biosimilar candidates. This $65 million round is part of a larger $100 million round, with a second round expected to close shortly. The new share issue values Alvotech at $1.5 billion.

October 26, 2020

Samsung Bioepis announces results from two post-marketing studies of Renflexis® (biosimilar infliximab) in Veteran Affairs patients with IBD. The first study evaluated the safety of switching from reference infliximab to Renflexis®, finding that patients who were on reference product or biosimilar infliximab can remain stable after switching to another biosimilar without major safety concerns. The second study looked at utilisation patterns of infliximab for IBD, finding that the uptake of Samsung Bioepis’ Renflexis® (following its listing as the preferred product on the Veterans Affairs National Formulary Policy) was faster than the adoption of the previous biosimilar listed in the year prior.

October 25, 2020

Industry Minister Karen Andrews announced it could take up to 12 months to roll out a COVID-19 vaccine, if the successful candidate is not protein-based. Andrews explained that while CSL has a lot of experience in producing protein-based vaccines, mRNA vaccines have never been successfully manufactured and distributed.

October 23, 2020

AstraZeneca announced it has resumed clinical trials in the US following authorisation from the FDA. The trials have now fully resumed globally.

October 20, 2020

Ph III clinical trials of FYB202 (proposed ustekinumab biosimilar developed by Formycon and Bioeq) commence recruiting in Poland.

October 20, 2020

NeuClone announces its proposed ustekinumab biosimilar has successfully met all primary and secondary endpoints in Ph I clinical trials. Noelle Sundstrom, CEO of NeuClone announced that the company plans to enter Ph III trials in 2021. The product is being jointly developed by NeuClone and the Serum Institute of India.

October 20, 2020

The American Journal of Managed Care reported a new study indicates Celltrion’s rituximab biosimilar CT-P10 could lower costs and expand patient access to biologic therapy for primary Sjogren syndrome.

October 20, 2020

Daily News Egypt announces Sandoz Egypt has partnered with the Egyptian Cancer Society to launch a rituximab biosimilar in Egypt. Sameh Elbagoury, Sandoz Country Head for Sandoz Egypt and Libya, announced that the biosimilar could reduce the cost of treating Non-Hodgkin Lymphoma by 40%.

October 16, 2020

Polpharma publishes ustekinumab biosimilar is under development.

October 16, 2020

Janssen announced that the CHMP has adopted a positive opinion recommending the expanded use of Tremfya® (guselkumab) to include the treatment of adult patients with active psoriatic arthritis.

October 15, 2020

Henlius and Essex announce they have entered into a co-development and exclusive license agreement for HLX04 (proposed bevacizumab biosimilar). Under the agreement, Essex will be granted an exclusive license to develop, manufacture and commercialise HLX04 globally. Essex will be responsible for 80% of the costs and expenses in relation to the development of HLX04. Henlius is entitled to milestone payments of up to US$43 million, as well as royalties of up to 10% of annual net sales of the product.

October 13, 2020

Korea Biomedical Review reports Celltrion has signed a contract to provide Herzuma® (biosimilar trastuzumab) and Truxima® (biosimilar rituximab) to the Brazilian Federal Government. Celltrion has also signed a contract to provide Truxima® to the Sao Paulo Provincial Government.

October 13, 2020

The Centre for Biosimilars reports two new studies for HD201 (Prestige Biopharma’s proposed trastuzumab biosimilar) were presented at ASCO20 Virtual, the annual meeting of the American Society of Clinical Oncology. The first study, TROIKA-I demonstrated that HD201 was safe and well tolerated with PK comparability to the originator. The second, TROIKA was designed to compare safety, PK and efficacy based on the total pathological complete response rate. The investigators reported that the studies demonstrated equivalence between the biosimilar and reference products.

October 12, 2020

Two amicus briefs were filed in the 7th Circuit Court of Appeals in support of the plaintiffs in the Humira® (adalimumab) antitrust legislation UFCW Local 1500 Welfare Fund v AbbVie, Inc. The US Public Interest Research Group jointly filed its brief with Consumer Action, arguing that AbbVie’s conduct was anticompetitive, and that the District Court’s decision should be overturned. In its brief, the Open Markets Institute argued that the District Court should have evaluated AbbVie’s patent applications and lawsuits as a series of sham filings.

October 10, 2020

Celltrion presents positive interim results from Ph I trials of CT-P13 of subcutaneous Remsima® (biosimilar infliximab) in IBD at the UEG Week Virtual 2020. The results indicated that subcutaneous infliximab may be associated with better clinical outcomes compared to intravenous infliximab.

October 9, 2020

Innovent and Eli Lilly jointly announce China’s NMPA has granted marketing approval for Halpryza® (biosimilar rituximab). Halpryza® is indicated for the treatment of patients with diffuse large b cell lymphoma, follicular lymphoma and chronic lymphocytic leukemia.

October 8, 2020

Korea Biomedical Review reports Celltrion has received approval for Ph III trials of CT-P39 (proposed omalizumab biosimilar).

October 7, 2020

In its annual 2020 budget, the Australian Government acknowledged the damage to Australia’s economy caused by vaccine uncertainty.  The Government also pledged $23.2 million over the next three years to the COVID-19 Vaccine Access and Health Security Program to support the development of national immunisation policies in Pacific and Southeast Asian countries.  A further $304.7 million has been pledged for additional recovery support for Pacific Island countries and Timor-Leste.

October 6, 2020

Samsung Bioepis and Biogen announce the European Medicines Agency has accepted for review its Marketing Authorisation Application for SB11 (proposed ranibizumab biosimilar).

October 6, 2020

Onco’Zine reports a new study released by the American Society of Clinical Oncology Quality Care Symposium indicates that Sandoz’s Zarxio® (biosimilar filgrastim) is not only safe and effective, but is cost effective in treating chemotherapy-induced febrile neutropenia in early-stage breast cancer patients.

October 5, 2020

Medicure announces it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences for a cardiovascular biosimilar product for EU, US and Canada. Medicure is responsible for the regulatory approval process for that product.

October 1, 2020

Lupin receives approval for biosimilar etanercept in Australia under the trade names Etera® and Rymti® in PFS presentations.

September 30, 2020

The University of Oxford announces it has commenced Ph II trials of adalimumab as a treatment for patients with COVID-19. The trial will enrol up to 750 patients from community care settings throughout the UK and is funded by the COVID-19 Therapeutics Accelerator, an initiative set up by Wellcome and Mastercard. The trial will assess Hyrimoz® (biosimilar adalimumab), developed by Sandoz.

September 29, 2020

Centus Biotherapeutics announces it has received EC marketing authorisation for Equidacent® (biosimilar bevacizumab). Equidacent® has been exclusively licensed to Fujifilm Kyowa Kirin Biologics on a worldwide basis.

September 28, 2020

Innovent announces its ph III trial of Byvasda® (proposed bevacizumab biosimilar) in combination with Tyvyt® (sintilimab) met its primary endpoints of progression-free survival and overall survival. Innovent reported that the safety profile of both products was consistent with previously reported studies, and no new safety signals were identified.

September 24, 2020

Accord Healthcare launches Zercepac® (biosimilar trastuzumab) in the UK. Zercepac® is indicated for HER2-positive early breast cancer, HER2-positive metastatic breast cancer and previously untreated HER2-positive metastatic gastric cancer and is available in a 150mg single-dose vial.

September 23, 2020

The Australian Government announced it has joined the COVAX facility, committing an initial $123.2 million for the ability to purchase vaccines when they become available. The COVAX facility is a collaboration between Gavi, the Coalition for Epidemic Preparedness Innovations, the WHO and other organisations and aims to ensure equitable access to COVID-19 vaccines.

September 23, 2020

Dong-A ST announces sales approval for biosimilar darbepoetin from Japan’s Ministry of Health, Labour and Welfare. 

BD | HK | ID | IN | KH | KR | MY | PH | PK | SG | TH | TW | VN | Alvotech expands strategic partnership with DKSH for biosimilar product commercialisation

September 22, 2020

Alvotech announces an expansion of its strategic partnership with DKSH to commercialise six new biosimilar product candidates for Asian markets, including Taiwan, Korea, Hong Kong, Philippines, Vietnam, Thailand, Cambodia, Myanmar, Malaysia, Singapore, Indonesia, India, Bangladesh and Pakistan. These biosimilar candidates’ brand values are estimated around US$1.5 billion in annual sales in the Asia Pacific region, according to IQVIA data.. The biosimilar candidates will address multiple therapeutic areas and represent an estimated (combined) US$1.5 billion in annual sales in the Asia Pacific region.

September 20, 2020

SBS News reported the Australian Government has committed $6 million to the research and development of three potential COVID-19 vaccines. The University of Melbourne will receive $3 million for the development of two vaccines, and the University of Sydney will receive $3 million to commence clinical trials of a novel DNA-based COVID-19 vaccine.

September 20, 2020

Regenxbio announces it has commenced dosing in Ph II trials comparing RGX-314 to monthly ranibizumab injections. RGX-314 is being developed as a novel, one-time subretinal treatment for wet AMD and diabetic retinopathy.

September 17, 2020

The Centre for Biosimilars reports that data presented at the ESMO Virtual Congress by PrestigeBiopharma demonstrates positive findings for Ph I trials of HD201 (proposed bevacizumab biosimilar). HD201 is current under review by the EMA.

September 17, 2020

Lotus Pharma announces it has signed a commercialisation agreement with Chong Kun Dang for Nesbell® (biosimilar darbepoetin-alpha). Under the agreement, Chong Kun Dang will supply Lotus with Nesbell® for sale in Taiwan, Vietnam and Thailand pending the success of clinical trials in those countries.

September 15, 2020

Merck announced Health Canada has approved Brenzys® (biosimilar etanercept) for four new indications:

  • adult patients with chronic moderate to severe plaque psoriasis (PsO) who are candidates for systemic therapy or phototherapy

  • pediatric patients ages 4 to 17 years with chronic severe PsO who are candidates for systemic therapy or phototherapy

  • reducing signs and symptoms, inhibiting the progression of structural damage of active arthritis and improving physical function in adult patients with psoriatic arthritis (PsA)

  • reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis (JIA) in patients aged 4 to 17 years

September 12, 2020

AstraZeneca announced it has resumed clinical trials in the UK and Brazil following confirmation by the Medicines Health Regulatory Authority (MHRA) that it was safe to do so.

September 10, 2020

A new study presented at the Congress of Clinical Rheumatology East indicates that ustekinumab is safe and efficacious in young and elderly patients with psoriatic arthritis. Researchers reported that there were no clinically meaningful differences in the effectiveness and safety in PsA patients 60 years or older compared with those younger than 60.

September 10, 2020

Neurology Advisor reported a new study indicates that natalizumab may be more effective than fingolimod or BRACETD in reducing relapses in patients with relapsing-remitting multiple sclerosis.

September 9, 2020

AstraZeneca announced it has voluntarily paused Ph III trials of AZD1222 to investigate a potentially unexplained illness in one of the trials. AZ said it will expedite the review of the single event to minimise any impact to the trial timeline.

September 6, 2020

CSL announced it will supply the Australian Government with 51 million doses of UQ’s vaccine candidate UQ-CSL V451 if proven successful. The first tranche of doses is expected to be available by mid-2021, with additional doses expected in late 2021 and early 2022. The vaccine candidate is currently in Ph I trials.

September 3, 2020

Bio-Thera Solutions commences dosing in Ph I clinical trials of BAT2206 (proposed ustekinumab biosimilar).

September 3, 2020

Lupus Foundation of Australia reports a new study demonstrates that rituximab may prove effective as a treatment option for refractory lupus. The study was conducted in 147 people with lupus, and found that six months after the first treatment, 45% of patients demonstrated a complete response to therapy, with another 28% demonstrated some improvement in disease activity.

September 3, 2020

Targeted Oncology reports the results of a Ph III trial of Samsung Bioepis’ proposed bevacizumab biosimilar, SB8. The researchers reported that the objective response rate ratio of SB8 and bevacizumab appeared equivalent, with comparable safety, pharmacokinetics and immunogenicity as a treatment of patients with metastatic or recurrent nonsquamous non-small cell lung cancer.

September 3, 2020

Innovent Biologics announces China’s NMPA has approved Sulinno® for the treatment of rheumatoid arthritis, ankylosing spondylitis and psoriasis.

September 1, 2020

A new study examining the analytical and functional similarity of Amgen/Allergan’s proposed rituximab biosimilar ABP798 concludes that it is highly analytically similar to Rituxan®.

September 1, 2020

NeuClone Pharmaceuticals disclosed it is working on biosimilars referencing Opdivo® (nivolumab) and Keytruda® (pembrolizumab).  The products are in the advanced stages of pre-clinical development and are being developed in partnership with the Serum Institute of India.

September 1, 2020

Generics update reports Xbrane is aiming to file an application for Xlucane® (biosimilar ranibizumab) in Europe and the US, and to license the product in Latin America, Japan and China in the next 12 months.

September 1, 2020

NeuClone Pharmaceuticals discloses it is working on a biosimilar referencing Keytruda® (pembrolizumab). The product is in the advanced stages of pre-clinical development and is being developed in partnership with the Serum Institute of India.

August 31, 2020

AstraZeneca announced it has commenced Ph III trials of AZD1222. Up to 30,000 adults in the US will be recruited, with testing sites also in Peru, Chile, UK, Brazil and South Africa. The results of the trial are anticipated later this year.

August 28, 2020

Healio reports the results of the UK Kings College/NHS Trust MERLOT trial demonstrated there was no benefit to epimacular brachytherapy as an adjunct to anti-VEGF injections, the results of which were worse than ranibizumab monotherapy, for the treatment of neovascular age-related macular degeneration.

August 28, 2020

Cadila Pharmaceuticals launches Cadalimab® (biosimilar adalimumab) in India. Cadalimab® is available in 40mg/0.8mL injection and is indicated for rheumatoid arthritis, juvenile idiopathic arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis. This is the fourth biosimilar launch in India by Cadila within 2 months following Bevaro® (biosimilar bevacizumab), Ritucad® (biosimilar rituximab) and NuPTH® (biosimilar teriparatide).

August 27, 2020

Rheumatology Advisor reports a study sponsored by China’s National Clinical Research Center for Orthopedics, Sports Medicine & Rehabilitation demonstrates that delayed administration of subsequent denosumab doses by greater than 16 weeks is associated with increased risk for vertebral fracture. This risk was observed in both the short delay (4-16 weeks) and the long delay (>16 weeks) groups. Additionally, there was a significant correlation between delayed subsequent injections and major osteoporotic fractures.

August 26, 2020

Multiple Sclerosis News Today reports a new real-life study demonstrates that Ocrevus® (ocrelizumab) carries a higher risk of infections but carries a lower risk of cancer and immune reactions than rituximab in patients with multiple sclerosis.

August 26, 2020

Lupin and Mylan launch Nepexto® (biosimilar etanercept) in Germany. Nepexto® is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, severe axial spondyloarthritis and plaque psoriasis.

August 24, 2020

Bio-Thera Solutions and BeiGene announce they have executed a license / distribution and supply agreement for BAT1706 (proposed bevacizumab biosimilar). Subject to approval by Bio-Thera’s shareholders in September, the agreement grants BeiGene the right to develop, manufacture and commercialise BAT1706 in mainland China, Hong Kong, Macau and Taiwan in return for milestone payments totalling US$165M, and tiered double-digit royalties on future net product sales.

August 24, 2020

Merck announces Keytruda® (pembrolizumab) has received two additional approvals from the Japanese Pharmaceuticals and Medical Devices Agency:

  • new indication for the treatment of patients whose tumours are PD-L1-positive, and have radically unresectable, advanced or recurrent esophageal squamous cell carcinoma;

  • and an additional dosage regimen of 400mg every six weeks as an IV infusion over 30 minutes, across all adult indications.

August 21, 2020

Pfizer’s application to PBS list its biosimilar bevacizumab (Zirabev®) under the same conditions as Avastin® was recommended.

August 21, 2020

PBS publishes the outcomes of the July 2020 meeting including a positive recommendation for Merck’s application to broaden out the PBS reimbursed indications for its Hadlima® (biosimilar adalimumab). Merck’s Hadlima® was first granted PBS listing in 2018 for rheumatoid arthritis only. The expanded recommendation follows Sandoz’s positive recommendation for Hyrimoz® earlier this year, which included the same indications as Humira®.

August 20, 2020

Intract Pharma and Celltrion announce an agreement to jointly develop the world’s first oral antibody therapeutic for the treatment of IBD. The infliximab product has been cleared by the UK’s MHRA to proceed to Ph 1b/2a clinical trials in patients with IBD during the second half of 2021.

August 20, 2020

Samsung Bioepis announces that the EC has granted marketing authorisation for Aybintio®, biosimilar bevacizumab (Avastin®) with a full indication set. EMA accepted Samsung’s application on 19 July 2019, and CHMP positive opinion was granted on 26 June 2020. This is Samsung’s 5th approved EU biosimilar, and the 3rd approved biosimilar to bevacizumab (following the approval of Amgen/Allergan’s Mvasti® in January 2018 and Pfizer’s Zirabev® in December 2018). Centus Biotherapeutics’ application for Equidacent® follows Samsung’s closely, having received CHMP positive opinion in July 2020.

August 19, 2020

Sandoz Canada announces it has entered an agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) regarding biosimilar medicines Ziextenzo® (biosimilar pegfilgrastim) and Riximyo® (biosimilar rituximab). Both products were approved by Health Canada in late April 2020. Under the pCPA agreement, Riximyo® is reimbursed in Ontario (from July 2020) for certain indications, through Cancer Care Ontario. Additionally, British Columbia announced the reimbursement of Riximyo® (from August 2020) through BC Cancer.

August 19, 2020

The Prime Minister’s office announced the Australian Government has signed a Letter of Intent with AstraZeneca for the supply of the University of Oxford’s COVID-19 vaccine candidate AZD1222. If trials prove successful, safe and effective, it is expected that every Australian will have access to the free vaccine.

August 19, 2020

Merck announces the results of Ph III trials of Keytruda® (pembrolizumab) in combination with chemotherapy for first-line treatment of patients with locally advanced or metastatic esophageal cancer. Merck reported that Keytruda® met the primary and secondary endpoints and that the safety profile was consistent with that observed in previously reported studies.

August 19, 2020

Sandoz Canada announces it has entered an agreement with the Pan-Canadian Pharmaceutical Alliance (pCPA) regarding biosimilar medicines Ziextenzo® (biosimilar pegfilgrastim) and Riximyo® (biosimilar rituximab). Both products were approved by Health Canada in late April 2020. 

August 18, 2020

CSL confirmed the development of the University of Queensland’s (UQ) vaccine candidate remains its priority. CSL also disclosed that it has entered discussions with AstraZeneca and the Australian Government to assess whether it can provide local manufacturing support for the Oxford University/AZ vaccine should it prove successful.

August 14, 2020

Shanghai Henlius Biotech announces China’s NMPA has approved its trastuzumab biosimilar Zercepac®. Zercepac® is indicated for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.

August 14, 2020

The Centre for Biosimilars reports that Celltrion has refuted the claims of a July 2020 study which critiqued the methods used by Celltrion and the FDA to determine whether Remsima® (biosimilar infliximab) was equivalent to Remicade®. Among its critiques of the study, Celltrion has argued that the study does not reflect the FDA review procedure and the principles of the regulatory guidelines.

August 14, 2020

Korea Biomedical Review reports that Celltrion will commence Ph I clinical trials of CT-P41 (biosimilar denosumab candidate) in September.

August 11, 2020

The Centre for Biosimilars reports that Polpharma is planning to file a modified application for FYB201 (biosimilar ranibizumab candidate) to the FDA within the next year.

August 11, 2020

Docwirenews reports a new post-approval safety surveillance study of Janssen’s golimumab Simponi® demonstrated that there is no association between exposure to golimumab and an increased risk of prespecified outcomes.

August 10, 2020

Samsung Bioepis launches Ontruzant® (biosimilar trastuzumab) in Brazil. Ontruzant® is indicated for the treatment of metastatic HER2-overexpressing breast cancer, early HER2-overexpressing breast cancer, and advanced gastric cancer.

August 10, 2020

AVEO Oncology releases its Q2 FY2020 earnings report. AVEO reported data from its Ph I study of ficlatuzumab and cetuximab in patients with advanced head and neck squamous cell carcinoma (HNSCC) demonstrated that the products have an acceptable safety profile and showed promising anti-tumour activity in a refractory HNSCC patient population. AVEO also announced that it is evaluating the process to secure additional clinical manufacturing of ficlatuzumab to potentially enable a Ph III clinical trial in 2022.

August 10, 2020

Healio reports a new article published in the Annals of the Rheumatic Diseases showed that ixekizumab demonstrated significantly greater joint and skin improvement than adalimumab among patients with psoriatic arthritis (PsA). The 52 week SPIRIT trial assessed 566 adults with PsA who had not yet been treated with a biological disease-modifying anti-rheumatic drugs.

August 7, 2020

OncLive publishes an interview with Manfred Welslau, MD on the findings from the interim results of Sandoz’s REFLECT study of SDX-RTX (rituximab biosimilar). These results reconfirmed the safety and efficacy profile of the product, which has already been approved in the EU, Switzerland, Japan, New Zealand and Australia. Welslau announced that the full results of this study will be released at the end of 2020 or the beginning of 2021.

August 7, 2020

Celltrion releases its Q2 FY20 earnings report. Celltrion reported that Remsima SC® remains in Ph III clinical trials in the US.

August 7, 2020

Celltrion releases its Q2 FY20 earnings report.  Celltrion reported that it is “preparing” its US approval application for CT-P17 (biosimilar adalimumab candidate), following the filing of its application in the EU in March this year. 

August 5, 2020

Alvotech and Teva announce a strategic partnership to collaborate on five biosimilar product candidates in the US market. Under the agreement, Alvotech will be responsible for the development, registration and supply of the biosimilars, while Teva will be exclusively commercialising the products in the US. The agreement includes an upfront payment, with subsequent milestone payments, with Alvotech and Teva to share the profits from commercialisation.

August 3, 2020

Celltrion gains WHO prequalification for its trastuzumab biosimilar Herzuma®. The prequalification status enables Celltrion to make a bid in global procurement by UN agencies, and is based on an evaluation of safety and efficacy.

July 30, 2020

Janssen announces the FDA approved an additional indication for Stelara® (ustekinumab) for paediatric patients with skin lesions or moderate to severe plaque psoriasis.

July 29, 2020

Cadila Pharmaceuticals announces it has launched Ritucad® (biosimilar rituximab). Ritucad® has been approved for Non-Hodgkin’s Lymphoma and rheumatoid arthritis. This follows Cadila’s launch of Bevaro® (biosimilar bevacizumab) in India last week.

July 29, 2020

Shanghai Henlius Biotech and Accord Healthcare jointly announce the European Commission has approved Zercepac® (biosimilar trastuzumab) for the treatment of HER2-positive early breast cancer, HER2-positive metastatic breast cancer and HER2-positive metastatic gastric cancer.

July 28, 2020

Pfizer releases its Q2 FY20 financial results. Pfizer reported a 16% decrease in international revenues for Enbrel® (etanercept), attributing this decrease to biosimilar competition in Europe, Japan and Brazil. 

July 28, 2020

Pfizer releases its Q2 FY20 financial results. Pfizer reveals that it plans to launch Nyvepria® (biosimilar pegfilgrastim) in the US later this year.

July 27, 2020

Celltrion announces the European Commission has granted marketing authorisation for Remsima® (biosimilar infliximab) subcutaneous formulation for the treatment of adult patients with ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis.

July 27, 2020

The Centre for Biosimilars reports a study presented at the American Academy of Dermatology’s Virtual Meeting Experience 2020 demonstrates the safety, efficacy and immunogenicity of Boehringer Ingelheim’s Cyltezo® (biosimilar adalimumab) is comparable to AbbVie’s Humira®.

July 24, 2020

A new study published by the Journal of Clinical Pathways demonstrates significant cost-savings generated by Sandoz’s pegfilgrastim biosimilar Ziextenzo®.

July 23, 2020

The CHMP adopts a positive opinion recommending the granting of marketing authorisation for Centus Biotherapeutics’ Equidacent® (biosimilar bevacizumab) for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer and carcinoma of the cervix.

July 22, 2020

Cadila Pharma announces it has launched Bevaro® (biosimilar bevacizumab) in India. Bevaro® s indicated for ovarian cancer, glioblastoma, colorectal cancer, breast cancer, lung cancer, cervical cancer and kidney cancer.

July 22, 2020

Genentech publishes the results from its Ph III Archway study, evaluating its Port Delivery System (PDS) with ranibizumab for the treatment of neovascular age-related macular degeneration (nAMD).  Genentech reported that 98.4% of patients were able to go six months without requiring additional treatment, and achieved vision outcomes equivalent to patients receiving monthly ranibizumab eye injections.

July 21, 2020

Novartis releases its Q2 FY20 financial results, reporting COVID-19 negatively impacted demand for Lucentis® (ranibizumab).

July 20, 2020

AstraZeneca announced interim results from ongoing Ph I/II trial showed AZD1222 was tolerated and generated robust immune responses against the SARS-CoV-2 virus in all evaluated participants.

July 20, 2020

Spherix reports that the EU market for AbbVie’s Humira® has been negatively impacted by gastroenterologists increasingly prescribing alternative mechanism of action agents, including Stelara® (ustekinumab) and Entyvio® (vedolizumab) for ulcerative colitis (UC) and Crohn’s disease (CD) and the increased prescription of adalimumab biosimilars. These increases have come at a cost to AbbVie, with use of Humira® in UC and CD decreasing in the EU.

July 17, 2020

VentureTECH, Duopharma and PanGen Biotech announce a joint venture to develop a Malaysian biosimilar production facility.

July 17, 2020

Bio-Thera Solutions annnounces a licensing agreement with Pharmapark for BAT2506 (biosimilar golimumab candidate). Under the agreement, Pharmapark will have exclusive rights to distribute and market the drug in Russia and other CIS countries.

July 17, 2020

In an interview with Generics update, Sandoz Canada announces it is aiming for 10 biosimilar launches in the next decade, with pegfilgrastim and rituximab to be launched shortly.

July 17, 2020

Bio-Thera Solutions annnounces a licensing agreement with Pharmapark for BAT2506 (biosimilar golimumab candidate). Under the agreement, Pharmapark will have exclusive rights to distribute and market the drug in Russia and other CIS countries.

July 15, 2020

In an interview with the Centre for Biosimilars, Celltrion’s head of marketing, Byoungseo Choi reports Phase I and III trials of Celltrion’s omalizumab candidate are ongoing, and are expected to conclude by 2022.

July 15, 2020

In an interview with the Centre for Biosimilars, Celltrion’s head of marketing, Byoungseo Choi reports Remsima® (biosimilar infliximab) is showing promise as a potential treatment for COVID-19.

July 15, 2020

In an interview with the Centre for Biosimilars, Celltrion’s head of marketing, Byoungseo Choi reports that Phase III trials for CT-P16 (proposed biosimilar bevacizumab) are set to commence, with EU submission planned for next year.

July 13, 2020

CSL announced it has commenced Ph I trials of its proposed COVID-19 vaccine. The clinical batch of vaccine for use in the trial has been manufactured by the UQ and CSIRO, with technical assistance from CSL and Cytiva.

July 9, 2020

Mylan announces FDA approval of Hulio® (biosimilar adalimumab) for PFS and auto-injector presentations.

July 8, 2020

The Journal of Clinical Pathways report a new study shows a triplet regimen of pembrolizumab, Herzuma® (biosimilar trastuzumab) and chemotherapy is effective in patients with HER-2 positive advanced gastric cancer.

July 7, 2020

Genentech and Amgen file stipulations in the US District Court of Delaware dismissing their BPCIA litigation relating to trastuzumab and bevacizumab biosimilars. This comes after the Court of Appeals refused to block Amgen’s Mvasi® from entering US markets on July 06.

July 7, 2020

Outlook Therapeutics announces it has completed patient enrolment for its NORSE 2 clinical trials of Lytenava® (proposed bevacizumab biosimilar).

July 1, 2020

Sandoz responds to the US Court of Appeals judgment which upheld a ruling from the New Jersey District Court which declared the Amgen patents relating to (etanercept) valid. Sandoz stated that it will continue its efforts to make Erelzi® available in the US, and is evaluating its options, including a possible appeal to the US Supreme Court.

July 1, 2020

The US District Court of Delaware refuses to combine Amgen’s two actions against Pfizer and Hospira relating to filgrastim. The original action was filed in July 2018, and the more recent action was filed in April 2020. In the oral order, (available courtesy of Goodwin), the Court ruled that as Amgen would not agree to use the same experts for both cases, they should bear the consequences of litigating an action nearly two years after the original action. The Court also indicated that it would entertain Pfizer/Hospira’s proposed motion to stay the second action.

June 30, 2020

BeiGene announces its has begun commercialising Xgeva® (denosumab) in China. Xgeva® was developed by Amgen, and is the first of the products to be commercialised by BeiGene under a January 2020 agreement.

June 30, 2020

Amgen receives Australian approval for Mvasi® (biosimilar bevacizumab) for all indications as Avastin®.

June 30, 2020

Samsung Bioepis announces it has commenced Ph III trials of SB15, proposed aflibercept biosimilar.

June 30, 2020

Genentech files a complaint against Samsung Bioepis in the District Court of Delaware under the BPCIA, alleging infringement of 14 patents related to SB8 (Samsung’s proposed bevacizumab biosimilar), and violation of the “patent dance” provisions.

June 29, 2020

Celltrion announces EU’s CHMP recommended expanding the marketing authorisation for its subcut Remsima® (biosimilar infliximab) to include the following additional indications: IBD, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and psoriasis. This extends the indications beyond RA which was approved in November 2019.

June 29, 2020

Merck announces the FDA has approved Keytruda® (pembrolizumab) for first-line treatment of patients with unresectable or metastatic microsatellite instability-high or mismatch repair deficient colorectal cancer.

June 29, 2020

Fujifilm Kyowa Kirin Biologics announces manufacturing and marketing approval in Japan for FKB237 (adalimumab biosimilar). This product was developed in partnership with Mylan and has been marketed as Hulio® in 20 countries across Europe.

June 28, 2020

Outlook India reports Dr Reddy’s is expecting to launch 25 products in the US market in the current financial year and that Dr Reddy’s Ph III trials of a proposed rituximab biosimilar are progressing as planned.

June 26, 2020

Janssen announces it has discontinued its Ph III LOTUS study of Stelara® (ustekinumab) in Systematic Lupus Erythematosus due to lack of efficacy.

June 26, 2020

Samsung Bioepis announces the CHMP has adopted a positive opinion for Aybintio® (biosimilar bevacizumab).

June 25, 2020

AbbVie and Sosei Heptares announce a $409M deal to discover and develop new immunology drugs.  The agreement covers the drug-discovery, development and commercialisation of small-molecule medicines that target autoimmune and inflammatory diseases using the G protein-coupled receptor.  AbbVie will pay Sosei Heptares up to $32M upfront and at milestones for an additional $377M, along with royalties.

June 25, 2020

Aptevo Therapeutics announces it will receive quarterly “low single digit” fixed royalty payments from Pfizer (Wyeth) for 7 years from the first launch of Ruxience® (biosimilar rituximab). The original royalty agreement was signed by Trubion Pharmaceuticals which was then acquired by Aptevo’s spin-off Emergent BioSolutions, and Wyeth, in 2016. The royalty is applied to net sales in the US, EU and Japan.

June 22, 2020

Ankylosing Spondylitis News reports new data from Germany indicates Simponi® (golimumab) is an effective therapy for people with ankylosing spondylitis and other chronic inflammatory conditions, regardless of pre-treatment with other TNF inhibitors.

June 19, 2020

Bio-Thera Solutions announces China’s NMPA has accepted its BLA for BAT1706 (proposed bevacizumab biosimilar).

June 19, 2020

Innovent Biologics announces China’s NMPA has approved Byvasda® (bevacizumab) for the treatment of patients with advanced non-small cell lung cancer and metastatic colorectal cancer in China.

June 17, 2020

Fresenius Kabi receives Australian approval for Idacio® (biosimilar adalimumab) with identical indications as Humira®, in 40mg vial, PFS and pen.

June 16, 2020

Henlius Biotech announces the results of Ph III trials of HLX04 (proposed bevacizumab biosimilar) in combination with oxaliplatin and fluoropyrimidine-based chemotherapy in patients with metastatic colorectal cancer. Henlius reports that the study successfully met the primary endpoint.

June 15, 2020

Samsung Bioepis announces it has received approval to commence a global Ph III trial of SB15 (proposed aflibercept biosimilar) in patients with age-related macular degeneration.

June 14, 2020

Celltrion presents new data from Phase II trials of a Truxima® (biosimilar rituximab), lenalidomide and acalabrutinib regime for the treatment of relapsed/refractory aggressive B-cell lymphoma. Celltrion reports that the regime was well tolerated by patients.

June 11, 2020

Celltrion announces a $278 million deal to acquire Takeda Pharmaceuticals Primary Care businesses in the Asia Pacific. Under the agreement, Celltrion will gain access to patent, trademark and marketing rights for 18 prescription and over-the-counter brands in 9 markets including South Korea, Thailand, Taiwan, Hong Kong, Singapore and Australia.

June 11, 2020

Pfizer announces the FDA has approved Nyvepria® (pegfilgrastim). Nyvepria® is indicated to decrease the incidence of infection, manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

June 11, 2020

A new study published in BMC Rheumatology reports that Hetero’s biosimilar adalimumab Mabura® was effective and well tolerated in comparison to Humira® in patients with active rheumatoid arthritis.

June 10, 2020

The University of Oxford announces Celltrion’s infliximab biosimilar CT-P13 (Inflectra®, Remsima®) would be one of the products trialled in the CATALYST Study. This study is examining possible treatments for patients with COVID-19. It is hoped that the CT-P13 will prevent the immune system response which leads to cytokine storm syndrome in COVID patients.

June 9, 2020

Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).

June 9, 2020

Sandoz announces Health Canada has granted marketing approval for Ziextenzo® (pegfilgrastim) and Riximyo® (rituximab).

June 9, 2020

The Big Molecule Watch reports that a US District Court Judge ruled AbbVie’s conduct in relation to its blockbuster Humira® (adalimumab), while preventing competitors from reaching the market in the US, was not illegal. The action was filed against AbbVie by a number of parties including the City of Baltimore and a pension for Police Officers, and alleges that by amassing a ‘patent thicket’ and settling litigation with competitors which prevented them launching in the US, AbbVie had engaged in conduct which breached federal and state antitrust laws.

June 5, 2020

The Coalition for Epidemic Preparedness Innovations, CSL and the University of Queensland announced they have entered into a partnering agreement to accelerate the development, manufacture and distribution of a COVID-19 vaccine candidate.

June 4, 2020

Mylan and Lupin announce EMA marketing authorisation for Nepexto® (etanercept) for all indications of the reference product Enbrel®.

June 4, 2020

Bloomberg Law reports on the ongoing US Court of Appeals for the Federal Circuit dispute between Genentech and Amgen regarding bevacizumab. In a hearing on 3 June 2020, Genentech asked the Court to prevent Amgen selling its biosimilar bevacizumab Mvasi® to new patients, despite the trial Court refusing to prevent Amgen’s launch, and the US Court of Appeals refusing to injunct Amgen early in the appeal. Decision reserved.

June 1, 2020

Eli Lilly announced that the FDA has approved Taltz® (ixekizumab) for the treatment of non-radiographic axial spondyloarthritis.

May 31, 2020

Henlius Biotech announces it has received a positive CHMP opinion, recommending marketing authorisation for HLX02 (proposed trastuzumab biosimilar).

May 29, 2020

In a filing to the Securities and Exchange Commission, Alexion announces it has settled its eculizumab dispute with Amgen. Under the agreement, Amgen will receive a non-exclusive, royalty-free license to market its product from 01 March 2025.

May 29, 2020

Fresenius Kabi announces it has signed an agreement with Medac to cooperate in Germany in the area of treatments for rheumatic illnesses. From 01 June 2020, Medac’s sales representatives will be able to offer Fresenius Kabi’s adalimumab biosimilar Idacio. Medac is already a provider of methotrexate, a product which is often used in combination with adalimumab.

May 28, 2020

The WHO certifies Celltrion’s Truxima® (rituximab) in its prequalification program. This program assesses clinical and other data related to biosimilars, and aims to guide low-income countries in their selection of medicines, vaccines and technologies for national procurement.

May 27, 2020

Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.

May 27, 2020

Shanghai Henlius Biotech announces that China’s National Medical Products Administration has approved its IND application for HLX14, a proposed denosumab biosimilar. 

May 27, 2020

Fresenius Kabi announces that the FDA has accepted its BLA for MSB 11455, a proposed pegfilgrastim biosimilar.

May 27, 2020

Shanghai Henlius Biotech announces that its adalimumab and trastuzumab products are under New Drug Application review, with the potential to be launched in 2020.

May 26, 2020

The American Journal of Managed Care reports two cost savings studies presented at a virtual meeting of the International Society for Pharmacoeconomics and Outcomes Research. The studies, which were sponsored by Pfizer, analysed the potential cost savings over a three year period from a US perspective in switching to bevacizumab and rituximab biosimilars. The studies concluded that over three years $14.7 million could be saved on bevacizumab used to treat 503-676 patients, with $3.8 million saved on rituximab used to treat 754-764 patients.

May 22, 2020

JD Supra reports on Mylan’s Q1 earnings call. In the call, Mylan announced its partner Biocon had received FDA pre-approval of its Malaysian manufacturing facility, as well as announcing a planned launch for Nepexto® (etanercept) in Europe within months.

May 22, 2020

JD Supra reports on Mylan’s Q1 earnings call. In the call, Mylan announced that the BLA and marketing authorisation for its bevacizumab candidate is currently under review by the FDA and European authorities. Mylan also confirmed that its biosimilar insulin and aflibercept projects remain on target.

May 18, 2020

JHL Biotech announces that the first group of subjects in the Australian randomised Ph I trials of JHL1266 (proposed denosumab) have been dosed.

May 18, 2020

Samsung Bioepis announces 24-week interim results from a Ph III trial of SB11 (a proposed ranibizumab biosimilar) in patients with neovascular age-related macular degeneration. Samsung Bioepis announced that the primary endpoints of the trial were met, suggesting that SB11 will be a valuable treatment option for nAMD.

May 15, 2020

Formycon releases an update on its biosimilar portfolio. Ph III clinical trials for a proposed ustekinumab biosimilar are scheduled to commence in Q3 2020.

May 15, 2020

Samsung Bioepis announces the results of a four year follow up study of Ontruzant® (trastuzumab) will be presented at the ASCO20 Virtual Scientific Program organized by the American Society of Clinical Oncology (ASCO) at the end of this month. The study assessed the cardiac safety and surival outcome in a subgroup of patients from the Ph III study.

May 15, 2020

Formycon releases an update on its biosimilar portfolio. In the statement, Formycon confirmed it is continuing to work with license partner Bioeq on a resubmission of the BLA for FYB201 (proposed ranibizumab biosimilar).

May 15, 2020

Formycon releases an update on its biosimilar portfolio, announcing its biosimilar aflibercept candidate is proceeding as expected, with Ph III clinical trials expected to begin mid-2020.

May 12, 2020

Biocon Biologics receives good manufacturing practice compliance certificate from the EMA for Bengaluru facilities.

May 12, 2020

Alvotech releases the results of two studies for AVT02, a proposed adalimumab biosimilar, announcing both studies met their primary endpoints. Alvotech announced that the Ph I clinical study demonstrated the PK similarity of AVT02 to the reference product Humira®, while the Ph III study demonstrated equivalent efficacy compared to Humira® in patients with moderate-to-severe chronic plaque psoriasis.

May 8, 2020

Results of the Novartis’ EXCEED study comparing adalimumab and secukinumab for the treatment of PSA (psoriatic arthritis) were released.  Researchers reported no statistically significant superiority between secukinumab and adalimumab as first-line treatment of psoriatic arthritis, but secukinumab was associated with a higher treatment retention rate than adalimumab.

May 8, 2020

AbbVie announces it has completed its acquisition of Allergan, following regulatory approval from all relevant Government agencies. AbbVie will now have access to Allergan’s neuroscience products including Vraylar® and Ubrelvy®, and aesthetic products including the Botox® and Juvederm® brands.

May 8, 2020

The American Journal of Medical Care publishes results of clinical trials of AryoGen’s BE1040V, biosimilar bevacizumab. Researchers reported the product was non-inferior to the reference product in terms of efficacy for the treatment of metastatic colorectal cancer.

May 6, 2020

Bausch + Lomb announce it has entered into an exclusive licensing agreement with STADA and Xbrane Biopharma for the development and commercialisation of a ranibizumab biosimilar. Under the agreement, Xbrane and STADA will be jointly responsible for finalising development of the biosimilar, with Xbrane to provide commercial supply and Bausch + Lomb responsible for sales, marketing and all other commercialisation efforts.

May 4, 2020

Teva and Celltrion announce the launch of Truxima® in the US. Truxima® is indicated for the treatment of rheumatoid arthritis, granulomatosis with polyangiitis and miscroscopic polyangiitis, making it the only approved biosimilar with the same indications as Rituxan®.

May 1, 2020

AbbVie released its Q1 2020 financial results, reporting a 13.7% increase in US sales of Humira® from Q1 2019. In global markets, Humira® sales were down 14.9%, a decline that was attributed to biosimilar competition.

May 1, 2020

Amgen filed suit against Hospira and Pfizer, alleging infringement of US patent 10,577,392, relating to the manufacture of Neupogen®. Interestingly, the patent was only granted on March 03, 2020, nearly 2 years after Hospira launched Nivestym®.

April 30, 2020

AstraZeneca and the University of Oxford announced an agreement for the global development and distribution of a potential recombinant adenovirus vaccine.

April 29, 2020

Gedeon Richter announces it has entered an asset purchase agreement with Mycenax Biotech for the purchase of a biosimilar tocilizumab product. Under the agreement, Richter will receive worldwide rights to develop, manufacture and commercialise the product which is expected to reach global markets in 2025.

April 28, 2020

Mylan and Biocon launch Fulphila® (pegfilgrastim) in Canada. Fulphila® is approved to decrease the incidence of infection, as manifested by febrile neutropenia, in patients with non-myeloid malignancies receiving myelosuppressive anti-neoplastic drugs.

April 24, 2020

J&J announces it has filed two supplemental marketing applications for Simponi Aria (golimumab) with the FDA. J&J have applied for the additional indications of polyarticular juvenile idiopathic arthritis and juvenile psoriatic arthritis in patients at least two years old.

April 23, 2020

Henlius Biotech announces it has received two EU GMP certificates related to its trastuzumab biosimilar HLX02.

April 15, 2020

Merck and Samsung Bioepis launch Ontruzant® (trastuzumab) in the US. Ontruzant® is indicated for adjuvant treatment of HER2 overexpressing node positive or node negative breast cancer as part of a treatment regimen and as a single agent following multi-modality anthracycline based therapy.

April 14, 2020

Mylan and Biocon launch Fulphila® (pegfilgrastim) in Australia. Fulphila® is indicated for the treatment of cancer patients following chemotherapy, to decrease the duration of severe neutropenia and so reduce the incidence of infections.

April 8, 2020

NeuClone Pharma announces it has completed monitoring visits and blood sampling for Ph I trials of NeuLara.

April 8, 2020

Pfizer announces the FDA has approved Braftovi® (encorafenib) in combination with Erbitux® (cetuximab) for the treatment of BRAF600E-mutant metastatic colorectal cancer after prior therapy.

April 2, 2020

Pfizer announces EC approval of Ruxience® for the treatment of non-hodgkin’s lymphoma, chronic lymphocytic leukemia, rheumatoid arthritis, granulomatosis with polyangiitis and microscopic polyangiitis, and pemphigus vulgaris.

April 2, 2020

Xbrane announces it is continuing clinical trials of its ranibizumab candidate and remained on-track for target dates for regulatory filings despite CoVid-19.

March 31, 2020

The UK High Court rules filing errors in a Supplementary Protection Certificate (SPC) for Lucentis® (ranibizumab) have cut almost two years from Roche/Genentech’s protection in the UK. These errors arose when a third party engaged by Roche/Genentech failed to pay the full lump sum fees at the start of the SPC term.

March 30, 2020

Eli Lilly announced that the FDA has approved Taltz® (ixekizumab) for the treatment of paediatric patients with moderate to severe plaque psoriasis.

March 30, 2020

Biocad announces it has received registration certificates from Bosnia and Herzegovina for Acellbia® (rituximab) and Herticad® (trastuzumab), with a launch expected in 2020.

March 30, 2020

BiosanaPharma releases the results of Ph I trials of BP001 (omalizumab), reporting comparability to Xolair®.

March 30, 2020

Genentech announces that in response to CoVid-19, it would extend physician payment terms for Lucentis® (ranibizumab) purchases to 120 days, up from the previous 60 day term. These new terms will be implemented from 01 April, 2020, as well as retroactively for Lucentis® purchased on or after March 1, 2020.

March 27, 2020

Mylan and Lupin announce the EU’s CHMP has adopted a positive opinion recommending Nepexto® (etanercept) for all indications as Enbrel®.

March 26, 2020

Janssen announces approval of additional indication of ulcerative colitis for Stelara® (ustekinumab) in Japan.

March 26, 2020

iBio and AzarGen Biotechnologies announce they have entered into a second Statement of Work under their Master Joint Development Agreement. Under this agreement, iBio will assist AzarGen in the manufacture and characterisation of supplies to enable pre-clinical studies of a rituximab biosimilar.

March 24, 2020

Alvotech and DKSH announce an exclusive license partnership for the commercialisation of AVT02 (adalimumab candidate) in 36 emerging countries in South-East Asia. Under the agreement, Alvotech will be responsible for development and supply and DKSH will be responsible for registration and commercialisation.

March 24, 2020

Samsung Bioepis announces the FDA has approved its 420mg multi-dose vial of Ontruzant® (trastuzumab).

March 17, 2020

A new study reports that Truxima®  is comparable to the originator in terms of efficacy and safety in the treatment of multiple sclerosis.

March 16, 2020

Teva and Celltrion launch Herzuma® (trastuzumab) in the US. Herzuma® is indicated for the treatment of breast cancer, metastatic breast cancer and metastatic gastric cancer.

March 14, 2020

J&J announces Dano® is now also indicated for the treatment of adults with moderate to severe Crohn’s Disease. 

March 12, 2020

Hisun Pharmaceuticals completes Phase III trials of HS016 (adalimumab). Researchers concluded that HS016 was similar to adalimumab in terms efficacy and safety in the treatment of ankylosing spondylitis.

March 9, 2020

Celltrion submits its application for CT-P17 (adalimumab) to the EMA. If approved, CT-P17 will be the first high-concentration adalimumab available.

March 9, 2020

The US Federal Court of Appeals for the Circuit Court affirms the lower court’s refusal to preliminary injunct Amgen for its sale of biosimilar trastuzumab. Trial is expected to begin on 20 April, 2020.

March 9, 2020

Shanghai Henlius Biotech announces China’s National Medical Administration had accepted its Investigational New Drug application for HLX14 (denosumab). HLX14 is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.

March 6, 2020

In its 2019 Q4 earnings call, Mylan announces the FDA has accepted its aBLA for a proposed bevacizumab biosimilar. The FDA’s decision is expected on or before December 27, 2020.

February 18, 2020

AbbVie outlines defence strategy for Humira® (adalimumab) competition in the US market. CEO Gonzalez stated that AbbVie’s strategy will be based on the strategy already employed in Europe and other markets, while also admitting that global competition was much more aggressive than had been predicted.

February 13, 2020

Despite receiving CHMP approval earlier this month, Pfizer has announced it does not currently plan to launch Amsparity® (adalimumab) in the EU, citing unfavourable market conditions. 

February 11, 2020

Amgen sues Hospira in the District Court of Delaware, alleging Hospira’s aBLA for a proposed pegfilgrastim biosimilar infringes Amgen’s Neulasta patent for protein purification (no. 8,273,707).​

February 3, 2020

Bio-Thera announces BAT1706 (bevacizumab candidate) met the primary endpoint in Ph III clinical trials.

January 31, 2020

Pfizer announces positive CHMP opinion for Ruxience® .

January 27, 2020

Health Canada approves ulcerative colitis as an additional indication for Stelara®.

January 23, 2020

Pfizer launches Ruxience® in the US at a 24% discount to Rituxan®.

January 23, 2020

Pfizer announces biosimilar TmAb Trazimera® will launch in the US on 15 February at a 22% discount to Herceptin.

January 22, 2020

The UK’s NICE announces it will not recommend Stelara® for moderately to severely active ulcerative colitis due to uncertainties over cost-effectiveness.

January 21, 2020

AbbVie management acknowledge losses will be felt when biosimilar adalimumab products launch in the US market in 2023. Drawing from an international profit erosion of 45-48% for Humira® in 2019, AbbVie’s CEO Gonzalez warned stakeholders that biosimilar competition in the US would further impact profits. Gonzalez also noted that the erosion rate in the US would not be directly comparable to European markets as it would be heavily impacted by negotiations with managed care and pharmacy benefit managers.

January 20, 2020

We previously reported that Fresenius Kabi surrendered its patent AU2015263246 in the patent office in November 2019, which was the subject of a revocation suit commenced by Samsung Bioepis in July 2019.  The Court entered orders today dismissing the proceeding by consent, and ordering Fresenius to pay Samsung’s costs.

January 17, 2020

Genentech and Roche commence Ph III clinical trials of ranibizumab Port Delivery System (PDS) in patients with diabetic macular edema. The PDS uses a refillable eye implant to release a ranibizumab formulation over several months.

January 16, 2020

Health New England, a nonprofit health plan in Massachusetts, announces savings of $1.7 million in the past year by reaching 93% utilisation of biosimilar infliximab.

January 15, 2020

Alvotech and JAMP announce agreement to commercialise five biosimilar products in Canada.

January 13, 2020

Mundipharma announces commercialisation agreement with Samsung. The agreement grants Mundipharma exclusive commercialisation rights to Samsung’s adalimumab candidate in Taiwan and Hong Kong.

January 13, 2020

Mundipharma announces commercialisation agreement with Samsung. The agreement grants Mundipharma exclusive commercialisation rights to Samsung’s adalimumab, etanercept, trastuzumab and bevacizumab candidates in Taiwan and Hong Kong.

January 13, 2020

Coherus exercises option under agreement with Innovent to acquire commercialisation rights to rituximab biosimilar in the US.

January 13, 2020

Coherus announces licensing agreement with Innovent for the commercialisation of Innovent’s bevacizumab candidate, with plans to file an aBLA in late 2020 or early 2021.

January 11, 2020

Clover announces it has commenced dosing in Ph III trials of etanercept.

January 10, 2020

Bio-Thera launches adalimumab biosimilar, Qletli® in China following Nov 2019 approval.

January 10, 2020

Samsung and AffaMed announce Chinese approval for Phase III trials of eculizumab candidate.

January 7, 2020

US Court of Appeals affirms US PTAB’s earlier decision, which invalidated three AbbVie patents (8,889,135, 9,017,680 and 9,073,987) as obvious. The initial challenges to these patents were brought by Coherus and Boehringer Ingelheim, who have since settled with AbbVie, leaving the appeal to be defended by the USPTO.

January 7, 2020

Pfizer launches bevacizumab biosimilar Zirabev® in the US, at a 23% discount to Avastin®.

January 6, 2020

Sorrento Therapeutics announces partner Mabpharm has submitted a New Drug Application for its biosimilar infliximab to the Chinese NMPA.

January 3, 2020

New study demonstrates noninferiority of Pfizer’s Nivestim® to reference Neupogen®. Additionally, the study demonstrated that those in the biosimilar group reported a shorter median hospitalisation period by two days.

January 2, 2020

Clover announces it has received approved to enter clinical trials in China with SCB-808, biosimilar etanercept.

2019

December 19, 2019

Amgen submits BLA for biosimilar rituximab to FDA. 

December 19, 2019

Amgen and Tanvex file a joint stipulation of dismissal in their filgrastim dispute. The stipulation of dismissal states that parties will bear their own costs and attorney’s fees.

December 18, 2019

NeuClone announces completion of patient recruitment and dosing in Ph I trials of ustekinumab biosimilar.

December 17, 2019

Qilu receives Chinese approval for its bevacizumab biosimilar, Ankada®. 

December 16, 2019

Dong-A Socio Holdings and Meiji Seika announce commencement of Ph I trials of ustekinumab biosimilar.

December 16, 2019

Lupin releases results of Ph III trials of etanercept biosimilar, reporting similarity with the reference product.

December 13, 2019

Pfizer receives positive CHMP opinion for its biosimilar adalimumab product.

December 13, 2019

Boehringer Ingelheim has released the results of its Ph III trials of its biosimilar adalimumab, announcing the product demonstrated non-inferior efficacy and similar safety profile to the originator.

December 13, 2019

A new study released by the Universities of Saskatchewan and Alberta reveal substantial savings for health services switching to Apotex’s Grastofil®. The study analysed Canadian sales between 2016 and 2018, finding that the biosimilar accounted for $13,443,873 in savings, but could have accounted for $36,348,476 in savings had it been used in 100% of cases.

December 10, 2019

AffaMed receives Chinese approval to commence Ph III trials of Samsung’s trastuzumab biosimilar SB3.

December 9, 2019

Celltrion releases results of Ph III trials of Truxima® at the American Society of Hematology, announcing it was non inferior to Rituxan® in terms of efficacy and safety.

December 6, 2019

Amgen announced that the FDA has approved Avsola® (infliximab) for all Remicade® approved indications.

December 5, 2019

NeuClone announces results of Ph I trials of trastuzumab biosimilar, reporting the product successfully met primary and secondary endpoints.

December 4, 2019

Bio-Thera announces NMPA approval to commence Ph I trials of ustekinumab biosimilar.

December 4, 2019

Amgen and pharmacy benefit manager Abarca announce outcome based agreement for Enbrel®, under which Amgen will provide rebates to Abarca’s clients who start etanercept to treat RA but discontinue treatment after 3 months.  This is the second outcome-based between Abarca and Amgen, the prebvious (2018) arrangement related to hyperlipidemia medicine Repatha.

December 2, 2019

Mylan and Biocon announced the launch of Ogivri® in the US. This FDA-approved product was co-developed by Biocon Biologics and Mylan.

November 28, 2019

Amneal and Amgen settle patent dispute over filgrastim biosimilar. Notice of the settlement was approved by a US Federal Court, however no further details have been published. Amgen had filed the complaint against Amneal in March 2018, alleging infringement of a number of patents.

November 27, 2019

Coherus and Amgen settle suit over adalimumab. Notice of the agreement has been approved by a US Federal Court, however no further details about the settlement have been published. This dispute arose when Amgen launched Amgevita® in Europe in 2018 (manufactured in the US), with Coherus alleging the product infringed 4 of its own patents. 

November 27, 2019

Biocon announces its supplemental BLA (sBLA) for biosimilar pegfilgrastim has been approved by the FDA. This additional approval relates to FDA approval of Biocon’s subsidiary Biocon Biologics’ new manufacturing facility in Bengalaru.

November 26, 2019

Shanghai Henlius announces proposed trastuzumab biosimilar met primary endpoint in Phase III clinical trials.

November 23, 2019

Coherus and Bioeq announce licensing agreement for Lucentis® (ranibizumab) in the US. Under the agreement, Bioeq will receive upfront and launch milestone payments, with both parties sharing the profits.

November 21, 2019

Pfizer receives Australian approval for bevacizumab biosimilar, Zirabev®.

November 19, 2019

FDA accepts BLA for proposed bevacizumab biosimilar.

November 18, 2019

Polpharma commences dosing in Phase III trials of proposed natalizumab biosimilar.

November 16, 2019

Sandoz launches pegfilgrastim product, Ziextenzo®, in the US, at a 37% discount to the reference product, Neulasta®.

November 15, 2019

FDA approves Pfizer’s adalimumab biosimilar Abrilada®. This product will not be launched until November 2023, under the terms of Pfizer’s agreement with AbbVie entered into in November 2018.

November 12, 2019

Sandoz releases results of Erelzi® studies, including interim results of the COMPACT study, and long-term cost savings modelling analysis.

November 7, 2019

Bio-Thera announces China’s National Medicinal Products Administration has approved its biosimilar adalimumab, Qletli® for the treatment of rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.

November 7, 2019

Teva and Celltrion announce launch of Truxima® in the US, at a 10% price reduction compared to Rituxan®.

November 6, 2019

Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilar ranibizumab and aflibercept for major markets world side including the US, Canada, Europe, Japan and Australia. Biogen has also acquired exclusive commercialisation rights for its anti-TNF portfolio, including BENEPALI® (etanercept), FLIXABI® (infliximab) and IMRALDI® (adalimumab), in China.  Under the agreement, Biogen will make one $100 million upfront payment, with up to $210 million payable at additional development, regulatory and sales-based milestones.

November 6, 2019

Alvotech announced that it has entered an exclusive strategic partnership with Stada Arzneimittel for the commercialisation of seven biosimilars in all key European markets and selected markets outside Europe.

Under the agreement Alvotech will be responsible for the development, registration and supply of the biosimilars within the EU and Stada will be responsible for commercialisation in the majority of the key European markets.

November 6, 2019

Henlius Biotech wins ‘Biosimilar Initiative of the Year’ for its biosimilar rituximab at the Global Generics and Biosimilars Awards.

November 6, 2019

Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilar ranibizumab and aflibercept for major markets world side including the US, Canada, Europe, Japan and Australia. Biogen has also acquired exclusive commercialisation rights for its anti-TNF portfolio, including BENEPALI® (etanercept), FLIXABI® (infliximab) and IMRALDI® (adalimumab), in China.  Under the agreement, Biogen will make one $100 million upfront payment, with up to $210 million payable at additional development, regulatory and sales-based milestones.

November 6, 2019

Biogen and Samsung Bioepis announce partnership for the commercialisation of biosimilars ranibizumab and aflibercept. The agreement covers the US, Canada, Europe, Japan and Australia. Under the agreement, Biogen will make one $100M upfront payment, with up to $210M payable at additional development, regulatory and sales-based milestones.

November 5, 2019

FDA approves Sandoz’s pegfilgrastim biosimilar Ziextenzo®.

November 3, 2019

Gene Techno Science and Kishi Kasei announce agreement for the joint development of an aflibercept biosimilar.

November 2, 2019

Pfizer releases positive interim analysis of data from clinical trials of Pfizer’s Inflectra®.

November 1, 2019

AbbVie releases Third-Quarter results, showing an overall decrease in Humira® revenues of 3.7% due to biosimilar competition. While Humira® revenues continued to increase in the US by 9.6%, internationally revenues decreased by 33.5%.

October 28, 2019

Formycon announces dosing has begun in PhI clinical trials of ustekinumab biosimilar.

October 25, 2019

The CHMP adopts a positive opinion for Mundipharma’s pegfilgrastim candidate, recommending marketing authorisation be granted.

October 24, 2019

Celltrion presents pooled data from 3 post marketing studies of etanercept biosimilar, reporting that the study shows real-world evidence of the safety of the product.

October 19, 2019

Amgen releases results of Phase I clinical trials of infliximab biosimilar, reporting PK similarity as well as similar safety and immunogenicity profiles.

October 17, 2019

NeuClone announces it has commenced dosing in Phase I clinical trials of biosimilar ustekinumab candidate. 

October 16, 2019

Samsung executives admit subsidiary Archigen Biotech failed to develop a Rituxan biosimilar. The admission was made in Korean court court proceedings, with 8 executives and employees of Samsung facing accounting fraud charges.

October 14, 2019

Roche announces results of Phase III clinical trials of MabThera/Rituxan® compared to mycophenolate mofetil (MMF) in adults with moderate to severe pemphigus vulgaris (PV). Roche has announced that the results demonstrate Rituxan’s superiority over MMF for PV patients.

October 13, 2019

Polpharma publishes details of upcoming phase III clinical trials of biosimilar natalizumab candidate. The study will involve approximately 260 patients with relapsing-remitting multiple sclerosis.

October 12, 2019

Prestige releases details of upcoming Phase III clinical trials of biosimilar bevacizumab candidate.

October 12, 2019

Alteogen announces Phase I clinical trials of biosimilar aflibercept candidate will begin this month.

October 11, 2019

Lupin announces plans to file applications for biosimilar etanercept in the US market by the fourth quarter of FY20.

October 9, 2019

Samsung Bioepis releases results of Benepali® psoriasis study, announcing results demonstrate the product’s effectiveness and safety in a real-world setting. The study was conducted by the British Association of Dermatologists, Biologics and Immunomodulators Registry and enrolled 269 patients with moderate to severe psoriasis.

October 8, 2019

The Institute for Clinical and Economic Review releases its report on Unsupported Price Increases, highlighting AbbVie’s Humira® as one of the products with price increases which are unsupported by new clinical evidence. 

October 8, 2019

The Institute for Clinical and Economic Review releases its report on Unsupported Price Increases, highlighting Roche’s Rituxan® as one of the products with price increases which are unsupported by new clinical evidence. 

October 3, 2019

Celltrion and Juno announce Australian co-marketing partnership agreement for Herzuma® (trastuzumab) and Truxima® (rituximab). Under the agreement, Celltrion will hold the marketing authorisation and will be responsible for distribution, and Juno will provide sales promotion and hospital contracting services.

September 25, 2019

FDA issues a complete response letter for Tanvex’s proposed filgrastim biosimilar. Tanvex has announced that the FDA did not request additional clinical data or express concern related to product safety, but that certain items needed to be addressed before the application could be approved.

September 22, 2019

CMHP adopts positive opinion for additional indication for Remsima®, to include the treatment of rheumatoid arthritis.

September 19, 2019

Innovent releases results of Phase III clinical trials of bevacizumab biosimilar, reporting no statistical difference in media progression-free survival rates.

September 19, 2019

Dr Reddy’s commences enrolment for Phase III trials of biosimilar rituximab

September 18, 2019

iBio announces it has entered into an initial “Statement of Work” under its MOU with AzarGen Biotechnologies. iBio will manufacture research quantities of a plant-made rituximab using iBio’s proprietary FastPharming™ System.

September 11, 2019

Celltrion announces Canadian approval for its biosimilar trastuzumab, Herzuma®, for the treatment of HER-2 positive early breast cancer, metastatic breast cancer, and metastatic gastric cancer.

September 10, 2019

Samsung Bioepis announces Brazilian approval for Brenzys®. For the first 10 years, Samsung Bioepis willl supply the drug to local distributors, during which a technology transfer with local partners will take place, allowing local partners to take over manufacturing after this period.

September 9, 2019

Janssen announces EC approval for additional indication for Stelara®. Stelara® is now indicated for the treatment of ulcerative colitis.

 

September 9, 2019

JHL announces it will immediately cease development and clinical trials of a number of biosimilars including rituximab, trastuzumab and bevacizumab as part of a settlement deal with Genentech. This agreement settles the 2018 dispute between the two parties, in which it was alleged that JHL had illegally obtained trade secrets from Genentech relating to these products.

September 9, 2019

Alexion reveals that the EPO denied two patent applications relating to its eculizumab product, as they await the full written response.

September 6, 2019

Australia’s TGA approves Ziextenzo® in 6mg/0.6mL solution for injection prefilled syringe for the treatment of cancer patients following chemotherapy.

September 5, 2019

TOT Biopharm releases results of Phase I study of proposed BmAb biosimilar, reporting PK similarity and safety in comparison to the originator.

September 3, 2019

Sandoz and Polpharma announced they have entered into a licensing deal for Polpharma’s natalizumab biosimilar.  Under the agreement, Polpharma will develop, manufacture and supply the product, while Sandoz will be responsible for commercialisation and distribution.

September 3, 2019

Celltrion announces patnership with Lonza for the production of Remsima®. Lonza will now work within Celltrion’s network to complement Celltrion’s own production capacity.

September 2, 2019

US Patent and Trial Board commences an inter partes review of Alexion’s eculizumab patents following Amgen’s claims that they were anticipated or obvious.

August 31, 2019

NHS announces saving of £110 million by using AmAb biosimilars since AbbVie’s Humira® lost patent protection in October 2018.

August 30, 2019

Results of Phase III trial of proposed adalimumab biosimilar demonstrate therapeutic equivalence in terms of efficacy, safety and immunogenicity. The results, published in the first issue of the Lancet Rheumatology, support Innovent’s bid to launch the first biosimilar adalimumab in China.

August 30, 2019

Henlius commences recruitment for Phase I clinical trial of bevacizumab candidate. The trial will enrol 30 patients with solid tumours and is expected to commence in September 2019.

August 26, 2019

Eli Lilly announced that the FDA has approved Taltz® (ixekizumab) for the treatment of adults with active ankylosing spondylitis.

August 22, 2019

Amgen presents results of clinical study comparing safety and efficacy of rituximab biosimilar candidate to originator, reporting clinical equivalence.

August 22, 2019

Celltrion announces Japanese approval for three-week cycle of Herzuma® for the treatment of breast cancer.

August 21, 2019

Amgen and Mylan enter joint status report in US District Court agreeing Mylan did not infringe Amgen’s ‘707 patent. This comes after the Federal Court affirmed Sandoz did not infringe Amgen’s ‘837 patent either.

August 19, 2019

Dr Reddy’s launches bevacizumab biosimiliar Versavo® in India. The product is available in 100mg and 400mg single use vials and is indicated for the treatment of metastatic colorectal cancer, non-squamous non-small cell lung cancer, recurrent glioblastoma, metastatic renal cell carcinoma, cervical cancer, metastatic breast cancer and epithelial ovarian, fallopian tube and primary peritoneal cancer.

August 16, 2019

JHL Biotech publishes ustekinumab biosimilar is under development.

August 16, 2019

Samsung Bioepis commences patient enrolment for Phase III clinical study of eculizumab biosimilar candidate, SB12.

August 14, 2019

Bio-Thera announced it has initiated Ph I trials for BAT 2506 (golimumab biosimilar).

August 14, 2019

Celltrion remains optimistic ahead of Truxima® launch, despite difficulty with biosimilar uptake in Australian market. Expanding its Australian office from 4 to 15 people, the company is hoping to launch 3 biosimilar products in Australia in the next 3 years, including Truxima® and Herzuma®.

August 14, 2019

Bio-Thera announces commencement of Ph I trials of proposed golimumab biosimilar.

August 13, 2019

Regeneron announces FDA approval for Eylea® in 2mg, single dose prefilled syringe. The product is expected to launch this year and will require fewer preparation steps in comparison to the previously approved vials.

August 12, 2019

Quarterly etanercept data reveals biosimilar uptake remains slow in the Australian market. While the uptake of Brenzys® (MSD) has steadily grown, the biosimilar still only forms 15% of total scripts.

August 9, 2019

Sandoz announces US District Court ruled against Sandoz in patent litigation, preventing the launch of Erelzi®. Sandoz has announced that they will appeal this decision, and that both parties have agreed to an expedited appeal.

August 2, 2019

Momenta announces it has dropped proposed AmAb biosimilar candidate, M923, citing changes in market opportunity due to patent litigation settlements.

August 1, 2019

Mylan and Biocon announce the launch of Ogivri® in Australia. This is the first TmAb biosimilar to be listed on the PBS, following approval in December 2018.

August 1, 2019

New study compares short-term effects of Lucentis® with biosimilar, Razumab® on vision and central foveal thickness (CFT). The study reveals that after one month,  CFT improved in 85.7% of the ranibizumab biosimilar group, and in 86.8% of the ranibizumab group.

July 31, 2019

Celltrion announces commencement of patient enrolment for Phase III clinical trials of subcutaneous biosimilar infliximab,CT-P13.

July 29, 2019

Coherus reports “victory” in patent dispute with Amgen, announcing that the US Federal Circuit affirmed the District Court’s (Delaware) finding that Coherus’ biosimilar Udencya® does not infringe Amgen’s 8,273,707 patent.  Amgen commenced this BPCIA suit on 10 May 2017, the District Court granted Coherus’ motion to dismiss in March 2018, the appeal was heard on 8 May 2019, and the Fed Cir decision handed down on 29 July 2019.

July 29, 2019

Alvotech and Cipla announce they have entered an exclusive arrangement relating to the commercialisation of AVT02, Alvotech’s biosimilar adalumimab.  Alvotech is responsible for development and supply of the product, while Cipla is responsible for registration and commercialisation. AVT02 is in Phase-3 clinical development with an expectation that applications will be filed with EMA and FDA by “early 2020”.

July 25, 2019

Novartis announces positive CHMP opinion for additional indication of Lucentis®: the treatment of retinopathy of prematurity in preterm infants.

July 25, 2019

JCR announces results of Ph III trials of biosimilar darbepoetin candidate JR131 in patients with renal anemia. 159 patients enrolled in the 52 week study, with JCR reporting no adverse drug reactions, and that patient hemoglobin levels remained within the required 10.0 to 12.0 g/dL range throughout the study.

July 24, 2019

Samsung announces FDA approval of adalimumab biosimilar, Hadlima® for RA, JIA, PSA, Crohn’s, UC, PP and AS.  This is Samsung’s third biosimilar anti-TNF Ab approval in the US.  It will be marketed by Merck in the US, after 30 June 2023 pursuant to the terms of Samsung’s settlement with AbbVie.

July 23, 2019

Pfizer announces FDA approval for rituximab biosimilar rituximab (Ruxience®) for the treatment of adult patients with non-Hodgkin’s lymphoma, chronic lymphocytic leukemia, granulomatosis with polyangiitis and microscopic polyangiitis. This is the second biosimilar RmAb approved in the US, following the approval of Celltrion’s Truxima in November 2018.

July 23, 2019

Sandoz announces commencement of patient enrolment in Ph I/III trials of proposed biosimilar denosumab. A total of 520 osteoporosis patients will be enrolled in the 52 week study.

July 23, 2019

Amgen files new patent infringement suit against Tanvex. Amgen’s complaint alleges that Tanvex did not provide certain manufacturing information required by BPCIA legislation.

July 19, 2019

Samsung announces that its application for BmAb candidate SB8 has been accepted for review by the EMA.

July 19, 2019

Both Amgen and Celltrion’s biosimilar trastuzumab products, Kanjiti® and Herzuma® respectively, were considered by Australia’s PBAC committee for PBS listing and A flagging (substitution).  This follows the May 2019 PBAC recommendations for PBS listing of Mylan and MSD’s biosimilar products.

July 18, 2019

Amgen launches Mvasi® in the US. Mvasi is approved for five types of cancer and was the first oncology therapeutic biosimilar approved by the FDA.

July 18, 2019

Celltrion announces creation of JVCo with Nan Fung Group for the commercialisation of Remsima®, Truxima® and Herzuma® in China. The joint venture company, Vcell Healthcare will obtain exclusive rights to develop, manufacture and commercialise these three products in mainland China.

July 18, 2019

US District Court refuses Genentech’s request for a temporary restraining order and preliminary injunction against Amgen following Amgen’s launch of biosimilar trastuzumab Kanjinti®. In a memorandum opinion the Court has called Genentech’s request ‘contrary to the spirit’ of the BPCIA, stating that Genentech had been given warning of the upcoming launch in May 2018.

July 18, 2019

Celltrion announces creation of a JV Co with Nan Fung Group for the commercialisation of Remsima®, Truxima® and Herzuma® in China. The new company Vcell Healthcare will obtain exclusive rights to develop, manufacture and commercialise these three products in mainland China.

July 18, 2019

Celltrion announces creation of JV Co with Nan Fung Group for the commercialisation of Remsima®, Truxima® and Herzuma® in China. The joint venture company, Vcell Healthcare will obtain exclusive rights to develop, manufacture and commercialise these three products in mainland China.

July 17, 2019

Revocation proceedings were commenced in the Federal Court by Samsung Bioepis on a Fresenius Kabi adalimumab formulation and use patent AU2015263246 (‘246).  The 246 patent covers a specific formulation of adalimumab with a histidine buffer, sugar, surfactant and pH, and use of that formulation.

July 15, 2019

Alvotech announces completion of enrolment in Phase III trials of biosimilar adalimumab AVT02.  407 participants across Europe have enrolled, while Phase I PK trials are ongoing.

July 15, 2019

Celltrion announces start of Phase I Clinical trials of omalizumab biosimilar, with Phase III trials expected to begin in the first half of 2020.

July 11, 2019

We previously reported that Samsung Bioepis commenced proceedings in July 2019 in the AU Federal Court seeking to revoke an adalimumab formulation and use patent owned by Fresenius Kabi.  In an interesting development, Fresenius Kabi surrendered the patent in the patent office on 12 November 2019.

July 11, 2019

Study finds mAbxienxe’s biosimilar rituximab candidate RTXM83 is not inferior to the reference drug in terms of efficacy.

July 9, 2019

Mylan launches Hulio® in Spain following EC approval in September 2018.

July 8, 2019

Catalyst Biosciences announce eptacog alfa biosimilar met primary endpoints in Ph II trials.

July 7, 2019

A new study reveals rituximab may be effective in managing mixed cryoglobulinemic vasculitis.

July 4, 2019

Samsung and Genentech settle patent dispute, allowing for the sale of Samsung’s Ontruzant®.

July 2, 2019

Prestige announces agreements with Pharmapark and Mundipharma for the supply and commercialisation of Tuznue® . An agreement reached with Pharmapark allows for supply and commercialisation in Russia, while the agreement with Mundipharma grants an exclusive license and supply of the drug.

July 1, 2019

Amgen withdraws its Marketing Authorisation application for biosimilar infliximab ABP710, citing a change in product strategy.

July 1, 2019

Shanghai Biomabs commences Ph I trials of biosimilar denosumab candidate.

July 1, 2019

Study reveals outcomes for the use of filgrastim in stem cell mobilisation prior to transplant, recording similar outcomes for tbo-filgrastim, the reference drug and biosimilar filgrastim (Zarxio).

June 28, 2019

FDA approves Pfizer’s bevacizumab biosimilar, Zirabev® for the treatment of metastatic colorectal cancer; unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer; recurrent gliobastoma; metastatic renal cell carcinoma; and persistent, recurrent or metastatic cervical cancer.

June 27, 2019

The CHMP recommended an extension of the approval of Dupixent® (dupilumab) to also include adolescents 12 to 17 years of age with moderate-to-severe atopic dermatitis who are candidates for systemic therapy. Dupixent was first approved by the EC in September 2017.

June 21, 2019

Henlius announces that EMA has accepted Henlius’ MAA for trastuzumab biosimilar HLX02. This is the first Chinese developed TmAb biosimilar to be accepted for review by the EMA.

June 14, 2019

Sandoz announces results of Hyrimoz® switching studies in patients with moderate-to-severe rheumatoid arthritis, announcing no clinically meaningful differences in safety, efficacy or immunogenicity.

June 13, 2019

FDA approves Amgen’s biosimilar TmAb Kanjinti® for all indications.

June 12, 2019

FDA accepts Roche’s BLA and grants priority review to Rituxan® for the treatment of granulomatosis with polyangiitis and microscopic polyangiitis in children. The FDA is yet to approve any treatments for these blood vessel disorders.

June 4, 2019

Samsung BioLogics announces Imraldi® dominates 46% share in European adalimumab biosimilar market.

June 4, 2019

Samsung Bioepis announces Benepali® dominates 40% share in European etanercept biosimilar market.

June 3, 2019

Innovent presents results of efficacy and safety study of BmAb biosimilar at the Annual Meeting of the American Society of Clinical Oncology (ASCO).

May 31, 2019

Xbrane and STADA announce expansion of biosimilar development partnership. This expansion will now include the development of Xbrane’s biosimilar candidates certolizumab pegol and nivolumab, as well as other biosimilars.

May 29, 2019

Tokyo District Court judge dismisses Genentech’s infringement suit against Sandoz and its local marketing partner Kyowa Hakko Kirin.

May 29, 2019

Results of 24 week switching study released, citing no changes in safety or efficacy outcomes. The study was conducted in patients with moderate to severe rheumatoid arthritis and compared the outcomes of those who swapped to the Sandoz candidate at 24 weeks and those who continued with the reference drug.

May 28, 2019

The EMA accepts Prestige Biopharma’s application for trastuzumab biosimilar Tuznue®.

May 22, 2019

Health Canada approves Ogivri® for the treatment of HER2-positive breast cancer and HER2-positive metastatic stomach cancer. The product is the first TmAb biosimilar to be approved in Canada and is expected to be launched in the current quarter.

May 20, 2019

Genentech moves to dismiss Pfizer’s counter-claims, claiming that BPCIA legislation prevents any declaratory judgement as Pfizer did not comply with requirements during the ‘patent dance’.

May 16, 2019

Amgen receives Australian approval for biosimilar trastuzumab Kanjinti®, in 60mg, 150mg and 420mg dosages.

May 15, 2019

AbbVie announces global settlement with Boehringer Ingelheim. This is the 9th global deal AbbVie has entered into, with BI securing a US market entry date of 1 July 2023, after Amgen (31 Jan 2023) and Samsung Bioepis (30 Jun 2023), and before Mylan (31 Jul 2023), Fresenius Kabi and Sandoz (30 Sept 2023), Momenta Pharmaceuticals and Pfizer (20 Nov 2023), and Coherus BioSciences (15 Dec 2023). The agreement is royalty bearing, however no further details have been released.

May 15, 2019

NeuClone confirms Ph1 trials of biosimilar ustekinumab will commence in the second half of 2019, as previously announced.

May 10, 2019

Federal Court affirms District Court finding Sandoz did not infringe Amgen’s ‘837 patent.

May 10, 2019

Federal Court affirms District Court finding Sandoz does not infringe Amgen’s ‘837 patent.

May 9, 2019

Innovent and Eli Lilly announce rituximab biosimilar IBI301 met primary endpoints in Phase III clinical trials and PK study.

April 29, 2019

Pfizer responds to Genentech’s complaint, seeking declaratory judgement of invalidity and noninfringement of all of the patents in Genentech’s complaint.

April 29, 2019

In response to FDA approval of Eticovo®, Amgen and Roche file a suit alleging the infringement of five patents. Within the complaint, Amgen and Roche allege that Samsung failed to provide them with a copy of its aBLA or details of the manufacturing process, as well as failing to provide the 180 day notice of commercial marketing.

April 29, 2019

FDA approves biosimilar etanercept Eticovo® for all eligible indications (RA, ankylosing spondylitis, plaque psoriasis, psoriatic arthritis and polyarticular juvenile idiopathic arthritis).

April 23, 2019

Xbrane commences Phase III trials for biosimilar ranibizumab candidate Xlucane®.

April 19, 2019

Sandoz reports results of long term studies (up to 54 weeks) on the efficacy, safety and immunogenicity of infliximab biosimilar.  This product was initially developed by Pfizer and acquired by Sandoz.

April 11, 2019

Sandoz and Roche settle long-running AU Federal Court dispute over rituximab biosimilar, allowing for the launch of Sandoz product Riximyo® “in the near future”.  The 2017 Federal Court proceedings before Burnley J were dismissed.

April 11, 2019

Selexis announces first biosimilar eculizumab approval in Russia through partnership with Generium. 

April 10, 2019

Health Canada approves Teva’s Truxima® for the treatment of non-Hodgkin lymphoma, chronic lymphocytic leukemia and rheumatoid arthritis in adult patients.

April 9, 2019

Alvotech and Fuji Pharma announce exclusive agreement for the commercialisation of Stelara® biosimilar in Japan. Alvotech will be responsible for development and supply while Fuji Pharma will receive exclusive rights to commercialise the drug in Japan. This follows Fuji Pharma’s recent US $50 million investment in Alvotech.

 

 

April 5, 2019

Genentech files complaint against Pfizer in the District Court of Delaware alleging infringement of 22 patents and requesting a declaratory judgment of infringement of several of these patents.

April 3, 2019

Fresenius Kabi announces European Commission approval of biosimilar adalimumab, Idacio® for all indications. 

April 2, 2019

Sandoz announces resubmission of its BLA for pegfilgrastim biosimilar candidate, including new data from pharmacokinetics and pharmacodynamics studies.

April 2, 2019

The Mayor and City Council of Baltimore files additional class action against AbbVie, alleging that anti-competitive behaviour prevented the introduction of biosimilars and allowed AbbVie to demand ‘supra competitive prices’. Additionally, the complaint alleges that through the agreements reached with AbbVie, Amgen has been awarded a 5 month period with reduced competition as the only biosimilar available from January 2023.

March 28, 2019

Celltrion announces completion of recruitment for Phase III clinical trials of biosimilar adalimumab.

March 26, 2019

Lupin announces approval of biosimilar etanercept in Japan for the treatment of moderate to severe Rheumatoid Arthritis. 

March 18, 2019

UFCW Local 1500 Welfare Fund, a grocery union, files class action against AbbVie, Amgen, Samsung Bioepis, Mylan, Sandoz, Fresenius Kabi, Pfizer and Momenta, alleging misconduct and antitrust violations. The union alleges that the hundreds of patents which protect Humira® and settlements reached which the other seven companies have resulted in a monopoly which has prevented any competition. The class action includes persons or entities who have purchased or paid for Humira® since January 1, 2017.

March 16, 2019

PBAC Committee recommends all 4 brands of Celltrion biosimilar products (Tuxella®, Rituzena®, Ritemvia®, Truxima) for PBS listing in AU for all TGA registered indications for which the reference brand Mabthera is currently listed on the PBS, despite approved skinny label). 

March 15, 2019

Roche announces EC approval for a label expansion of MabThera®. The approval now includes the treatment of pemphigus vulgaris, the first major advancement for the treatment of this disease in more than 60 years.

March 14, 2019

UK Competition and Markets Authority closes investigation into Merck discount scheme after finding no grounds for further action. This decision is contrary to the provisional findings in May 2017 which indicated a breach of competition law.

March 13, 2019

Alvotech commences Phase III trial of 100mg/mL adalimumab biosimilar. 400 participants will be enrolled across 30 sites in Europe in this comparability study.

March 11, 2019

Pfizer announces FDA approval of biosimilar trastuzumab Trazimera® for the treatment of HER2 positive breast cancer and HER2 metastic gastric or gastroesophageal junction adenocarcinoma.

March 8, 2019

Celltrion claims results of 1 year comparison study of subcutaneous formulation of infliximab biosimilar demonstrate comparable efficacy and safety with intravenous formulation.

March 1, 2019

Napp launches biosimilar pegfilgrastim, Pelmeg®, in the UK. This biosimilar was developed by Cinfa Biotech and acquired by Mundipharma.

March 1, 2019

Sandoz obtains Sandoz Australian approval for biosimilar adalimumab Hyrimoz®. This is the third biosimilar adalimumab approval in Australia.

March 1, 2019

Celltrion gains Australian approval for biosimilar rituximab under two product names, Rituzena® and Tuxella®.

February 28, 2019

Apotex division Apobiologix launches pegfilgrastim biosimilar, Lapelga® in Canada.

February 28, 2019

FDA approves subcutaneous formulation of Herceptin for the treatment of HER2-overexpressing breast cancer.

February 27, 2019

In ongoing litigation between Boehringer and AbbVie, the court has ordered Boehringer to release its plans for biosimilar adalimumab, Cytelzo®. Cytelzo® has been approved by the FDA but has not yet been launched.

February 26, 2019

Samsung Bioepis partners with C-Bridge to commercialise biosimilars in China. Under the deal, C-Bridge will develop a new company, AffaMed Therapeutics to launch candidates such as ranibizumab, eculizumab and trastuzumab biosimilars.

February 25, 2019

Sandoz files suit against Amgen, seeking DJ of non-infringement and invalidity. This comes as Sandoz awaits FDA decision on its pegfilgrastim biosimilar, with Sandoz hoping to block any preliminary injunction motions from Amgen.

February 25, 2019

China’s National Medical Products Administration approves first rituximab biosimilar, Hanlikon®.

February 22, 2019

Alteogen announces new drug application to the Ministry of Food and Drug Safety for aflibercept biosimilar, ALT-L9.

February 21, 2019

Biosana announces approval for Phase 1 trials of biosimilar omalizumab, with results expected in the fourth quarter of 2019.

February 19, 2019

Pfizer announces EU approval for Zirabev®, biosimilar BmAb.

February 15, 2019

In its final appraisal of pertuzumab, the National Institute for Health and Care Excellence (NICE) has recommended it for the treatment of lympth node-positive disease. The final appraisal comes following the promise of a large discount offered by Roche.

February 11, 2019

Samsung Bioepis announces partnership with C-Bridge to commercialise biosimilars in China. Under the deal, C-Bridge will develop a new company, AffaMed Therapeutics to launch candidates such as ranibizumab, eculizumab and trastuzumab biosimilars.

February 5, 2019

Mundipharma launches pegfilgrastim biosimilar, Pelmeg®, in Europe. Pelmeg® was developed by Cinfa Biotech, and is the fourth biosimilar commercialised by Mundipharma.

February 1, 2019

The CHMP recommends granting approval for two AmAb biosimilars, Idacio® and Kromeya®. Both products are indicated for RA, psoriasis, psoriatic athritis and Crohn’s disease.

January 25, 2019

Coherus announces an 8th global deal with AbbVie for the commercialisation of biosimilar AmAb, under which Coherus has global, non-exclusive license rights which are royalty bearing.  Coherus’ US rights commence on 15 Dec 2023, just under a month after Momenta’s & Pfizer’s.

January 24, 2019

Amgen announces results of Phase 1/Phase 3 study of rituximab biosimilar candidate, confirming the study demonstrated favourable efficacy and safety profiles.

January 23, 2019

Alvotech announces development in biosimilar pipeline with $300 million raised through a private bond offering.

January 22, 2019

Bio-Thera announces commencement of Ph III trials of BAT1806, its proposed tocilizumab biosimilar. Results are expected in the second half of 2020.

January 21, 2019

FDA approves biosimilar trastuzumab for all eligible indications. This is Samsung Bioepis’ first oncology biosimilar to receive FDA approval.

January 21, 2019

Health Canada approves new indication for Erelzi®, allowing for the treatment of psoriatic arthritis. 

January 18, 2019

Celltrion announces success in litigation against Samsung Biogen, invalidating Samsung Biogen’s patent for biosimilar rituximab. 

January 14, 2019

Bio-Thera announces partnership with Cipla to commercialise BmAb candidate in emerging markets.

January 9, 2019

Samsung Bioepis obtains AU approval for Ontruzant®, biosimilar trastuzumab, in Australia.  This is the third biosimilar TmAb to be approved in AU, following Celltrion’s approval of Simabtra® in July 2018, and Mylan’s approval of Ogivri® in December 2018.

January 7, 2019

Regeneron announces $4.07 billion in 2018 US net sales for Eylea®, as it awaits the commencement of new clinical trials for a high dose formulation.  Additionally, the FDA has assigned 13 May 19 as the action date for a potential new indication in diabetic retinopathy.

January 7, 2019

Samsung Bioepis announces partnership with 3SBio to commercialise biosimilars in China. Under the agreement, Samsung Bioepis will be be responsible for manufacturing and supplying the products, while 3SBio will be responsible for regulatory registration and commercialisation.

January 6, 2019

Celltrion announces it will establish a direct sales network minimising sales partners, including for its biosimilar infliximab, Remsima®.

January 5, 2019

Coherus announces launch of pegfilgrastim biosimilar Udencya® in the US, confirming sales began on January 3rd.

January 4, 2019

Alteogen announces it has been granted a process patent for producing aflibercept biosimilar, ALT-L9.  Alteogen reports the process improves the productivity and quality of large-scale production of fusion proteins.

2018

December 28, 2018

Sandoz announces agreement with Gan & Lee Pharmaceutical to commercialise biosimilar insulins.

December 27, 2018

JHL announces first patient in randomised Phase III study conducted in China. The trial is being conducted in patients with previously untreated diffuse large B-cell lymphoma.

December 24, 2018

Mycenax announces positive results from Ph I PK clinical trials, reporting the product met the primary endpoint in PK comparison.

December 24, 2018

Chong Kun Dang announces approval for biosimilar darbepoetin from the Ministry of Food and Drug Safety of South Korea. This is the first biosimilar darbepoetin to be approved in a highly regulated country.

December 23, 2018

Shanghai Henlius’ research team presented an update on its TmAb clinical program with Phase III trials underway in Poland, Ukraine, Phillippines and China.

December 23, 2018

Prestige announces licensing agreement with Cipla, granting Cipla exclusive rights to distribute and market Prestige’s TmAb biosimilar in emerging markets.

December 20, 2018

The NHS announces negotiations for the supply of adalimumab biosimilars have concluded with Amgen, Biogen, Mylan, Sandoz and AbbVie. This deal is predicted to save the NHS £300M per year.

December 20, 2018

Biocon announces EU marketing authorisation for biosimilar trastuzumub, Ogivri®. Ogivri® is indicated for the treatment of HER2 positive early breast cancer, metastatic breast cancer and metastic gastric cancer.

December 20, 2018

FDA approves TmAb biosimilar for the treatment of HER2-positive breast cancer. Herzuma® is the second TmAb biosimilar to be approved in the US. Celltrion is currently defending the biosimilar against Genentech, and while Genentech and Pfizer have reached a settlement, Celltrion, Amgen and Samsung Bioepis remain in litigation.

December 19, 2018

Xbrane submits first CTA to FDA for clinical trials of ranibizumab biosimilar candidate, Xlucane®. The Phase III trials will be conducted in patients with wet form of age-related macular degeneration.

December 17, 2018

Amgen files BLA for biosimilar infliximab.

December 17, 2018

NeuClone announces that it has biosimilar pertuzumab in preclinical development.

December 15, 2018

French study supports the use of Remsima® in the treatment of Crohn’s disease, showing equivalency to reference product in safety and effectiveness.

December 14, 2018

PBAC releases results from November PBAC meeting. The PBAC recommended Alphapharm’s Fulphila® for listing on the PBAC for all indications with “A” flagging.  Fulphila® and Amgen’s Neulasta® and Ristempa® brands of pegfilgrastim are now considered equivalent for the purpose of substitution (i.e. “A” flagged).

December 14, 2018

The EMA’s Committee for Medicinal Products for Human Use recommends approval of Pfizer’s BmAb biosimilar Zirabev®.  This is Pfizer’s second oncology biosimilar to receive positive EMA opinion this year.

December 14, 2018

Results of two year study demonstrate similar safety and efficacy between Celltrion’s Truxima® and the reference product in the treatment of advanced follicular lymphoma.

December 13, 2018

Innovent announces BmAb candidate met pre-defined endpoints in Phase III trials.

December 13, 2018

Genentech and Pfizer voluntarily dismiss all claims in litigation commenced in November 2017, each covering their own legal costs. While no details have been published, the dismissal suggests a settlement has been reached.

December 11, 2018

Alphapharm receives TGA approval for its biosimilar TmAb in Australia (Ogivri®) in 2 dosage forms (150mg, and 440mg powder for injection), four months after Celltrion received approval for its TmAb biosimilar products on 17 July 2018.

December 8, 2018

Samsung Bioepis announces comparable efficacy and safety to reference Trastuzumab in one-year follow-up study published at the San Antonio Breast Cancer Symposium.

December 5, 2018

Pfizer notifies the CHMP it wishes to withdraw its application for Fyzoclad®, biosimilar adalimumab, due to changes in the company’s strategy.  

December 2, 2018

The EMA accepts Celltrion’s application for a subcut formulation of biosimilar infliximab, Remsima SC®.

December 1, 2018

At the ASH Annual meeting, a paper was presented indicating positive results for Sandoz’s proposed RmAb biosimilar to EU reference drug, and concluding “efficacy, safety and immunogenicity, PK and PD of PF‑05280586 and rituximab-EU were similar up to Week 26 in subjects with previously untreated CD20-positive, LTB-FL”

November 30, 2018

AbbVie announces a 7th global deal for biosimilar adalimumab. A non-exclusive royalty bearing license to Pfizer for AmAb will begin on 20 November 2023 in the US and on approval in the EU (no other dates disclosed).  Pfizer’s US launch date is the same as Momenta’s, 10 months after the first licensed biosimilar launch (Amgen).

November 28, 2018

Tanvex announces that the FDA has accepted its BLA for biosimilar filgrastim.

November 28, 2018

FDA approves Celltrion’s rituximab biosimilar CTP-10 (Truxima®), for the treatment of non-Hodgkin’s lymphoma. This is the first US biosimilar RmAb to be approved.

November 28, 2018

Daiichi Sankyo launches first trastuzumab biosimilar in Japan.

November 27, 2018

Sandoz announces EC marketing approval for pegfilgrastim biosimilar Ziextenzo®.

November 20, 2018

EMA approves biosimilar pegfilgrastim Pelmeg® for patients undergoing cytotoxic chemotherapy for malignancy, with the exceptions of chronic myeloid leukaemia and myelodysplastic syndromes.

November 16, 2018

Sandoz receives approval for rituximab biosimilar under two presentations and two brands. The approval includes 500mg/50mL Rixonfya®, 100mg/10 mL Rixonfya®, 500mg/50mL Rixvyda® and 100mg/10mL Rixvyda®. Sandoz is currently prevented from supplying for use, selling, supplying or offering to sell biosimilar rituximab (under injunction) until 11 August 2019, with a Federal Court hearing set down for 3 weeks beginning on 3 June 2019.

November 13, 2018

China’s National Medical Products Administration accepts Innovent’s application for biosimilar adalimumab. The application seeks approval for the treatment of ankylosing spondylitis, rheumatoid arthritis, and psoriasis.

November 8, 2018

Coherus discloses newly approved biosimilar Udencya® will be available at a 33% discount to Neulasta®, matching the price point for Mylan’s biosimilar Fulphila®. The product is due to be launched on 3 January 2019.

November 6, 2018

AbbVie announces a 6th global deal for biosimilar AmAb, this time with Momenta.  Momenta has obtained a global royalty bearing licence beginning on 20 November 2023 for the US, and in the EU “on approval” (no other dates disclosed). Momenta will be able to launch in the US 10 months after Amgen, with Samsung, Mylan, Fresenius and Sandoz able to launch between June and September of 2023.

November 2, 2018

FDA approves Coherus’ biosimilar pegfilgrastim Udencya® for patients receiving myelosuppressive chemotherapy. This is the first US/EU approved biosimilar approved for this indication.

November 2, 2018

Sandoz announces it will not pursue biosimilar rituximab in the US following requests from the FDA for additional information to complement the BLA.

November 1, 2018

Sandoz’s biosimilar Zarxio® is included in Express Script’s 2018 National Preferred Formulary.

November 1, 2018

Sandoz reports etanercept biosimilar is comparable to originator at 48 weeks.

October 31, 2018

FDA approves Sandoz adalimumab biosimilar Hyrimoz® for treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spodylitis, adult Crohn’s disease, ulcerative colitis and plaque psoriasis.

October 29, 2018

Samsung announces Phase III trials of ranibizumab biosimilar are underway.

October 25, 2018

Regeneron announces completion of Phase III clinical trials of Eylea® (aflibercept) in patients with moderately severe and severe non-proliferative diabetic retinopathy.  The company reported the trial met its one year primary endpoint and key secondary endpoints.

October 23, 2018

NeuClone commences Phase I clinical trials for biosimilar trastuzumab.

October 19, 2018

Mylan announces launch of Hulio®, biosimilar adalimumab in Europe.

October 19, 2018

In advance of US biosimilar competition, Genentech announces expanded indication set, including follow up treatment in adult patients with Granulomatosis with Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) who have achieved disease control with induction treatment.

October 19, 2018

Mylan and Biocon announce the CHMP’s positive opinion recommending Ogivri® (biosimilar TmAb) for approval in EMA.  Approval is expected before the end of the year.

October 18, 2018

AbbVie and Fresenius separately announce global deal with Fresenius Kabi under which Fresenius has a US licence from 30 Sept 2023 (the same date as Sandoz), and may sell in EU on approval.  The deal is global, and different dates apply for other regions.  The Fresenius (and Sandoz) US launch date is 9 months after Amgen’s (31 Jan 2023), 3 months after Samsung Bioepis’ (30 Jun 2023), and 2 months after Mylan’s (31 Jul 2023).

October 15, 2018

BmAb biosimilar approved by China’s National Medical Products Administration for clinical development for Non-Small Cell Lung Cancer and hepatocellular carcinoma.

October 15, 2018

Sandoz, Samsung and Amgen launch their biosimilar adalimumab products (Hyrimoz®, Imraldi® and Amgevita®) pursuant to the terms of their IP licences with AbbVie.  Mylan also has EMA approval (but no AbbVie EU IP licence) but has indicated an intention to launch their biosimilar Hulio® on or after 16 October.  Similarly Boehringer has no IP licence, but we have no indication of BI’s launch plans for approved Cyltezo®

October 15, 2018

BmAb biosimilar approved for Phase I and Phase III Clinical Trials by NMPA. 

October 11, 2018

AbbVie announces global settlement with Sandoz, under which Sandoz receives a royalty-bearing, non-exclusive licence to AbbVie’s Humira® patents from 30 Sep 2023 in the US, and 16 Oct 2018 in EU (and other dates elsewhere).  The EU date is the same as AbbVie has given to Amgen and Samsung Bioepis (note – Mylan has no EU license), and the US date is later than those given to Amgen (31 Jan 2023), Samsung Bioepis (30 Jun 2023) and Mylan (31 Jul 2023).

October 10, 2018

Munidpharma acquires Cinfa Biotech, gaining immediate access to pegfilgrastim biosimilar and a platform to potentially develop more biosimilars in the future.

October 10, 2018

US’ Oncologic Drug Advisory Committee unanimously recommends Celltrion’s CT-P10 for approval as a biosimilar to Rituxan.

October 9, 2018

Fresenius Kabi announces that clinical trials for Neulasta® biosimilar met primary endpoints for EU and US.

October 7, 2018

Merck secures 5 year, $117.5M deal with US Department of Veterans Affairs to supply rituximab biosimilar developed by Samsung.

October 4, 2018

Xbrane announces biosimilar ranibizumab shows equivalent pharmacokinetic profile and equivalent tolerability to originator in study conduct in rabbits.

October 1, 2018

Momenta announces a shift in focus from biosimilars to novel therapeutics. The 5 year re-structuring plan will involve cuts to staff of 50%, however the company will continue to develop biosimilar aflibercept candidate M710.

October 1, 2018

Momenta announces an end to its strategic review, revealing a sole focus to advance a Humira® biosimilar. Momenta announced it will file a BLA with the FDA and is working to find a commercialisation partner for the product. 

September 27, 2018

FDA accepts BLA for biosimilar adalimumab. 

September 20, 2018

Mylan announces the EU approval of Hulio®, biosimilar adalimumab licensed from Fujifilm in April 2018.

September 18, 2018

Researchers release results of pre-clinical study of cetuximab candidate APZ001. 

September 14, 2018

FDA announces approval of Amgen’s Mvasi®, the first BmAb biosimilar to gain approval in the US

September 10, 2018

Significant increase in the use of alternative filgrastim products reported among Medicare Part B beneficiaries.

September 3, 2018

Iranian AryoGen receives GMP certification from the European Medicines Agency, becoming the first mAb manufacturer in the Middle East and North Africa region to do so. 

August 24, 2018

Bio-Thera announces that the CNDA (China National Drug Administration) has accepted its BLA for biosimilar adalimumab BAT1406.  This is expected to be Bio-Thera’s first drug approval.

August 22, 2018

Pfizer accuses originators of using scare campaigns to undermine confidence in biosimilars in a citizen’s petition seeking guidance on the representations which can be made about biosimilar products. Pfizer criticises the slower uptake of biosimilars in the US in comparison to Europe, alleging that false and misleading statements made by originators have contributed to this.

August 20, 2018

Qilu commences Ph 1 trials of biosimilar denosumab candidate.

August 20, 2018

Nippon Kayaku launches Celltrion’s trastuzumab biosimilar in Japan, but only for the treatment of gastric cancers.

August 20, 2018

The National Institute for Health and Care Excellence (NICE) again recommends against Roche’s application for pertuzumab as an adjuvant treatment in patients with a high risk of recurrence. NICE confirmed its earlier findings that pertuzumab is unlikely to be cost-effective, with clinical trials revealing only a small incremental treatment benefit.

August 10, 2018

Celltrion set to commence Phase III Clinical Trials for BmAb biosimilar in 150 sites across Europe, Asia and South America.

August 7, 2018

Amgen files third suit against Apotex based on aBLAs for biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).  The patent under scrutiny, US Patent No. 9,856,287 was issued on 2 January this year and therefore was not included in earlier ‘patent dances’ claiming priority to the original ‘138 patent.  With three additional pending patent applications claiming priority to the ‘138 patent, it is likely that further litigation will result.

August 7, 2018

Amgen files third suit against Apotex based on aBLAs for biosimilars of Neupogen® (filgrastim) and Neulasta® (pegfilgrastim).  US patent 9,856,287 was issued on 2 January 2018 and was not included in earlier ‘patent dances’.  With three additional pending patent applications in this family, it is likely that further litigation will result.

August 7, 2018

Celltrion announces Phase I and III trials for AmAB biosimilar across 75 sites in 8 European nations, expected to be completed by 2020.

August 7, 2018

iBio and CC-Pharming enter agreement to develop biosimilar rituxumab for the Chinese market.

August 4, 2018

Clover announces that Phase I trials of a potential etanercept biosimilar are underway.

July 31, 2018

Intas announces subsidiary Accord Healthcare will release pegfilgrastim biosimilar across Europe after receiving a positive response from the Committee for Medicinal Products for Human Use.

July 31, 2018

Pfizer announces EMA approval of biosimilar trastuzumab, Trazimera® for the treatment of human epidermal growth factor (HER2+) breast cancer and HER2+ metastatic gastric or gastroesophageal junction adenocarcinoma.  This is Pfizer’s 4th biosimilar to receive EU approval.

July 28, 2018

AU’s PBAC has confirmed that Amgen and Samsung’s biosimilar adalimumab (respectively Amgevita and Hadlima) will be “A-flagged”, enabling pharmacy substitution.

July 27, 2018

Coherus announces that it received a positive response from the CHMP for its pegfilgrastim biosimilar.

July 27, 2018

Sandoz announces EC approval for Hyrimoz®, biosimilar adalimumab for use in all indications.

July 27, 2018

Mylan and Fujifilm announce positive response from CHMP for biosimilar adalimumab for use in all indications. 

July 26, 2018

Glenmark releases Phase I results of biosimilar omalizumab, suggesting similarity in pharmacokinetic, pharmacodynamic, safety and immunogenicity profiles to Xolair®.

July 26, 2018

Dr Reddy’s announces biosimilar trastuzumab available in India for the treatment of HER2-positive cancers.

July 25, 2018

Teva launches first biosimilar filgrastim in South Africa at 70% of the price of Amgen’s product. This comes more than 5 years after Teva first sought regulatory approval, demonstrating the backlog of products awaiting approval from the South African Health Products Regulatory Authority.

July 20, 2018

Pfizer announces FDA approval of Pfizer’s Nivestym®, biosimilar to filgrastim for all indications.

July 17, 2018

AbbVie announces a global settlement with Mylan under which Mylan acknowledges Humira® AbbVie’s patents are valid, and Mylan receives a royalty-bearing, non-exclusive global license (excluding Europe) from 31 July 2023.  This date will not be accelerated by entry of Amgen or Samsung Bioepis.

July 17, 2018

Celltrion obtains approval for its biosimilar TmAb products in Australia (150mg products branded as Simabtra®Herzuma®, and Hertuzu®).  These are the first biosimilar TmAb products to be approved in AU.

July 12, 2018

Xbrane and STADA announce they have entered into an agreement to develop a ranibizumab biosimilar for US, EU and other markets.  Under the agreement, Xbrane will be responsible for developing the product while STADA will be responsible for the marketing authorisations and sales and marketing.

July 4, 2018

Biocon receives EU CGMP certification for its facility in Bangalore, clearing the way for the approval of pegfilgrastim and trastuzumab biosimilars.

June 28, 2018

Prestige and Alvogen announce partnership to commercialise Prestige’s trastuzumab biosimilar, Hervelous®, in Central and Eastern Europe.

June 28, 2018

Lupin and Mylan announce agreement to commercialise etanercept biosimilar in Europe, Australia, New Zealand, Latin America, Africa and Asia.

June 27, 2018

Amgen releases results of Phase III study of infliximab biosimilar, revealing no clinically meaningful differences to Remicade®.

June 25, 2018

Celltrion launches infliximab biosimilar in Libya and Tunisia. The product will be distributed through Celltrion’s local partner Hikma Pharmaceuticals and is part of Celltrion’s overall plan to expand sales networks across Africa and into the Middle East.

June 22, 2018

US Senators Chuck Grassley and Amy Klobuchar urge FTC to investigate ‘pay-for delay’ settlements, in particular AbbVie’s Humira settlements, for anti-competitive behaviour.  Of particular concern is investigating whether these settlements are keeping biosimilars out of the hands of patients.

June 17, 2018

Celltrion resubmits application for marketing approval of trastuzumab biosimilar to the FDA. This follows CRLs from the FDA related to the February warning letter regarding Celltrion’s manufacturing facility in South Korea.

June 15, 2018

Sandoz reports results of long term switching studies for biosimilars Zessly®(infliximab) and Erelzi® (etanercept) in RA.

June 15, 2018

Biocad announces phase III clinical trials of ASART-2, biosimilar infliximab, reveal non-inferiority to Remicade at week 54.

June 15, 2018

The National Institute for Health and Care Excellence (NICE) rejects pertuzumab for adjuvant treatment of early breast cancer. The draft guidance reports that the drug may not extend patient’s lives and is not cost effective.

June 15, 2018

Sandoz reports results of long term switching studies for biosimilars Zessly® (infliximab) and Erelzi® (etanercept) in RA.

June 14, 2018

Fresenius reports the results of its Ph III studies for biosimilar adalimumab MSB11022 in moderate-to-severe chronic plaque psoriasis at the European League Against Rheumatism’s Annual European Congress of Rheumatology.

June 12, 2018

Celltrion reports preliminary results for new sub-cut formulation of infliximab.

June 12, 2018

Walgreen and Kroger also file suit against J&J in the Pennsylvania District Court, echoing Pfizer’s earlier (Nov 17) complaint alleging J&J has engaged in anti-competitive behaviour regarding the US sale of Remicade®.

June 4, 2018

FDA approves Mylan/Biocon’s pegfilgrastim (Fulphila®) on Mylan’s resubmitted application.  This is a the first US Neulasta® biosimilar approved; the second US biosimilar approved from the Mylan/Biocon portfolio; and the tenth US biosimilar overall.  See related FDA media release here.

June 1, 2018

Apotex achieves world first approval of pegfilgrastim biosimilar (Lapelga®) in Canada.

June 1, 2018

FDA provides CRL rejecting Amgen’s application for biosimilar trastuzumab ABP 980, filed August 2017.  Amgen states “we do not expect this to impact our US launch plans.”

June 1, 2018

CHMP recommends granting a marketing authorisation to Pfizer for its biosimilar trastuzumab (Trazimera®) for the treatment of breast and gastric cancer.

May 31, 2018

CHMP recommends granting marketing authorisation for 3 biosimilar AmAbs developed by Sandoz – HalimatozHefiya and Hyrimoz.

May 30, 2018

Celltrion resubmits its aBLA for CT-P10 (rituximab) biosimilar Rituxan®.  According to Celltrion, the FDA has resumed the approval procedure and Celltrion expects approval in 2018.

May 30, 2018

Celltrion announces that it intends to refile its aBLA for CT-P6 (trastuzumab) in June 2018 with a view to obtaining approval in 2018.

May 25, 2018

Lupin announces that its MA application for biosimilar etanercept has been accepted for review by the EMA.

May 24, 2018

Sandoz announces it has received EU approval for Zessly® (inflliximab) for all originator indications.

May 15, 2018

The FDA approved Hospira’s Retacrit®, biosimilar to Amgen’s Epogen® (epoetin alfa-epbx), to treat anaemia and to reduce allogeneic red blood cell transfusions in patients undergoing elective, noncardiac, nonvascular surgery.

May 15, 2018

FDA approves epoetin alfa biosimilar for the treatment of anaemia caused by chronic kidney disease, chemotherapy or use of zidovudine.

May 10, 2018

Australia’s NeuClone announces preclinical results for its biosimilar ustekinumab, which are now scheduled for Ph 1 clinical trials in 2019.

 

May 10, 2018

Coherus BioSciences discloses that preclinical studies will be ongoing in 2018 for CHS-2020 biosimilar aflibercept.

May 10, 2018

Coherus provides 2018 forecasts in its Q1/2018 results, including EU approval opinion by 28 June 2018, and US BLA acceptance by 3 June 2018. Commercial discussions ongoing.

May 10, 2018

Coherus BioSciences confirms its 2022 target launch date for CHS-1420, biosimilar adalimumab.  Commercial partnering options are being considered.

May 10, 2018

Coherus announces it expects to initiate clinical studies for biosimilar ranibizumab CHS-3351 in 2018.

May 8, 2018

Lupin announced YL Biologics has filed a BLA for biosimilar etanercept (YBL113) in Japan. YL Biologics is a joint venture between Yoshindo and Kyowa (Lupin’s subsidiary), and YBL113 is the first biosimilar developed by the JV.

May 7, 2018

Amneal announces it has entered into a licensing agreement with mAbxience for its US biosimilar bevacizumab.  See subsequent mAbxience announcement here.

May 4, 2018

Celltrion announces that the FDA has rejected its BLA for biosimilars to trastuzumab (CT-P6) and rituximab (CT-P10).  The FDA complete response letter (CRL) followed a FDA warning letter received by Celltrion in January this year.  Celltrion promises that the BLAs will be resubmitted “relatively soon” and that approvals are expected “in 6 months after resubmission”.   The rejections were received 9 months after the BLAs were filed, and less than 2 months following the EU approval of Celltrion’s trastuzumab.

May 3, 2018

Coherus announces resubmission of its BLA for biosimilar Peg-Filgrastim CHS-1701

May 2, 2018

Sandoz announces that the FDA has provided a CRL rejecting its BLA for biosimilar rituximab.

May 2, 2018

Formycon/Bioeq announce interim positive results for their ph III studies for biosimilar ranibizumab FYB201.

May 2, 2018

Mundipharma announces their biosimilar trastuzumab (in-licensed from Celltrion) is available in Europe. This is Mundi’s third biosimilar to be launched in EU, but the second biosimilar TmAb, following MSD’s launch in March 2018.

April 26, 2018

Biocon announces Biocon and Mylan add insulin glargine 300 and pertuzumab to their collaboration.

April 23, 2018

Pfizer announces that it has received a CRL from the FDA for its BLA for biosimilar trastuzumab.  The FDA has highlighted the need for further technical information.

April 14, 2018

Celltrion’s rituximab biosimilar Truxima® is approved by the TGA. This is the second biosimilar approved in 4 months, following the approval of Sandoz’s Riximyo™ in December 2017.

April 11, 2018

Mylan announces EU deal with Fujifilm (with other territories still under negotiation) relating to Fujifilm’s biosimilar adalimumab, filed in EMA on 18 May 2017 with approval expected “late 2018”.  Mylan’s existing partner Biocon will receive payments under the deal.

April 6, 2018

Celltrion announces that the FDA has rejected its BLA for biosimilars to trastuzumab (CT-P6) and rituximab (CT-P10).  The FDA complete response letter (CRL) followed a FDA warning letter received by Celltrion in January this year.  Celltrion promises that the BLAs will be resubmitted “relatively soon” and that approvals are expected “in 6 months after resubmission”.   The rejections were received 9 months after the BLAs were filed, and less than 2 months following the EU approval of Celltrion’s trastuzumab.

April 5, 2018

Samsung announces a royalty-bearing, global settlement with AbbVie enabling Samsung to launch its SB5 biosimilar adalimumab in Europe from 16 October 2018 and in the US from 30 June 2023.  The EU date is the same as AbbVie gave Amgen’s in its September 2018 global settlement, but the US date is 5 months later than Amgen’s licensed date of 31 Jan 2023.  SB5 is registered in EU as Imraldi® and in AU as Hadlima®.

March 26, 2018

Coherus announces that Judge Stark (US District Court for the District of Delaware) dismissed with prejudice Amgen’s patent infringement complaint alleging infringement of US8,273,707.

 

March 23, 2018

Sandoz announces that it has received a positive CHMP opinion for biosimilar infliximab Zessly®.

March 22, 2018

EMA’s CHMP adopted a positive opinion for ABP 980, Amgen/Allergan’s trastuzumab biosimilar Kanjinti®, 12 months after they announced filing the EC application.

March 19, 2018

Mundi and Celltrion enter exclusive distribution and marketing agreement for biosimilar trastuzumab, Herzuma®, for 7 EU countries including UK, DE and IT.

March 17, 2018

LG Chem (formerly LG Life Sciences) obtains Korean regulatory approval for biosimilar etanercept.  This is the second biosimilar etanercept approved in Korea (after Samsung’s 2015 approval of Brenzys), and follows the Japanese approval of LG Chem’s biosimilar etanercept in January this year.

March 14, 2018

TRpharm announces it is ready to launch biosimilar rituximab (developed by Dr Reddy’s) in Turkey, following approval on 30 Jan 2018.

March 9, 2018

Merck launches the first TmAb biosimilar in Europe by selling the product developed by Samsung Bioepis (SB3) as Ontruzant® in the UK.

March 2, 2018

Cadila announces it intends to file an aBLA for biosimilar pegfilgastim by end of 2019.

February 14, 2018

Celltrion announces it has begun development of a pembrolizumab biosimilar. Merck’s patents for this product are set to expire in 2028.

February 13, 2018

EC approves Celltrion’s Herzuma® (biosimilar trastuzumab), 2 months after the positive opinion from the CHMP on 14 December, 2017.  This is Celltrion’s third EU approval and the second EU biosimilar trastuzumab approved in 3 months.

February 10, 2018

Lupin declares its intention to file an application in the EU and JP for biosimilar etanercept in July 2019.

February 3, 2018

Gedeon Richter announces refiling of MA for pegfilgrastim, following the completion of further clinical trials. GR withdrew its previous application in Dec 2016.  See Stada subsequent announcement here.

January 24, 2018

The second biosimilar AmAb, Samsung Bioepis’ Hadlima®, is registered on the ARTG in 2 different dosages.

January 24, 2018

Pfizer announces positive top line results for PF-05280586, biosimilar to Rituxan/MabThera.

January 23, 2018

US Court of Appeals (Fed Cir) affirms patent invalidity.

January 23, 2018

GE announces it is building a FlexFactory (single use technology with 2 x 2000L bioreactors) facility in China for Clover, which is expected to be up and running by the end of 2018. Clover intends to manufacture biosimilar etanercept for the Chinese market there.

January 19, 2018

Celltrion and Teva commence proceedings in District Court (Northern District of California) seeking DJ that 38 patents relating to trastuzumab are invalid, unenforceable and/or not-infringed.  This follows Celltrion/Teva’s US ABLA filing for biosimilar trastuzumab in late July 2017, and subsequent patent dance, and will test the boundaries of the availability of “DJ-within ABLA”.

January 19, 2018

Mochida receives approval for the first biosimilar etanercept in Japan, developed in Japan in collaboration with LG Chem, to be distributed in Japan by Ayumi.  The application took approximately 11 months to be approved by the PMDA.

January 18, 2018

Amgen and Allergan announce the first EU approval of biosimilar bevacizumab, to be marketed as Mvasti®.  Their application was filed with EMEA on 2 Dec 2016

January 18, 2018

FDA approves Xbrane’s Phase III clinical trial for a biosimilar ranibizumab candidate Xlucane®.  Xbrane expects to enrol approximately 600 patients in 16 countries with the first patient expected in March 2019.

January 17, 2018

Korean Biosimilar company Alteogen announces completion of pre-clinical studies relating to ALT-L9, biosimilar aflibercept, and that it intends to file an investigational NDA with the US in 2018.  It also intends to roll out aflibercept in Japan (through partner Kissei Pharmaceutical) and China in 2022 “when the patents of the brand-name drug lapse”.

January 17, 2018

Kissei announces positive Ph III trials for JR131, biosimilar darbepoetin, with a view toward regulatory filing in 2018.

January 16, 2018

Sandoz announced the FDA has accepted for review its application under s351(k) for biosimilar adalimumab.   

January 14, 2018

Genentech has sued Sandoz and Kyowa Hakko Kirin (Sandoz’s exclusive distributor) in Japan, alleging the sale of biosimilar RmAb (Rixathon®/Riximyo®) infringes 3 Genentech patents. Rixathon®/Riximyo® was approved in JP in Sep 2017.

January 11, 2018

At the JP Morgan conference, Richard Gonzalez, (chairman of the board and CEO of AbbVie) confirms that AbbVie does not expect biosimilar competition for Humira® until 2022.

January 11, 2018

Teva and Celltrion file DJ action in the District Court (Northern District of California) against 37 rituximab patents alleging they are invalid, unenforceable and/or not-infringed. FDA accepted Celltrion’s ABLA on 27 June 2017, and the parties entered a patent dance.  On the same day, parallel proceedings were also filed in the same Court relating to (some overlapping) 38 patents to trastuzumab.

January 10, 2018

Biocad obtains approval for its biosimilar infliximab in Russia.

January 10, 2018

Amgen discloses at JP Morgan Healthcare Conference that it is in process development for a cetuximab biosimilar.

January 8, 2018

Australia’s NeuClone confirms ongoing development of biosimilar ustekinumab, which is on target to enter Ph I trials in 2018.  Read more

January 8, 2018

Australia’s Neuclone discloses the 5th product in its pipeline is biosimilar denosumab, which is at the pre-clinical stage.

January 4, 2018

Glenmark announces the launch of biosimilar adalimumab (developed by Zydus, marketed as Adaly®), in India.

January 3, 2018

Mylan and Momenta announce deal relating to the development of M710, biosimilar aflibercept.  Pivotal clinical trials are planned for early 2018.

2017

December 21, 2017

Roche has sued Sandoz in the Federal Court in Sydney over its recent approval of Riximyo®, alleging infringement of 5 patents: AU2008207357, 761844, 2005211669, 2009201403, and 2007242919.

December 13, 2017

FDA approves biosimilar infliximab, Ixifi® for the treatment of patients with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriosis.

December 3, 2017

FDA approves Mylan/Biocon trastuzumab biosimilar Ogivri® for all “on-label” indications.  This is the first US approved trastuzumab biosimilar, and Mylan’s first US biosimilar approved.

December 1, 2017

The Australian government’s biosimilar uptake initiative results in changes to PBS listing for Samsung’s Brenzys® in Australia. “A” flagging (substitution at the pharmacy level) remains unchanged.

November 30, 2017

Sandoz’s biosimilar etanercept (Erelzi®)  approved in Australia in 3 dosages, the second approved biosimilar etanercept.

November 30, 2017

Sandoz’s biosimilar rituximab, Riximyo® approved in Australia, following its approval in Europe 5 months earlier.

November 28, 2017

German Formycon announced it intends to bring biosimilar ranibizumab to the US market in 2020 with commercialisation partner Bioeq (JV between Santo and Polpharma).

November 23, 2017

Biocon launches Krabeva®, biosimilar bevacizumab, in India.

November 19, 2017

Samsung Bioepis receives regulatory approval for EU’s first biosimilar trastuzumab, Ontruzant® (to be marketed by MSD) for the treatment of early breast cancer, metastatic breast cancer and metastatic gastric cancer.

November 17, 2017

Roche sues Pfizer in District Court of Delaware, alleging infringement of 40 patents, the first US lawsuit involving trastuzumab.

November 17, 2017

Amgen announces US launch of new ENBREL Mini® single-dose prefilled cartridge with AutoTouch® reusable autoinjector.

November 10, 2017

Amgen/Allergan announce the EMA’s CHMP has adopted a positive opinion for ABP 215, biosimilar to Avastin® (bevacizumab) for the same indications as the originator. Read more

November 10, 2017

EMA approves BI’s Cyltezo® (adalimumab biosimilar) for the treatment of multiple chronic inflammatory diseases in adults and children.

November 10, 2017

Janssen withdraws suit against Samsung Bioepis filed in the District Court of New Jersey for patent infringement under the BPCIA in May 2017.

November 9, 2017

Samsung Bioepis announces that Samfenet®, biosimilar trastuzumab is approved by MFDS (South Korea) for the treatment of metastatic breast cancer, early-stage breast cancer and metastatic gastric cancer.

November 9, 2017

The first biosimilar adalimumab, Amgen’s Amgevita®, is registered on the ARTG in 3 different dosages.

November 9, 2017

BI publishes results from switching study showing efficacy and safety maintained in patients who switched from Humira® to biosimilar Cyltezo®.

November 9, 2017

During its Q3/17 earnings update, Pfenex reports that it has ceased development of PF582 (biosimilar ranibizumab) and PF529 (biosimilar pegfilgrastim) due to resource constraints.  Pfenex reports during its Q3/17 earnings update that it has ceased development of PF582 (biosimilar ranibizumab) and PF 529 (biosimilar pegfilgrastim) due to resource constraints.

November 7, 2017

Mylan refiles EU applications for biosimilar pegfilgrastim and trastuzumab.

November 7, 2017

Coherus publishes phase 3 studies on proposed biosimilar adalimumab, CHS-1420.

November 7, 2017

Hexal/Parexel publishes results of PK, immunogenicity and safety studies relating to proposed adalimumab biosimilar GP2017. 

November 1, 2017

Cinfa Biotech announces it will present further clinical data relating to B12019 at the 59th ASH Annual Meeting in Atlanta in December.

October 30, 2017

During its Q3/17 earnings update, Pfenex reports that it has ceased development of PF582 (biosimilar ranibizumab) and PF529 (biosimilar pegfilgrastim) due to resource constraints.

October 29, 2017

Celltrion releases phase III results for switching studies comparing Biosimilar infliximab CT-P13 (marketed by Celltrion as Remsima® and by Pfizer as Inflectra®) and Remicade®, and phase I (open label) studies for sub-cutaneous infliximab.

October 27, 2017

Sandoz’s (refiled) EU application for biosimilar pegfilgrastim accepted for regulatory review by EMA. Sandoz received an FDA rejection in Jul 2016, and withdrew its earlier EMA application in Jan 2017.

October 27, 2017

Russian biosimilars company Biocad succeeds in Russian patent challenge relating to the use of rituximab for RA, and announces intention to launch in EU.

October 23, 2017

Genentech files a further suit under seal (District of Delaware) against Amgen, the third litigation existing between the parties relating to Amgen’s Mvasti® (biosimilar bevacizumab). The 25 patents at issue in this suit are the 24 patents included in the first Genentech suit and US patent 7,297,334. Read more

October 17, 2017

Amgen withdraws EU application for Kyomarc® (biosimilar bevacizumab), for “marketing reasons”, but will continue with existing application for Mvasti®.  Read more

October 10, 2017

FDA issues Complete Response Letter for Biocon’s pegfilgrastim. FDA has completed its review, but requires further CMC data.

October 9, 2017

Amgen files suit (Central District of California) seeking DJ that 27 patents are invalid/unenforceable/not infringed by Amgen’s biosimilar bevacizumab Mvasti®. Read more.  On the same day, Genentech commenced suit in District of Delaware against Amgen relating to Mvasti®, alleging infringement of 24 patents and non compliance with the BPCIA disclosure requirements. Read more

October 4, 2017

EMA accepts Cinfa Biotech’s application for B12019, biosimilar pegfilgrastim.

September 28, 2017

Sanofi announced that the EC has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis who are candidates for systemic therapy.  Dupixent was approved by the FDA in March 2017.

September 28, 2017

Amgen and AbbVie settle global patent disputes regarding adalimumab, and Amgen secures a royalty-bearing, non-exclusive license to AbbVie’s Humira® IP.  Amgen’s license commences in the US on 31 Jan 2023, in most EU countries on 16 Oct 2018, and “on other dates in various countries in which AbbVie has intellectual property.”

September 26, 2017

Iranian biopharmaceutical company AryoGen Pharmed commences phase III denosumab trials comparing the efficacy and safety of AryoGen’s 60mg denosumab and Amgen’s 60mg denosumab among osteoporotic post-menopausal women.

September 20, 2017

Samsung says it has approval to sell biosimilar adalimumab in South Korea, but will delay launch due to patent expiry.

September 20, 2017

Samsung is approved by the Ministry of Food and Drug Safety in South Korea to commence Phase III clinical trials for biosimilar ranibizumab.

September 15, 2017

Samsung Bioepis announces it has received positive CHMP opinion on Ontruzant®, biosimilar trastuzumab for early breast cancer, metastatic breast cancer and metastatic gastric cancer.  This is the first biosimilar trastuzumab recommended for EU approval.

September 15, 2017

BI receives positive CHMP opinon on Cyltezo®, biosimilar to adalimumab.  Approval is expected in Q4/17.

September 14, 2017

Amgen/Allergan’s bevacizumab biosimilar (Mvasti®) (bevacizumab-awwb) approved in the US for colorectal, lung, brain, kidney and cervical cancer.  Read more 

September 14, 2017

Sandoz announces at the EADV results from 51 week clinical study confirming that Sandoz’s biosimilar adalimumab matches Humira® in safety and efficacy profile.

September 13, 2017

Lupin secures external funding for its etanercept biosimilars program.

September 12, 2017

FDA accepts Sandoz’s s351(k) application for rituximab.

September 11, 2017

FDA accepts Adello Biologic’s BLA for biosimilar filgrastim.

September 9, 2017

Pfizer announces positive findings in pivotal Phase III study for TmAb candidate PF-05280014 at ESMO 17.

September 9, 2017

Amgen/Allergan present Phase III data on biosimilar trastuzumab ABP 980 at ESMO 2017.

September 7, 2017

PTAB denies institution of Coherus Biosciences’ 4 IPR petitions against AbbVie’s 9,085,619 relating to the Humira® formulation.

September 6, 2017

FDA releases Form 483 raising 12 issues arising from the May/June inspections of the Celltrion Incheon biologics manufacturing facility, where Celltrion and Pfizer/Hospira’s biosimilar Inflectra® (infliximab-dyyb) is made.

September 2, 2017

FDA extends its decision deadline by 3 months on a s351(k) application for MYL-1401O, Mylan and Biocon’s trastuzumab (Herceptin) biosimilar.  Final decision is now expected by 3 Dec 2017.

August 30, 2017

Samsung Bioepis has filed three petitions seeking joinder with Hospira’s IPR against key Genentech trastuzumab patents (IPR2017-01958 against 6,627,196 patent; IPR2017-01959 against 7,371,379, and  IPR2017-01960 against  7,892,549).  Hospira’s petitions against the same patents (IPR2017-00804, IPR2017-00805, and IPR2017-00737) were instituted by the Board.

August 29, 2017

Boehringer Ingelheim Pharmaceuticals, Inc. receives FDA approval for Cyltezo® (adalimumab-adbm), a biosimilar to Humira®.  This is the first biosimilar from BI to be FDA approved.  According to the release:

  • Cyltezo® is not yet commercially available due to the active patent litigation between Boehringer Ingelheim and AbbVie.
  • EMA is expected to provide an opinion on BI’s EU application in 2017.

August 24, 2017

Imraldi®, Biogen/Samsung’s adalimumab biosimilar approved in the EU.

August 21, 2017

Sandoz launches Erelzi® in Canada.

August 16, 2017

Biocon/Mylan withdraw EU applications for biosimilar trastuzumab & pegfilgrastim.

August 2, 2017

AbbVie commences BPCIA proceedings against Boehringer Ingelheim for Humira® (adalimumab) biosimilar in the District Court of Delaware, alleging infringement of 8 patents: (8,926,975; 9,018,361; 9,090,867; 9,096,666; 9,255,143; 9,266,949; 9,272,041; and 9,546,212), a subset of the 74 listed under § 262(l)(3)(C) and § 262(l)(7).  Two of the patents in suit overlap with the 10 patents in suit in the earlier Delaware proceedings commenced against Amgen in August 2016 (8,663,945; 8,911,964; 8,916,157; 8,961,973; 8,986,693; 9,096,666; 9,220,781; 9,272,041; 9,359,434; and 9,365,645) which has been set down for hearing on 4 November 2019.   AbbVie alleges those 10 patents are a subset of 61 patents in dispute, the remainder of which could be addressed in phase 2 BPCIA litigation.

August 1, 2017

Celltrion/Mundipharma claim their biosimilar rituximab (Truxima®) has 30% of total EU market due to rapid growth.

August 1, 2017

Merck’s biosimilar infliximab (Renflexis®), co-developed with Samsung Bioepis, is the second biosimilar to be PBS listed in Australia.

July 31, 2017

Amgen and Allergan announce BLA filing for ABP980, biosimilar trastuzumab.

July 31, 2017

Celltrion & Teva announce the FDA has accepted for review their BLA for CT-P6, biosimilar Herceptin® (INN: trastuzumab).

July 28, 2017

BI commences interchangeability studies between biosimilar BI695501 and Humira 40mg/0.8ml, with the results expected in second half of 2019.

July 27, 2017

PTAB instituted IPR on 3 of Hospira’s 5 IPR requests relating to trastuzumab.  The Board instituted IPR of the following patents: 7,371,379 (IPR2017-00805), 6,627,196 (IPR2017-00804), and 7,892,549 (IPR2017-00737). IPR was denied against 7,892,549 (IPR2017-00739) and 7,846,441 (IPR2017-00731).

July 24, 2017

Samsung Biopeis launches Renflexis® , biosimilar to J&J’s Remicade® in the US following its April approval in the US.

July 21, 2017

Korean BIOCND shares its plans to complete the phase 1 clinical trials of Lucentis biosimilar (BCD 300) by the end of 2017 and then will seek a partner.

July 17, 2017

Celltrion to commence ph 1 clinical trials for biosimilar bevacizumab in South Korea. Read more

July 13, 2017

Mylan’s biosimilar trastuzumab goes before the FDA Oncology Drugs Advisory Committee in the afternoon session on 13 July 2017, and receives unanimous recommendation for approval by FDA OCAC.

July 13, 2017

Janssen announced that the FDA has approved Tremfya® (guselkumab) for the treatment of adults with plaque psoriasis.

July 13, 2017

Amgen/Allergan’s biosimilar becvacizumab recommended for approval by FDA ODAC. Read more 

July 13, 2017

Amgen’s biosimilar BmAb goes before the FDA Oncology Drugs Advisory Committee in the morning session on 13 July 2017. Read more

June 29, 2017

FDA accepted Teva/Celltrion’s aBLA for CT-P10, biosimilar rituximab.

June 27, 2017

Biosimilar etanercept (Erelzi®) approved in EU to treat multiple inflammatory diseases.

June 23, 2017

Imraldi®, Samsung’s adalimumab biosimilar (SB5) receives positive opinion from CHMP in EMA.

June 19, 2017

EU approval received for Sandoz’s Rixathon® (biosimilar rituximab) to treat blood cancers and immunological diseases.

June 12, 2017

FDA sends Complete Response Letter regarding Coherus’ Neulasta biosimilar 351(k) application for CHS-1701.

May 24, 2017

Celltrion files BLA for Herzuma®, biosimilar trastuzumab, to be marketed by Teva.

May 22, 2017

Fujifilm announces EC has accepted its MA for biosimilar adalimumab (FKB327) which Fujifilm filed in April 2017.   Clinical trials were conducted in RA and commenced in Dec 2014.

May 19, 2017

Janssen commences BPCIA proceedings against Samsung Bioepis in the District Court of New Jersey based on Samsung’s aBLA application for Renflexis® infliximab-abda, biosimilar to J&J’s Remicade®.

May 17, 2017

Cinfa Biotech S.L announces positive top-line data from second clinical study for biosimilar pegfilgrastim (B12019).

May 11, 2017

Germany’s Formycon is developing biosimilar ustekinumab, targeting 2023 for a US launch, and 2024 for EU launch.  Read more

May 1, 2017

Plaintiffs Sanofi and Regeneron filed a notice of voluntary dismissal, discontinuing without prejudice the proceedings they commenced in the District Court of Massachusetts in March 2017 in which they were seeking a declaration of non-infringement in relation to Amgen’s Dupixent patent.

April 25, 2017

Glenmark announces FDA approval for Phase I clinical trials of omalizumab.

April 24, 2017

FDA approves Samsung Biopeis’ Renflexis® infliximab-abda, biosimilar to J&J’s Remicade® for all eligible indications.

April 4, 2017

Sandoz receives a Notice of Compliance for Erelzi® for the treatment of moderately to severely active rheumatoid arthritis in adults with or without methotrexate and for reducing signs and symptoms of active ankylosing spondylitis.  (Sandoz did not seek registration for psoriatic arthritis or plaque psoriasis).

April 1, 2017

Samsung’s biosimilar etanercept, Brenzys, is listed on the PBS in Australia with “A” flagging enabling substitution at the pharmacy level

March 28, 2017

Sanofi and Regeneron announced that the FDA has approved Dupixent® (dupilumab) for the treatment of moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.

March 24, 2017

Amgen announces during a conference presentation that it has filed an application in EMA for biosimilar trastuzumab ABP 980.

March 23, 2017

Sanofi and Regeneron filed a petition against Immunex, requesting an inter partes review (IPR) of patent 8,679,487.  The petitioners argue that the ‘487 patent is invalid on novelty grounds.  Earlier this month Sanofi and Regeneron filed a complaint in the District Court of Massachusetts, seeking a declaration of non-infringement.

March 23, 2017

EMA approves Amgen’s biosimilar adalimumab Amgevita® with a full indication set.  This is the first EU approval for biosimilar adalimumab.

March 20, 2017

Sanofi-Aventis, Genzyme Corporation and Regeneron filed a complaint in the District Court of Massachusetts seeking a declaration judgement that its development, manufacturing, sale, promotion and related activities for Dupixent® (dupilumab) do/will not directly or indirectly infringe Amgen’s US patent 8,679,487.

March 14, 2017

Mylan announces global settlement with Genentech & Roche on TmAb with global licenses (excluding Japan, Brazil and Mexico).

March 3, 2017

UK High Court hands down decision in Samsung v Abbvie.

March 2, 2017

PTAB institutes IPR filed by Hospira against Genentech on bevacizumab patents IPR2016-01771 (Patent 7,622,115) and IPR2016-01837 (Patent 7,807,799) from requests filed 9 September 2016.

March 2, 2017

Judge Sleet dismissed Genentech’s suit filed 15 Feb 17 (see below) under Fed Cir’s finding in Amgen v Sandoz.

February 22, 2017

Mundi’s biosimilar rituximab (Truxima®, developed by Celltrion) approved by EMA, and intended for launch in the UK, Germany, Italy, Netherlands, Belgium, Ireland and Luxembourg.

February 15, 2017

Genentech sues Amgen in District Court of Delaware alleging non compliance with BPCIA disclosure obligations in patent dance relating to bevacizumab.

January 27, 2017

Sandoz withdraws EU application for Zioxtenzo, biosimilar pegfilgrastim.

January 27, 2017

CHMP (Committee for Medicinal Products for Human Use) for EMA gives positive opinion for Amgen’s biosimilar adalimumab.

2016

December 22, 2016

Biograstim’s withdrawal of marketing authority, declared by European Commission following voluntary withdrawal from CT Arzneimittel’s biosimilar representative Marketing-Authorisation holder (MAH).

December 19, 2016

Gedeon Richter announces withdrawal of its MA for biosimilar pegfilgrastim.

December 16, 2016

Samsung Bioepis receives positive CHMP opinion for its  application for indication extension of Benepali® (etanercept) to include juvenile idiopathic arthritis and pediatric plaque psoriasis.

December 15, 2016

The results of two Regeneron ph III studies published in the New England Journal of Medicine report that dupilumab, a human monoclonal antibody against interleukin-4 receptor alpha, improved the signs and symptoms of atopic dermatitis, symptoms of anxiety and depression, and quality of life, compared with placebo.

December 2, 2016

Amgen/Allergan submit EMA application for biosimilar adalimumab.

November 25, 2016

Commercial (at risk) launch by Pfizer/Celltrion of Inflectra® (infliximab-dyyb).

November 15, 2016

Amgen and Allergan submit BLA for ABP 215, bevacizumab biosimilar. Read more

 

October 25, 2016

Sandoz indicates it plans to conduct further studies with a target of 2018 for further submissions to the FDA.

October 6, 2016

FDA accepts Coherus BioSciences 351(k) filing for pegfilgrastim.

October 6, 2016

Teva and Celltrion announce exclusive marketing deal under which Teva will commercialise Celltrion’s biosimilar rituximab and trastuzumab products in the US and CA.

October 3, 2016

Samsung application for SB3, biosimilar trastuzumab accepted for review by EMA.

September 23, 2016

FDA approves Amgen’s biosimilar to adalimumab, Amjevita™ (adalimumab-atto), 11 months after Amgen’s application was filed.

September 12, 2016

Brenzys®(SB4)  is the first biosimilar etanercept to be approved in Canada.

August 8, 2016

Pfizer terminates its relationship with Pfenex to develop PF582, biosimilar ranibizumab.

July 22, 2016

Brenzys® (SB4) becomes the first biosimilar etanercept to be approved in Australia.

July 21, 2016

EMA accepts Mylan/Biocon application for biosimilar pegfilgrastm for review.

July 20, 2016

FDA rejects Sandoz’s application for Zioxtenzo®, biosimilar pegfilgrastim.

July 19, 2016

Sandoz receives complete response letter from FDA relating to Zioxtenzo, Biosimilar pegfilgrastim, and is “working with the agency to address remaining questions.”

July 18, 2016

Samsung announces the EMA has accepted for its review its application for adalimumab biosimilar.

July 13, 2016

FDA approves Sandoz’s Erelzi® for all indications included in the reference product label, including rheumatoid arthritis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and polyarticular juvenile idiopathic arthritis.

June 13, 2016

Amgen announces FDA Advisory Committee Meeting to review ABP 501 (biosimilar adalimumab).  FDA has set a Biosimilar User Fee target action date of 25 September 2016.

June 13, 2016

FDA’s Arthritis Advisory Committee reviews data supporting Amgen’s BLA for ABP 501 (biosimilar adalimumab).

May 30, 2016

Biogen/Samsung Biopeis receive EMA approval for Flixabi®, biosimilar Infliximab.

May 16, 2016

Sorrento releases results of Phase II and III clinical trials of biosimilar omalizumab, announcing the candidate STI-004 demonstrated clinical efficacy and safety.

April 5, 2016

Pfizer/Celltrion received FDA approval for Inflectra®, biosimilar infliximab.

April 1, 2016

EU’s CHMP gives green light for Flixabi®, Samsung Bioepis’ biosimilar infliximab.

March 24, 2016

Samsung Bioepis files suit in the UK to remove Abbvie patents regarding adalimumab.

February 11, 2016

EMA accepts Sandoz’s filing for Zioxtenzo, biosimilar pegfilgrastim.

January 17, 2016

EMA approves Benepali®, biosimilar etanercept (SB4) for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis. CHMP positive opinion was announced on 20 Nov 2015.  Samsung says it developed, tested and had its Benepali® approved in under 4 years.

January 11, 2016

MabTech announces successful Chinese Ph III clinical trials for Sorrento’s “biosimilar/biobetter” cetuximab STI-001, and infliximab STI-002.

January 11, 2016

MabTech announces successful Chinese Ph III clinical trials for Sorrento’s “biosimilar/biobetter” cetuximab STI-001, and infliximab STI-002.

2015

December 7, 2015

Health Canada confirms Authorisation of Filgrastim biosimilar Grastofil®.

December 1, 2015

Hospira’s biosimilar infliximab becomes the first biosimilar infliximab to be PBS listed in Australia.

November 25, 2015

Amgen submits BLA under s351(k) pathway for ABP 501 (proposed adalimumab biosimilar).

September 7, 2015

Samsung Bioepis announces Brenzys® (SB4), biosimilar etanercept received approval in South Korea with launch intended late 2015/early 2016.

September 3, 2015

Sandoz launches filgrastim biosimilar Zarxio® in US.

March 6, 2015

Sandoz biosimilar Zarxio® approved for US sale with the same indications as Neupogen®, and with a “placeholder” name “figrastim-sndz”.  This is the first approval of a biosimilar product in the US.

February 17, 2015

Canadian drug manufacturer Apotex announces FDA has accepted for filing its Biosimilar application for Filgrastim (Grastofil®) along side previous patent Neupogen® within the US Marketplace.

January 5, 2015

FDA accepts Apotex’s s351(k) application for biosimilar Neulasta.

2014

September 18, 2014

US based manufacturer granted approval from EMA to distribute filgrastim biosimilar Accofil®.

 

January 15, 2014

CA approval for Celltrion/Hospira’s infliximab biosimilar products to be marketed as Remsima® and Inflectra®.

2013

October 17, 2013

EMA welcomes Apotex’s biosimilar Filgrastim rendition, Grastofil®, throughout Europe.

September 10, 2013

Hospira/Celltrion’s infliximab biosimilar products approved in EU (Remsima® and Inflectra®).

2011

September 2, 2011

Stada and Gedeon Richter announce collaboration deals to develop and sell biosimilars rituximab and trastuzumab.

April 20, 2011

European Commission (EC) withdraws EU marketing authorisation following Filgrastim Ratiopharm® MAH’s voluntary withdrawal.

2010

June 25, 2010

A Biosimilar product of Filgrastim was approved by the European Commission and marketed across several European countries under the name of Nivestim®.

January 16, 2010

Tanvex submits New Drug Submission to Health Canada for biosimilar filgrastim.

2009

February 17, 2009

Sandoz’ EP2006 was approved by EMA for marketing in the European Union (EU) under the trade name Zarzio® as a biosimilar product to EU-approved Neupogen®.

February 6, 2009

Hexal releases European biosimilar version of filgrastim, Filgrastim Hexal®.

2008

September 30, 2008

In accordance to the 2014 European Public Assessment Report (EPAR) Certified by EMA, Ratiopharm marketed a biological medicine in late 2008 known as Ratiograstin®. This medicine is a biosimilar to the previously pattened EU authorised Filgrastim (Neupogen®).

September 29, 2008

The European Commission’s Directorate General for Enterprise and Industry granted Teva a Marketing Authorization for its human G-CSF product, Tevagrastim®.

September 15, 2008

New filgrastim drug Biograstim® given the green light for market authorisation and distribution by European Commission (EC) and EMA.

BioBlast® extract From September 15, 2008 to March 15, 2024