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%.
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.
The Medicines and Healthcare Regulatory Agency issued a safety update regarding (dupilumab) and ocular side effects. The regulator warned that side effects can include conjunctivitis and ulcerative keratitis.
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.
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.
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.
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.
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%.
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.
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.
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 ravulizumab or eculizumab 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.
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.
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.
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.
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®.
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.
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.
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).
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.
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.
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Chantal Savage
Special Counsel, Lawyer
Chantal is an intellectual property disputes lawyer with experience advising across the spectrum of IP rights, including patents, trade marks, copyright, plant breeder’s rights and trade secrets/confidential information. Recognised as a Rising Star in IP by the Legal 500 Asia Pacific (2021-2024), Chantal has previously worked for international and top tier law firms in Australia and the United Kingdom and now at Pearce IP.
With a science degree specialising in molecular biology and biochemistry, Chantal’s practice focuses particularly on complex, high-value, multi-jurisdictional patent infringement and revocation proceedings for clients in the life sciences sectors.