Home / News / BioBlast® / Biosimilar Deals 2021

EXPLORE OUR

Biosimilars Deals 2021

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.

J&J & Janssen Sue Samsung Bioepis in US For Private Label Ustekinumab

Feb 24, 2025

On 24 February 2025, Johnson & Johnson (J&J) and Janssen Biotech filed a complaint in the US District Court for the District of New Jersey alleging that Samsung Bioepis has breached a settlement and licence agreement entered in July 2023 (announced in November 2023), permitting Samsung Bioepis to launch Pyzchiva® (SB17) (ustekinumab), biosimilar to J&J/Janssen’s Stelara®, in the US from 22 February 2025. The settlement agreement resolved pending US patent litigation between the companies at the time it was signed.

The complaint, filed the same day on which the US launch of Pyzchiva® was announced, claims that Samsung Bioepis has entered into an unauthorised sublicence with a private label provider. While the private label provider has not been publicly identified, it is described in J&J’s complaint as a member of a vertically integrated health conglomerate that includes a health insurer, health care provider, pharmacy chain and pharmacy benefits manager (PBM). According to J&J, the 2023 settlement agreement did not permit Samsung Bioepis to authorise the private label provider to launch in the US an additional, private label version of Pyzchiva®.

J&J is seeking a preliminary injunction preventing US sales of the private label version of Samsung Bioepis’ ustekinumab biosimilar and compensatory damages “in an amount to be determined at trial”. Samsung Bioepis has not yet filed a defence.

Pyzchiva® was approved by the US FDA in July 2024 for multiple indications, including moderate to severe plaque psoriasis, active psoriatic arthritis and moderately to severely active Crohn’s disease and ulcerative colitis. It is commercialised in the US (and Europe and Canada) by Sandoz pursuant to a deal entered into in September 2023 between Sandoz and Samsung Bioepis.

J&J has previously entered into ustekinumab settlement agreements with Amgen (which launched its biosimilar, Wezlana®, in early January 2025 through Optum Health Solution’s private label subsidiary Nuvaila), Alvotech and Teva (Selarsdi® launched on 21 February 2025), Biocon (Yesintek™ launched on 24 February 2025), Celltrion (US licence date of 7 March 2025) and Fresenius Kabi and Formycon (US licence date no later than 15 April 2025).

Janssen and Samsung Bioepis remain in patent infringement litigation in Australia, with the trial scheduled in June 2025. In October 2024, the Canadian Federal Court dismissed a motion by Janssen to add an infringement counterclaim in proceedings brought by Samsung Bioepis to invalidate one of Janssen’s Canadian patents covering ustekinumab.

Approval Alert: Celltrion’s Biosimilar Tocilizumab EU-Approved

Feb 24, 2025

On 24 February 2025, Celltrion announced that the European Commission has approved Avtozma® (CT-P47), biosimilar to Roche’s RoActemra® (tocilizumab). Avtozma® is approved for all indications of RoActemra®, including moderate to severely active rheumatoid arthritis (RA), active systemic juvenile idiopathic arthritis (sJIA), polyarticular juvenile idiopathic arthritis (pJIA) and giant cell arteritis (GCA).

Celltrion’s Avtozma® is the third tocilizumab biosimilar approved in the EU, following Fresenius Kabi’s Tyenne®, in both IV and SC forms, in November 2023, and Biogen’s IV Tofidence™, in June 2024.

Earlier this month, Celltrion’s SC tocilizumab formulation was approved in Korea, following Korean approval of IV tocilizumab in 200mg/10ml and 400mg/20ml formulations in December 2024.

In January 2025, Avtozma® became the third tocilizumab biosimilar approved in the US, trailing Fresenius Kabi’s Tyenne® (tocilizumab-aazg) (SC formulation, March 2024) and Biogen/Bio-Thera’s Tofidence®/BAT1806 (tocilizumab-bavi) (IV formulation, September 2023).

Semaglutide Compounders Sue FDA Over Removal of Novo Nordisk’s Ozempic® and Wegovy® from US Drug Shortages List

Feb 24, 2025

Following the FDA’s decision on 21 February 2025 to remove Novo Nordisk’s semaglutide products (Ozempic® and Wegovy®) from the Drug Shortages List, the regulator has been sued by the Outsourcing Facilities Association, a compounding industry group, and FarmaKeio Superior Custom Compounding, a Texas based compounding pharmacy.

The Complaint, lodged on 24 February 2025, alleges that the FDA’s decision was arbitrary and reckless and is contrary to law.

In removing semaglutide from the Drug Shortages List, the FDA confirmed it will take action from 22 April 2025 against state-licensed pharmacies which sell compounded versions of the drug and from 22 May 2025 against outsourcing facilities which compound, distribute or sell semaglutide copies.

Novo Nordisk has argued that semaglutide is challenging to produce safely due to its complex formulation involving yeast-based recombinant DNA technology. Furthermore, compounded versions lack clinical testing, exhibit different impurity profiles, and have raised safety concerns. This is consistent with alerts issued by the FDA to US healthcare providers in July 2024 in relation to risks associated with compounded semaglutide, and the position taken by the Australian Therapeutic Goods Administration (TGA) which has banned compounded copies of Ozempic® since 1 October 2024 due to serious safety concerns.

FDA Accepts sBLA for Opdivo® and Yervoy® for Unresectable or Metastatic MSI-H or dMMR Colorectal Cancer

Feb 24, 2025

BMS has announced that the FDA has accepted a supplemental biologics licence application (sBLA) for Opdivo® (nivolumab) plus Yervoy® (ipilimumab) as a potential first-line treatment option for adult and paediatric patients (12 years and older) with unresectable or metastatic microsatellite instability-high (MSI-H) or mismatch repair deficient (dMMR) colorectal cancer (mCRC). The FDA granted the application Breakthrough Therapy Designation and Priority Review status and assigned a Prescription Drug User Fee Act (PDUFA) goal date of 23 June 2025.

The Opdivo®/Yervoy ® combination was approved for these indications in Europe in December 2024, and similar applications are pending elsewhere.

The second quarter of 2025 should also see the result of the FDA’s consideration of the sBLA for the same combination therapy for the treatment of unresectable hepatocellular carcinoma, with a PDUFA goal date of 21 April 2025. Expansion of approval to this indication in Europe was recommended in January 2025.

Alvotech/Teva’s Selarsdi® is Second Ustekinumab Biosimilar Launched in US

Feb 21, 2025

On 21 February 2025, Alvotech and Teva announced the US launch of Selarsdi® (AVT04, ustekinumab-aekn for injection), biosimilar to J&J/Janssen’s Stelara®.

This follows Alvotech’s and Teva’s US ustekinumab settlement with Johnson & Johnson in June 2023, which permitted US launch of the biosimilar from 21 February 2025. Selarsdi® is now the second biosimilar available in the US, following the launch of Amgen’s Wezlana® in January 2025 through Optum Health Solution’s private label subsidiary Nuvaila.

Selarsdi® was first approved by the FDA in April 2024 in 45 mg/0.5 mL and 90 mg/mL in a single-dose prefilled syringe for subcutaneous injection for treating psoriatic arthritis and plaque psoriasis. In October 2024, the FDA approved an additional presentation for 130 mg/26 ml in a single-dose vial for intravenous infusion and expanded the label to include treatment of adults with Crohn’s disease and ulcerative colitis.

The FDA has granted Selarsdi® a provisional determination of interchangeability following the expiry of exclusivity for Wezlana® (the first interchangeable biosimilar) on 30 April 2025.

AVT04 was launched in Canada in Q1 2024 (marketed by JAMP as Jamteki®), in Europe in July 2024 (marketed by STADA as Uzpruvo®) and in Japan in May 2024 (marketed by Fuji Pharma as Ustekinumab BS (F)).

Selarsdi® was developed by Alvotech and is commercialised by Teva in the US, pursuant to an August 2020 strategic partnership between the companies for the exclusive commercialisation of five of Alvotech’s biosimilar product candidates. The partnership was expanded in July 2023 to include four additional products.

FDA Removes Novo Nordisk’s Ozempic® and Wegovy® From Drug Shortages List

Feb 21, 2025

On 21 February 2025, the FDA announced that the US semaglutide injection product shortage has resolved, such that semaglutide can now be removed from the drug shortages list. The FDA has confirmed it will take action from 22 April 2025 against state-licensed pharmacies which sell compounded versions of the drug and from 22 May 2025 against outsourcing facilities which compound, distribute or sell semaglutide copies.

Semaglutide injection products, namely Novo Nordisk’s popular weight-loss drug Wegovy® and its diabetes drug Ozempic®, were first added to the FDA’s drug shortages list in March 2022 and August 2022, respectively. While it was announced in October 2024 that all doses of Wegovy® and Ozempic® were available in the US, the FDA has continued to monitor the availability of the drugs. Based on information provided by Novo Nordisk, the FDA has now concluded that Novo Nordisk’s supply of semaglutide is currently meeting or exceeding demand and it has sufficient reserves to meet or exceed projected demand.

Korean Court Rules in Favour of Samsung Bioepis in Aflibercept Biosimilar Patent Dispute

Feb 21, 2025

On 21 February 2025, Korean Economic Daily reported that Samsung Bioepis has succeed in a patent dispute regarding Afilivu® (SB15), biosimilar to Regeneron’s Eylea® (aflibercept). Regeneron had commenced the proceeding in January 2023 in the Seoul Central District Court seeking to prevent Samsung Bioepis from producing and selling Afilivu® in Korea. However, the Court has now ruled in Samsung Bioepis’ favour, clearing the way for its biosimilar in Korea, at least for now.

Samsung Bioepis may face further hurdles if the decision is appealed or if Regeneron prevails in a second injunction application filed by Regeneron with the same Court last week. The second injunction application requests a sales ban on Afilivu® in Korea for “other reasons” not cited in the KED report.

Afilivu® was the first aflibercept biosimilar approved in Korea in February 2024. In April 2024, it was reported that Samil Pharmaceutical would launch Samsung Bioepis’ aflibercept biosimilar in the Korean market from 1 May 2024.

On 29 January 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Samsung Bioepis from launching its aflibercept biosimilar in the US without a licence from Regeneron. This ruling affirmed an earlier decision of the US District Court for the Northern District of West Virginia in June 2024, finding that Samsung Bioepis infringed, and had failed to raise a substantial question of invalidity of, Regeneron’s US Patent No. 11,084,865 regarding ophthalmic formulations of aflibercept.

GSK’s Nucala® (Mepolizumab) Under Review in China for COPD

Feb 20, 2025

On 20 February 2025, GSK announced that China’s National Medical Products Administration (NMPA) has accepted for review a new drug application for the use of Nucala® (mepolizumab) as add-on maintenance treatment for patients with chronic obstructive pulmonary disease (COPD) with an eosinophilic phenotype. According to GSK, if approved, Nucala® could be the first approved biologic with monthly dosing for patients with COPD.

Nucala® has been approved in China for a number of indications, including as an add-on therapy with intranasal corticosteroids for the treatment of adult patients with chronic rhinosinusitis with nasal polyps (CRSwNP) (January 2025), and as add-on maintenance treatment for severe eosinophilic asthma in adults and adolescents aged 12 years and older (January 2024).

In December 2024, GSK announced that the US FDA accepted for review data to support a new indication for the use of Nucala® as add-on maintenance treatment for patients with COPD with an eosinophilic phenotype.

Approval Alert: CSL’s Garadacimab Approved in Japan

Feb 20, 2025

On 20 February 2025, CSL announced that its Andembry® (garadacimab) has been approved by Japan’s Ministry of Health, Labour and Welfare (MHLW) in subcutaneous 200mg injection pens for the prevention of acute attacks of hereditary angioedema (HAE).

This approval makes Japan the fourth jurisdiction to approve Andembry® (previously referred to as CSL312). Australia was the first to approve Andembry® globally in January 2025, closely followed by the UK (January 2025) and the EU (February 2025).

Andembry® is currently under review by the FDA, with CSL’s Biologics Licence Application (BLA) for the drug accepted in December 2023. According to CSL, Andembry® is also under review by regulatory agencies in Switzerland and Canada.

New Indication Alert: Genmab’s Epkinly® (Epcoritamab) Approved in Japan for R/R Follicular Lymphoma

Feb 20, 2025

On 20 February 2025, Genmab announced that Japan’s Ministry of Health, Labour and Welfare has approved Epkinly® (epcoritamab) for the treatment of patients with relapsed or refractory (R/R) follicular lymphoma (FL; Grades 1 to 3A) who have received two or more prior lines of therapy.

Epkinly® (marketed as Tepkinly® in the EU) was co-developed by Genmab and AbbVie, and the companies share commercial responsibilities in the US and Japan.

In January 2025, New Zealand’s Medicines and Medical Devices Safety Authority (Medsafe) provisionally approved Epkinly® (epcoritamab) in 4mg/0.8mL concentrate and 48mg/0.8mL solution for injection, indicated for the treatment of adult patients with R/R diffuse large B-cell lymphoma (DLBCL) after two or more lines of systemic therapy. This followed provisional approval of the same formulation and indications by Australia’s Therapeutic Goods Administration (TGA) in early January 2025.

Health Canada Approves Bayer/Regeneron’s Eylea® HD PFS with

Feb 20, 2025

On 20 February 2025, Bayer announced that Health Canada has approved Eylea® HD (aflibercept injection, 8mg) in a pre-filled syringe with integrated OcuClick™ dosing system for the treatment of nAMD and diabetic macular oedema (DME).

Eylea® 8mg was jointly developed by Bayer and Regeneron. Regeneron holds the exclusive rights to both low (2mg) and high dose Eylea® in the US, while Bayer holds those outside the US, where the companies equally share the profits from sales of the products.

High dose Eylea® pre-filled syringe (OcuClick™) has also been approved in Australia (October 2024) and Europe (September 2024).

High dose Eylea® for intravitreal injection is approved for nAMD and DME in the EU (January 2024), Japan (January 2024), the UK (January 2024) and Australia (June 2024). On 10 February 2025, Bayer announced that it submitted a marketing authorisation application to the European Medicines Agency (EMA) for expanded treatment intervals of up to 6 months with Eylea™ 8 mg for nAMD and DME.

Approval Alert: Celltrion’s Denosumab Biosimilars Third to be Approved in Europe

Feb 19, 2025

On 19 February 2025, Celltrion announced that the European Commission has approved Stoboclo® and Osenvelt® (CT-P41), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively, for the same indications as the reference medicines.

Celltrion’s denosumab biosimilars are the third to be approved in Europe, following approval of Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024).

Stoboclo® and Osenvelt® received positive opinions from the EMA’s CHMP in December 2024.

The EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).

Celltrion filed an abbreviated Biologics Licence Application for CT-P41 in the US in December 2023. However, in May 2024, Celltrion was sued by Amgen in the District Court of New Jersey for alleged infringement of 29 patents regarding denosumab. That litigation was settled in January 2025, allowing Celltrion to launch its denosumab biosimilars in the US from 1 June 2025.

Approval Alert: Henlius’ Biosimilar Bevacizumab Achieves First Overseas Approval in Bolivia

Feb 19, 2025

On 19 February 2025, Shanghai Henlius Biotech announced that its HANBEITAI, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) has received marketing approval from Bolivia’s Agencia Estatal de Medicamentos y Tecnologías en Salud (AGEMED) under the trade name Longiva™.

This is the drug’s first approval outside China (approved December 2021), making it the fourth self-developed product from Shanghai Henlius Biotech to be marketed overseas.

The first bevacizumab biosimilar was approved in the US in September 2017 and in Europe in January 2018.

GSK’s Blenrep® and AbbVie’s Elahere® Under Review in AU; Expanded Indications for 4 More Biologics

Feb 19, 2025

Australia’s Therapeutic Goods Administration (TGA) has updated its online list of prescription medicines for evaluation for the month of January. Among the applications for new medicines to be reviewed is GSK’s Blenrep® (belantamab mafodotin) for the treatment of patients with multiple myeloma that has returned or did not respond to treatment.

Meanwhile, AbbVie’s Elahere® (mirvetuximab soravtansine) has been accepted for review for the treatment for adult patients with a specific type of ovarian, fallopian tube, or peritoneal cancer that is resistant to platinum-based chemotherapy. Elahere® received EU approval for this indication in November 2024.

Applications for new indications of biopharmaceuticals currently under evaluation by the TGA include:

AstraZeneca’s Imfinzi® (durvalumab) for muscle invasive bladder cancer. Imfinzi® is already also under review by the TGA for the treatment of patients with limited-stage small cell lung cancer;
Takeda’s Adcetris® (brentuximab vedotin) for the treatment of adult patients with previously untreated Hodgkin Lymphoma, in combination with other anti-cancer drugs;
Janssen’s Darzalex SC® (daratumumab) for the treatment of patients with newly-diagnosed multiple myeloma who are ineligible for a stem cell transplant, and high-risk smouldering multiple myeloma; and
Janssen’s Tremfya® (guselkumab) for the treatment of children aged 6 years and older with moderate to severe plaque psoriasis who are eligible for systemic (whole-body) therapy or phototherapy (ultraviolet light therapy.

Approval Alert: European Commission Approves Celltrion’s Aflibercept Biosimilar

Feb 18, 2025

On 18 February 2025, Celltrion announced that the European Commission has approved Eydenzelt® (CT-P42), biosimilar to Bayer/Regeneron’s Eylea® (aflibercept), for the treatment of multiple retinal disorders, including nAMD, macular oedema following retinal vein occlusion (RVO), diabetic macular oedema (DME) and myopic choroidal neovascularisation (myopic CNV). Eydenzelt® received a positive opinion from the CHMP in December 2024.

Eydenzelt® is the fifth aflibercept biosimilar to be approved in the EU, following: Biocon’s Yesafili® (September 2023), Sandoz’s Afqlir® (November 2024), Samsung Bioepis/Biogen’s Opuviz™ (SB15) (November 2024) and Formycon/Klinge’s FYB203/Baiama®/Ahzantive® (January 2025). Amgen’s Pavblu® and Skojoy® received positive recommendations for marketing approval from the CHMP in January 2025, while Alvotech/Advanz Pharma and Altos Biologics have submitted MAA’s to the EMA for aflibercept biosimilars.

Celltrion filed an NDA with the FDA in June 2023 for Eydenzelt® and received Korean approval for the product in May 2024.

Approval Alert: Biocon’s Ustekinumab Biosimilar Approved in Europe

Feb 18, 2025

On 18 February 2025, Biocon Biologics announced that the European Commission has granted marketing authorisation for Yesintek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab). Yesintek® is indicated for the treatment of adults and children with plaque psoriasis and treatment of adults with psoriatic arthritis and Crohn’s disease. The marketing authorisation approval follows a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on 14 December 2024.

On 29 August 2024, Biocon announced that it signed a patent settlement and licence agreement with Janssen, which enables Biocon to commercialise Bmab 1200/Yesintek® in Europe, the United Kingdom, Canada and Japan. The agreed launch dates for these jurisdictions remain confidential.

There are a number of ustekinumab biosimilars being marketed in the EU, with three launched during 2024, STADA/Alvotech’s Uzpruvo® and Sandoz’s Pyzchiva® in July 2024, and Celltrion’s SteQeyma® in November 2024. Previously approved ustekinumab biosimilars in Europe include Formycon/Fresenius’ Otulfi®/FYB202 (September 2024), Samsung Bioepis’ Eksunbi™ (September 2024) and Amgen’s Wezenla™ (June 2024). Bio-Thera’s MAA for BAT2206 (ustekinumab) was also accepted by the EMA in July 2024.

Yesintek® was approved in the US in early December 2024 for the treatment of Crohn’s disease, ulcerative colitis, plaque psoriasis and psoriatic arthritis. In January 2025, Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) approved Biocon’s subcutaneous ustekinumab (Bmab 1200).

Biocon can launch Yesintek® in the US in February 2025 as agreed in a settlement deal between Biocon and J&J entered in February 2024.

Merus’ Petosemtamab Granted FDA Breakthrough Therapy Designation for HNSCC in Combination with Pembrolizumab

Feb 18, 2025

On 18 February 2025, Merus announced that the FDA has granted Breakthrough Therapy Designation (BTD) to petosemtamab in combination with pembrolizumab for the first-line treatment of adults with recurrent or metastatic PD-L1 positive head and neck squamous cell carcinoma (r/m HNSCC).

This is the second BTD for petosemtamab following the same designation given in May 2024 for treatment of patients with r/m HNSCC whose disease has progressed following chemotherapy and an anti-PD-1 antibody. Petosemtamab received Fast Track designation for this indication in August 2023.

Approval Alert: Galderma’s Nemolizumab Approved in the UK and Switzerland

Feb 18, 2025

On 18 February 2025, Galderma announced that Nemluvio® (nemolizumab) for subcutaneous administration has been approved in the UK and Switzerland for two indications:

moderate-to-severe atopic dermatitis in combination with topical corticosteroids and/or calcineurin inhibitors in adults and adolescents 12 years of age and older with a body weight of at least 30kg, who are candidates for systemic therapy; and
moderate-to-severe prurigo nodularis in adults who are candidates for systemic therapy.

According to Galderma, these are the first approvals from countries within the Access Consortium framework, an international collaborative initiative comprised of regulatory authorities which work together to address shared challenges. Nemluvio® is currently under review in Australia and Singapore, the remaining members of the Access Consortium, with decisions expected later this year.

Just four days earlier, Galderma announced the approval of Nemluvio® in the EU for the same indications. Nemluvio® has also been approved in the US for moderate to severe atopic dermatitis (December 2024) and prurigo nodularis (August 2024).

Regeneron/Sanofi’s Dupixent® sBLA Accepted for Priority Review for Treating Bullous Pemphigoid

Feb 18, 2025

On 18 February 2025, Regeneron and Sanofi announced that the US FDA has accepted their sBLA for priority review of Dupixent® (dupilumab) for the targeted treatment of bullous pemphigoid (BP). The FDA’s decision is expected by 20 June 2025. If approved, Dupixent® will be the first and only targeted medicine to treat BP in the US.

The FDA is also reviewing a Dupixent® sBLA for chronic spontaneous urticaria (CSU), with action due on 18 April 2025.

Despite the appearance of “business as usual”, Regeneron’s litigation against Sanofi in the US District Court for the Southern District of New York remains on foot, in which Regeneron alleges Sanofi violated the terms of their Dupixent® collaboration agreement.

FDA to Review Alvotech/Teva’s BLA for Biosimilar Aflibercept

Feb 18, 2025

On 18 February 2025, Alvotech and Teva announced that the US FDA has accepted for review a Biologics Licence Application (BLA) for Alvotech-developed AVT06, biosimilar to Regeneron’s Eylea® (aflibercept, 2mg). The companies expect that regulatory approval will be obtained in Q4/2025.

Alvotech and Teva’s partnership commenced in August 2020 for the commercialisation of 5 biosimilars in the US and has subsequently expanded. In addition to AVT06, Alvotech is also developing AVT29, biosimilar to Regeneron’s Eylea HD® (aflibercept, 8 mg). Teva also holds commercialisation rights for AVT29 in the US.

There are currently five aflibercept (2 mg) biosimilars approved in the US: Sandoz’s Enzeevu™ (August 2024), Amgen’s Pavblu™ (August 2024), Formycon/Klinge’s Ahzantive®/FYB203 (June 2024), Biocon’s Yesafili™ (May 2024) and Samsung Bioepis’ Opuviz™/SB15 (May 2024). Amgen’s Pavblu® was the first aflibercept biosimilar to be launched in the US in October 2024, following the Court of Appeals for the Federal Circuit’s denial of Regeneron’s application for an injunction against Amgen.

On 15 August 2024, Alvotech and its European commercialisation partner, Advanz Pharma announced that the European Medicines Agency (EMA) had accepted a Marketing Authorisation Application (MAA) for AVT06, with marketing authorisation expected to be granted in Q3 2025.

Pearce IP BioBlast® for the week ending 14 February 2025

Feb 17, 2025

Pearce IP provides weekly reports on global biosimilars activities in the Pearce IP BioBlast®. Significant biosimilar activities for the week ending the 14 February 2025 are set out below:

Aflibercept

10 February 2025 | EU | Bayer Submits MAA in Europe for High Dose Eylea™ with Expanded Treatment Intervals

On 10 February 2025, Bayer announced that it has submitted a marketing authorisation application (MAA) to the European Medicines Agency (EMA) for expanded treatment intervals of up to 6 months… Read more here.

Bevacizumab

12 February 2025 | NZ | NZ’s Pharmac Expands Funding of and Awards “Principal Supply Status” to Celltrion’s Bevacizumab Biosimilar

On 12 February 2025, New Zealand’s Pharmac announced that, from 1 March 2025, it will extend funding of Celltrion’s Vegzelma®, biosimilar to Roche/Genentech’s Avastin® (bevacizumab), for… Read more here.

Bimekizumab

12 February 2025 | UCB’s Two-Year Data for Bimzelx® Demonstrates Sustained Disease Control in HS

On 12 February 2025, UCB announced that two-year data from the BE HEARD trials for Bimzelx® (bimekizumab) demonstrated sustained disease control in patients with moderate to severe… Read more here.

Brentuximab vedotin

12 February 2025 | US | New Indication Alert: FDA Approves Pfizer’s Adcetris® (Brentuximab Vedotin) Combination Therapy for LBCL

On 12 February 2025, Pfizer announced that the US FDA has approved Adcetris® (brentuximab vedotin) in combination with lenalidomide and rituximab for the treatment of adult patients with… Read more here.

Denosumab

16 February 2025 | EU | Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in EU

13 February 2025 | US | Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in US

On 13 February 2025, the US FDA approved Samsung Bioepis’ Ospomyv™ and Xbryk™ (denosumab-dssb, SB16), biosimilars to Amgen’s Prolia® and Xgeva® respectively. The biosimilars… Read more here.

4 February 2025 | US | Cytiva Subsidiary Seeks to Quash Subpoena Issued in Amgen’s US Denosumab Litigation Against Fresenius Kabi

On 4 February 2025, Cytiva subsidiary media supplier HyClone Laboratories filed a motion in the US District Court for the District of Utah, seeking to quash a subpoena issued to it by Amgen in the… Read more here.

Durvalumab, Cemiplimab, Olaparib, Lecanemab

10 February 2025 | GB-SCT | NHS Scotland to Reimburse Durvalumab, Cemiplimab, and Olaparib; Lecanemab Rejected

On 10 February 2025, the Scottish Medicines Consortium (SMC) issued its February 2025 decisions on medicines for reimbursement by NHS Scotland, including accepting three biologics and rejecting… Read more here.

Enfortumab vedotin

10 February 2025 | Pfizer and Astellas Announce Positive Ph 3 Results for Enfortumab Vedotin/Pembrolizumab Combo

On 10 February 2025, Pfizer and Astellas Pharma announced positive results from their Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39). The trial evaluated the efficacy and safety of… Read more here.

Garadacimab

13 February 2025 | EU | Approval Alert: CSL’s Garadacimab Approved in Europe

On 13 February 2025, CSL announced that the European Commission has approved Andembry® (garadacimab) to prevent attacks of hereditary angioedema (HAE) in adult and adolescent patients… Read more here.

Golimumab

10 February 2025 | US | Bio-Thera and Intas Partner to Commercialise Golimumab Biosimilar in US

On 10 February 2025, Bio-Thera Solutions announced that it has entered an exclusive US commercialisation and licence agreement with Intas Pharmaceuticals for BAT2506 (golimumab)… Read more here.

Insulin aspart

14 February 2025 | US | Approval Alert: FDA Approves Sanofi’s Merilog™/Merilog™ SoloStar as First Rapid Acting Insulin Biosimilars to Novo Nordisk’s Novolog®

On 14 February 2025, the FDA approved Sanofi-Aventis US’s Merilog™ (injection, 10 mL)/Merilog™ SoloStar (injection, 3 mL) (insulin-aspart-szjj), biosimilars to Novo Nordisk’s Novolog® (insulin aspart)… Read more here.

Linvoseltamab

11 February 2025 | US | FDA Accepts Regeneron’s Resubmitted Linvoseltamab BLA

On 11 February 2025, Regeneron announced that the US FDA has accepted for review its resubmitted Biologics Licence Application (BLA) for linvoseltamab. Linvoseltamab, a BCMAxCD3… Read more here.

Nemolizumab

14 February 2025 | EU | Approval Alert: European Commission Approves Galderma’s Nemolizumab

On 14 February 2025, Galderma announced that the European Commission has approved Nemluvio® (nemolizumab) for both moderate to severe atopic dermatitis and prurigo nodularis… Read more here.

Pembrolizumab

11 February 2025 | CA | New Indication Alert: Health Canada Approves Merck/MSD’s Keytruda® (Pembrolizumab) for Resectable NSCLC

On 11 February 2025, Merck (known as MSD outside the US and Canada) announced that Health Canada has approved Keytruda® (pembrolizumab) for the treatment of adults with resectable Stage… Read more here.

Tocilizumab

13 February 2025 | KR | Celltrion’s Biosimilar Tocilizumab SC Formulation Approved in Korea

On 13 February 2025, Celltrion announced that Korea’s Ministry of Food and Drug Safety has approved its subcutaneous formulation for Aptozma™/CT-P47, biosimilar to Roche’s Actemra®… Read more here.

Ustekinumab

12 February 2025 | CN | Approval Alert: China’s NMPA Approves Qyuns Therapeutics’ Biosimilar Ustekinumab for Crohn’s Disease

On 12 February 2025, Qyuns Therapeutics Co., Ltd. announced that China’s National Medical Products Administration (NMPA) has accepted the marketing authorisation application and supplemental… Read more here.

11 February 2025 | AU | Approval Alert: Alvotech/Cipla’s Ustekinumab Biosimilar Approved in Australia

On 11 February 2025, the Australian Therapeutic Goods Administration (TGA) approved Alovtech and Cipla’s Uteknix®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in two formulations… Read more here.

Vedolizumab

9 February 2025 | IN | Intas Receives CDSCO Panel Nod for Biosimilar Vedolizumab Ph 1 Study

Medical Dialogues reports that Intas Pharmaceuticals has received approval from India’s Central Drug Standard Control Organisation (CDSCO) to conduct a Phase I bioequivalence study of its… Read more here.

About Pearce IP

Pearce IP is a boutique firm offering intellectual property specialist lawyers, patent attorneys and trade mark attorneys to the life sciences industries (in particular, pharmaceutical, biopharmaceutical, biotech, ag-tech and food tech). Pearce IP is the 2021 ‘Intellectual Property Team of the Year’ (Lawyers Weekly Australian Law Awards) and was shortlisted for the same award in 2022. Pearce IP is ranked in IAM Patent 1000 and Managing IP (MIP) IP Stars, in Australasian Lawyer 5 Star Awards as a ‘5 Star’ firm, and the Legal 500 APAC Guide for Intellectual Property.

Our leaders have been recognised in virtually every notable IP listing for their legal, patent and trade mark excellence including: IAM Patent 1000, IAM Strategy 300, MIP IP Stars, Doyles Guide, WIPR Leaders, 5 Star IP Lawyers, Best Lawyers, and Australasian Lawyer 5 Star Awards, and have been honoured with many awards including Australian Law Awards – IP Partner of the Year, Women in Law Awards – Partner of the Year, Women in Business Law Awards - Patent Lawyer of the Year (Asia Pacific), Most Influential Lawyers (Changemaker), among other awards.

Naomi Pearce

CEO, Executive Lawyer (AU, NZ), Patent Attorney (AU, NZ) & Trade Mark Attorney (AU)

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.

Nathan Kan

Graduate (Law)

Nathan is a Graduate (Law) focused on providing legal services and advice to life sciences clients, with a focus on litigation support regarding intellectual property (patents, trade marks, designs, copyright, domain names, plant breeders rights and confidential information) and commercial disputes.

Nathan is passionate about the intersection of law and science. Whilst serving as Sponsorship Director and subsequently as Vice President of the Science and Technology Law Association (SATLA) at the University of Melbourne, he led various engagement events, workshops and publications covering a range of STEM fields, including life sciences, artificial intelligence and digital transformation.

New Indication Alert: Novo Nordisk’s Wegovy® AU-Approved for Heart Disease

Feb 17, 2025

The Australian Financial Review reports that on 17 February 2025, Novo Nordisk confirmed that Australia’s Therapeutic Goods Administration (TGA) approved an indication extension for Wegovy® (semaglutide) as an adjunct to standard of care therapy to reduce the risk of major adverse cardiovascular events (MACE) in overweight and obese adults with established cardiovascular disease (CVD) and without established Type 1 or Type 2 diabetes. The indication extension was registered by the TGA on 19 December 2024.

Novo Nordisk obtained US approval for the same indication of Wegovy® in March 2024. In July 2024, the CHMP adopted a positive opinion for an update to the label for Wegovy® in Europe to reflect a risk reduction of MACE in adults with established CVD and either overweight or obesity without diabetes.

Formycon to Terminate Ph 3 Trial and Pursue US-Approval of Pembrolizumab Biosimilar Based on Ph 1/Analytical Data

Feb 17, 2025

On 17 February 2025, Formycon announced that it will be prematurely terminating the “Lotus” Phase 3 trial of FYB206, biosimilar to MSD’s Keytruda® (pembrolizumab). According to Formycon, based on “intensive scientific dialogue” with the US FDA, it has concluded that the Phase 3 study is no longer necessary for the development and US approval of FYB206. Instead, Formycon proposes to rely on data from its ongoing Phase 1 trial (“Dahlia”), combined with “a comprehensive analytical program”.

The Phase 1 trial was commenced in June 2024 and is comparing the pharmacokinetics, safety and tolerability of FYB206 with Keytruda® in malignant melanoma. The Lotus Phase 3 trial was commenced in July 2024 to compare the efficacy and safety of FYB206 with Keytruda® in combination with chemotherapy in patients with non-small cell lung cancer (NSCLC).

In October 2024, Formycon announced that results of a comparative analytical evaluation of FYB206, published in Drugs in R&D, showed FYB206 to be structurally and functionally “highly similar” to Keytruda®.

Other pembrolizumab biosimilars in clinical trials include Celltrion’s CT-P51 (Ph 3 trial plan approved by FDA in August 2024), Bio-Thera’s BAT3306 (Ph 1/3 in nsNSCLC commenced 25 July 2024), Amgen’s ABP 234 (Ph 3 in nsNSCLC initiated May 2024), Samsung Bioepis’ SB27 (Ph 3 in metastatic nsNSCLC commenced April 2024) and Sandoz’s GME751 (Ph 1 and 3 commenced in April 2024 (Ph 3)/May 2024 (Ph 1)). In September 2024, Shanghai Henlius Biotech received approval in China for a clinical trial of its pembrolizumab biosimilar, HLX17.

Approval Alert: Samsung Bioepis’ Denosumab Biosimilars Second to be Approved in EU

Feb 16, 2025

On 16 February 2025, Samsung Bioepis announced that the European Commission has approved Obodence™ (60mg pre-filled syringe) and Xbryk™ (120mg vial), biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. The biosimilars are approved for the same indications as the reference medicines.

This announcement came just days after the FDA approval of Samsung Bioepis’ Ospomyv™and Xbryk™(denosumab-dssb) on 13 February 2025.

Obodence™ and Xbryk™ received positive CHMP opinions in November 2024, and are the second set of denosumab biosimilars to be approved in the EU, following Sandoz’s Wyost® and Jubbonti® (approved May 2024).

The European Medicines Agency has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Gedeon Richter (July 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024). The CHMP adopted positive opinions for Celltrion’s Osenvelt®/CT-P41 and Stoboclo®/CT-P41 in December 2024.