Other Updates

On 7 March 2025, Biocon Biologics announced the results of a Phase 3 study comparing Yesintek™ (biosimilar ustekinumab) with J&J/Janssen’s Stelara® in adults with moderate to severe chronic plaque psoriasis (PsO).  The study reportedly demonstrated equivalent efficacy, safety, immunogenicity and pharmacokinetics between the biosimilar and its reference product and continued efficacy and safety of switching from Stelara® to Yesintek™ from week 16 to week 52. Biocon intends to present the results at the March 2025 American Academy of Dermatology (AAD) Annual Meeting in Orlando, Florida.

Biocon launched Yesintek™ in the US in February 2025 following its approval in early December 2024 for adult patients with moderate to severe PsO who are candidates for phototherapy or systemic therapy, active psoriatic arthritis, moderately to severely active Crohn’s disease and moderately to severely active ulcerative colitis.

The European Commission granted marketing authorisation for Yesintek™ in February 2025 for the treatment of adults and children with plaque psoriasis and treatment of adults with psoriatic arthritis and Crohn’s disease.  The European approval followed a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) on 14 December 2024.

On 7 March 2025, the US FDA approved Celltrion’s Omlyclo® (omalizumab-igec, CT-P39), as the first interchangeable biosimilar to Genentech/Novartis’ Xolair® (omalizumab).  Omlyclo® is approved as a 75 mg/0.5ml and 150mg/ml injection in a single pre-filled syringe for subcutaneous use.  The approval covers all US indications of Xolair®, including moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, IgE-mediated food allergy and chronic spontaneous urticaria.

Omlyclo® was the first omalizumab biosimilar to be approved in Canada (December 2024), Australia (November 2024), the UK (July 2024), South Korea (June 2024), and Europe (May 2024).

On 30 January 2025, the Patents Court (England and Wales) ruled that Genentech/Novartis’ UK patent for a formulation of omalizumab (EP (UK) 3 805 248) was valid and infringed by Celltrion.  The UK Court judgment followed a decision of the Dusseldorf Local Division of the UPC in September 2024, which rejected Novartis/Genentech’s application for a preliminary injunction against Celltrion for “imminent infringement” of the EP ‘248 patent.

Disputes between Novartis/Genentech and Celltrion regarding omalizumab are ongoing in the Netherlands (with accelerated proceedings on the merits before the District Court of The Hague), and in the European Patent Office (EPO), where Celltrion (and another party) filed an opposition against EP 3 805 248 in October 2023.  In a preliminary opinion issued on 2 September 2024, the Opposition Division of the EPO indicated its view that EP ‘248 is valid.  The oral proceedings in the opposition are due to take place in April 2025.

Kashiv Biosciences/Alvotech, Aurobindo, Teva and Glenmark have previously been reported to have omalizumab biosimilars under development.

On 7 March 2025, Bristol Myers Squibb (BMS) announced that the European Commission has approved Opdivo® (nivolumab) plus Yervoy® (ipilimumab) for the first line treatment of adults with unresectable or advanced hepatocellular carcinoma (HCC).  The EC approval follows the CHMP’s positive opinion for the expanded indication in January 2025.

The same indication for the Opdivo®/Yervoy® combination is currently under review by the FDA, with BMS’ sBLA accepted in August 2024.  The FDA assigned a PDUFA goal date of 21 April 2025.

In December 2024, the European Commission approved Opdivo®/Yervoy® for the first-line treatment of adult patients with microsatellite instability–high (MSI-H) or mismatch repair deficient (dMMR) unresectable or metastatic colorectal cancer (mCRC).  Applications for this indication are also pending in countries including the US (sBLA accepted in February 2025), Australia (TGA application filed in July 2024) and Japan (supplemental application filed in September 2024).

On 7 March 2025, the US District Court for the District of New Jersey ordered the dismissal of all claims and counterclaims in Amgen’s BPCIA patent infringement proceeding against Fresenius Kabi in relation to its denosumab biosimilar.  The order followed a stipulation by the parties as to their settlement of the litigation, which was filed with the Court on 4 March 2025.

Neither Amgen nor Fresenius Kabi have issued press releases about the settlement as at the date of this report and the terms on which the proceeding was settled, including the US launch date for Fresenius’ denosumab biosimilars, are currently unknown.

Amgen originally commenced proceedings against Fresenius Kabi on 4 October 2024 in the US District Court for the Northern District of Illinois (Eastern Division) alleging infringement of 33 US patents relating to denosumab.  The litigation followed Fresenius’ submission of an abbreviated Biologics Licence Application (aBLA) to the US FDA seeking approval to manufacture and sell its FKS518, biosimilar to Amgen’s Prolia® and Xgeva® (denosumab).  Fresenius’ aBLA for denosumab was accepted for review by the FDA on 27 May 2024.

In the context of the litigation, Amgen issued a subpoena to Cytiva subsidiary media supplier HyClone Laboratories requesting information including the full formulation of HyClone’s off-the-shelf cell culture supplement, HyClone™ Cell Boost™ 7a (CB7A).  Amgen has now withdrawn that subpoena given the settlement of the underlying litigation with Fresenius.

The BPCIA proceeding against Fresenius was one of five that Amgen had commenced in the US in relation to denosumab biosimilars, which were centralised in the US District Court for the District of New Jersey in February 2025.  A dispute with Sandoz, commenced in May 2023, was resolved in April 2024, enabling Sandoz to launch Jubbonti® and Wyost® from 31 May 2025 (or earlier in certain undisclosed circumstances).  Amgen also settled its US litigation against Celltrion in January 2025, permitting launch of Celltrion’s yet to be US-approved denosumab biosimilar from 1 June 2025.  The remaining court proceedings, against Samsung Bioepis (Ospomyv™/Xbryk™/SB16 approved February 2025, litigation commenced August 2024) and Accord/Intas (INTP23, litigation commenced November 2024), remain pending.

On 6 March 2025, Sun Pharma’s liraglutide became the first approved generic to Novo Nordisk’s Saxenda® in Australia.  The product was approved by Australia’s Therapeutic Goods Administration (TGA) across three brands:

• Benedo: liraglutide 6 mg/mL solution for injection pre-filled pen (428573);
• Liraglutide RBX: liraglutide 6 mg/mL solution for injection pre-filled pen (428571); and
• Liraglutide Sun: liraglutide 6 mg/mL solution for injection pre-filled pen (428572).

All three brands are indicated as an adjunct to a reduced-calorie diet and increased physical activity for weight management in adult patients with an initial Body Mass Index (BMI) of:

• ≥30 kg/m² (obese); or
• ≥27 kg/m² to <30 kg/m² (overweight) in the presence of at least one weight related comorbidity, such as dysglycaemia (pre-diabetes and type 2 diabetes mellitus), hypertension, dyslipidaemia, or obstructive sleep apnoea.

Sun Pharma’s generic liraglutide was accepted for review by the TGA in January 2024.  There are currently two other generic liraglutide products being reviewed by the TGA: Freyr’s Lobezyl® (accepted for review in September 2024) and Cipla’s unnamed generic liraglutide (accepted for review in October 2023).

On 12 December 2024, the Federal Court of Australia rejected Cipla’s challenge to the patent term extension of Novo Nordisk’s liraglutide formulation patent (AU 2004290862).  As a result, the term of the AU formulation patent remains due to expire in August 2025.  The Federal Court decision has not been appealed.

Adalvo’s generic liraglutide was the first to be approved in the EU in June 2024, while Biocon’s liraglutide was the first generic approved in the UK in March 2024.  Teva Pharmaceuticals launched the first authorised generic liraglutide in the US in June 2024.

On 6 March 2025, the UK’s National Institute for Health and Care Excellence (NICE) opened a second consultation period in respect of the use of Eisai/Biogen’s Leqembi® (lecanemab) on the NHS in England for treating mild cognitive impairment (MCI) or mild dementia caused by Alzheimer’s disease.  The consultation follows NICE’s draft guidance in August 2024 determining that the benefits of lecanemab were too small to warrant making the drug available on the NHS for this indication.

The closing date for comments to be provided to the evaluation committee is 27 March 2025.  An evaluation committee meeting is scheduled for 14 May 2025, with publication of the decision expected in July 2025.

The UK was the first country in Europe to authorise Leqembi® in August 2024 for the treatment of MCI or mild dementia due to Alzheimer’s disease.  After NICE’s draft guidance against recommending making the drug available on the NHS for this indication, in February 2025, the Scottish Medicines Consortium (SMC) similarly declined to recommend reimbursement of Leqembi® for treating early-stage Alzheimer’s disease, citing uncertainties surrounding the drug’s clinical benefits and cost-effectiveness.

Leqembi® has been approved for MCI and mild dementia due to Alzheimer’s disease in the US, Japan, China, South Korea, Hong Kong and Israel, and the UAE, and applications are under review in Brazil, Canada, India, Russia, Taiwan, Singapore, and Switzerland.  While Australia’s Therapeutic Goods Administration (TGA) has declined to approve Leqembi® (lecanemab) for the treatment for early Alzheimer’s Disease, in February 2025, the CHMP reaffirmed its positive recommendation for approval of this indication.

On 5 March 2025, the Wall Street Journal (WSJ) reported that Halozyme Therapeutics has offered Merck (known as MSD outside the US and Canada) an opportunity to licence patents owned by Halozyme in relation to a specific enzyme, known as Mdase.  Halozyme executives reportedly claimed during a recent investor conference that MSD’s subcutaneous (SC) version of Keytruda® (pembrolizumab) infringes those patents.

WSJ reports that a spokesperson from Merck/MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that Merck/MSD “strongly believe” that any Halozyme patents that attempt to cover the  enzyme variant are invalid.

The WSJ report follows petitions for post-grant review filed by Merck/MSD with the US Patent Trial and Appeal Board challenging the validity of seven of Halozyme’s US patents.  The petitions, which are currently pending, were filed between November 2024 and February 2025 in relation to: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758 and US 12060590.

In November 2024, MSD revealed positive topline results from its Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy.  The SC pembrolizumab demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC).  At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, Merck/MSD announced an expected 2025 launch for SC Keytruda®.

On 5 March 2025, the Wall Street Journal (WSJ) reported that Halozyme Therapeutics has offered Merck (known as MSD outside the US and Canada) an opportunity to licence patents owned by Halozyme in relation to a specific enzyme, known as Mdase.  Halozyme executives reportedly claimed during a recent investor conference that MSD’s subcutaneous (SC) version of Keytruda® (pembrolizumab) infringes those patents.

WSJ reports that a spokesperson from Merck/MSD said the enzyme used in SC Keytruda® was “developed independently” from Halozyme and that Merck/MSD “strongly believe” that any Halozyme patents that attempt to cover the  enzyme variant are invalid.

The WSJ report follows petitions for post-grant review filed by Merck/MSD with the US Patent Trial and Appeal Board challenging the validity of seven of Halozyme’s US patents.  The petitions, which are currently pending, were filed between November 2024 and February 2025 in relation to: US 11952600, US 12018298, US 12152262, US 12123035, US 12110520, US 12054758 and US 12060590.

In November 2024, MSD revealed positive topline results from its Phase 3 trial evaluating SC pembrolizumab (MK-3475A), together with Alteogen’s berahyaluronidase alfa, administered with chemotherapy.  The SC pembrolizumab demonstrated noninferior pharmacokinetics compared to intravenous (IV) Keytruda® (pembrolizumab) in combination with chemotherapy, in adults with metastatic non-small cell lung cancer (NSCLC).  At the JP Morgan Healthcare Conference in San Francisco on 14 January 2025, Merck/MSD announced an expected 2025 launch for SC Keytruda®.

On 5 March 2025, Generics Bulletin reported that Amgen has launched Bkemv® (eculizumab-aeeb) in the US as the first available interchangeable biosimilar to Alexion’s Soliris®.

Bkemv® was approved by the FDA in May 2024 for the same indications as Soliris® (atypical haemolytic uremic syndrome (aHUS) and paroxysmal nocturnal haemoglobinuria (PNH)), and in the same dosage form and strength.

The timing of the US launch of Bkemv® was governed by a settlement reached by Amgen and Alexion in May 2020, permitting launch from 1 March 2025.  The only other eculizumab biosimilar currently approved in the US is Samsung Bioepis’ Epysqli® (SB12) (approved July 2024).

Amgen’s eculizumab biosimilar was approved in the EU as Bekemv® in April 2023.  On 19 March 2024, Alexion filed proceedings against Amgen in the Unified Patents Court (UPC), seeking provisional measures in relation to alleged infringement of EP3167888, concerning a method of treating PNH using eculizumab.  The UPC (June/July 2024) and the UPC Court of Appeal (December 2024) refused to grant preliminary injunctions against Amgen (and Samsung Bioepis) in relation to the sale of their eculizumab biosimilars in the EU.

On 5 March 2025, the US Court of Appeals for the Federal Circuit refused to overturn a preliminary injunction preventing Celltrion from launching its biosimilar to Regeneron’s Eylea® (aflibercept) in the US without a licence from Regeneron.

In doing so, the Appeals Court affirmed the 28 June 2024 decision of the US District Court for the Northern District of West Virginia, finding that Celltrion 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.

Celltrion’s CT-P42 (aflibercept) has not yet been approved in the US, although Celltrion filed an NDA with the FDA in June 2023.  CT-P42 (marketed as Eydenzelt®) was approved in Korea in May 2024 and received a positive CHMP opinion from the European Medicines Agency in December 2024.

The decision against Celltrion follows similar Appeals Court decisions in January 2025 upholding preliminary injunctions against Samsung Bioepis’ and Formycon’s aflibercept biosimilars, Opuviz™/SB15 (US approval received May 2024) and Ahzantive®/FYB203 (FDA-approved in June 2024), respectively.

The US District Court for the Northern District of West Virginia has also granted a permanent injunction against Biocon (11 June 2024), based on findings of infringement of the same patent (US ‘865).  Biocon filed a Notice of Appeal from the permanent injunction order on 21 June 2024.  That appeal remains pending.

In October 2024, the Court of Appeals denied Regeneron’s application for an injunction against Amgen.  As a result, Amgen launched its aflibercept biosimilar, Pavblu®, in the US later the same month.

Samsung Bioepis, Formycon and Celltrion are challenging Regeneron’s ‘865 patent before the USPTO, each having filed a petition for inter partes review (in November 2024, December 2024 and January 2025, respectively).