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On 18 November 2025, Celltrion announced that it has received European Commission approval for a new 300 mg (2 mL) prefilled syringe form of Omlyclo®, biosimilar to Novartis’ Xolair® (omalizumab).  According to Celltrion, the additional strength of Omlyclo® “can significant...

On 18 November 2025, Celltrion announced that the European Commission has approved its Remsima™ IV liquid formulation for all approved indications of the powder formulation, including rheumatoid arthritis, adult and paediatric Crohn’s disease and ulcerative colitis, ankylos...

On 17 November 2025, Formycon revealed that it is developing FYB208, a biosimilar candidate to Sanofi/Regeneron’s Dupixent® (dupilumab).  According to Formycon, preclinical development is completed and it is working on the study design for the planned clinical pharmacokinet...

Between 28 October 2025 and 17 November 2025, the US Patent Trial and Appeal Board (PTAB) issued final decisions invalidating Johns Hopkins University’s (JHU’s) 10,934,356 (IPR2024-00622), 11,325,974 (IPR2024-00623), 11,325,975 (IPR2024-00624) and 11,643,462 (IPR2024-00648)...

On 17 November 2025, Sandoz announced the US launch of Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab).  Tyruko® is the only natalizumab biosimilar approved (August 2023) and launched in the US and is available for all reference indications.

Tyruko® was develo...

On 14 November 2025, Amgen filed BPCIA proceedings in the US District Court for the District of New Jersey against Alkem Laboratories and its subsidiaries, Ascend Laboratories and Enzene Biosciences, alleging infringement of 35 US patents covering denosumab, pharmaceutical ...

At its November 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two biosimilars:

Enzene/Theramex’s Osqay®, biosimilar to Amgen’s Prolia® (denosumab). Enzene and Theramex entered into ...

On 13 November 2025, the FDA announced that it has approved Shanghai Henlius’ Poherdy™ (formerly HLX11, pertuzumab-dpzb) as an interchangeable biosimilar to Roche’s Perjeta®, including in combination with trastuzumab.  Henlius’ Poherdy™ is the first pertuzumab biosimilar ap...