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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...

On 13 November 2025, Outlook Therapeutics announced that the US FDA has accepted its Biologics License Application (BLA) for its ophthalmic formulation of bevacizumab, ONS-5010/Lytenava™ for wet AMD.

The acceptance follows the resubmission of the BLA earlier this mon...

On 12 November 2025, Sandoz and EirGenix announced a global licensing agreement for the commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab).  Under the agreement, Sandoz will have exclusive worldwide commercial rights to the biosimilar, excluding certa...

On 12 November 2025, Shanghai Henlius announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorisation applications (MAAs) for two denosumab injections: 60mg (Bildyos®; biosimilar to Amgen’s Prolia®) and 120mg (Bilpre...