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Nov 17, 2025
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) in four inter partes review proceedings (IPRs) brought by MSD.
Nov 17, 2025
On 17 November 2025, Sandoz announced the US launch of Tyruko®, biosimilar to Biogen’s Tysabri® (natalizumab).
Nov 14, 2025
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…
Nov 14, 2025
At its November 2025 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two biosimilars…
Nov 13, 2025
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.
Nov 13, 2025
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.
Nov 12, 2025
On 12 November 2025, Sandoz and EirGenix announced a global licensing agreement for the commercialisation of EG1206A, biosimilar to Roche’s Perjeta® (pertuzumab).
Nov 12, 2025
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 (Bilprevda®; biosimilar to Amgen’s Xgeva®).
Nov 11, 2025
On 11 November 2025, Viet Nam News, reported that the Vietnam Ministry of Health has granted marketing authorisation for Pembroria™, biosimilar to MSD’s Keytruda® (pembrolizumab), in Vietnam for a three-year period.
Nov 11, 2025
On 11 November 2025, Johnson & Johnson announced that the Scottish Medicines Consortium (SMC) has accepted Tremfya® (guselkumab) for use in NHS Scotland for adult patients with moderately to severely active Crohn’s disease
Nov 10, 2025
On 10 November 2025, Alvotech announced that the UK High Court has rejected Regeneron/Bayer’s request for an injunction to prevent UK manufacturing activities under the SPC waiver notice provisions in relation to Alvotech’s AVT06 (Mynzepli®), biosimilar to Regeneron/Bayer’s Eylea® (aflibercept).
Nov 10, 2025
On 10 November 2025, Bio-Thera announced that it has entered into an exclusive commercialisation and licence agreement with Dr Reddy’s in relation to BAT2306, biosimilar to Novartis’ Cosentyx® (secukinumab).
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