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BMS has applied to the Supreme Court of India for leave to appeal against the 12 January 2026 decision of the High Court of Delhi appellate division, which allowed Zydus to launch Tishtha®, biosimilar to BMS’ Opdivo®/Opdyta®, in India pending resolution of the patent infrin...

On 29 January 2026, Alvotech announced a settlement and licence agreement with Regeneron & Bayer in relation to all remaining patent disputes worldwide (excluding the US) concerning Alvotech’s AVT06, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg).  This follo...

On 28 January 2026, Korea Biomedical Review reported that Dong-A ST’s Imuldosa®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), has received marketing approval from Health Canada.

Imuldosa® has already been launched in 19 countries, including the UK and Irel...

On 26 January 2026, MS Pharma announced that it has entered an exclusive agreement with Hetero Group in relation to the commercialisation in Algeria of 5 undisclosed “established biosimilars” in therapeutic areas including oncology, immunology and haematology.

The bi...

On 29 January 2026, Celltrion announced the Canadian approval of its high-dose Omlyclo® (omalizumab), biosimilar to Genentech/Novartis’ Xolair®, in 300mg pre-filled syringe (PFS) and autoinjector (AI) formulations.  Celltrion now has Canadian approved PFS and AI formulation...

On 23 January 2026, Samsung Bioepis published its twelfth US Biosimilar Market Report, which has been released every quarter since April 2023.  The report provides an overview of the US biosimilar market and details average sales price (ASP) and wholesale acquisition cost (...

On 22 January 2026, Daiichi Sankyo announced that Enhertu® (trastuzumab deruxtecan) has been approved by China’s National Medical Products Administration (NMPA) as the first and only HER2-directed antibody-drug conjugate for the second line treatment of adults with HER2 pos...