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On 30 January 2026, a Joint Stipulation of Dismissal was filed in the US District Court for the District of New Jersey dismissing all claims in the BPCIA litigation commenced by Genentech/Roche in August 2025 in relation to Shanghai Henlius/Organon’s Poherdy® (HLX11, pertuz...

On 29 January 2026, the European Medicine Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended authorisation of BMS’s Opdivo® (nivolumab) in combination with brentuximab vedotin for the treatment of children 5 years of age and older, adolescents and ad...

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...