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On 14 January 2026, Korea Biomedical Review reported that Korean-headquartered Chong Kun Dang has received approval from the European Medicines Agency (EMA) and the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its phase 1 clinical trial protocol for CKD...

On 13 January 2026, Celltrion revealed at the 44th Annual J.P. Morgan Healthcare Conference that it plans to commercialise up to 18 biosimilar products by 2030 and 41 products by 2038.  This is a slight reduction of its plans announced in September 2024 to have a “portfolio...

On 13 January 2026, Shanghai Henlius Biotech announced that its Biologics Licence Application (BLA) for HLX04, biosimilar to Roche/Genentech’s Avastin® (bevacizumab) has been accepted for review by the FDA.

HLX04 has previously been approved in China (2021) and in mu...

On 12 January 2026, an appellate Division of the High Court of Delhi issued its judgment overturning the grant of a preliminary injunction awarded to Bristol Myers Squibb (BMS) in July 2025, restraining Zydus’ Indian launch of nivolumab ZRC-3276, biosimilar to BMS’ Opdivo®....

On 12 January 2026, Ono Pharmaceutical announced that the Taiwan Food and Drug Administration has approved a new indication for Opdivo® (nivolumab) intravenous infusion in combination with Yervoy® (ipilimumab), for the treatment of adult patients with unresectable or metast...

On 9 January 2026, Aurobindo Pharma announced in a regulatory filing that its subsidiary, CuraTeQ Biologics, has received approval from Health Canada for Dyrupeg®, biosimilar to Amgen’s Neulasta® (pegfilgrastim).  In the same regulatory filing, CuraTeq also disclosed that i...

On 9 January 2026, Boan Biotech announced that it has received regulatory approval from Bolivia’s National Agency of Medicines and Health Technologies (AGEMED) for BA6101, its 60 mg denosumab injection, biosimilar to Amgen’s Prolia®.  BA6101 is approved for the same i...