Read our latest updates & insights

On 15 January 2026, Zydus Lifesciences Ltd and Agenus Inc. announced the closing of a deal in which Zydus acquired Agenus’ biologics manufacturing facilities in Emeryville and Berkeley, California, and obtained exclusive rights to develop and commercialise Agenus’ botensili...

On 14 January 2026, Samsung Bioepis announced that Korea’s Ministry of Food and Drug Safety has approved a pre-filled pen formulation (PFP) of Epyztek®, biosimilar to J&J/Janssen’s Stelara® (ustekinumab).  According to Samsung Bioepis, this is the first PFP presentation...

On 14 January 2026, Sandoz announced that the European Commission has approved Ondibta® (insulin glargine solution for injection in pre-filled pen), biosimilar to Sanofi’s Lantus® Solostar®.  Ondibta® is registered in Europe by Gan & Lee Pharmaceuticals and received a p...

At the J.P. Morgan Healthcare Conference on 14 January 2026, Samsung Epis Holdings announced the addition of six biosimilar candidates to Samsung Bioepis’ pipeline: dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab.

The ...

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...