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On 19 January 2026, Hikma announced the US launch of Enoby™ and Xtrenbo™ (denosumab-gbde), biosimilars to Amgen’s Prolia® and Xgeva® respectively.

Enoby™ and Xtrenbo™ were approved by the FDA in September 2025.  The biosimilars were developed and are manufactured by ...

On 16 January 2026, Bayer announced that the European Commission has approved Eylea™ 8mg  (aflibercept 8mg, 114.3 mg/ml solution for injection) for macular oedema following retinal vein occlusion (RVO) including branch, central and hemiretinal vein occlusion.  This is the t...

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...