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On 22 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) announced the outcomes of its May 2026 meeting, including positive opinions for one biosimilar, one “hybrid” medicine and recommended extended indications for a number of b...

On 21 May 2026, Mabwell announced that China’s National Medical Products Administration (NMPA) approved an expanded set of indications for Maiweijian™, biosimilar to Amgen’s Xgeva® (denosumab), developed by its wholly-owned subsidiary T-mab.  The drug is now approved to hel...

On 20 May 2026, Samsung Bioepis announced that it has launched SB17, biosimilar to J&J/Janssen’s Stelara® (ustekinumab), in Japan through its local marketing partner NIPRO Corporation.  SB17 will be marketed in Japan as “Ustekinumab BS Subcutaneous Injection 45 mg ̶...

On 20 May 2026, The Economics Times reported that Zydus Lifesciences plans to commercialise its generic semaglutide formulation across more than 20 markets over the next two years.

Zydus was one of the first companies to launch generic semaglutide in India (marketed ...

On 20 May 2026, Korea Biomedical Review reported that Korea’s Ministry of Food and Drug Safety has approved MSD’s Keytruda SC™ (pembrolizumab and berahyaluronidase alfa) for 35 indications across 18 cancer types.  MSD plans to launch the product in Korea in Q4/2026.

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On 19 May 2026, Formycon and Klinge Biopharma announced that the European launch of FYB203, biosimilar to Regeneron/Bayer’s Eylea® (aflibercept, 2mg), commenced on 15 May 2026 in key European markets, including Germany, France and Italy.

The launch follows a March 20...

On 18 May 2026, Accord BioPharma announced that the FDA has approved Immgolis™ and Immgolis Intri™ (golimumab) as interchangeable biosimilars to Janssen’s Simponi® and Simponi® Aria, respectively.  These are the first golimumab biosimilars to be approved in the US.

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