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On 29 May 2026, Boan Biotech announced that it has submitted Biologics License Applications (BLAs) to the FDA for two denosumab biosimilars: BA6101 (denosumab 60 mg) and BA1102 (denosumab 120 mg), biosimilars to Amgen’s Prolia® and Xgeva® respectively.  The BLAs seek ...

On 26 May 2026, Shanghai Henlius announced that the first patient has been dosed in its phase 1 international multicentre clinical trial of HLX15-SC (daratumumab and hyaluronidase-fihj), biosimilar to J&J’s Darzalex Faspro®, for the treatment of multiple myeloma.

On 26 May 2026, Outlook Therapeutics announced that the FDA has granted an appeal following the completion of a Formal Dispute Resolution (FDR) process for ONS-5010/Lytenava™ (bevacizumab-vikg) for wet AMD.  The FDR process is an appeal mechanism that permits a sponsor to o...

On 26 May 2026, Amneal Pharmaceuticals and Kashiv Biosciences filed a petition with the Patent Trial and Appeal Board for inter partes review of Genentech/Novartis’ US Patent No. 12,030,959.  The patent relates to methods for treating food allergies in paediatric patients b...

On 22 May 2026, Polpharma Biologics and Tuteur announced that they have entered into an exclusive licensing agreement for the commercialisation of an unnamed biosimilar for the treatment of an autoimmune disease in Latin America, excluding Brazil.

Under the agreement...

On 22 and 23 May 2026, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions for two new formulations of Novo Nordisk’s semaglutide:

Wegovy® pill (once-daily oral semaglutide 25 mg); and
high-dose We...

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 ̶...