On 25 April 2025, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended marketing approval for eight denosumab biosimilars.
Gedeon Richter’s Junod® and Yaxwer®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, received positive opinions for all indications of the reference medicines. The EMA had accepted Richter’s MAA for review in July 2024. Gedeon Richter’s denosumab biosimilars are the first monoclonal antibodies in the company’s biosimilar portfolio.
Biocon Biologics’ Vevzuo® (reference: Xgeva®) and Denosumab BBL (brand name currently under approval) (reference: Prolia®) were also recommended by CHMP. The European sponsor for the products is Biosimilar Collaborations Ireland Limited, an indirect wholly owned subsidiary of Biocon Biologics.
Positive recommendations were also given to mAbxience’s Izamby® and Zentiva’s Zadenvi®, both biosimilars to Prolia®.
To date, there have been three sponsors with denosumab biosimilars approved in Europe: Celltrion’s Stoboclo®/Ozenvelt® (February 2025), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), and Sandoz’s Wyost® and Jubbonti® (May 2024). Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted MAAs for a number of other denosumab biosimilars including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).