On 1 December 2025, Sandoz announced the EU launch of Jubbonti® and Wyost®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), respectively. Jubbonti® and Wyost® were approved for all reference indications by the European Commission (EC) in May 2024, and are the first and only denosumab biosimilars to be launched in the EU.
The EU launch comes 6 months after the US launch of Jubbonti® and Wyost® in June 2025, which followed a settlement agreement entered into by Sandoz and Amgen in April 2024 resolving US patent infringement litigation commenced by Amgen in May 2023 and permitting US launch of Jubbonti® and Wyost® from 31 May 2025.
There are a number of other denosumab biosimilars approved in Europe, although none have launched to date: Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025), Accord Healthcare’s Jubereq® and Osvyrti® (May 2025); Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025), Fresenius Kabi’s Conexxence® and Bomyntra® (July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025), Alvotech’s AVT03 (marketed as Kefdensis® and Zvogra® by STADA; marketed as Acvybra® and Xbonzy® by Dr Reddy’s; November 2025 and Teva’s Ponlimsi™ and Degevma™ (November 2025).
The EC’s CHMP has also issued positive opinions for Intas’ Denosumab Intas (referencing Prolia®) (September 2025) and Enzene/Theramex’s Osqay® (referencing Prolia®) (November 2025).