On 1 and 2 December 2025, European launches of denosumab biosimilars were announced by the following sponsors:
- Fresenius Kabi announced the 1 December launch of Conexxence® and Bomyntra® (EU approved in July 2025), biosimilars to Amgen’s Prolia® and Xgeva® respectively;
- Samsung Bioepis announced that Obodence™ (60mg PFS, referencing Prolia®) will be available in Europe from December 2025, with Xbryk™ (120 mg vial, referencing Xgeva®) to follow in January 2026. Obodence™ and Xbryk™ were approved by the European Commission in February 2025;
- Zentiva announced the 1 December launch of its denosumab biosimilar, its first entry into the biosimilar market. Zentiva’s Zadenvi®, referencing Prolia®, was approved in Europe in June 2025; and
- Accord Healthcare announced the 2 December launches of Osvyrti® and Jubereq® (EU approved May 2025), biosimilars to Prolia® and Xgeva® respectively.
Sandoz’s Jubbonti® and Wyost® (denosumab) were also launched on 1 December 2025, as previously reported here.
In addition, Biocon announced a settlement agreement with Amgen, permitting Biocon to commercialise Evfraxy® and Vevzuo® (approved July 2025) in Europe from 2 December 2025.
There are a number of other denosumab biosimilars already approved in Europe which are yet to launch: Gedeon Richter’s Junod® and Yaxwer® and mAbxience’s Izamby® and Denbrayce® (July 2025), Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025), Alvotech/STADA’s Kefdensis® and Zvogra® and Alvotech/Dr. Reddy’s Acvybra® and Xbonzy® (both in November 2025), and Teva’s Ponlimsi® and Degevma® (also November 2025).