Over the last week, the European Commission (EC) has approved denosumab biosimilars for three sponsors:
- Gedeon Richter’s Junod® and Yaxwer® (announced 1 July 2025);
- mAbxience’s Izamby® and Denbrayce® (announced 2 July 2025); and
- Biocon’s Evfraxy® and Vevzuo® (announced 3 July 2025).
The biosimilars all received positive CHMP opinions in April 2025.
Richter’s and Biocon’s denosumab biosimilars are approved for the same indications as Amgen’s Prolia® and Xgeva®, respectively. mAbxience’s Izamby® is approved for one of Prolia®’s indications (treatment of osteoporosis in postmenopausal women and in men at increased risk of fractures), while the indications for Denbrayce® mirror those of Xgeva®.
There are now 6 sponsors with denosumab biosimilars approved in Europe, with previous approvals for Celltrion’s Stoboclo® and Osenvelt® (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 denosumab biosimilar MAAs including for STADA/Alvotech (AVT03, October 2024), Teva (TVB-009P, October 2024), Fresenius Kabi (FKS518, July 2024), and Shanghai Henlius/Organon (HLX14, May 2024).