On 23 July 2025, Fresenius Kabi announced that the European Commission (EC) has granted approval for Conexxence® and Bomyntra®, biosimilars to Prolia® and Xgeva® (denosumab), for all reference indications.
Conexxence® and Bomyntra® were recommended for approval at the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) in May 2025, alongside Sandoz’s second Prolia® biosimilar, Rolcya®.
Fresenius Kabi entered a global settlement with Amgen in respect of its denosumab biosimilars in March 2025. The settlement resulted in the dismissal of all claims and counterclaims in US BPCIA litigation commenced by Amgen against Fresenius in October 2024. The global settlement permits European launch of Fresenius’ biosimilars at the end of November 2025. Fresenius announced the US launch of Conexxence® and Bomyntra® on 1 July 2025.
There are now 7 sponsors with denosumab biosimilars approved in Europe, with previous approvals for Sandoz’s Wyost® and Jubbonti® (May 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (February 2025), Celltrion’s Stoboclo® and Osenvelt® (February 2025) and Gedeon Richter’s Junod® and Yaxwer®, mAbxience’s Izamby® and Denbrayce®, Biocon’s Evfraxy® and Vevzuo® (July 2025).
Accord Healthcare’s Jubereq® and Osvyrti® received CHMP positive opinions in March 2025 and the EMA has accepted denosumab biosimilar MAAs including for Shanghai Henlius/Organon (HLX14, May 2024), Teva (TVB-009P, October 2024) and STADA/Alvotech (AVT03, October 2024).