On 2 December 2025, Biocon announced that it has reached a settlement and licence with Amgen for Europe and ROW, permitting Biocon to launch its Evfraxy® and Vevzuo®, biosimilars to Amgen’s Prolia® and Xgeva® (denosumab), in Europe from 2 December 2025. The settlement follows a US settlement between the companies resolving pending BPCIA denosumab patent litigation and permitting Biocon’s 1 October 2025 US launch of Bosaya™ and Aukelso™. The dates Biocon is licensed to commercialise denosumab biosimilars in ROW remain confidential.
Biocon’s Evfraxy® and Vevzuo® received European and UK approval in July 2025. Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in Europe (May 2024), and were launched on 1 December 2025. European launches of denosumab biosimilars of the following sponsors were also announced on 1-2 December 2025: Samsung Bioepis’ Obodence™ and Xbryk™ (approved February 2025), Accord Healthcare’s Osvyrti® and Jubereq® (approved May 2025), Zentiva’s Zadenvi® (approved June 2025), and Fresenius Kabi’s Conexxence® and Bomyntra® (approved July 2025).