On 24 November 2025, Alvotech announced that the European Commission has approved denosumab biosimilar, AVT03, in two presentations referencing Amgen’s Prolia® and Xgeva®.
Alvotech has semi-exclusive commercialisation agreements for European markets with both STADA (June 2024) and Dr Reddy’s (May 2024) in relation to AVT03. STADA will market AVT03 as Kefdensis® (referencing Prolia®) and Zvogra® (referencing Xgeva®), while Dr. Reddy’s will market AVT03 as Acvybra® (referencing Prolia®) and Xbonzy® (referencing Xgeva®).
The next day, on 25 November 2025, Teva Pharmaceuticals announced that it also received European Commission approval for its two denosumab biosimilars, Ponlimsi® (referencing Prolia) and Degevma® (referencing Xgeva®).
The flurry of approvals follow the positive opinions adopted by the EMA’s CHMP in September 2025 for STADA’s, Dr Reddy’s and Teva’s denosumab products.
Sandoz’s Wyost® and Jubbonti® were the first denosumab biosimilars approved in Europe (May 2024), and on 1 December 2025, became the first to launch. There are a number of other denosumab biosimilars already 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) and Shanghai Henlius/Organon’s Bildyos® and Bilprevda® HLX14) (September 2025).