On 12 November 2025, Shanghai Henlius announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorisation applications (MAAs) for two denosumab injections: 60mg (Bildyos®; biosimilar to Amgen’s Prolia®) and 120mg (Bilprevda®; biosimilar to Amgen’s Xgeva®).
Just five days earlier, Boan Biotech announced that its MAAs for denosumab biosimilars, BA6101 (60mg, referencing Prolia®) and BA1102 (120mg, referencing Xgeva®), were also accepted by the MHRA.
There are a number of denosumab biosimilars approved in the UK, including: Sandoz’s Wyost® and Jubbonti® (November 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (March 2025), Celltrion’s Stoboclo® and Osenvelt® (May 2025), Accord’s Osvyrti® (June 2025) and Biocon’s Evfraxy® and Vevzuo® (July 2025).
The EMA’s CHMP adopted positive opinions in September 2025 for STADA/Alvotech’s Kefdensis® and Zvogra® (AVT03, MAA accepted October 2024), Dr Reddy’s Acvybra® and Xbonzy®, Teva’s Ponlimsi™ and Degevma™ (TVB-009P, MAA accepted October 2024), and Intas’ Denosumab Intas.