On 7 November 2025, Boan Biologics announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has accepted its marketing authorisation applications (MAAs) for two denosumab injections: 60mg (BA6101; biosimilar to Amgen’s Prolia®) and 120mg (BA1102; biosimilar to Amgen’s Xgeva®).
There are five sponsors with 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).
Boan Biotech’s denosumab biosimilars have previously been approved in China in 2024 (Boluojia®; BA11021) and 2022 (Boyoubei®; BA6101).