On 7 July 2025, Biocon announced that it has received marketing authorisations from the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) for its denosumab products Evfraxy® and Vevzuo®, biosimilars to Amgen’s Prolia® and Xgeva® respectively, across all indications of the reference products.
Biocon is the fifth sponsor to have received marketing authorisation for its denosumab biosimilars in the UK, following Sandoz’s Wyost® and Jubbonti® (November 2024), Samsung Bioepis’ Obodence™ and Xbryk™ (March 2025), Celltrion’s Stoboclo® and Osenvelt® (May 2025) and Accord’s Osvyrti® (June 2025).
The UK approval of Evfraxy® and Vevzuo® comes a week after Biocon received EU approval for them.