Posted by Michael Wonder on 04 Nov 2025
US FDA grants interchangeability designation to Celltrion's denosumab biosimilars, Stoboclo (denosumab-bmwo) and Ozenvelt (denosumab-bmwo)
30 October 2025 - The US FDA approved Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) as interchangeable with the reference products Prolia (denosumab) and Xgeva (denosumab), respectively, for all approved indications, effective as of 29 October 2025.
Celltrion today announced that the US FDA has designated Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo) as interchangeable biosimilars to the reference products Prolia (denosumab) and Xgeva (denosumab), respectively, for all approved indications.
