FDA grants interchangeability designations to Celltrion’s denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo), making them fully substitutable at the pharmacy level for Amgen’s reference biologics Prolia and Xgeva, respectively.
Medical Devices
Safety Data Update on Hintermann Ankle Device
FDA issues an updated safety communication confirming long-term post-approval data showing that the Hintermann Series H3 Total Ankle Replacement system continues to demonstrate a higher-than-expected risk of device failure.
