India, March 4 -- Celltrion USA, affiliated to South Korean biopharmaceutical company Celltrion, Inc., announced that the U.S. Food and Drug Administration has approved STOBOCLO (CT-P41, denosumab-bmwo) and OSENVELT (CT-P41, denosumab-bmwo) biosimilars for all indications of reference products PROLIA (denosumab) and XGEVA (denosumab) respectively, from Amgen Inc. (AMGN).
In accordance with a settlement agreement with Amgen, STOBOCLO and OSENVELT are expected to be available in the U.S. in June 2025.
The company noted that the FDA approval is based on clinical evidence, which show no clinically meaningful differences from the reference products.
The clinical evidence includes results from Phase III clinical trials in postmenopausal women ...