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 with osteoporosis designed to evaluate the efficacy, pharmacodynamics (PD), pharmacokinetics (PK), safety and immunogenicity of CT-P41 to reference denosumab.
The trial results demonstrated that CT-P41 had equivalent efficacy and PD to reference denosumab with similar PK and comparable safety and immunogenicity profiles.
Celltrion said its biosimilar portfolio, with the FDA approval of STOBOCLO and OSENVELT, continues to grow, expanding treatment options to reach more patients.
Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, said, "The approval of STOBOCLO and OSENVELT is another step forward in our efforts to deliver cost-effective and high-quality treatments that address critical unmet needs in osteoporosis-related fracture as well as cancer-related skeletal events. Patients deserve therapeutic options that have the potential to make real impacts on their care and their lives. We are committed to continuous innovation to meet these goals leveraging our experience and successful track record with biosimilar and novel biologics."
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