South Korean biopharmaceutical company Celltrion announced on Monday that it has received approval from the US Food and Drug Administration (FDA) for STOBOCLO (CT-P41, denosumab-bmwo) and OSENVELT (CT-P41, denosumab-bmwo), biosimilars referencing PROLIA (denosumab) and XGEVA (denosumab) respectively for all indications of the reference products.

The FDA approval is based on clinical evidence, including 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. Study results demonstrated that CT-P41 had equivalent efficacy and PD to reference denosumab with similar PK and comparable safety and immunogenicity profiles.

In accordance with a settlement agreement with Amgen Inc (NASDAQ:AMGN), STOBOCLO and OSENVELT are expected to be available in the United States in June 2025.

Thomas Nusbickel, Celltrion USA chief commercial officer, 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."