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Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®

Celltrion's STOBOCLO and OSENVELT received FDA approval for all indications of their reference products, PROLIA and XGEVA, respectively.
The FDA's approval is based on comprehensive clinical evidence showing no meaningful differences from the reference products, according to Celltrion.
Thomas Nusbickel, Chief Commercial Officer at Celltrion USA, stated that the approval is a step forward for cost-effective treatments for osteoporosis and cancer-related skeletal events.
STOBOCLO and OSENVELT will be available in the U.S. In June 2025 due to a settlement agreement with Amgen Inc.

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Rutland Herald

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Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®

STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) are approved by FDA for all indications of reference products PROLIA® (denosumab) and XGEVA® (denosumab) respectively[1], [2]The FDA approval is based on robust clinical evidence, which show no clinically meaningful differences from the reference productsWith…

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