The FDA has approved Stoboclo (denosumab-bmwo), a biosimilar to Prolia (denosumab), and Osenvelt (denosumab-bmwo), a biosimilar to Xgeva (denosumab).

Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) ...

The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for ...

Stoboclo, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Osenvelt, a ...

The Food and Drug Administration (FDA) has approved Stoboclo® (denosumab-bmwo), a biosimilar to Prolia® (denosumab), and Osenvelt® (denosumab-bmwo), a ...

US FDA approves Celltrion’s Stoboclo and Osenvelt biosimilars referencing Prolia and Xgeva: Jersey City, New Jersey Wednesday, March 5, 2025, 18:00 Hrs [IST] Celltrion, a leadin ...

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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 ...

JERSEY CITY, N.J., March 3, 2025 /PRNewswire/ -- Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) and OSENVELT® (CT-P41 ...

Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt ...