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

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

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 ...

The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.

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The FDA has approved 2 biosimilars, denosumab-bmwo (CT-P41; Stoboclo) and (Osenvelt), for all indications of their respective reference products (Prolia) and (Xgeva), Celtrion stated in a news release ...

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

The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, ...

The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat ...

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 ...

South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt ...