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

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

STOBOCLO ® (denosumab-bmwo) and OSENVELT ® (denosumab-bmwo) are approved by FDA for all indications of reference products ...

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

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

The products are expected to be available in June 2025. Osenvelt is indicated to prevent skeletal-related events in patients with multiple myeloma and in patients with bone metastases from solid ...

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

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 ...

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

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 ...