JD Supra1d
FDA Approves Celltrion’s Denosumab Biosimilars
On March 3, 2025, the FDA approved Celltrion’s denosumab biosimilars, STOBOCLO® (denosumab-bmwo; 60 mg/mL injection) and OSENVELT® (denosumab-bmwo; ...
Healio4d
Two new denosumab biosimilars earn FDA approval
The FDA has approved two new biosimilars of denosumab for all indications of the reference medications Prolia and Xgeva, ...
The American Journal of Managed Care4d
FDA Approves Denosumab Biosimilars Stoboclo and Osenvelt
The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for ...
MPR4d
Denosumab Biosimilar Stoboclo, Osenvelt Get FDA Approval
The Food and Drug Administration (FDA) has approved Stoboclo® (denosumab-bmwo), a biosimilar to Prolia® (denosumab), and Osenvelt® (denosumab-bmwo), a ...
Targeted Oncology2d
Two Denosumab Biosimilars Pocket FDA Approval in Multiple Indications
The FDA has approved 2 biosimilars, denosumab-bmwo (CT-P41; Stoboclo) and (Osenvelt), for all indications of their respective reference products (Prolia) and (Xgeva), Celltrion stated in a news ...
Center for Biosimilars4d
FDA Approves Third Pair of Denosumab Biosimilars
The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat ...
Managed Healthcare Executive4d
FDA Accepts Amneal’s BLA for Two Denosumab Biosimilars
The FDA has accepted Amneal’s biologics licensing application for two biosimilars referencing Prolia and Xgeva.
PharmExec4d
FDA Approves Celltrion’s Biosimilars Stoboclo and Osenvelt
Stoboclo, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Osenvelt, a ...
The Manila Times4d
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 ...
Cancer Therapy Advisor2d
Denosumab Biosimilars Stoboclo and Osenvelt Get FDA Approval
The FDA has approved Stoboclo (denosumab-bmwo), a biosimilar to Prolia (denosumab), and Osenvelt (denosumab-bmwo), a biosimilar to Xgeva (denosumab).
Morningstar4d
Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®
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 ...
Renal & Urology News4d
Denosumab Biosimilar Stoboclo, Osenvelt Get FDA Approval
The Food and Drug Administration (FDA) has approved Stoboclo ® (denosumab-bmwo), a biosimilar to Prolia ® (denosumab), and Osenvelt ® (denosumab-bmwo), a biosimilar to Xgeva ® (denosumab).