The American Journal of Managed Care1d
FDA Approves Denosumab Biosimilars Stoboclo and Osenvelt
The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for ...
PharmExec1d
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 ...
MPR1d
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 ...
Drug Store News23h
Celltrion receives FDA nod for Prolia, Xgeva biosimilars
Celltrion has received permission from the Food and Drug Administration for Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt ...
Healio1d
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, ...
Managed Healthcare Executive1d
FDA Approves Prolia and Xgeva Biosimilars, Stoboclo and Osenvelt
Managed Healthcare Executive provides C-suite executives at health plans and provider organizations with news, analysis, insights, and strategies to pursue value-driven solutions.
Pharmabiz1d
US FDA approves Celltrion’s Stoboclo and Osenvelt biosimilars referencing Prolia and Xgeva
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 ...
Managed Healthcare Executive1d
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.
Celltrion receives U.S. FDA approval for STOBOCLO® (denosumab-bmwo) and OSENVELT® (denosumab-bmwo) biosimilars referencing PROLIA® and XGEVA®
Celltrion today announced that the U.S. Food and Drug Administration (FDA) has approved STOBOCLO® (CT-P41, denosumab-bmwo) ...
Center for Biosimilars1d
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 ...
Korea JoongAng Daily on MSN2d
Celltrion's bone disease biosimilars get approval in U.S.
Celltrion, a major Korean biopharmaceutical firm, said Tuesday that its two new biosimilars for bone disease treatment, Stoboclo and Osenvelt, have obtained approval from the United States.