Healio5h
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 Executive1h
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) ...
The American Journal of Managed Care6h
FDA Approves Denosumab Biosimilars Stoboclo and Osenvelt
The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for ...
Monthly Prescribing Reference4h
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 Oncology4h
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), Celtrion stated in a news release ...
The Pharma Letter8h
FDA nod for two Celltrion denosumab biosimilars
South Korea-based Celltrion today announced that the US Food and Drug Administration (FDA) has approved Stoboclo and Osenvelt ...
Pharm Exec7h
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 ...
Amneal’s BLA Submissions for Two Denosumab Biosimilars Accepted for Review by U.S. FDA
(Nasdaq: AMRX) ("Amneal" or the "Company"), a global biopharmaceutical company, and mAbxience ("mAbxience") today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its ...
Managed Healthcare Executive1h
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.
Contract Pharma9h
FDA Approves Celltrion’s Biosimilars Referencing Prolia and Xgeva
The U.S. Food and Drug Administration (FDA) has approved Celltrion’s Stoboclo (CT-P41, denosumab-bmwo) and Osenvelt (CT-P41, ...
Amneal Pharmaceuticals BLA submissions for denosumab biosimilars accepted by FDA
Amneal Pharmaceuticals (AMRX) “announced that the FDA has accepted for review its Biologics Licensing Application for two proposed denosumab ...