The American Journal of Managed Care9h
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 Reference8h
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 ...
Pharm Exec11h
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 ...
Managed Healthcare Executive5h
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.
Healio8h
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 Executive5h
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) ...
centerforbiosimilars9h
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 ...
Hosted on MSN4h
Compounders Sue FDA; Young Women in Perimenopause; More Osteoporosis Biosimilars
A significant number of women ages 30 to 45 said they experience perimenopause-related symptoms, according to a study with 4,432 U.S. participants. (npj Women's Health) The CDC will stop processing ...
Contract Pharma12h
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, ...
The Pharma Letter11h
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 ...
Hosted on MSN20h
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.