Managed Healthcare Executive6h
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.
Managed Healthcare Executive6h
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.
Targeted Oncology8h
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 ...
Monthly Prescribing Reference9h
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 ...
Healio9h
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 Care10h
FDA Approves Denosumab Biosimilars Stoboclo and Osenvelt
The FDA approved Stoboclo and Osenvelt, denosumab biosimilars that could offer more affordable treatment options for ...
centerforbiosimilars10h
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 ...
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 ...
The Pharma Letter12h
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 ...
Contract Pharma13h
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, ...
Celltrion's bone disease biosimilars get approval in US
Celltrion, a major South Korean biopharmaceutical firm, said on Tuesday its two new bio-similars for bone disease treatment ...
Daijiworld21h
Celltrion’s bone disease biosimilars secure FDA approval for US market
South Korean biopharmaceutical giant Celltrion announced on Tuesday that its two new biosimilars for bone disease treatment have received approval from the United States Food and Drug Administration ...