JD Supra2h
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; ...
JD Supra1h
Federal Circuit Affirms Injunction Against Celltrion in Aflibercept BPCIA Litigation
On March 5, 2025, the U.S. Court of Appeals for the Federal Circuit affirmed the District Court for the Northern District of West Virginia’s entry ...
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) ...
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 ...
Drug Store News2d
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 ...
The Pharma Letter3d
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 ...
PharmExec3d
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 ...
Contract Pharma3d
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, ...
Morningstar3d
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 ...
Medpage Today on MSN23h
Humira Copycats for Psoriasis Backed by Real-World Outcomes
In a cohort of more than 11,000 patients from the U.K. and Ireland, a comparable proportion of new adalimumab users achieved ...
Celltrion secures FDA approval for bone disease biosimilars
Celltrion announced Tuesday that its biosimilars Stoboclo and Osenvelt, referencing bone disease treatments Prolia and Xgeva (denosumab), have received marketing approval from the US Food and Drug ...