The Pharma Letter2h
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 Pharma3h
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 ...
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) ...
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 ...
Healio14d
FDA approves two new biosimilars of denosumab
The FDA has approved two new biosimilars of denosumab-dssb to treat osteoporosis, increase bone mass, prevent skeletal-related events for people with multiple myeloma and other indications, Samsung ...
Healio4d
Baseline BMD T-score can help determine first-line therapy for women with osteoporosis
Women with osteoporosis have at least a 50% chance of reaching their target bone mineral density at 3 years if they have a ...
The American Journal of Managed Care14d
Denosumab Biosimilars Approved With Interchangeability to Address Osteoporosis, Fracture Risk
Clinical studies confirmed equivalent efficacy, safety, and pharmacokinetics between denosumab biosimilars and reference products. Common adverse events for Ospomyv include back pain and ...
rheumatologyadvisor7d
FDA Approves Denosumab Biosimilars Ospomyv and Xbryk
The FDA has approved the BLA for Ospomyv™ and Xbryk™, biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively.
Business Wire17d
FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva
INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYV™ (denosumab ...
Business Wire13d
Celltrion Expands Biosimilar Portfolio in the European Union Following European Commission Approval of Two Biosimilars
Celltrion today announced that the European Commission (EC) has granted marketing authorization for three products across two biosimilars: Eydenzelt® ...
Monthly Prescribing Reference14d
FDA Approves Denosumab Biosimilars Ospomyv and Xbryk
Findings from a phase 3 trial showed denosumab-dssb had comparable efficacy, safety, immunogenicity, PK and PD to Prolia in patients with postmenopausal osteoporosis. Ospomyv is approved to treat ...