JD Supra1y
FDA Accepts BLA for Amneal’s Denosumab Biosimilars
On March 3, 2025, Amneal announced FDA acceptance of its Biologics License Application (BLA) for two proposed denosumab biosimilars referencing Amgen’s PROLIA® and XGEVA®. According to Amneal ...
JD Supra13d
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; 70 mg/mL injection), referencing Amgen’s ...
The American Journal of Managed Care1mon
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 ...
Business Wire1mon
FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva
A randomized, double-blind, three-arm, parallel group, single-dose Phase 1 study demonstrated the pharmacokinetic (PK) equivalence between SB16, EU-sourced denosumab (EU-DEN), and US-sourced ...