Pharm Exec6d
FDA Approves Samsung Bioepis Biosimilars Ospomyv and Xbryk
Ospomyv, a biosimilar to Prolia, is indicated for postmenopausal women and men at high risk of fracture, while Xbryk, a ...
Monthly Prescribing Reference3d
FDA Approves Denosumab Biosimilars Ospomyv and Xbryk
The approval was based on a comprehensive clinical data package, which included a single phase 1 trial and a phase 3 trial.
FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva
Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OSPOMYVâ„¢ (denosumab-dssb; SB16; 60 mg pre-filled ...
The Post-Journal6h
Story Behind The Story
The following article, which first appeared in The Post-Journal in May 2014, is an example of why there can more to a story ...
Observer6h
Act of kindness
The following article, which first saw the light of day in May 2014, is an example of why there can more to a story than ...
Business Wire9d
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 ...
Morningstar9d
FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to Prolia and Xgeva
OSPOMYV™ and XBRYK™ approved by the U.S. Food and Drug Administration (FDA) for all indications referencing Prolia and Xgeva, respectively Samsung Bioepis’ first endocrinology biosimilar to ...