The Pharma Letter11 小时
FDA and EMA green light Samsung Bioepis’ Prolia and Xgeva copies
South Korean biosimilars company Samsung Bioepis has announced that the US Food and Drug Administration (FDA) and European ...
Managed Healthcare Executive12 小时
FDA Approves Second Biosimilars for Prolia/Xgeva
Samsung Bioepis’ biosimilars Ospomyv and Xbryk have been approved to be interchangeable with Prolia/Xgeva treat osteoporosis ...
Healio9 小时
FDA approves two new biosimilars of denosumab-dssb
The FDA has approved two new biosimilars of denosumab-dssb to treat osteoporosis, increase bone mass, prevent ...
Verywell Health on MSN9 个月
Evenity vs. Prolia: Which Is Better for Osteoporosis?
The dose for Prolia is one prefilled syringe administered by a healthcare professional every six months. The dose for Evenity ...
Business Wire2 天
FDA Approves Samsung Bioepis’ OSPOMYV™, XBRYK™ (denosumab-dssb), a Biosimilar to ...
Samsung Bioepis Co., Ltd. today announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for OS ...
Business Wire2 天
Samsung Bioepis Gains European Commission (EC) Approval for Denosumab Biosimilar (OBODENCE ...
Samsung Bioepis Co., Ltd. today announced that the European Commission (EC) has granted marketing authorization for OBODENCE™ (60mg pre-filled syringe ...
centerforbiosimilars6 小时
FDA, EMA Approve Second Pair of Denosumab Biosimilars
The FDA and European Medicines Agency (EMA) granted approval, with interchangeability in the US, to Samsung Bioepis' denosumab biosimilars, which will be marketed under different names depending on ...