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Samsung Bioepis joins denosumab battle with FDA, EU nod as Amgen’s $5.5-bil. stronghold nears patent cliff
Samsung Bioepis has secured FDA and European Commission (EC) approval for its denosumab biosimilars, OSPOMYV (marketed as OBODENCE in Europe) and XBRYK, just weeks before Amgen’s U.S. patent for Prolia and Xgeva expires on Wednesday. The approvals, …