Posted by Michael Wonder on 17 Feb 2025
Samsung Bioepis gains European Commission approval for denosumab biosimilar (Obodence, Xbryk)
16 February 2025 - Obodence and Xbryk approved by the European Commission for all indications referencing Prolia and Xgeva, respectively.
Samsung Bioepis today announced that the European Commission has granted marketing authorization for Obodence (60 mg pre-filled syringe) and Xbryk (120 mg vial), denosumab biosimilars referencing Prolia and Xgeva – formerly referred to as SB16.
