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Approval alert: EC grants MA for Samsung Bioepis’ Epysqli® biosimilar to Alexion’s Soliris® (eculizumab)

May 30, 2023

The European Commission (EC) has granted Marketing Authorisation for Samsung Bioepis’ Epysqli® (eculizumab), biosimilar to Alexion’s Soliris®.  Epysqli® is approved for the treatment of adult and children patients with paroxysmal nocturnal hemoglobinuria (PNH), and is Samsung Bioepis’ first hematology biosimilar. 

The EMA Committee for Medicinal Products for Human Use (CHMP) gave a positive opinion for Epysqli® on 30 March 2023.