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Approval Alert: Samsung Bioepis’ Episcli® (SB12) (eculizumab) Approved in Korea

Jan 22, 2024

PulseNews reported that Samsung Bioepis has received approval for Episcli® (SB12), biosimilar to Alexion’s Soliris® (eculizumab), from the Korean Ministry of Food and Drug Safety.  Episcli® is approved to treat nocturnal hemoglobinuria.

On 3 January 2024 Alexion sued Samsung Bioepis in the US District Court for the District of Delaware asserting infringement of six of its eculizumab patents.