
Samsung Bioepis Co., Ltd. announced that the FDA approved EPYSQLI® (eculizumab-aagh) as a biosimilar to Soliris® (eculizumab). EPYSQLI is approved for treating paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). The FDA’s approval was based on comprehensive evidence showing EPYSQLI’s similarity to Soliris in safety, efficacy, and pharmacokinetics. The Phase I and Phase 3 studies demonstrated clinical equivalence and no significant differences between the two drugs. This approval aims to enhance patient access and reduce treatment costs. EPYSQLI has also been approved by the European Commission and Korea’s Ministry of Food and Drug Safety.
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