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July 22, 2024July 22, 2024 - Samsung Bioepis Co., Ltd. announced that the U.S. Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for Epysqli (eculizumab-aagh) infusion as a biosimilar to Soliris (eculizumab).
- Epysqli has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.
- Epysqli is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).
Source: Samsung Bioepis Co., Ltd.