Samsung Bioepis (“Samsung”) announced on July 22 that the FDA approved its BLA for EPYSQLI, an eculizumab biosmilar referencing Alexion’s SOLIRIS. EPYSQLI has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. After…
