FDA Approves Samsung’s Eculizumab Biosimilar | Goodwin
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 Amgen’s BKMEV, Samsung’s EPYSQLI is the second FDA-approved eculizumab biosimilar.
Alexion’s BPCIA case against Samsung regarding EPYSQLI remains pending in the District Court for the District of Delaware. As we have previously reported, Alexion’s motion for a preliminary injunction was denied. Alexion appealed the denial to the Federal Circuit and filed an emergency motion in the district court for injunction pending resolution of the appeal. The district court denied that motion, and on June 21, Alexion filed a motion with the Federal Circuit for an injunction pending resolution of the appeal. The Federal Circuit has not yet ruled on Alexion’s motion.
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