On April 7, 2025, Teva Pharmaceuticals and Samsung Bioepis Co., Ltd. announced the U.S. launch of EPYSQLI® (eculizumab-aagh), a biosimilar referencing Alexion Pharmaceuticals’ SOLIRIS®. As we reported in January, Teva and Samsung Bioepis entered into a strategic partnership regarding EPYSQLI®, with Samsung Bioepis handling development, manufacturing, and supply and Teva handling U.S. commercialization.
EPYSQLI® has been approved by the U.S. Food and Drug Administration (FDA) for the treatment of three rare complement-mediated autoimmune disorders: paroxysmal nocturnal hemoglobinuria (PNH), atypical hemolytic uremic syndrome (aHUS), and generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor antibody positive. The FDA provisionally determined that EPYSQLI® will have interchangeable biosimilar status with SOLIRIS® once the exclusivity period for the first SOLIRIS® interchangeable biosimilar, Amgen’s BKEMV™, expires.
Teva and Samsung have said that EPYSQLI® will be offered at a 30% discount of the Wholesale Acquisition Cost (WAC) of SOLIRIS®.