On 22 July 2024, Samsung Bioepis announced FDA approval of Epysqli™ (SB12, eculizumab-aagh), biosimilar to Alexion’s Soliris® (eculizumab), for paroxysmal nocturnal hemoglobinuria (PNH) and atypical haemolytic uremic syndrome (aHUS).
This is the second eculizumab biosimilar approved by the FDA, following the approval of Amgen’s Bkemv (eculizumab-aeeb) in May 2024.
Alexion sued Samsung Bioepis in the UPC in March 2024 and the US in January 2024 alleging infringement of eculizumab patents. In June 2024, the US Court refused Alexion’s application for an emergency injunction, as reported here.
Samsung Bioepis’ SB12 (Epysqli®) was EU approved in May 2023. It was launched in Germany, Italy and Spain in 2023 and in Korea in April 2024.