On 28 May 2024, Amgen’s Bkemv® (eculizumab-aeeb) was approved by the FDA as the first interchangeable biosimilar to Alexion’s Soliris® (eculizumab). Bkemv® is approved for the same indications as Soliris® (atypical hemolytic uremic syndrome (aHUS) and paroxysmal nocturnal hemoglobinuria (PNH)) in the same dosage form and strength.
Bkemv® is set to be launched in the US in March 2025, under a settlement reached by Amgen and Alexion in May 2020.
Amgen’s eculizumab biosimilar was approved in the EU as Bekemv® on 19 April 2023. On 19 March 2024, Alexion filed proceedings against Amgen in the Unified Patents Court (UPC), seeking provisional measures in relation to alleged infringement of EP3167888, concerning a method of treating PNH using eculizumab.
Alexion has also sued Samsung Bioepis in the UPC and the US alleging infringement of eculizumab patents. Samsung Bioepis’ SB12 (Epysqli®) was granted EU marketing approval in May 2023 and its aBLA was accepted by the FDA in July 2023