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Approval Alert: FDA Approves Amgen’s Bkemv (eculizumab) as the First Interchangeable Biosimilar Ahead of March 2025 Launch

May 28, 2024

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