On 5 March 2025, Generics Bulletin reported that Amgen has launched Bkemv® (eculizumab-aeeb) in the US as the first available interchangeable biosimilar to Alexion’s Soliris®.
Bkemv® was approved by the FDA in May 2024 for the same indications as Soliris® (atypical haemolytic uremic syndrome (aHUS) and paroxysmal nocturnal haemoglobinuria (PNH)), and in the same dosage form and strength.
The timing of the US launch of Bkemv® was governed by a settlement reached by Amgen and Alexion in May 2020, permitting launch from 1 March 2025. The only other eculizumab biosimilar currently approved in the US is Samsung Bioepis’ Epysqli® (SB12) (approved July 2024).
Amgen’s eculizumab biosimilar was approved in the EU as Bekemv® in 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. The UPC (June/July 2024) and the UPC Court of Appeal (December 2024) refused to grant preliminary injunctions against Amgen (and Samsung Bioepis) in relation to the sale of their eculizumab biosimilars in the EU.