Amgen Confirms Launch Of First US Eculizumab Rival

Debuts Bkemv Interchangeable Biosimilar To Soliris

Amgen has confirmed to Generics Bulletin details of its launch of Bkemv, the first US biosimilar to Soliris.

Amgen has launched its Soliris biosimilar in the US (Shutterstock)

Amgen has launched its Bkemv (eculizumab-aeeb) biosimilar to Alexion’s Soliris in the US, entering the market as the first interchangeable biosimilar to the brand under the terms of a settlement agreement struck with the originator back in 2020 that allowed market entry from 1 March.

Bkemv was approved by the US Food and Drug Administration in May 2024 in the same dosage form and strength as Soliris, and with the same route of administration and dosing regimen

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