Amgen Snatches First FDA Approval For Soliris Biosimilar

Amgen’s Interchangeable Bkemv Is Expected To Launch In The US In March 2025

Amgen has established its frontrunner position in the eculizumab race with a recent FDA approval and an interchangeability designation. Meanwhile, a US District Court has sided with runner-up Samsung Bioepis.

Business people crossing a finish line
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While adding a 53rd biosimilar under its belt, the US Food and Drug Administration also marked a first. The agency approved Amgen’s Bkemv (eculizumab-aeeb) as the first biosimilar rival to Alexion’s Soliris (eculizumab), along with a designation of interchangeability.

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