U.S. FDA announcements or Amgen press releases

FDA Approves $AMGN's Bkemv, First Biosimilar to $AZN's Soliris

May 28, 2024, 10:11 PM

The U.S. Food and Drug Administration (FDA) has approved Amgen Inc's Bkemv, the first biosimilar to AstraZeneca's Soliris. This biosimilar is designed to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and patients with atypical hemolytic uremic syndrome (aHUS) to inhibit hemolysis. The approval marks a significant milestone as Bkemv is the first interchangeable biosimilar for these rare diseases. The approval is a notable development for $AMGN and $AZN.