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FDA Approves Amgen's Interchangeable Biosimilar to AstraZeneca's Soliris on Tuesday

May 28, 2024, 10:30 PM

The U.S. Food and Drug Administration (FDA) has approved Amgen's Bkemv, the first interchangeable biosimilar to AstraZeneca's Soliris, a treatment for rare blood disorders. Bkemv is approved for treating paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. This approval, announced on Tuesday, marks a significant milestone in the availability of biosimilar treatments for rare diseases.