Mario Tama/Getty Images News The U.S. FDA has approved Bkemv (eculizumab-aeeb), the first interchangeable biosimilar for AstraZeneca ( NASDAQ: AZN ) subsidiary's Alexion Pharmaceuticals' Soliris (eculizumab).
Eculizumab is approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome. Like Soliris, Bkemv has a "black box" warning that the drug increases the risk of serious and potentially life-threatening meningococcal infections. In Q1 2024, Soliris brought in revenue of $739M.
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