Datapoint: FDA Approves First Soliris Biosimilar

The FDA on May 28 approved Amgen’s Bkemv (eculizumab-aeeb), the first biosimilar to AstraZeneca’s monoclonal antibody Soliris (eculizumab). Bkemv will be an interchangeable biosimilar, approved to treat two rare blood disorders: paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Soliris was first approved in 2007 for the treatment of PNH, an indication for which it currently holds covered or better status for 86% of all insured lives under the medical benefit.

SOURCE: MMIT Analytics, as of 6/5/24

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