FDA approves first interchangeable biosimilar for two rare diseases

FDA

28 May 2024 - Today, the US FDA approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. 

Bkemv is approved for the following treatment indications, which are also currently approved for Soliris:

  • The treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis
  • The treatment of patients with atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy

Read FDA press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Biosimilar