FDA Approves Bkemv, an Interchangeable Biosimilar to Soliris

May 28, 2024

The FDA has approved Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to Soliris (eculizumab) to treat certain rare diseases. As an interchangeable biosimilar, Bkemv is highly similar with no clinically meaningful differences to Soliris.

  • Bkemv is approved for the following treatment indications, which are also currently approved for
    o the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce
    hemolysis; and
    o the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit
    complement-mediated thrombotic microangiopathy.
  • Bkemv is available only through a restricted program called the Bkemv Risk Evaluation and Mitigation Strategy (REMS).

Source: FDA

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