FDA approves first interchangeable biosimilar for two rare diseases

30 May 2024

The US Food and Drug Administration has approved US biotech major Amgen’s (Nasdaq: AMGN) 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 UK pharma major AstraZeneca’s (LSE: AZN) Soliris:

the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; and
the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

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