Amgen's rare-disease treatment biosimilar Bkemv gets FDA approval

By Ben Glickman

Pharmaceutical regulators approved Amgen's (AMGN) Bkemv, a biosimilar to rare-disease treatment Soliris.

The Food and Drug Administration said Tuesday that Bkemv, a monoclonal antibody, had been approved for treating paroxysmal nocturnal hemoglobinuria, a rare blood disorder, and atypical hemolytic uremic syndrome, another rare disease affecting kidneys and blood-clotting.

Soliris, developed by AstraZeneca (AZN)-owned Alexion Pharmaceuticals, is approved for the same treatment indications.

In patients with paroxysmal nocturnal hemoglobinuria, Bkemv is given to reduce hemolysis, while in treating atypical hemolytic uremic syndrome, the drug inhibits complement-mediated thrombotic microangiopathy.

The FDA said that Bkemv was the first interchangeable biosimilar to Soliris to treat the diseases.

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05-28-24 1849ET

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