FDA approves Amgen rare disease biosim
29 May 2024
Drug ApprovalBiosimilar
The U.S. FDA approved Amgen's Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca's Soliris (eculizumab) for treating two rare diseases.
Bkemv is now approved for reducing hemolysis in patients with paroxysmal nocturnal hemoglobinuria (PNH) and inhibiting complement-mediated thrombotic microangiopathy in patients with atypical hemolytic uremic syndrome (aHUS).
The approvals align with the indications currently approved for Soliris, which was first approved in 2007. PNH and aHUS are characterized by the breakdown of red blood cells. PNH results in anemia, blood clots, low blood cell counts, and dark urine, while aHUS results in anemia, low platelets, and kidney failure. Bkemv, a monoclonal antibody, binds to the complement C5 protein, inhibiting the complement system and preventing the breakdown of red blood cells in PNH and aHUS patients.
Bkemv is the 53rd approved biosimilar in the U.S., with 13 approved as interchangeable biosimilars. An interchangeable biosimilar can be substituted for the reference product without consulting the prescriber, subject to state pharmacy laws, similar to generic drug substitution for brand-name drugs.
Recently, the FDA also approved AstraZeneca's voydeya as an add-on to the standard-of-care — Ultomiris or Soliris — to address the needs of the approximately 10-20% of patients with PNH who experienced clinically significant extravascular hemolysis (EVH) while treated with a C5 inhibitorC5 inhibitor. For some patients, EVH, which is the destruction of red blood cells outside of the blood vessels, resulted in continued symptoms of anemia and may require blood transfusions.
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