Amgen Earns FDA Approval for Bkemv as First Interchangeable Biosimilar to Soliris

The FDA approved Amgen’s Bkemv (eculizumab-aeeb) as the first interchangeable biosimilar to AstraZeneca’s Soliris (eculizumab) to treat the rare diseases paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

Bkemv is a monoclonal antibody that binds to the complement C5 protein and inhibits activation of the complement system, a part of the body’s immune system. This binding prevents the breakdown of red blood cells in the bloodstream in patients with PNH and aHUS.

Bkemv, like Soliris, has a boxed warning that states that eculizumab products increase the risk of serious and life-threatening meningococcal infections caused by Neisseria meningitidis, the bacteria that causes meningitis and other potentially severe infections, the FDA said in its announcement. Patients should have meningococcal vaccination before starting Bkemv or Soliris, and be monitored for early signs and symptoms of meningococcal infections.

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