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MAY 30, 2024

FDA Approves Bkemv, Interchangeable Biosimilar to Soliris


Originally published by our sister publication Specialty Pharmacy Continuum

By SPC Staff

The FDA approved Bkemv (eculizumab-aeeb, Amgen) as the first interchangeable biosimilar to Soliris (eculizumab, Alexion) to treat two rare diseases that cause red blood cells to break down.

Both the biosimilar and reference product are approved to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Bkemv is a monoclonal antibody that binds to the complement C5