Drug Topics May 29, 2024
Eculizamab-aeeb is the 53rd FDA-approved biosimilar in the US.
The FDA has approved eculizumab-aeeb (Bkemv) from Amgen Inc as the first interchangeable biosimilar to eculizumab (Soliris) for the treatment of rare diseases paroxysmal nocturnal hemoblobinuria (PNH) and atypical hemolytic uremic syndrome.
“Many rare conditions are life-threatening, and many do not have treatments,” said Sarah Yim, director of the Office of Therapeutic Biologics and Biosimilars in the FDA’s Center for Drug Evaluation and Research, in a news release.1 “The FDA is committed to help facilitate the development of safe and effective interchangeable biosimilar treatments that can expand access for individuals with rare diseases whose current treatment options are limited.”
Eculizumab-aeeb, a monoclonal antibody, targets the complement C5 protein in the...
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