Biosimilar for 2 Rare Diseases Accepted by FDA

Atypical hemolytic uremic syndrome and paroxysmal nocturnal hemoglobinuria are two conditions for which the FDA has authorized eculizumab-aeeb as an equivalent biosimilar to eculizumab in order to prevent complement-mediated thrombotic microangiopathy and minimize hemolysis.

Sarah Yim, director of the Office for Drug Evaluation and Research at the FDA, commented: “Many rare conditions are life-threatening, and many do not have treatments.”

She continued: “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.”