31 May 2024 • Earlier this week, the U.S. Food and Drug Administration authorized eculizumab-aeeb, the 1st interchangeable biosimilar to eculizumab, for the treatment of two rare disorders.

Eculizumab-aeeb and eculizumab are used to decrease hemolysis and block complement-mediated thrombotic microangiopathy in paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome respectively.

The manufacturer has listed meningococcal infection caused by Neisseria meningitidis as a serious adverse effect of this biosimilar. Before starting these recombinant humanized monoclonal antibodies, patients should receive a meningococcal vaccination and should be continuously monitored for signs and symptoms of the infection.

Source: FDA | Read full story