The U.S. Food and Drug Administration (FDA) approved Samsung Bioepis’ eculizumab-aagh as a biosimilar to eculizumab to reduce hemolysis in paroxysmal nocturnal hemoglobinuria (PNH) and to inhibit complement-mediated thrombotic microangiopathy in patients with atypical hemolytic uremic syndrome (aHUS). Eculizumab-aagh is a monoclonal antibody and anti-C5 complement inhibitor.
Approval was granted based on the results of a randomized phase I and randomized phase III trial, which demonstrated clinical equivalence in pharmacokinetics, pharmacodynamic, efficacy, safety, tolerability, and immunogenicity between the two treatments.
Common adverse reactions include nasopharyngitis, nausea, back pain, and headache in patients with PNH and vomiting, headache, abdominal pain, anemia, hypertension, cough, diarrhea, nasopharyngitis, urinary tract infections, pyrexia, peripheral edema, nausea, and upper respiratory infection in patients with aHUS.
The approval “marks an important milestone for the PNH and aHUS communities since biosimilars have a potential to positively impact patients and health care systems by reducing health care costs and improving access to treatments,” said Christopher Hansung Ko, PhD, president and chief executive officer at Samsung Bioepis.
The treatment has also been approved as a biosimilar to eculizumab in Europe and Korea.
Source: Samsung Bioepis, July 22, 2024.
