FDA Approves Epysqli, Second Biosimilar to Soliris

Samsung Bioepis’ biologics license application for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab) has been approved by the U.S. Food and Drug Administration (FDA) to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Approval of Epysqli is based on a totality of evidence, including analytical, nonclinical and clinical data demonstrating it is highly similar to Soliris, with no clinically meaningful differences between Epysqli and Soliris in terms of safety, purity and potency. The randomized Phase I, double-blind, three-arm, parallel group, single-dose study in healthy volunteers demonstrated pharmacokinetics (PK) equivalence and comparable pharmacodynamic, safety, tolerability and immunogenicity profiles between Epysqli and Soliris. The randomized Phase III, double-blind, multicenter, cross-over study in PNH patients demonstrated clinical equivalence in efficacy, safety, PK and immunogenicity between Epysqli and Soliris.

“The FDA approval of Epysqli as a biosimilar to Soliris marks an important milestone for PNH and aHUS communities since biosimilars have a potential to positively impact patients and healthcare systems by reducing healthcare costs and improving access to treatments,” said Christopher Hansung Ko, PhD, president and chief executive officer at Samsung Bioepis. “Our mission has been, and always will be, improving the lives of patients by providing quality-assured, safe and effective biologic medicines, and our work to fulfill this mission is expanding into rare disease areas where patients continue to suffer from limited access to life-enhancing medicines.”