FDA Approves Soliris Biosimilar Eculizumab-aagh (Epysqli)

Credit: US Food and Drug Administration

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) for the eculizumab (Soliris) biosimilar eculizumab-aagh (Epysqli) for the treatment of atypical hemolytic uremic syndrome (aHUS) to prevent complement-mediated thrombotic microangiopathy and paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis. The biosimilar, a monoclonal antibody and anti-C5 complement inhibitor, has previously been approved by the European Commission (EC) and Korea’s Ministry of Food and Drug Safety (MFDS).¹

“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,” Christopher Hansung Ko, president and chief executive officer at Samsung Bioepis, said in a statement.¹

Announced by Samsung Biopeis on July 22, 2024, the approval was based on the clinical, non-clinical, and analytical data of 2 trials proving its bioequivalence to the reference product, with no clinically significant differences regarding safety, potency, and purity. PNH and aHUS are considered rare diseases with an estimated prevalence of approximately 50,000 and 5000, respectively, in the US.¹

The first trial was a randomized phase 1, double-blind, 3-arm, parallel group, single-dose study of healthy volunteers evaluating the pharmacokinetics, pharmacodynamics, immunogenicity, safety, and tolerability between the reference drug and proposed biosimilar. An additional randomized phase 3, double-blind, multicenter, crossover study enrolled patients with PNH to determine clinical equivalence in terms of pharmacokinetics, immunogenicity, safety, and efficacy.¹

“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,” Ko stated.¹

The current approval marks Samsung Bioepis’ 8th FDA-approved biosimilar.¹

References

1. ^{NEWSWIRE) SB-(GLOBE. FDA approves Samsung Bioepis’ EPYSQLI® (eculizumab-aagh) as a biosimilar to Soliris (eculizumab). The Bakersfield Californian. July 22, 2024. Accessed July 22, 2024. https://www.bakersfield.com/ap/news/fda-approves-samsung-bioepis-epysqli-eculizumab-aagh-as-a-biosimilar-to-soliris-eculizumab/article_5b01c16c-b2f1-5065-8840-908bb2e70174.html.}