FDA Grants Approval for Samsung Bioepis’ EPYSQLI® as a Biosimilar to Soliris®

FDA Grants Approval for Samsung Bioepis’ EPYSQLI® as a Biosimilar to Soliris®

By, Admin 24 July 2024

Overview

Samsung Bioepis Co., Ltd. has received FDA approval for EPYSQLI® (eculizumab-aagh) as a biosimilar to Soliris® (eculizumab). EPYSQLI is indicated for treating paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis and atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. It is not approved for Shiga toxin E. coli-related hemolytic uremic syndrome (STEC-HUS).

EPYSQLI and Soliris Similarity

  • The FDA’s decision was based on extensive evidence showing that EPYSQLI is highly similar to Soliris with no significant differences in safety, purity, or effectiveness. 
  • This includes results from a randomized Phase I study in healthy volunteers (NCT03722329), which confirmed equivalence in pharmacokinetics and comparable safety and immunogenicity profiles. 
  • A Phase 3 study in PNH patients (NCT04058158) also demonstrated that EPYSQLI and Soliris are clinically equivalent in terms of efficacy, safety, and pharmacokinetics.

Samsung Bioepis

  • Samsung Bioepis, highlighted the significance of this approval for the PNH and aHUS communities. 
  • He noted that biosimilars like EPYSQLI can potentially lower healthcare costs and increase patient access to necessary treatments, aligning with the company’s mission to improve patient lives through high-quality, effective biologic medicines.

About EPYSQLI

  • EPYSQLI, an anti-C5 complement inhibitor, is designed for use in treating PNH and aHUS, conditions that affect an estimated 50,000 and 5,000 people in the U.S., respectively.
  • Given the high cost and issues with current treatments, biosimilars may provide a more affordable option without compromising on quality or safety.

EPYSQLI Approvals

  • In addition to the U.S., EPYSQLI has also been approved by the European Commission (EC) and Korea’s Ministry of Food and Drug Safety (MFDS) for these indications. 
  • However, it is not approved for other uses for which Soliris is indicated.

Risks with EPYSQLI

  • As with other eculizumab products, EPYSQLI carries a risk of serious meningococcal infections. 
  • Patients should be vaccinated against meningococcal disease before starting treatment and continue to be monitored for infection signs. 
  • EPYSQLI is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS) program.

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