FDA Grants Approval for Samsung Bioepis’ EPYSQLI® as a Biosimilar to Soliris®
Tuesday, July 23, 2024
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).
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, 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.
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.
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.
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.
Source: samsungbioepis.com
