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.
