FDA Approves Samsung Bioepis' Soliris Biosimilar EPYSQLI

Samsung Bioepis has received approval from the US Food and Drug Administration (FDA) for its biologics licence application (BLA) for EPYSQLI (eculizumab-aagh). This approval designates EPYSQLI as a biosimilar to Soliris (eculizumab), a treatment used for paroxysmal nocturnal haemoglobinuria (PNH) to reduce haemolysis, and for atypical haemolytic uraemic syndrome (aHUS) to prevent complement-mediated thrombotic microangiopathy.

EPYSQLI is not indicated for the treatment of Shiga toxin E coli-related haemolytic uraemic syndrome (STEC-HUS). The FDA’s approval was based on extensive evidence comprising analytical, non-clinical, and clinical data that demonstrated EPYSQLI’s high similarity to Soliris, without significant differences in terms of safety, purity, and potency.

The evidence included a randomized, double-blind, three-arm, parallel-group, single-dose Phase I trial conducted on healthy subjects. This study confirmed the pharmacokinetics (PK) equivalence and comparable pharmacodynamic, safety, tolerability, and immunogenicity profiles between EPYSQLI and Soliris. Additionally, a randomized, double-blind, multicenter, crossover Phase III trial with PNH patients demonstrated the clinical equivalence of EPYSQLI and Soliris in terms of efficacy, safety, PK, and immunogenicity.

Eculizumab, the active ingredient in Soliris, is a monoclonal antibody and a C5 complement inhibitor. Biosimilars like EPYSQLI are biologic medicines that closely resemble an FDA-approved biologic product without clinically meaningful differences in safety, purity, or potency. The introduction of biosimilars is anticipated to reduce the financial burden on healthcare systems and enhance patient access to biologic therapies, as they are required to meet the same rigorous standards for quality, safety, and efficacy as their reference products.

In addition to the US, EPYSQLI has also been approved by the European Commission and Korea’s Ministry of Food and Drug Safety as a biosimilar to Soliris for the treatment of PNH and aHUS.

Christopher Hansung Ko, president and CEO of Samsung Bioepis, commented on the FDA approval, emphasizing its significance for the PNH and aHUS communities. Ko highlighted that biosimilars have the potential to lower healthcare costs and improve treatment accessibility for patients. He reiterated Samsung Bioepis’s commitment to enhancing patients' lives by offering quality-assured, safe, and effective biologic medicines, and noted the company's expanding focus on rare diseases where patients have limited access to essential treatments.