Samsung Bioepis Receives FDA Approval for Eculizumab-aagh (Epysqli), a Biosimilar to Soliris, for Treatment of PNH and aHUS

Jul 24, 2024 18:00 CST Updated 18:00

Samsung Bioepis

Biosimilar Developer

On July 22, Samsung Bioepis announced that the U.S. FDA had approved its biosimilar Epysqli (eculizumab-aagh) for the Biologics License Application (BLA), used to treat paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS).

Eculizumab is a C5 complement inhibitor developed by Alexion, a subsidiary of AstraZeneca, and marketed under the brand name Soliris, with global sales reaching $3.145 billion in 2023. Epysqli is the second biosimilar of eculizumab approved by the FDA, following Amgen's Bekemv.

FDA Approval of Epysqli Based on Comprehensive Non-Clinical and Clinical Evidence Demonstrating High Similarity to Soliris. No Clinically Meaningful Differences in Safety, Purity, and Potency Between Epysqli and Soliris.

A randomized, double-blind, three-arm, single-dose Phase I clinical study conducted in healthy volunteers (NCT03722329) indicate that Epysqli and Soliris are consistent in terms of pharmacokinetics (PK), pharmacodynamics (PD), safety, tolerability, and immunogenicity.

A randomized, double-blind, multicenter, crossover Phase III clinical study (NCT04058158) conducted in PNH patients demonstrated that Epysqli and Soliris are clinically equivalent in terms of efficacy, safety, PK, and immunogenicity.

Outside the United States, Epysqli has also been approved by the European Commission and the South Korean Ministry of Food and Drug Safety as a biosimilar to eculizumab for the treatment of PNH and aHUS patients.

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