South Korean pharma firm Samsung Bioepis has secured approval from the US Food and Drug Administration (FDA) for EPYSQLI (eculizumab-aagh) as a biosimilar to Alexion Pharmaceuticals’ Soliris (eculizumab).
The approved biologics licence application (BLA) permits the use of EPYSQLI in treating patients with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS), conditions also addressed by Soliris.
EPYSQLI, which is a monoclonal antibody and anti-C5 complement inhibitor, marks the eighth biosimilar for which Samsung Bioepis has obtained FDA approval.
Samsung Bioepis president and CEO Christopher Hansung Ko said: “The FDA approval of EPYSQLI as a biosimilar to Soliris marks an important milestone for PNH and aHUS communities since biosimilars have a potential to positively impact patients and healthcare systems by reducing healthcare costs and improving access to treatments.
“Our mission has been, and always will be improving the lives of patients by providing quality-assured, safe and effective biologic medicines, and our work to fulfill this mission is expanding into rare disease areas where patients continue to suffer from limited access to life-enhancing medicines.”
The FDA’s decision was based on a review of data showing that EPYSQLI is highly similar to Soliris. This evaluation included analytical, non-clinical, and clinical studies confirming that EPYSQLI and Soliris have comparable safety, purity, and potency.
The approval process included a randomised Phase 1 study, which was double-blind and involved a three-arm, parallel group, single-dose design in healthy volunteers. This study demonstrated that EPYSQLI exhibits equivalent pharmacokinetics (PK) and comparable pharmacodynamics (PD), safety, tolerability, and immunogenicity profiles to Soliris.
Additionally, a randomised Phase 3, double-blind, multicentre, cross-over study in patients with PNH showed clinical equivalence between EPYSQLI and Soliris in terms of efficacy, safety, PK, and immunogenicity.
According to Samsung Bioepis, EPYSQLI is not approved for treating Shiga toxin E. coli-related haemolytic uraemic syndrome (STEC-HUS).
Outside the US, EPYSQLI has also received approval from the European Commission (EC) and South Korea’s Ministry of Food and Drug Safety (MFDS) as a biosimilar to Soliris for PNH and aHUS.
In countries where EPYSQLI is available, it is not authorised for indications beyond those for which Soliris is approved.