Samsung Bioepis’ Epyscyi gets FDA approval as biosimilar to Soliris

South Korean pharma firm Samsung Bioepis has secured approval from the US Food and Drug Administration (FDA) for Epyscyi (eculizumab-aagh) as a biosimilar to Alexion Pharmaceuticals’ Soliris (eculizumab).

The approved biologics licence application (BLA) permits the use of Epyscyi in treating patients with paroxysmal nocturnal haemoglobinuria (PNH) and atypical haemolytic uraemic syndrome (aHUS), conditions also addressed by Soliris.

Epyscyi, which is a monoclonal antibody and anti-C5 complement inhibitor, marks the eighth biosimilar for which Samsung Bioepis has obtained FDA approval.

The FDA’s decision was based on a review of data showing that Epyscyi is highly similar to Soliris. This evaluation included analytical, non-clinical, and clinical studies confirming that Epyscyi 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 Epyscyi 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 Epyscyi and Soliris in terms of efficacy, safety, PK, and immunogenicity.

According to Samsung Bioepis, Epyscyi is not approved for treating Shiga toxin E. coli-related haemolytic uraemic syndrome (STEC-HUS).

Outside the US, Epyscyi 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 Epyscyi is available, it is not authorised for indications beyond those for which Soliris is approved.

July 24, 2024