FDA green light for Samsung Bioepis’ Soliris biosimilar

The US Food and Drug Administration (FDA) has approved the Biologics License Application (BLA) submitted by South Korea’s Samsung Bioepis for Epysqli (eculizumab-aagh) as a biosimilar to Soliris (eculizumab).

Epysqli has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy. Epysqli is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Soliris is marketed by UK pharma major AstraZeneca (LSE: AZN) and generated global sales of $3.15 billion last year. Another company with an FDA-approved biosimilar of Soliris is Amgen (Nasdaq: AMGN) with its Bekemv.