Samsung Bioepis’ Epysqli gains expanded EC approval

The European Commission (EC) has approved an expanded indication for South Korean drugmaker Samsung Bioepis’ Epysqli.

This is a biosimilar to AstraZeneca’s (LSE: AZN) Soliris (eculizumab), and has now been cleared for the treatment of adults and children with atypical hemolytic uremic syndrome (aHUS). Originated by Alexion, which AstraZeneca acquired, Soliris generated $3.15 billion in global sales for the UK pharma major last year.

In May 2023, Epysqli was initially granted marketing authorization by the EC for treatment of adult and child pat  ients with paroxysmal nocturnal hemoglobinuria (PNH), a rare disorder that leads to the premature des ruction and impaired production of blood cells.