Having already taken leadership of the eculizumab biosimilar market in Europe, Samsung Bioepis’ Soliris copycat will now be available in the U.S. The South Korean biopharma announced Monday the FDA has approved Epysqli for a rare, life-threatening disease of the blood.

Samsung’s Epysqli is a biosimilar to AstraZeneca’s Soliris (eculizumab), picked up by the company in its $39 billion acquisition of Alexion in 2020. Soliris generated $3.15 billion in 2023 global sales for AstraZeneca, down 14% from the prior year after Epysqli’s European launch.

Epysqli is now FDA-approved for patients with paroxysmal nocturnal hemoglobinuria (PNH) and atypical hemolytic uremic syndrome (aHUS). Initially approved in May 2023 for PNH in the European Union, Samsung announced in March 2024 the European Commission expanded the indication to also include aHUS.