Samsung Bioepis obtains FDA nod for Soliris biosimilar

Samsung Bioepis has received permission from the Food and Drug Administration for Epysqli (eculizumab-aagh), which is a biosimilar to Alexion’s Soliris. 

Epysqli has been approved for the treatment of patients with paroxysmal nocturnal hemoglobinuria to reduce hemolysis, atypical hemolytic uremic syndrome to inhibit complement-mediated thrombotic microangiopathy. 

“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,” said Christopher Hansung Ko, president and CEO at Samsung Bioepis. 

[Read more: Prioritizing Lower-Priced Biosimilar Medications]

Ko added, “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."

[Read more: Samsung Bioepis releases Q3 2024 U.S. biosimilar market report]