The South Korean company’s Epysqli is now FDA-approved for paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome in the U.S., having grabbed the lead in the Soliris biosimilar market in Europe.
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.
“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,” Samsung Bioepis CEO Christopher Hansung Ko said in a statement.
Epysqli is a monoclonal antibody and anti-C5 complement inhibitor. Despite being a well-established treatment for PNH and aHUS, around two-thirds of eculizumab-treated PNH patients quit the drug within 1.5 years, according to Samsung. The company attributes the discontinuation rate to several factors including the high treatment cost. Samsung contends biosimilars have the potential to “relieve the financial burden” and “improve access to biologic therapies.”
The company said at the ERA Congress in May 2024 that Epysqli already commands the lion’s share of the Soliris biosimilar market in Europe, sold through direct marketing channels. Only Samsung and Amgen have approved eculizumab copycats on the market currently. Amgen’s Bkemv was approved by the FDA in May 2024 as the first interchangeable biosimilar to Soliris.
Once its top rare disease asset, AstraZeneca has seemingly pivoted away from Soliris marketing. A visit to the drug website directs you to their newer C5 complement inhibitor, Ultomiris, approved in March 2024 for a subset of patients with a rare disease dubbed neuromyelitis optica spectrum disorder.
