FDA Approves Second Biosimilar of Soliris

The FDA has approved another biosimilar of Soliris (eculizumab). Samsung Bioepis’ Epysqli (eculizumab-aagh) has been approved to treat patients with paroxysmal nocturnal hemoglobinuria (PNH) and to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS).

PNH is an ultra-rare blood disorder that is characterized by the destruction of red blood cells. PNH occurs when the complement system — a part of the body’s immune system — over-responds, leading the body to attack its own red blood cells. Atypical hemolytic uremic syndrome is a rare genetic disease in which tiny blood clots form in blood vessels and block blood flow. It can lead to kidney failure and heart disease.

Soliris, a product of Alexion, an AstraZeneca company, is also indicated to treat patients with generalized myasthenia gravis, an autoimmune disease that affects muscle control, and neuromyelitis optica spectrum disorder, a rare inflammatory disease that effects the optical nerves and spinal cord.

The FDA’s approval of Epysqli is based on the totality of evidence including analytical, non-clinical and clinical data demonstrating it is highly similar to Soliris, with no clinically meaningful differences between Epysqli and Soliris in terms of safety, purity and potency, according a news release from Samsung Bioepis. A phase 3 cross-over study in patients with PNH clinical equivalence in efficacy, safety, PK, and immunogenicity between Epysqli and Soliris.

No additional information is available about when Epysqli will launch or the pricing.

Related: FDA Approves First Interchangeable Biosimilar of Soliris

Epysqli is the second Soliris biosimilar approved by the FDA. In May 2024, the FDA approved Amgen’s Bkemv (eculizumab-aeeb) as an interchangeable biosimilar to Soliris. An Amgen spokesperson said at the time that Bkemve will launch no later than March 2025 as part of its agreement with Alexion. A price will be available at that time.