News Briefs: Two Soliris Biosimilars Are Now Available
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Apr 10, 2025
Two biosimilars of Alexion, AstraZeneca Rare Disease’s Soliris (eculizumab) are now available. Amgen Inc.’s interchangeable Bkemv (eculizumab-aeeb) launched in early March, and Epysqli (eculizumab-aagh) from Teva Pharmaceutical Industries Ltd.’s Teva Pharmaceuticals and Samsung Bioepis Co., Ltd. became available in early April. The FDA approved Bkemv on May 28, 2024, and Epysqli on July 19, 2024. The agents are approved to treat paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis, atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy and generalized myasthenia gravis (gMG) in adults who are anti-acetylcholine receptor (AchR) antibody positive. Soliris also is approved to treat gMG in pediatric patients at least 6 years old and neuromyelitis optica spectrum disorder (NMOSD) in adults who are anti-aquaporin-4 (AQP4) antibody positive. The wholesale acquisition cost of a single-dose vial of Soliris is $6,523. Bkemv’s WAC is more than $5,870 for a single-dose vial, about 10% below Soliris’ price, and Epysqli’s is $4,566, a 30% discount off Soliris’ WAC.
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