Eculizumab Products [eculizumab (Soliris®), eculizumab-aagh(Epysqli), eculizumab-aeeb (Bkemv)] Injection

Eculizumab is a terminal complement (C5) inhibitor. This Medical Drug Criteria applies to the reference product Soliris® (eculizumab) and to its FDA-approved interchangeable biosimilars Epysqli® (eculizumab-aagh) and Bkemv™ (eculizumab-aeeb). Eculizumab and its biosimilars are indicated for the treatment of paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis; atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy; generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive; and neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.