Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH

Summary

It is a multicenter, open-label, randomized, parallel-group study of the efficacy and safety of Elizaria® (eculizumab, GENERIUM JSC, Russia) versus Soliris® (Alexion Pharma GmbH, Switzerland) in patients with paroxysmal nocturnal hemoglobinuria.

Timeline

Start

2017-11-29

Primary completion

2018-10-16

Completion

2018-10-16

Publications

• Kulagin AD, Ptushkin VV, Lukina EA, Davydkin IL, Korobkin AV, Shamrai VS, Konstantinova TS, Kaporskaya TS, Mitina TA, Ksenzova TI, Zuev EV, Markova OA, Gapchenko EV, Kudlay DA. Randomized multicenter noninferiority phase III clinical trial of the first biosimilar of eculizumab. Ann Hematol. 2021 Nov;100(11):2689-2698. doi: 10.1007/s00277-021-04624-7. Epub 2021 Aug 16.

Drugs

Indications