[Results of phase Ib open multicenter clinical trial of the safety, pharmacokinetics and pharmacodynamics of first biosimilar of eculizumab in untreated patients with paroxysmal nocturnal hemoglobinuria during induction of therapy].
Vadim V PtushkinAlexander Dmitrievich KulaginElena A LukinaIgor L DavydkinTatyana S KonstantinovaVladimir S ShamraiN V MinaevaDmitry Anatolievich KudlayElena V GapchenkoOksana A MarkovaA Y BorozinetsPublished in: Terapevticheskii arkhiv (2020)
The study evaluated the pharmacokinetic and pharmacodynamic properties of the drug Elizaria in the regimen of induction therapy in previously untreated patients with PNH, confirming its efficacy. The study demonstrated the safety and low immunogenicity of the study drug.