Analytical and functional similarity of biosimilar Elizaria® with eculizumab reference product

• Published in: Journal of pharmaceutical and biomedical analysis 2022-10, Vol.220, p.115004-115004, Article 115004
• Main Authors: Gusarova, Valentina, Degterev, Maxim, Lyagoskin, Ivan, Simonov, Vladimir, Smolov, Maxim, Taran, Sergey, Shukurov, Rahim
• Format: Article
• Language: English
• Subjects: Atypical haemolytic uraemic syndrome (aHUS); Biosimilar; Eculizumab; Elizaria; Paroxysmal nocturnal hemoglobinuria (PNH); Soliris
• ISSN: 0731-7085; 1873-264X
• DOI: 10.1016/j.jpba.2022.115004

A recombinant humanized monoclonal antibody (mAb) Eculizumab, C5-complement cascade inhibitor, is an important treatment of complement-based diseases recommended by international guidelines. Elizaria® Drug Product (DP), developed by IBC Generium, Russia, is the world's first registered biosimilar of eculizumab (Soliris®, Alexion Pharmaceuticals). Using sensitive state-of-the-art analytical techniques extensive similarity assessment has been conducted to demonstrate the structural and functional similarity of original Soliris® (Eculizumab Reference Product, RP) and the biosimilar Elizaria®, focusing on the physicochemical and biological quality attributes, including those known to affect the mechanisms of action. A multitude of analyses revealed that amino acid sequence is identical, the higher order structures, post-translational modifications, purity, and product variants are highly similar between Elizaria® DP and Eculizumab RP, except for minor differences in the relative abundance of the charge variants and glycan moieties considered not clinically significant. The results demonstrate that Elizaria® is highly analytically similar to Eculizumab RP in terms of physicochemical properties and biological activities. [Display omitted] •Elizaria® drug preparation is licensed in Russia in 2019 and Turkey in 2022 as a biosimilar of Soliris® (eculizumab) by Alexion Pharmaceuticals Inc.•Eculizumab biosimilar Elizaria® was found to be highly similar to the originator product Soliris® for all functional activities.•Elizaria® and the Eculizumab RP show identical primary sequences and high similarity in more than 60 physicochemical parameters.