Tocilizumab Biosimilar (Generium)

GNR-087 developed by IBC Generium, Russia is a biosimilar candidate to Tocilizumab reference product. A comprehensive analytical assessment of the structural and functional similarity of GNR-087 and Tocilizumab reference product is one of the steps of the stepwise approach and was performed using a sensitive state-of-the-art analytical techniques. Appropriate product quality attributes were taken into account, including those known to affect the mechanisms of action, efficacy and safety. GNR-087 was demonstrated to have the same amino acid sequence and high-order structure, similar N-glycosylation pattern and post-translational modification profile, and biological activities as Tocilizumab reference product. The minor differences in attributes (in particular, the content of individual types of glycans) were considered clinically insignificant, which was confirmed by biological and functional tests. The results of the comparative similarity assessment demonstrate high analytical comparability of GNR-087 and Tocilizumab reference product. GNR-087 (Complarate® drug product) was licensed in the Russian Federation in 2024 for the treatment of rheumatoid arthritis.