Physicochemical and functional characterization of a biosimilar adalimumab ZRC-3197

Abstract:

ZRC-3197 has been developed indigenously by Cadila Healthcare Ltd as a biosimilar adalimumab of originator HUMIRA^®. Biosimilarity has been demonstrated with a comprehensive set of state-of-the-art analytical techniques to characterize the physicochemical and functional properties of ZRC-3197 in comparison with originator HUMIRA^®. The biosimilar ZRC-3197 showed indistinguishable primary and secondary structures with similar level of purity and heterogeneity as compared to that of the originator product. When analyzed, in parallel, the two products were observed to show a high degree of sameness of the carbohydrate structure and charge heterogeneity profile. Both biosimilar ZRC-3197 and the originator HUMIRA^® appeared to show highly comparable key functional properties, as assessed by in vitro cell-based assay and surface plasmon resonance technique. The biosimilar ZRC-3197 exhibited highly similar tumor necrosis factor alpha neutralizing activity as well as binding affinity for FcγRIIIa receptor compared to that of the originator product. The biosimilar ZRC-3197 was observed to show similar level of efficacy and safety profile in rheumatoid arthritis patients, when submitted to a head-to-head double-blind trial, in India, with the originator (reference) product, HUMIRA^®. Based on the demonstrated biosimilarity, market authorization has been granted for ZRC-3197, as a biosimilar of originator HUMIRA^®, in India. Here, we report the characterization of physicochemical and functional properties of the biosimilar ZRC-3197 and originator HUMIRA^®.

Keywords::

• adalimumab
• biosimilars
• tumor necrosis factor (TNF)

Acknowledgments

Cadila Healthcare Ltd, the Zydus group, Ahmedabad, Gujarat, India, funded the whole development program of the ZRC-3197 project. The experimental activity, data analysis, and interpretation of data were performed by the authors and the ZRC-3197 project team members. All the project team members are acknowledged for their contribution to the development of the biosimilar ZRC-3197. The authors would also like to acknowledge Ms Anita Nair for her help in the literature search.

Disclosure

The authors report no conflicts of interest in this work.