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Physicochemical and functional characterization of a biosimilar adalimumab ZRC-3197

Authors Bandyopadhyay S, Mahajan M, Mehta T, Singh AK, Parikh A, Gupta AK, Kalita P, Patel M, Mendiratta SK

Received 9 October 2014

Accepted for publication 17 November 2014

Published 31 December 2014 Volume 2015:5 Pages 1—18


Checked for plagiarism Yes

Review by Single-blind

Peer reviewer comments 5

Editor who approved publication: Dr Ajay Singh

Sanjay Bandyopadhyay, Mukesh Mahajan, Tulsi Mehta, Arun K Singh, Aashini Parikh, Ajit K Gupta, Pankaj Kalita, Mihir Patel, Sanjeev Kumar Mendiratta

Zydus Research Centre, Biotech Division, Cadila Healthcare Ltd, The Zydus Group, Ahmedabad, Gujarat, India

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)

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