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BioMed Research International
Volume 2017, Article ID 4926168, 13 pages
https://doi.org/10.1155/2017/4926168
Research Article

Physicochemical and Biological Characterization of the Proposed Biosimilar Tocilizumab

1State Key Laboratory of Bioreactor Engineering, East China University of Science and Technology, Shanghai 200237, China
2Hisun Pharmaceutical (Hangzhou) Co., Ltd., Fuyang, Hangzhou, Zhejiang 311404, China

Correspondence should be addressed to Wen-Song Tan; nc.ude.tsuce@natsw

Received 13 July 2016; Revised 18 October 2016; Accepted 27 October 2016; Published 2 March 2017

Academic Editor: Yves Renaudineau

Copyright © 2017 Shiwei Miao et al. This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

Abstract

HS628 has been developed as a proposed biosimilar product of originator tocilizumab (Actemra®). An extensive physicochemical and biological characterization was conducted to assess similarity between HS628 and originator tocilizumab. The amino acid sequence was shown to be identical between HS628 and originator tocilizumab. The higher order structure was found to be indistinguishable from originator tocilizumab. Concerning purity and heterogeneity, HS628 was demonstrated to have similar posttranslational modifications, charge heterogeneity, size heterogeneity, and glycosylation to originator tocilizumab. Moreover, HS628 exhibited highly similar binding affinity and antiproliferative activity as well as capability of inhibiting STAT3 phosphorylation compared to originator tocilizumab. Taken together, HS628 can be considered as a highly similar molecule to originator tocilizumab in terms of physicochemical and biological properties.