文献类型：期刊文献

英文题名：Physicochemical and Biological Characterization of the Proposed Biosimilar Tocilizumab

作者：Miao, Shiwei[1];Fan, Li[1];Zhao, Liang[1];Ding, Ding[2];Liu, Xiaohui[2];Wang, Haibin[2];Tan, Wen-Song[1]

机构：[1]East China Univ Sci & Technol, State Key Lab Bioreactor Engn, Shanghai 200237, Peoples R China;[2]Hisun Pharmaceut Hangzhou Co Ltd, Hangzhou 311404, Zhejiang, Peoples R China

年份：2017

卷号：2017

外文期刊名：BIOMED RESEARCH INTERNATIONAL

收录：;WOS:【SCI-EXPANDED(收录号:WOS:000398223700001)】；

基金：This work was supported by the National Natural Science Foundation of China (nos. 21206040 and 21406066).

语种：英文

摘要：HS628 has been developed as a proposed biosimilar product of originator tocilizumab (Actemra (R)). 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.