Physicochemical characterization and phase I study of CMAB008, an infliximab biosimilar produced by a different expression system

Physicochemical characterization and phase I study of CMAB008, an infliximab biosimilar produced by a different expression system
Title:
Physicochemical characterization and phase I study of CMAB008, an infliximab biosimilar produced by a different expression system
Other Titles:
Drug Design, Development and Therapy
Keywords:
Publication Date:
12 March 2019
Citation:
An Q, Zheng Y, Zhao Y, Liu T, Guo H, Zhang D, Qian W, Wang H, Guo Y, Hou S, Li J. Physicochemical characterization and phase I study of CMAB008, an infliximab biosimilar produced by a different expression system. Drug Des Devel Ther. 2019;13:791-805 https://doi.org/10.2147/DDDT.S170913
Abstract:
Infliximab (Remicade), a chimeric monoclonal antibody against human TNFα, will inevitably face competition from biosimilar products, because of its effectiveness in autoimmune diseases and rapidly increasing market demand. According to guidelines for biosimilar development, the “biosimilar-expression system” may differ from that of the innovator, but more appropriate studies should be carried out to demonstrate the comparability between biosimilar and innovator. CMAB008 is an infliximab biosimilar candidate developed by the State Key Laboratory of Antibody Medicine and Targeted Therapy of China. Infliximab was expressed in SP2/0 cells, while CMAB008 was produced in a CHO-expression system.
License type:
http://creativecommons.org/licenses/by-nc/4.0/
Funding Info:
This work was supported by grants from the Ministry of Science and Technology of China (863 projects 2014AA021004), Shanghai Rising-Star Program (16QB1404300), and Shanghai Key Technologies R&D Program of Biological Medicine (15431906100, 16431901200, 16431904700, 16431904100, and 16DZ1910400).
Description:
This document is the Version of Record of a Published Work that appeared in final form in Drug Design, Development and Therapy, Dove Medical Press after peer review and technical editing by the publisher. To access the final edited and published work see https://doi.org/10.2147/DDDT.S170913.
ISSN:
1177-8881
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