Comparison and Suggestions on the Registration and Regulation of Biosimilars between China and the USA

Abstract

Objective To put forward some suggestions for improving the registration and regulation, the efficiency of evaluation, and approval of biosimilar in China so as to promote the development of biopharmaceutical industry and increase the accessibility of therapeutic drugs in China. Methods Literature related to the registration and regulation, evaluation and approval of biosimilars were sorted out to analyze the differences in China and the USA. Results and Conclusion Based on the analysis of the current situation of registration and regulation of biosimilars between China and the USA, it is suggested to improve the registration and regulation of biosimilars in China from the following four aspects: Establishing a biosimilar regulatory department, expanding the professional evaluation personnel, scientifically simplifying the registration and approval procedures, and constantly refining the types of communication meetings.

Keywords

biosimilar / registration and regulation / review / approve