Performance of registration regulation policies on biosimilars in Japan and its enlightenment / 中国卫生政策研究

ABSTRACT

Objective:This paper intends to provide reference for consummation of biosimilar registration poli-cies in China. Methods:This paper evaluates the performance of Japanese registration regulation policies on biosimi-lars by analyzing the procedure and reviewing the features of biosimilars. Results and Conclusions:According to the findings of the present investigation, the availability and affordability of biosimilars have been improved, and the bio-medicine industry has achieved great development. On the other hand, it's recommended that the guideline for the de-velopment and evaluation of biosimilars should be amended on the principle of appropriate simplification, which means to simplify the research and development procedure and exempt partial application dossier. Besides, the regis-tration procedures should be adopted continuously to ensure the stability of biosimilars' R&D and registration.