日本生物类似药注册监管政策绩效评价研究及启示

目的:为完善我国生物类似药的注册监管提供参考。方法:以日本生物类似药研发注册审评政策为研究对象,分析其注册审评流程及核心特征,并探讨政策实施效果。结果与结论:日本注册监管政策有助于提高生物类似药的可获得性与可支付性,同时促进了生物医药产业的健康发展。启示:我国可以引入适度简化原则,减免部分研发程序和申报资料要求,促进生物类似药的研发上市;沿用新药审评程序,确保生物类似药研发注册的稳定性。

Performance of registration regulation policies on biosimilars in Japan and its enlightenment

Objective:This paper intends to provide reference for consummation of biosimilar registration policies in China. Methods:This paper evaluates the performance of Japanese registration regulation policies on biosimilars 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 biomedicine industry has achieved great development. On the other hand, it''s recommended that the guideline for the development 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 registration procedures should be adopted continuously to ensure the stability of biosimilars'' R&D and registration.