各国生物类似药沟通交流机制及生物类似药可互换性对比研究及建议

药品注册中的沟通交流对于控制风险、提高研发注册效率具有重要作用。对美国、欧盟、日本、韩国等国家生物类似药沟通交流机制进行对比研究,结合我国沟通交流的现状,问卷调研和专家研讨,提出完善我国生物类似药沟通交流机制的建议。各国对生物类似药的"可互换性"有着不同的界定和管理。对美欧等国家生物类似药的"可互换性"进行研究,结合问卷调研和专家研讨,提出完善我国生物类似药可互换性的建议。

Comparative study on the communication mechanism and interchangeability of biosimilar drugs in different countries and recommendation on improvement for China

Communication in drug registration plays an important role in controlling risks and improving the efficiency of R&D registration. This paper makes a comparative study on the communication mechanism of biosimilar drugs in the United States, Europe, Japan, South Korea, and other countries, and puts forward suggestions on improving the communication mechanism of biosimilar drugs in China based on the current situation of communication in China, questionnaire survey and expert discussion. Different countries have different definitions and regulations on "interchangeable" biosimilar drugs. In this paper, the "interchangeability" of biosimilar drugs in the United States and Europe, and other countries is studied, combined with questionnaire survey and expert discussion, and suggestions for improving the interchangeability of biosimilar drugs in China are put forward.