各国生物类似药适应症外推技术要求的比对研究及完善我国生物类似药适应症外推技术要求的建议

Comparative study on the technical requirements of extrapolation for indications of biosimilar drugs in different countries and recommendation on improvement for China

生物类似药的适应症外推,需要满足科学的前提条件。通过对美国、欧盟等国家以及WHO生物类似药适应症外推技术要求进行比对研究,提炼生物类似药适应症外推的前提条件,设计问卷、开展调研和研讨;结合对比研究、调研及专家研讨,提出完善我国生物类似药适应症外推技术要求考量的建议。

The indication extrapolation of biosimilar drugs needs to meet the preconditions of science.In this paper,a comparative study was conducted on the technical requirements for the indication extrapolation of biological similar drugs in the United States,the European Union and other countries as well as WHO,so as to extract the preconditions for the indication extrapolation of biological similar drugs.Questionnaires were designed,and investigations and discussions were conducted.Combined with the comparative study,investigation and expert discussion,some suggestions are put forward to improve the technical requirements for the extrapolation of indications for biosimilar drugs in China.