生物类似药研发的总体目标是证明与原研药的相似性、不存在具有临床意义的差异。为有效指导生物类似药的研发，各国均制定了技术指南体系。对美欧日韩等国家、WHO及我国的生物类似药技术指南体系，包括药学研究、非临床研究、临床研究等进行对比研究，提炼构建技术指南体系的关键要素，结合问卷调研及专家研讨，提出完善我国生物类似药技术指南体系框架的建议。

The overall goal of bio-similar drug research and development is to prove that there are no clinically significant differences between bio-similar drugs and original drugs. In order to effectively guide the research and development of bio-similar drugs, countries have developed a technical guidance system. In this paper, the US, Europe, Japan, Korea, and other countries, the WHO and bio-similar drugs technical guidance system in China, including pharmaceutical research, clinical research, clinical research are made a comparison research, such as extracting key elements of the building technical guide system. The questionnaire survey and expert discussion are combined, and the recommendations of consummating bio-similar drugs technical guide system framework in China are proposed in this paper.