生物类似药法规体系研究在我国尚属空白。为保证研究方向的质量，确立了我国生物类似药相关法规体系研究的总体原则：以解决国内患者生物制品药物的可及性为核心目标、以遵循生物类似药研发规律为原则、以夯实生物制品民族产业基础为出发点、汲取化药仿制药产业发展的经验教训以及研究建议的可操性。主要对我国生物类似药相关法规体系研究的总体原则进行阐述。

The research on the regulatory system of biosimilar drugs is still a blank in China. To ensure the quality of the research direction, the general principles of relevant laws and regulations system of bio-similar drugs are established in China:in order to solve the domestic biological products in patients with drug accessibility as the core goal, in order to follow the principle of bio-similar drugs research and development of biological products, in order to strengthen national industrial base as the starting point, draw experiences and lessons from the generic medicines industry development, and research suggests that can hold. The general principles of relevant laws and regulations system of bio-similar drugs in China are reviewed in this paper.