通过对美国、欧盟、日本、韩国及我国生物类似药的立法发展及法规进行梳理，了解我国生物类似药法规方面存在的主要差异。通过对美国、欧盟、日本、韩国及我国生物类似药的批准及在研情况进行梳理，摸清国内外生物类似药的上市及研发现状，为我国生物类似药法规体系研究奠定基础。主要综述了各国生物类似药立法发展现状和批准产品的研究进展。

Through reviewing the legislative development and regulations of bio-similar drugs in the United States, European Union, Japan, Korea, and China, the main differences in bio-similar drugs laws and regulations in China are understood. Through reviewing the approval and research status of bio-similar drugs in the United States, the European Union, Japan, Korea, and China, the status quo of domestic and foreign bio-similar drugs' marketing and research are found out, and lay a foundation for the research of bio-similar drugs regulatory system in China. The current situation of bio-similar drug legislation and approved products in various countries are reviewed in this paper.