随着多个"重磅炸弹"级原研生物药的专利逐渐到期，全球生物类似药的研发呈现出蓬勃发展的态势，各个国家及地区的监管机构也逐步明确了技术指南要求，生物类似药的发展也因各国监管方式及监管理念的不同而各具特色。介绍韩国生物类似药的批准上市情况和临床在研状况，对韩国生物类似药的研究进展进行综述。

With the patent of several "blockbuster" biological drugs being expired one after another, the research and development of global biosimilar products showing a booming trend. Regulators in various countries and regions have also gradually clarified the technical guidelines for research and development. The development of biosimilar products also has its own characteristics due to the different regulatory approaches and regulatory concepts in various countries. The approval and listing and the status of clinical trials of biosimilar products in Korea were introduced, and research progress on Korean biosimilar products was reviewed in this paper.