隨著多個(gè)"重磅炸彈"級(jí)原研生物藥的專利逐漸到期，全球生物類似藥的研發(fā)呈現(xiàn)出蓬勃發(fā)展的態(tài)勢(shì)，各個(gè)國(guó)家及地區(qū)的監(jiān)管機(jī)構(gòu)也逐步明確了技術(shù)指南要求，生物類似藥的發(fā)展也因各國(guó)監(jiān)管方式及監(jiān)管理念的不同而各具特色。介紹韓國(guó)生物類似藥的批準(zhǔn)上市情況和臨床在研狀況，對(duì)韓國(guó)生物類似藥的研究進(jìn)展進(jìn)行綜述。

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.