隨著生物技術(shù)產(chǎn)業(yè)的發(fā)展，韓國開始把重點(diǎn)放在提升生物醫(yī)藥制造和臨床標(biāo)準(zhǔn)上，逐步從生產(chǎn)仿制藥轉(zhuǎn)變?yōu)殚_發(fā)更多新分子實(shí)體、生物制品和生物類似藥。2009年韓國發(fā)布了《生物類似藥評估指南》，2010年推行了動(dòng)態(tài)藥品生產(chǎn)管理規(guī)范（cGMP），目前韓國大多數(shù)工廠都通過了美國FDA和歐盟藥品局（EMA）檢查，韓國公司與跨國生物醫(yī)藥公司的合作也越加緊密。從注冊分類、注冊程序和技術(shù)指南體系方面對韓國生物類似藥注冊管理法規(guī)體系做出框架性梳理。

With the development of biotechnology industry, South Korea has begun to focus on the promotion of biomedical manufacturing and clinical standards, and gradually from the production of generic drugs to the development of more new molecular entities, biological products, and biosimilars. In 2009, South Korea issued the "Guidelines on the Evaluation of Biosimilar Products" and introduced cGMP in 2010. Most factories in South Korea have passed inspections by the FDA and the EMA, and the cooperation between Korean companies and multinational biopharmaceutical companies is more closely. A framework review of the registration classification, registration procedures, and technical guidance system of Korean Biosimilar registration and management system are made in this article.