South Korean Biosimilars Guideline

August 16, 2011 6:53 AM

Korea Food and Drug Administration (KFDA) was set up in April 1996. The KFDA is responsible of preventing and managing Food and Drug related risks, establishing a communication network and support relevant parties within South Korea.

With the support of Korean Governments during the recent years, South Korea became a hub of biotechnology and they have invested millions of dollars to develop the domestic industry. Now, the country is a regional leader in developing regulatory gudelines for biotechnological products.

There is a separate bureau in KFDA, dealing with the biological products, namely “Biopharmaceuticals and Herbal Medicines Bureau”. They are responsible for management of Biopharmaceuticals, Herbal Medicines and Cosmetics Policies as well as evaluation of the safety issues of these product classes.

Biosimilars, actually copies of biological products, were first introduced in 1990s in Korea. As there were no biosimilar pathways, the NDA procedure was followed at that time.

Korea introduced biosimilar guidelines in mid-2009 which is quite similar to the EU guidelines. Additionally, Korea is working on a biobetters guideline which is expected to be published in late this year.

The Korean guideline for biosimilars can be accessed from here.


Source: KFDA

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