South Korean guidelines for biosimilars

The regulatory body for approval of medicines in South Korea is the Korean Food and Drug Administration (KFDA). The agency, through its Biopharmaceuticals and Herbal Medicines Bureau, is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in the South Korea.

The KFDA issued a guideline regarding the regulation of biosimilar products (Guideline on Evaluation of Biosimilar Products) in July 2009. The KFDA guideline is an overarching guideline covering general considerations for biosimilar approval, selection of reference drugs, and quality, non-clinical and clinical testing of biosimilars. The Korean biosimilar guideline is based on the European, Japanese and WHO guidelines and is thus similar to them in its scope, data requirements for authorisation, etc.

KFDA has the following guidelines regarding biosimilars:

Overarching Guideline

This guideline covers all biosimilar products.

Guidelines on the evaluation of biosimilar products
Effective date: 2010
www.kfda.go.kr/eng

According to the Korean biosimilar guideline, a biosimilar is defined as a biological product demonstrated to be comparable, in terms of quality, safety, and efficacy, to a reference drug already approved by the KFDA as a new drug. Under the Korean biosimilar guideline, the reference drug is used in demonstrating the ‘comparability’ of a biosimilar product through quality, non-clinical and clinical studies.

Demonstration of ‘comparibility’ means that a significant amount of data is required in an abridged biosimilar application compared to a classic small-molecule generic drug application. The type and amount of data is also determined on a case-by-case basis. However, a comprehensive characterisation and quality comparison provides the basis for a reduction in the amount of non-clinical and clinical data required for biosimilars, see Figure 1.

Figure 1: KFDA data requirements for drug approval in South Korea

Source: KFDA

Exclusivity
There is no market exclusivity in Korea for biological products. Since there is no regulation in Korea that prohibits an application for approval of a biosimilar from being filed, an application for biosimilar approval may be filed at any time after the approval of the originator reference drug. Practically, however, it would not be easy to file a biosimilar application before the expiration of the re-examination period of a reference drug, i.e. six years, in Korea. The re-examination is carried out in order to fully assess the originator drug’s safety and efficacy through post-marketing surveillance.

Extrapolation of indications
In Korea, if similar efficacy and safety of the biosimilar and the reference product have been demonstrated for a particular clinical indication, then the biosimilar product may receive authorisation for other indications of the reference product. The extrapolation of clinical indications of a biosimilar product is allowed for indications where the post-marketing surveillance period of the reference product has expired and if all of the following conditions are fulfilled:

• A sensitive clinical test model to detect potential differences (between the biosimilar and the reference drug) is used.
• The clinically relevant mechanisms of action and the involved receptors are the same for the different indications.
• The safety and immunogenicity of the biosimilar have been sufficiently characterised.

Editor’s comment
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Related article

EU guidelines for biosimilars

Source: www.gabionline.net

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