Last update: 10 April 2015
The regulatory body for approval of medicines in South Korea is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration. 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.
MFDS issued a guideline regarding the regulation of biosimilar products (Guideline on Evaluation of Biosimilar Products) in July 2009. The MFDS 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 guideline covers ‘well-characterized recombinant protein products’. 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 authorization, etc.
MFDS has the following guidelines regarding biosimilars:
1. Overarching Guideline
This guideline covers all biosimilar products.
Guideline on evaluation of biosimilar products
Effective date: 2010
2. Revisions to Overarching Guidelines
The overarching guideline is being revised in 2014 to reflect the current thinking of MFDS.
3. Specific Guidelines
These guidelines are specific to the type of biosimilar product:
Guideline on non-clinical and clinical evaluation of erythropoietin and somatropin biosimilar products
Effective date: 2011
Guideline on non-clinical and clinical evaluation of G-CSF biosimilar products
Effective date: 2012
Guideline on non-clinical and clinical evaluation of monoclonal antibody biosimilar products
Effective date: 2013
4. Other guidelines/documents
Other guidelines or documents relevant for biosimilars from MFDS include:
Questions & answers regarding biosimilar guideline
Standards and specifications for biologics
Guidelines on immunogenicity evaluation of recombinant products
Analytical methods for characterization of biosimilars (erythropoietin)
According to the Korean biosimilar guideline, a biosimilar is defined as as ‘a biological product that is comparable to an already marketed reference product in terms of quality, safety and efficacy’. 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 characterization and quality comparison provides the basis for a reduction in the amount of non-clinical and clinical data required for biosimilars .
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 authorization 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 characterized.
If you would like to receive an English copy* of the South Korean guidelines please contact us via email.
*For profit organizations subject to a fee
EU guidelines for biosimilars
1. Joung J. Korean regulations for biosimilars. Generics and Biosimilars Initiative Journal (GaBI Journal). 2015;4(2):93-4. doi:10.5639/gabij.2015.0402.019
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