Regulations for biosimilars in South Korea

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The legislative basis for the regulation of biosimilars and its guideline for evaluation of biosimilars in South Korea was established in 2009 [1, 2].

Regulation V13H16

The Ministry of Food and Drug Safety (MFDS) guideline is a general guideline covering considerations for the authorization of biosimilars, selection of reference products, and quality, non-clinical and clinical evaluation of biosimilars. The guideline covers ‘well-characterized recombinant protein products’. The guideline was revised in 2014 to reflect the current thinking of MFDS.

Product-specific guidelines are also being published annually, with guidelines for erythropoietin and somatropin (2011), granulocyte colony-stimulating factor (2012) and monoclonal antibody (2013) biosimilars already issued.

The Korean guideline for biosimilars was co-developed with the World Health Organization (WHO) guidelines and is thus harmonized with the European Union guidelines in its scope, data requirements for authorization. The guideline therefore requires a demonstration of similarity and a comprehensive characterization and comparison at the quality level to enable a reduction in the non-clinical and clinical data required for authorization. The regulatory decision is then based on a comprehensive evaluation of quality, safety and efficacy data.

MFDS defines a biosimilar as ‘a biotechnological product that is comparable to already marketed reference products in terms of quality, safety and efficacy.

Dossier requirements
A comprehensive characterization and quality comparison provides the basis for a reduction in the amount of non-clinical and clinical data required for biosimilars [3].

Clinical studies
The purpose of clinical studies of biosimilars is to demonstrate similarity to the reference product. Sensitive endpoints are therefore required in order to detect differences. For example, overall survival/progression-free survival (OS/PFS) are traditional anti-tumour endpoints for new drugs but may not be suitable for biosimilars.

Selection of endpoints and time points for evaluation should be justified and traditional endpoints should be included as secondary endpoints.

Reference products
Evidence of the similarity of the biosimilar to the reference product should be demonstrated. Such similarity should be based on a totality of evidence approach, which should include:

  • differences between the biosimilar and its reference product, e.g. terminal sequences, post-translational modifications
  • rationale of similarity criteria via statistical analysis of data from a sufficient number of samples during comparability tests
  • any difference in the similarity criteria between the biosimilar and its reference product should be assessed and the impact justified, especially when related to safety and/or efficacy.

The similarity of a biosimilar will be accepted if it can be shown to be comparable in biological assays and in non-clinical and clinical studies.

Reference products should be already approved on the basis of a complete dossier package in Korea and should be used throughout studies supporting the quality, safety and efficacy of the biosimilar. Use of non-Korean (outsourced) reference products may be acceptable, provided that sufficient information to justify the comparability to Korean reference products is demonstrated.

Reference products approved in South Korea include Remicade (infliximab), Enbrel (etanercept), MabThera (rituximab), Humira (adalimumab), Herceptin (trastuzumab), Nesp (darbepoetin alfa), Lantus (insulin glargine) and Eprex (epoetin alfa).

Editor’s Comment
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1.   Joung J. Biosimilar regulation in Republic of Korea and Asia-Pacific Economic Cooperation (APEC) developments. Ministry of Food and Drug Safety. 2014.
2.   GaBI Online – Generics and Biosimilars Initiative. South Korean guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Apr 10]. Available from: 
3.   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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