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 Guidelines on the evaluation of biosimilar products 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 Extrapolation of indications |
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