Regulatory guideline for biosimilar products in Korea.

The regulatory framework of biosimilar products in Korea is a 3-tiered system: 1) Pharmaceutical Affairs Act; 2) Notification of the regulation on review and authorization of biological products; 3) Guideline on evaluation of biosimilar products. A biosimilar product is regulated under the same regulation as biological products. The difference from new biological product is that biosimilar product requires full comparability data with reference product. Based on these data, some of the non-clinical and clinical data could be abbreviated. As Korean guideline for biosimilar products was developed along with that of the WHO's, most of the recommendations were based on similar principle except the clinical evaluation to demonstrate similarity. No biosimilar products are licensed yet, however, 4 IND products have been approved for phase I or III clinical trials. The addressed issues during review were as follows: acceptability of reference products manufactured in different sites, determination of acceptable criteria for differences and selection of analytical tests for the comparability exercise to detect potential differences in quality attributes, relevant species for non-clinical study, and duration of toxicity study, etc. These and other future issues will be dealt with scientific advancement, experiences of collaborating work with WHO or other NRAs, which will be reflected in the guidelines on regulations of biosimilar products in Korea.