Biological products are usually recombinant protein molecules manufactured in living organisms by biotechnology. Most biologic products are difficult to identify or characterize due to the inherent variability based on highly complex manufacturing processes and structural complexity. As with small molecules drugs, the expiration of patents provides an opportunity for generic version of biological products to enter the market. Since biological product can not be an identical copy of the originator products, the term ‘biosimilars’ is used instead of ‘biogeneric’.

Biosimilar products are defined as a biological product that is comparable to already marketed reference products in terms of quality, safety and efficacy. It would therefore be mandatory to demonstrate their comparability to a reference product through an extensive comparability exercise of the quality, non-clinical and clinical studies. (Guidelines on Evaluation of Biosimilar Products, MFDS Guideline 2015) (Regulation on Approval and Review of Biological Products, MFDS Notification)

Manufacturers can develop a biosimilar product based on knowledge of safety and efficacy from clinical experience of a reference product. It is critical to demonstrate biosimilarity to the reference product using comprehensive head-to-head comparision in physicochemical & biological characteristics, and immunologenicity, efficacy and safety, through quality, non-clinical, clinical studies by a stepwise-approach.

Biosimilar product should be demonstrated to be biosimilar to already marketed reference product in terms of quality, safety and efficacy under Regulation on Approval and Review of Biological Products, MFDS Notification.

Comprehensive comparability assessment should be carried out between the biosimilar product and the reference product based on all the data obtained from comparative quality, nonclinical and clinical studies.

After demonstration of biosimilarity, extrapolation of other indications is acceptable with appropriate scientific evidence and justification.

In approval of a biosimilar product, a totality of evidence approach should be considered, i.e. all data generated during the comparability assessment.

MFDS established the scientific guidelines for the biosimilar assessment

MFDS has approved 28 biosimilar products (marketed 53 presentations)

MFDS has disclosed review summaries to promote transparency and consistency of its review and approval processes after approval of biosimilar products.

For biosimilars, in particular, MFDS has developed the Template for Assessment Summary Information for Biosimilar (PASIB) as Chair of the IPRP Biosimilars Working Group, which is currently publicly accessible

MFDS also has prepared the 'Reflection Paper on Extrapolation of Indications in Authorization of Biosimilar Products', which is currently publicly accessible.

MFDS also has prepared the 'Reflection Paper on Extrapolation of Indications in Authorization of Biosimilar Products', which is currently publicly accessible.