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Biosimilar

1. What is a Biosmilar product?

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)



2. How to develop the biosimilar product?

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.

Quality studies

3. How to approve the biosimilar product?

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

 Guidelines on the Evaluation of Biosimilar Products, English version, Revision1 (2015.10.)
Guideline on the Evaluation of Biosimilar Products Containing Recombinant Erythropoietins
   (Korean)(2011.12.)
Guideline on the Evaluation of Biosimilar Products Containing Somatropin(Korean)(2011.12.)
Guideline on the Evaluation of Biosimilar Products Containing Recombinant Granulocyte-Colony
   Stimulating Factor(Korean)(2012.10)
Guideline on the Evaluation of Biosimilar Products Containing Monoclonal Antibodies(Korean)(2013.9.)
Guideline on the Evaluation of Biosimilar Products Containing Recombinant Insulin and Insulin Analogues
   (Korean)(2015.10.)
Questions and Answers on Biosimilar Products(Korean)(2014.12.)
Guideline on the Evaluation of Quality, Safety, and Efficacy of Recombinant Protein Products
   (Korean)(2014.12)
Guideline on Stability Testing of Biological Products(Korean)(2015.11.)
Guideline on the Immunogenecity Evaluation of Biotechnology-Derived Therapeutic Proteins
   (Korean)(2010.10.)
Guideline on the Comparability of Biothechnological/Biological Products to Changes in their Manufacturing    Process(Korean)(2009.6.)
Guideline on the Clinical Evaluation of Biological Products for the Treatment of Rheumatoid Arthritis    (Korean)(2007)
Guideline on the Characterization and Specification of the Sugar Chain of Glycoprotein Products
   (Korean)(2015.6.)

The English version of the guidelines will continue to be uploaded.



4. MFDS has approved 8 biosimilar products (marketed 11 different products)

No Product name Company Reference
product
(Active
Ingredient)
Approval
date
Withdrawal
date
Remarks
1 Remsima 100mg Celltrion, Inc. Remicade
(Infliximab)
2012.07.20 - manufacturing
& marketing
2 Herzuma 150mg Celltrion, Inc. Herceptin
(Trastuzumab)
2014.01.15 - manufacturing
& marketing
3 Herzuma 440mg Celltrion, Inc. Herceptin
(Trastuzumab)
2014.01.15 - manufacturing
& marketing
4 SciTropin A™
5mg(15IU)
SciGen Korea
Ltd.
Genotropin
(Somatropin)
2014.01.28 - imported
5 SciTropin A™
5mg(30IU)
SciGen Korea
Ltd.
Genotropin
(Somatropin)
2014.01.28 - imported
6 Davictrel
25mg
Hanwha
Chemical Co.
Enbrel
(Etanercept)
2014.11.11 2015.09.30 manufacturing
& marketing
7 Brenzys 50mg Samsung
Bioepis Co. Ltd
Enbrel
(Etanercept)
2015.09.07 - imported
8 Basaglar cartridge
100unit/mL
Lilly Korea Lantus
(Insulin glargine)
2015.11.25 - imported
9 Basagla KwikPen
100unit/mL
Lilly Korea Lantus
(Insulin glargine)
2015.11.25 - imported
10 Renflexis
100mg
Samsung
Bioepis Co. Ltd
Remicade
(Infliximab)
2015.12.04 - imported
11 Truxima 500mg Celltrion, Inc. Mabthera
(Rituximab)
2015.07.16
(for domestic
marketing
2016.11.16)
- manufacturing
& marketing


5. MFDS published the assessment report of biosimilar products

MFDS has disclosed review summaries to promote transparency and consistency of its review and approval processes after approval of biosimilar products.
(Click here to visit the MFDS website)

No Product name Company Reference product
(Active Ingredient>
PASIB
1 Remsima 100mg Celltrion, Inc. Remicade
(Infliximab)
Download
2 Herzuma 150mg Celltrion, Inc. Herceptin
(Trastuzumab)
Download
Herzuma 440mg Celltrion, Inc. Herceptin
(Trastuzumab)
3 Brenzys 50mg Samsung Bioepis Co. Ltd Enbrel
(Etanercept)
Download
4 Renflexis 100mg Samsung Bioepis Co. Ltd Remicade
(Infliximab)
Download


6. MFDS' Performance as Chair of the IPRF Biosimilar Working Group

For biosimilars, in particular, MFDS has developed the Template for Assessment Summary Information for Biosimilar (PASIB) as Chair of the IPRF Biosimilars Working Group, which is currently publicly accessible.
(Click here to visit the IPRF website)

MFDS also has prepared the 'Reflection Paper on Extrapolation of Indications in Authorization of Biosimilar Products', which is currently publicly accessible.
(Click here to visit the IPRF website)
Reflection Paper on Extrapolation of Indications in Authorization of Biosimilar Products

Page last updated : 2017.11.17.