Ministry of food and drug safety

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Biosimilar

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)

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.
biosimilar Process Zoom
How to develop the biosimilar product?
Quality Studio Submission Review
Structure, Physicochemical characteristics, Biological characteristics, Immunological characteristics, Purity(process-or product-related impurities) Potench & Content, Specification, Stability Etc. In vitro and in vivo biological and pharmacodynamics properites, Non-clinical toxicity, Local tolerance study Pharmacokinetic studies, Pharmacodynamic studies, Efficacy, Safety, Immunogencity

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)(2018.12.)
  • 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)(2019.7.)
  • Guideline on the Comparability of Biothechnological/Biological Products to Changes in their Manufacturing Process (Korean)(2018.11.)
  • 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.

MFDS has approved 15 biosimilar products (marketed 25 different products)

MFDS has approved 15 biosimilar products (marketed 25 different products)
NO  Product Name  Company  Reference product
(Active Ingredient)
Approval date Withdrawal date Remarks 
1 Remsima Inj. 100mg Celltrion, Inc. Remicade
(Infliximab)
2012.07.20 - manufacturing
& marketing
2 Herzuma Inj. 150mg Celltrion, Inc. Herceptin
(Trastuzumab)
2014.01.15 - manufacturing
& marketing
3 Herzuma Inj. 440mg Celltrion, Inc. Herceptin
(Trastuzumab)
2014.01.15 - manufacturing
& marketing
4 SciTropin A™ Catridge
5mg(15IU)
SciGen Korea Ltd. Genotropin
(Somatropin)
2014.01.28 - imported
5 SciTropin A™ Catridge
10mg(30IU)
SciGen Korea Ltd. Genotropin
(Somatropin)
2014.01.28 - imported
6 Davictrel Inj. 25mg Hanwha
Chemical Co.
Enbrel
(Etanercept)
2014.11.11 2015.09.30 manufacturing
& marketing
7 Etoloce (Brenzys) 50mg
Prefilled Syringe
Samsung
Bioepis Co. Ltd
Enbrel
(Etanercept)
2015.09.07 - imported
8 Basaglar cartridge
100unit/mL
Lilly Korea Lantus
(Insulin glargine)
2015.11.25 2019.09.26 imported
9 Basagla KwikPen
100unit/mL
Lilly Korea Lantus
(Insulin glargine)
2015.11.25 - imported
10 Remaloce (Renflexis) Inj. 100mg Samsung
Bioepis Co. Ltd
Remicade
(Infliximab)
2015.12.04 - imported
11 Truxima Inj. 500mg Celltrion, Inc. Mabthera
(Rituximab)
2015.07.16
(for domestic
marketing
2016.11.16)
- manufacturing
& marketing
12 Adaloce (Hadlima) Prefilled
Syringe Inj. 40mg
Samsung
Bioepis Co.
Ltd
Humira
(Adalimumab)
2017.09.20 - Imported
13 Samfenet Inj. 150mg Samsung
Bioepis Co.
Ltd
Hercetpin
(Trastuzumab)
2017.11.08 - Imported
14 Glargia Prefilled Pen Green Cross Ltd Lantus
(Insulin glargine)
2018.03.07 - Imported
15 Eucept Autoinjector Inj. LG Chem Ltd Enbrel
(Etanercept)
2018.03.16 - Manufacturing&
marketing
16 Eucept Prefilled
Syringe Inj.
LG Chem Ltd Enbrel
(Etanercept)
2018.03.16 - Manufacturing&
marketing
17 Nesbell Prefilled
Syringe Inj. 20
Chong Kun Dang Pharm. Nesp
(Darbepoetin alfa)
2018.11.29 - Manufacturing&
marketing
18 Nesbell Prefilled
Syringe Inj. 30
Chong Kun Dang Pharm. Nesp
(Darbepoetin alfa)
2018.11.29 - Manufacturing&
marketing
19 Nesbell Prefilled
Syringe Inj. 40
Chong Kun Dang Pharm. Nesp
(Darbepoetin alfa)
2018.11.29 - Manufacturing&
marketing
20 Nesbell Prefilled
Syringe Inj. 60
Chong Kun Dang Pharm. Nesp
(Darbepoetin alfa)
2018.11.29 - Manufacturing&
marketing
21 Nesbell Prefilled
Syringe Inj. 120
Chong Kun Dang Pharm. Nesp
(Darbepoetin alfa)
2018.11.29 - Manufacturing&
marketing
22 Etoloce 50mg
Prefilled Pen Inj.
Samsung Bioepis Co. Ltd Enbrel
(Etanercept)
2019.08.19 - Imported
23 Terrosa Cartridge
Inj.
Daewon Pharmaceutical Co., Ltd Forsteo
(Teriparatide)
2019.09.29 - Imported
24 Panpotin Prefilled
Syringe Inj. 2000IU
PanGen Biotech Inc. Eprex
(Epoetin alfa)
2019.11.28 - Manufacturing
& marketing
25 Panpotin Prefilled
Syringe Inj. 4000IU
PanGen Biotech Inc. Eprex
(Epoetin alfa)
2019.11.28 - Manufacturing
& marketing

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.
MFDS published the assessment report of biosimilar products
No Product name Company Reference product PASIB
(Active Ingredient>
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
5 Truxima 500mg Celltrion, Inc. Mabthera
(Rituximab)
Download
6 Hadlima 40mg Samsung
Bioepis Co. Ltd
Humira
(Adalimumab)
Download
7 Samfenet 150mg Samsung
Bioepis Co. Ltd
Hercetpin
(Trastuzumab)
Download
8 Eucept
Autoinjector Inj.
LG Chem. Ltd Enbrel
(Eternercept)
Download
Eucept Prefilled
Syringe Inj.
9 Nesbell
(20/30/40/60/120)
Chong Kun Dang
Pharm.
Nesp
(Darbepoetin alfa)
Download
10 Panpotin Prefilled
Syringe 2000IU
PanGen Biotech Inc. Eprex
(Epoetin alfa)
Download
Panpotin Prefilled
Syringe 4000IU

MFDS' Performance as Chair of the IPRP Biosimilar Working Group

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.
Download
  • Page last updated : 2020.03.31.