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.
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
- Biosimilar Product Evaluation Guideline, English Version, (2022.7)
- 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.
Approval of Biosimilar Products in Korea
MFDS has approved 37 biosimilar products (marketed 71 presentations)
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.
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 |
||||
11 | Onbevzi | Samsung
Bioepis Co. Ltd |
Avastin
(Bevacizumab) |
Download |
12 | Yuflyma | Celltrion, Inc. | Humira (Adalimumab) |
Download |
13 | Amelivu | Samsung Bioepis Co. Ltd |
Lucentis (Ranibizumab) |
Download |
14 | Chong Kun Dang Ranibizumab Inj | Chong Kun Dang Pharm. |
Lucentis (Ranibizumab) |
Download |
15 | Vegzelma | Celltrion, Inc. | Avastin (Bevacizumab) |
Download |
16 | Xelenka | LG Chem, Ltd. | Humira (Adalimumab) |
Download |
17 | Epysqli | Samsung Bioepis Co. Ltd. |
Soliris (Eculizumab) |
Download |
18 | Afilivu | Samsung Bioepis Co. Ltd. |
Eylea (Aflibercept) |
Download |
19 | Epyztek Pre-filled syringe |
Samsung Bioepis Co. Ltd. |
Stelara pre-filled syringe (Ustekinumab) |
Download |
20 | Epyztek IV injection |
Samsung Bioepis Co. Ltd. |
Stelara injection (Ustekinumab) |
Download |
21 | Eydenzelt Pre-filled Syringe |
Celltrion, Inc. | Eylea (Aflibercept) |
Download |
Eydenzelt Injection | ||||
22 | Steqeyma Pre-filled syringe |
Celltrion, Inc. | Stelara pre-filled syringe (Ustekinumab) |
Download |
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 : 2021.12.15.