Last update: 26 March 2021
In South Korea, the regulatory body for the approval of medicines, including biologicals and biosimilars, is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration.
Last update: 26 March 2021
In South Korea, the regulatory body for the approval of medicines, including biologicals and biosimilars, is the Ministry of Food and Drug Safety (MFDS), formerly the Korean Food and Drug Administration.
The agency, through its Biopharmaceuticals and Herbal Medicines Bureau, is responsible for the scientific evaluation of medicines developed by pharmaceutical companies for use in South Korea.
In July 2009, an overarching guideline for biosimilars, based on the European, Japanese and WHO guidelines, was published by the MFDS [1].
The guideline covers general considerations for approval of biosimilars, selection of reference drugs, and quality, non-clinical and clinical testing of biosimilars.
The first biosimilar to receive approval in South Korea was Celltrion’s arthritis treatment Remsima (infliximab) in July 2012. To date, the MFDS has approved 13 biosimilars within the product classes of HER2-inhibitor, insulin, tumour necrosis factor (TNF)-inhibitor and monoclonal antibody, for use in South Korea, see Table 1.
Table 1: MFDS approved biosimilars* | ||||
Product name | Active substance | Therapeutic area | Authorization date | Manufacturer/ Company name |
Basaglar | insulin glargine | Diabetes | Nov 2015 | Eli Lilly/Boehringer Ingelheim |
Brenzys | etanercept |
Ankylosing spondylitis Psoriasis Psoriatic arthritis Rheumatoid arthritis |
8 Sep 2015 | Merck/Samsung Bioepis |
Davictrel | etanercept | Ankylosing spondylitis Psoriasis Psoriatic arthritis Rheumatoid arthritis | 11 Nov 2014 | Hanwha Chemical |
Eucept | etanercept |
Ankylosing spondylitis Psoriasis Psoriatic arthritis Rheumatoid arthritis |
18 Mar 2018 | LG Chem |
Glarzia | insulin glargine | Diabetes | 8 Mar 2018 | GC Pharma |
Hadlima | adalimumab |
Psoriasis Psoriatic arthritis Juvenile idiopathic arthritis Rheumatoid arthritis Ulcerative colitis |
21 Sep 2017 | Samsung Bioepis |
Herzuma | trastuzumab | HER2+ breast cancer Advanced (metastatic) stomach cancer | 15 Jan 2014 | Celltrion |
Omnitrope | somatropin | Pituitary dwarfism Prader-Willi syndrome Turner syndrome | Jan 2014 | Sandoz |
Remsima | infliximab |
Ankylosing spondylitis Crohn’s disease Psoriasis Rheumatoid arthritis Ulcerative colitis |
23 Jul 2012 | Celltrion |
Renflexis | infliximab |
Ankylosing spondylitis Crohn’s disease Psoriasis Psoriatic arthritis Rheumatoid arthritis Ulcerative colitis |
4 Dec 2015 | Merck/Samsung Bioepis |
Samfenet | trastuzumab |
Early-stage breast cancer Metastatic breast cancer Metastatic gastric cancer |
9 Nov 2017 | Samsung Bioepis/ Daewoong Pharmaceutical |
Terossa | teriparatide | Osteoporosis | Nov 2019 | Daewon Pharmaceutical/Richter-Helm BioTec |
Truxima | rituximab |
Chronic lymphocytic leukaemia Non-Hodgkin’s Lymphoma Rheumatoid arthritis |
17 Nov 2016 | Celltrion |
*Data updated on 26 March 2021. Source: MFDS |
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Reference
1. GaBI Online - Generics and Biosimilars Initiative. South Korean guidelines for biosimilars [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 14]. Available from: www.gabionline.net/Guidelines/South-Korean-guidelines-for-biosimilars
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Source: MFDS
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