Biosimilars approved in South Korea

Biosimilars/General | Posted 14/03/2014 post-comment0 Post your comment

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.

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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
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
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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1.  GaBI Online - Generics and Biosimilars Initiative. South Korean guidelines for biosimilars []. Mol, Belgium: Pro Pharma Communications International; [cited 2014 Mar 14]. Available from:

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Source: MFDS

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