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Biosimilars approved in South Korea Posted 14/03/2014

Last update: 22 June 2018

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 11 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 Sept 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 March 2018	LG Chem
Glarzia	insulin glargine	Diabetes	8 March 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
Truxima	rituximab	Chronic lymphocytic leukaemia Non-Hodgkin’s Lymphoma Rheumatoid arthritis	17 Nov 2016	Celltrion
*Data collected on 7 March 2014, updated on 22 June 2018 Source: MFDS, company announcements

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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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