Home / Biosimilars / General / Biosimilars approved in South Korea
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 8 Sept 2015 Merck/Samsung Bioepis Davictrel etanercept Ankylosing spondylitis Psoriasis Psoriatic arthritis Rheumatoid arthritis 11 Nov 2014 Hanwha Chemical Eucept etanercept
Ankylosing spondylitis 18 March 2018 LG Chem Glarzia insulin glargine Diabetes 8 March 2018 GC Pharma Hadlima adalimumab
Psoriasis 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 23 Jul 2012 Celltrion Renflexis infliximab
Ankylosing spondylitis 4 Dec 2015 Merck/Samsung Bioepis Samfenet trastuzumab
Early-stage breast cancer 9 Nov 2017 Samsung Bioepis/ Daewoong Pharmaceutical Truxima rituximab
Chronic lymphocytic leukaemia 17 Nov 2016 Celltrion
*Data collected on 7 March 2014, updated on 22 June 2018 Related articles Biosimilar trastuzumab approved in Korea Biosimilars approved in Europe
Reference Permission granted to reproduce for personal and non-commercial use only. All other reproduction, copy or reprinting of all or part of any ‘Content’ found on this website is strictly prohibited without the prior consent of the publisher. Contact the publisher to obtain permission before redistributing. Copyright – Unless otherwise stated all contents of this website are © 2015 Pro Pharma Communications International. All Rights Reserved.
Psoriatic arthritis
Rheumatoid arthritis
Psoriasis
Psoriatic arthritis Rheumatoid arthritis
Psoriatic arthritis
Juvenile idiopathic arthritis
Rheumatoid arthritis
Ulcerative colitis
Crohn’s disease
Psoriasis Rheumatoid arthritis
Ulcerative colitis
Crohn’s disease
Psoriasis
Psoriatic arthritis
Rheumatoid arthritis
Ulcerative colitis
Metastatic breast cancer
Metastatic gastric cancer
Non-Hodgkin’s Lymphoma
Rheumatoid arthritis
Source: MFDS, company announcements
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
Comments (0)
Generics News Research General
- Adherence improves long-term prognosis and medi...Generics/Research | Posted 19/02/2021
- Anti-competitive strategic patenting by pharmac...Generics/Research | Posted 12/02/2021
- Biocon and Lupin launch generic tacrolimus caps...Generics/News | Posted 05/02/2021
- New generics company to offer low-cost versions...Generics/General | Posted 29/01/2021
Biosimilars News Research General
- Canada approves infliximab biosimilar Remsima SCBiosimilars/News | Posted 19/02/2021
- Innovent starts phase II trial for ipilimumab c...Biosimilars/News | Posted 19/02/2021
- EMA recommends approval of adalimumab biosimila...Biosimilars/News | Posted 12/02/2021
- Canada approves insulin aspart biosimilar TrurapiBiosimilars/News | Posted 12/02/2021