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Biosimilars approved in South Korea Posted 14/03/2014

Last update: 2 December 2016

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 seven biosimilars within the product classes of HER2-inhibitor and tumour necrosis factor (TNF)-inhibitor, for use in South Korea, see Table 1.

Table 1: MFDS approved biosimilars*

Product name

Active substance

Therapeutic area

Authorization date

Manufacturer/ Company name

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

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

Truxima

rituximab

Chronic lymphocytic leukaemia
Non-Hodgkin’s Lymphoma
Rheumatoid arthritis

17 Nov 2016

Celltrion

*Data collected on 7 March 2014, updated on 2 December 2016
Source: MFDS, company announcements

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Biosimilars approved in Europe

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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