Biosimilars in Developed and Developing East and Southeast Asian Countries: Japan, South Korea, and Malaysia—Overview, Evolution, and Regulations Assessment

Table 5

MFDS approved biosimilars in South Korea.

Product name	Active substance	Therapeutic area	Authorization date	Manufacturer/company name
Remsima	Infliximab	Ankylosing spondylitis Crohn’s disease Psoriasis/rheumatoid arthritis/ulcerative colitis	Jul. 23, 2012	Celltrion
Omnitrope	Somatropin	Pituitary dwarfism, Prader-Willi syndrome, and Turner syndrome	Jan. 2014	Sandoz
Herzuma	Trastuzumab	HER2 + breast cancer Advanced (metastatic) stomach cancer	Jan. 15, 2014	Celltrion
Davictrel	Etanercept	Ankylosing spondylitis Psoriasis/rheumatoid arthritis/psoriatic arthritis	Nov. 11, 2014	Hanwha Chemical
Brenzys	Etanercept	Ankylosing spondylitis Psoriasis/rheumatoid arthritis/psoriatic arthritis	Sep. 3, 2015	Merck/Samsung Bioepis

Source: MFDS, 2015 [23].