Korea’s Ministry of Food and Drug Safety (MFDS-former KFDA) has moved quickly to develop its biosimilar product guideline. Due to the targeted nature of treatment, biological products are well known to have low adverse events and high efficacy. However their cost is often excessive, limiting their availability to patients. To resolve these issues, the MFDS is encouraging the development of inexpensive biosimilar products as a publishing guideline.
After consulting numerous scientific advisory boards, as well as reviewing guidelines and literature from overseas authorities, scientific experts and WHO, the MFDS published its biosimilar product guideline in 2009. Since then, a range of clinical trials for biosimilar products, including Phase I/Ib, IIb and III, have taken place and continue to do so. In July 2012 the guideline was granted first approval for monoclonal antibody biosimilar products. Among the guideline’s sponsors are some of Korea’s largest pharmaceutical and biological companies, including Celltrion, Samsung Biologics, Daewoong, LG Life Science, Hanwha Chemical, Dong-A Pharma and CKD. It is no doubt that Korea is one of the leading countries for introducing biosimilar products into the global market.