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.
Like other biological products, a biosimilar product is evaluated in terms of quality, safety and efficacy. When compared with a new drug, less information is submitted for marketing authorisation. However this practice is only acceptable when the comprehensive physico-chemical and biological study results demonstrate its comparability to the innovator product. To develop extensive characterisation studies, a pre-consultation meeting with the MFDS is strongly recommended. Quality and S&E technical officers will provide full advice and consultation.
Indication extrapolation is accepted if it demonstrates similar levels of efficacy and safety to the preexisting innovator product, even if all the clinical studies are not performed, although post-marketing surveillance will be required. The MFDS is also highlighting the importance of immunogenicity in line with the EMA. It is required to obtain and provide immunogenicity data until the efficacy studies are completed and if necessary, follow-up data should be submitted. Since it is limited to submit accumulated immunogenicity data at pre-authorisation stage, further characterization of the immunogenicity profile is recommended. If immunogenicity is likely to be rare, additional post-marketing analysis is called for.
The major difference from the EU biosimilar product guideline is that the Korean MFDS will accept the purchase of reference products from overseas market. However it will only do so under certain conditions; if the reference product authorized in Korea is not commercially available, or if there are other justifiable reasons, such as showing the same biological product as the one authorized in Korea, including the manufacturing site and the manufacturing process. The US FDA accepts the usage of data derived from animal or clinical studies that compares a proposed product with a non-US license product, under certain circumstances. In such a case, the adequate data or information to justify the relevance of the comparative data to an assessment of biosimilarity, and to establish an acceptable bridge to the US-license reference product, must be provided.
The EMA is also considering revising the guideline in step with the FDA. It may be possible to compare the biosimilarity in certain clinical studies and in vivo non-clinical studies with a non-EEA authorised comparator and by establishing an acceptable bridge to the EEA-authorized reference product. The revision is still in its infancy but it will help avoid the unnecessary repetition of clinical trials and in vivo non-clinical studies and facilitate the global development of biosimilar products.
About the author:
JinHee Kang, is a former associate senior manager for Central Research Institute RA/CO with Celltrion Pharmaceuticals, Jin-Hee Kang was previously one of the key leaders behind the first monoclonal antibody biosimilar registration within the EMEA region. JinHee was supervising the marketing authorisation from the feasibility studies to full launch logistics for new chemical entities, generics and biosimilar products in over 130 countries.
She previously worked with Otsuka Pharmaceutical as RA manager for six years.
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Guiding light: JinHee Kang discusses the way in which Korea’s Ministry of Food and Drug Safety (MFDS-former KFDA) has moved quickly to develop its biosimilar product guideline