日本における再生医療関連製品の臨床応用化に対する障壁と解決策

京都大学0048新制・課程博士博士(社会健康医学)甲第15641号社医博第34号新制||社医||7(附属図書館)28178京都大学大学院医学研究科社会健康医学系専攻(主査)教授 今中 雄一, 教授 戸口田 淳也, 教授 横出 正之学位規則第4条第1項該当Doctor of Public HealthKyoto UniversityDA

Industry views of biosimilar development in Japan

Objective To understand the issues around biosimilar development by pharmaceutical companies in Japan, which has emerged as an urgent issue in guaranteeing the availability of affordable biopharmaceuticals and a reduction in drug costs.Methods Various regulatory guidelines related to biosimilar development are carefully reviewed. We then interviewed representatives of 11 Japanese companies to explore issues related to the manufacturing, immunogenicity, development costs and regulation of biosimilars.Results Our investigations show that Japan is unlikely to produce more than a handful of biosimilars domestically in the near future. We also found that regulatory guidelines for biosimilars will be needed for Japanese developers to plan and initiate production, in order to provide affordable biopharmaceuticals to Japanese patients.Conclusion These results represent that regulatory guidelines for biosimilars, encouraging competition with maintaining incentive for innovation, will be needed for Japanese developers to plan and initiate biosimilar development.Biosimilars Follow-on proteins Regulatory guideline Interview survey Biopharmaceuticals

Overview of the clinical application of regenerative medicine products in Japan

Objective To identify barriers to the clinical application of regenerative medicine products (RMPs) in Japan.Methods Current Japanese regulatory systems and guidelines were compared with those of the United States (US) and the European Union (EU). A questionnaire was administered to representatives from 23 Japanese companies and 10 research institutes, and an in-person semi-structured interview was conducted with representatives from 10 companies that develop RMP.Results We found that Japan, the US and the EU have similar pre-clinical safety guideline frameworks relating to RMP. However, differences exist between these countries with respect to their review and approval systems and the implementation of guidelines, and these represent major barriers to the clinical application of RMP in Japan. Most companies studied are facing regulatory hurdles such as stringent review processes and regulatory guidelines that do not provide detailed practical examples of the pre-clinical quality and safety data required.Conclusions These results suggest that effective regulatory infrastructure including regulatory systems, guidelines, and communication channels between product developers and regulatory bodies are essential for the prompt clinical application of RMP in Japan.