Historical Overview of Regulatory Approvals and PMDA Assessments for Biosimilar Products in Japan During 2009–2022

Declerck P, Danesi R, Petersel D, Jacobs I. The language of biosimilars: clarification, definitions, and regulatory aspects. Drugs. 2017;77(6):671–7.

Article  PubMed  PubMed Central  Google Scholar 

MHLW. Trend of medical costs in fiscal year 2021 [in Japanese]. Available at: https://www.mhlw.go.jp/topics/medias/year/21/dl/iryouhi_data.pdf. Accessed 18 Sep 2022.

News. Japan FY 2021 Medical Costs Hit Record 44.2. T. Yen. https://sp.m.jiji.com/english/show/22037. Accessed 24 Nov 2022.

Ministry of Health, Labour and Welfare. Leaflet for medical personnel to definitely understand the biotechnological and biosimilar products [in Japanese]. Available at: https://www.mhlw.go.jp/content/10800000/000496081.pdf. Accessed 24 Nov 2022.

Ministry of Health, Labour and Welfare. Leaflet for patient to definitely understand the biotechnological and biosimilar products [in Japanese]. Available at: https://www.mhlw.go.jp/content/10800000/000496082.pdf. Accessed 24 Nov 2022.

News. Seniors account for record 29.1% of Japan's population. Available at: https://english.kyodonews.net/news/2021/09/e8d7087c9447-seniors-account-for-record-291-of-japans-population.html. Accessed 11 Sep 2022.

News. Pharmaceutical products sales amount ranking in 2021 of Japan [in Japanese]. https://answers.ten-navi.com/pharmanews/23443/. Accessed 11 Sep 2022.

Yamaguchi T, Arato T. Quality, safety and efficacy of follow-on biologics in Japan. Biologicals. 2011;39(5):328–32.

Article  PubMed  Google Scholar 

Abe T. Will Authorised Biologics Deter Biosimilars? Utilising JFTC’s Expertise in Drug Pricing. Chapter 11. In: Negishi A, Wakui M, Mariyama N (eds). Competition Law and Policy in the Japanese Pharmaceutical Sector. Springer, Berlin 2022. pp. 181–99.

World Health Organization. Guidelines on evaluation of similar biotherapeutic products. WHO/SBP/DRAFT/22. 2021. Available at: https://cdn.who.int/media/docs/default-source/biologicals/ecbs/who-sbps_22-april-2021.pdf?sfvrsn=f283c924_5. Accessed 25 Mar 2023.

European Medicines Agency. Guideline on similar biological medicinal products (CHMP/437/04 Rev 1). 2014. Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2014/10/WC500176768.pdf. Accessed 25 Mar 2023.

US FDA. Scientific considerations in demonstrating biosimilarity to a reference product. Guidance for industry. 2015. Available at: https://www.fda.gov/media/82647/download. Accessed 25 Mar 2023.

Socinski MA, Curigliano G, Jacobs I, Gumbiner B, MacDonald J, Thomas D. Clinical considerations for the development of biosimilars in oncology. MAbs. 2015;7:286–93.

Article  PubMed  PubMed Central  Google Scholar 

Declerck P, Farouk-Rezk M, Rudd PM. Biosimilarity versus manufacturing change: two distinct concepts. Pharm Res. 2016;33:261–8.

Article  CAS  PubMed  Google Scholar 

Pharmaceuticals and Medical Devices Agency. List of Approved Products. Available at: https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html. Accessed 18 Sep 2022.

Ministry of Health, Labour and Welfare. Notification of approval application of follow-on biologics [in Japanese]. 2009. Available at: http://www.nihs.go.jp/dbcb/TEXT/yakusyokuhatu-0304004.pdf. Accessed 18 Sep 2022.

Ministry of Health, Labour and Welfare. Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics. 2009. Available at: https://www.pmda.go.jp/files/000153851.pdf. Accessed 18 Sep 2022.

Ministry of Health, Labour and Welfare. Notification of handling of nonproprietary name and brand name for follow-on biologics [in Japanese]. 2009. Available at: https://www.nihs.go.jp/dbcb/TEXT/yakusyokushinsahatu-0304011.pdf. Accessed 18 Sep 2022.

Arato T, Yamaguchi T. Experience of reviewing the follow-on biologics including somatropin and erythropoietin in Japan. Biologicals. 2011;39(5):289–92.

Article  PubMed  Google Scholar 

Ministry of Health, Labour and Welfare. Questions and answers (Q&A) regarding the guideline for the quality, safety, and efficacy assurance of follow-on biologics (Biosimilars) (1). 2009. Available at: https://www.jga.gr.jp/english/assets/english/uploads/2020/QA-Biosimilars01.pdf. Accessed 18 Sep 2022.

Ministry of Health, Labour and Welfare. Questions and answers (Q&A) regarding the guideline for the quality, safety, and efficacy assurance of follow-on biologics (Biosimilars) (2). 2010. Available at: https://www.jga.gr.jp/english/assets/english/uploads/2020/QA-Biosimilars02.pdf. Accessed 18 Sep 2022.

Ministry of Health, Labour and Welfare. Notification of handling of nonproprietary name and brand name for follow-on biologics [in Japanese]. 2013. Available at: https://www.pmda.go.jp/files/000206759.pdf. Accessed 18 Sep 2022.

Kuribayashi R, Sawanobori K. Current Japanese regulatory systems for generics and biosimilars. J Pharm Sci. 2018;107(3):785–7.

Article  CAS  PubMed  Google Scholar 

Ministry of Health, Labour and Welfare. Questions and Answers (Q&A) regarding the Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics (Biosimilars) (3). 2015. https://www.jga.gr.jp/english/assets/english/uploads/2020/QA-Biosimilars03.pdf. Accessed 18 Sep 2022.

Ministry of Health, Labour and Welfare. Guideline for the quality, safety and efficacy of follow-on biologics [in Japanese]. 2020. Available at: http://www.nihs.go.jp/dbcb/TEXT/yakuseiyakushinnhatsu_0204_1.pdf. Accessed 11 Sep 2022.

Ministry of Health, Labour and Welfare. Questions and Answers (Q&A) regarding the Guideline for the Quality, Safety, and Efficacy Assurance of Follow-on Biologics (Biosimilars) (4) [in Japanese]. 2020. Available at: http://www.nihs.go.jp/dbcb/TEXT/Q&A_0204_1.pdf. Accessed 18 Sep 2022.

Ishii-Watabe A, Kuwabara T. Biosimilarity assessment of biosimilar therapeutic monoclonal antibodies. Drug Metab Pharmacokinet. 2019;34(1):64–70.

Article  CAS  PubMed  Google Scholar 

Egrie JC, Browne JK. Development and characterization of novel erythropoiesis stimulating protein (NESP). Br J Cancer. 2001;84(Suppl 1):3–10.

Article  CAS  PubMed  PubMed Central  Google Scholar 

ICH S6 (R1). Preclinical safety evaluation of biotechnology-derived pharmaceuticals. Available at: https://www.pmda.go.jp/files/000156596.pdf. Accessed 26 Nov 2022.

ICH E9 Q&A. Statistical principles for clinical trials [in Japanese]. 1998. Available at: https://www.pmda.go.jp/files/000156112.pdf. Accessed 18 Sep 2022.

Asami Y, Pan J, Oh M, Sato A. Statistical considerations on clinical efficacy studies of biosimilar for PMDA submission. Ther Innov Regul Sci. 2020;54(5):1134–7.

Article  PubMed  Google Scholar 

Pharmaceuticals and Medical Devices Agency. Review report for Filgrastim BS Injection [Mochida] and [F] [IN Japanese]. 2012. Available at: https://www.pmda.go.jp/drugs/2012/P201200149/790005000_22400AMX01419000_A100_2.pdf Accessed 1 Apr 2023.

Pharmaceuticals and Medical Devices Agency. Review report for Filgrastim BS Injection [NK] and [Teva] [in Japanese]. 2012. Available at: https://www.pmda.go.jp/drugs/2013/P201300017/530191000_22500AMX00855_A100_1.pdf. Accessed 1 Apr2023.

Pharmaceuticals and Medical Devices Agency. Review report for Filgrastim BS Injection [Sandoz] [in Japanese]. 2012. Available at: https://www.pmda.go.jp/drugs/2014/P201400028/270428000_22600AMX00524000_A100_1.pdf. Accessed 1 Apr 2023.

US FDA. Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. Guidance for industry. 2016. Available at: https://www.fda.gov/media/88622/download. Accessed 2 Apr 2023.

US FDA. Development of Therapeutic Protein Biosimilars: Comparative Analytical Assessment and Other Quality-Related Considerations. Draft Guidance for industry. 2019. Available at: https://www.fda.gov/media/125484/download. Accessed 2 Apr 2023.

US FDA. Questions and Answers on Biosimilar Development and the BPCI Act. Guidance for Industry. 2021. Available at: https://www.fda.gov/media/119258/download. Accessed 2 Apr 2023.

Pharmaceuticals and Medical Devices Agency. Review report for Insulin Glargine BS Injection [Lilly] [in Japanese]. 2014. Available at: https://www.pmda.go.jp/drugs/2014/P201400152/530471000_22600AMX01373_A100_1.pdf. Accessed 1 Apr 2023.

Pharmaceuticals and Medical Devices Agency. Review report for Insulin Glargine BS Injection [FFP] [in Japanese]. 2015. Available at: https://www.pmda.go.jp/drugs/2016/P20160421001/671423000_22800AMX00368_A100_1.pdf Accessed 1 Apr 2023.

Pharmaceuticals and Medical Devices Agency. Review report for Insulin Lispro BS Injection HU [Sanofi] [in Japanese]. 2019. Available at: https://www.pmda.go.jp/drugs/2020/P20200402003/780069000_30200AMX00421_A100_1.pdf. Accessed 1 Apr 2023.

Pharmaceuticals and Medical Devices Agency. Review report for Insulin Aspart BS Injection NR [Sanofi] [in Japanese]. 2020. Available at: https://www.pmda.go.jp/drugs/2021/P20210408001/780069000_30300AMX00240_A001_1.pdf. Accessed 1 Apr 2023.

US FDA. BsUFA III Regulatory Research Pilot Program: Reserch Roadmap. 2023. Available at: https://www.fda.gov/media/164751/download. Accessed 2 Apr 2023.

Pharmaceuticals and Medical Devices Agency. Review report for Adalimumab BS SC Injection [FKB] [in Japanese]. 2020. Available at: https://www.pmda.go.jp/drugs/2020/P20200624002/230971000_30200AMX00466_A100_1.pdf. Accessed 4 Apr 2023.

Pharmaceuticals and Medical Devices Agency. Review report for Adalimumab BS SC Injection [Daiichi sankyo] [in Japanese]. 2021. Available at: https://www.pmda.go.jp/drugs/2021/P20210122001/430574000_30300AMX00017_A100_2.pdf. Accessed 4 Apr 2023.

Pharmaceuticals and Medical Devices Agency. Review report for Adalimumab BS SC Injection [MA] [in Japanese]. 2021. Available at: https://www.pmda.go.jp/drugs/2021/P20210324004/790005000_30300AMX00236_A100_1.pdf. Accessed 4 Apr 2023.

留言 (0)

沒有登入
gif