Trend Analysis of Regulatory Approvals for Generics and Biosimilars in Japan: 15 Years of PMDA During Fiscal Years 2009–2023

MHLW. Overview of National Medical Care Expenditures in FY 2021. https://www.mhlw.go.jp/toukei/saikin/hw/k-iryohi/21/dl/data.pdf. Accessed 17 August 2024 (In Japanese).

MHLW. Changes in National Medical Care Expenditure and Percentage Distribution. https://www.mhlw.go.jp/english/wp/wp-hw14/dl/02e.pdf. Accessed 17 August 2024.

Japan’s Senior Population Falls for the First Time on Record. https://www.nippon.com/en/japan-data/h01796/. Accessed 14 May 2024.

PMDA. Pharmaceuticals and Medical Devices Safety Information. No 346. https://www.pmda.go.jp/files/000219988.pdf. Accessed 19 May 2024.

MHLW. New target for generics in Japan. https://www.mhlw.go.jp/content/12401000/001227199.pdf. Accessed 14 May 2024 (In Japanese).

Regulatory News. Japan to Set Value-Based Share of 65% as Secondary Target for Generic Use. https://pj.jiho.jp/article/250601. Accessed 14 May 2024.

News. Increase Biosimilars with Over 80% Market Share to 60%” New Goal to Promote Biosimilars in Japan. https://idec-inc.com/blog/2023/06/19/new-goal-to-promote-biosimilars-in-japan/. Accessed 14 May 2024.

Kuribayashi R, Nakano A, Hariu A, Kishioka Y, Honda F. Historical overview of regulatory approvals and PMDA’s assessments for biosimilar products in Japan during 2009–2022. BioDrugs. 2023;37(4):443–51.

Article  PubMed  Google Scholar 

Pfizer. https://www.pfizerbiosimilars.com/biosimilars-development. Accessed 20 May 2024.

McKinsey & Company. Three imperatives for R&D in biosimilars. 2022. https://www.mckinsey.com/industries/life-sciences/our-insights/three-imperatives-for-r-and-d-in-biosimilars Accessed 20 May 2024. Accessed 20 May 2024.

Moore TJ, Mouslim MC, Blunt JL, Alexander GC, Shermock KM. Assessment of availability, clinical testing, and US food and drug administration review of biosimilar biologic products. JAMA Intern Med. 2021;181(1):52–60.

Article  CAS  PubMed  Google Scholar 

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 

PMDA. Results of operation. https://www.pmda.go.jp/about-pmda/annual-reports/0001.html. Accessed 20 May 2024.

NIHS. Bioequivalence. https://www.nihs.go.jp/drug/index-E.html#BE. Accessed 19 May 2024.

PMDA website for biosimilars. https://www.pmda.go.jp/english/review-services/reviews/0005.html. Accessed 1 June 2024.

MHLW. Guideline for Bioequivalence Studies of Generic Products. 2012. https://www.nihs.go.jp/drug/be-guide(e)/Generic/GL-E_120229_BE_rev140409.pdf. Accessed 2 June 2024.

MHLW. Questions and Answers (Q&A) on Guideline for Bioequivalence Studies of Generic Products. 2012. https://www.nihs.go.jp/drug/be-guide(e)/Generic/QA-E_120229_BE.pdf. Accessed 2 June 2024.

Kuribayashi R, Takishita T, Mikami K. Regulatory considerations of bioequivalence studies for oral solid dosage forms in Japan. J Pharm Sci. 2016;105(8):2270–7.

Article  CAS  PubMed  Google Scholar 

MHLW. Basic Principles on Bioequivalence Evaluation of Generic Dry Powder Inhalers. 2016. https://www.nihs.go.jp/drug/be-guide(e)/Powder%20Inhalers.pdf. Accessed 2 June 2024.

Kuribayashi R, Yamaguchi T, Sako H, Takishita T, Takagi K. Bioequivalence evaluations of generic dry powder inhaler drug products: similarities and differences between Japan, USA, and the European Union. Clin Pharmacokinet. 2017;56(3):225–33.

Article  CAS  PubMed  Google Scholar 

MHLW. Basic Principles on Bioequivalence Studies of Generic Ophthalmic dosage forms. 2018. https://www.nihs.go.jp/drug/be-guide(e)/Ophthalmic%20dosage%20forms.pdf. Accessed 2 June 2024.

Myoenzono A, Kuribayashi R, Yamaguchi T, Ogawa T, Takagi K. Current regulation for bioequivalence evaluations of generic ophthalmic dosage forms in Japan. Eur J Drug Metab Pharmacokinet. 2020;45(6):697–702.

Article  PubMed  Google Scholar 

MHLW. Guideline for Bioequivalence Studies of Generic Products. 2020. https://www.nihs.go.jp/drug/be-guide(e)/2020/GL1_BE_2020.pdf. Accessed 2 June 2024.

MHLW. Questions and Answers (Q&A) on Guideline for Bioequivalence Studies of Generic Products. 2020. https://www.nihs.go.jp/drug/be-guide(e)/2020/QA1_BE_2020.pdf. Accessed 2 June 2024.

Kuribayashi R, Yamaguchi T, Takagi K. Modernization and strengthening of bioequivalence guidelines in Japan. Clin Pharmacokinet. 2021;60(2):145–51.

Article  PubMed  Google Scholar 

MHLW. Basic principles on bioequivalence studies of generic semi-solid topical dermatological products. 2022. https://www.pmda.go.jp/files/000250534.pdf. Accessed 22 June 2024 (In Japanese).

ICH M13A Guideline. Bioequivalence for immediate release solid oral dosage forms. https://database.ich.org/sites/default/files/ICH_M13A_Step4_Final_Guideline_2024_0723.pdf. Accessed 16 August 2024.

ICH M13A Q&As. Q&As of bioequivalence for immediate release solid oral dosage forms. https://database.ich.org/sites/default/files/ICH_M13A_Step4_QAs_2024_0723.pdf. Accessed 16 August 2024.

MHLW. Guideline for ensuring quality, safety, and efficacy of biosimilars. 2009. https://www.jga.gr.jp/english/assets/english/uploads/2020/Interim-Translation1.pdf. Accessed 1 June 2024.

MHLW. Questions and Answers (Q&A) 1 on guideline for ensuring the quality, safety, and efficacy of Biosimilars. 2009. http://www.nihs.go.jp/dbcb/TEXT/Q&A-1.pdf. Accessed 8 June 2024 (In Japanese).

MHLW. Questions and Answers (Q&A) 2 on guideline for ensuring the quality, safety, and efficacy of Biosimilars. 2010. http://www.nihs.go.jp/dbcb/TEXT/Q&A-2.pdf. Accessed 8 June 2024 (In Japanese).

MHLW. Questions and Answers (Q&A) 3 on guideline for ensuring the quality, safety, and efficacy of Biosimilars. 2015. http://www.nihs.go.jp/dbcb/TEXT/Q&A-3.pdf. Accessed 8 June 2024 (In Japanese).

MHLW. Guideline for ensuring quality, safety, and efficacy of biosimilars. 2020. https://www.pmda.go.jp/files/000267479.pdf. Accessed 8 June 2024.

MHLW. Questions and Answers (Q&A) 4 on guideline for ensuring the quality, safety, and efficacy of Biosimilars. 2020. http://www.nihs.go.jp/dbcb/TEXT/Q&A_0204_1.pdf. Accessed 8 June 2024 (In Japanese).

MHLW. Questions and Answers (Q&A) on guideline for ensuring the quality, safety, and efficacy of Biosimilars. 2024. https://www.pmda.go.jp/files/000267480.pdf. Accessed 8 June 2024.

Kuribayashi R, Goto K, Hariu A, Kishioka Y. Revisions to the requirement of the Japanese clinical study data for biosimilar developments in Japan. Expert Opin Biol Ther. 2024;24(7):637–45.

Article  PubMed  Google Scholar 

Schiestl M, Ranganna G, Watson K, Jung B, Roth K, Capsius B, et al. The path towards a tailored clinical biosimilar development. BioDrugs. 2020;34(3):297–306.

Article  CAS  PubMed  PubMed Central  Google Scholar 

Cohen HP, Turner M, McCabe D, Woollett GR. Future evolution of biosimilar development by application of current science and available evidence: The developer’s perspective. BioDrugs. 2023;37(5):583–93.

Article  PubMed  PubMed Central  Google Scholar 

Woollett GR, Park JP, Han J, Jung B. The role of PD biomarkers in biosimilar development - To get the right answer one must first ask the right question. Clin Pharmacol Ther. 2023;113(1):50–4.

Article  CAS  PubMed  Google Scholar 

Strauss DG, Wang YM, Florian J, Zineh I. Pharmacodynamic biomarkers evidentiary considerations for biosimilar development and approval. Clin Pharmacol Ther. 2023;113(1):55–61.

Article  CAS  PubMed  Google Scholar 

Guillen E, Ekman N, Barry S, Weise M, Wolff-Holz E. A data driven approach to support tailored clinical programs for biosimilar monoclonal antibodies. Clin Pharmacol Ther. 2023;113(1):108–23.

Article  CAS  PubMed  Google Scholar 

MHRA. Guidance on the licensing of biosimilar products. 2022. https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products. Accessed 8 June 2024.

WHO. Guidelines on evaluation of biosimilars. 2022. https://cdn.who.int/media/docs/default-source/biologicals/annex-3---who-guidelines-on-evaluation-of-biosimilars---sj-ik-5-may-2022.pdf?sfvrsn=9b2fa6d2_1&download=true. Accessed 8 June 2024.

EMA. Concept paper for the development of a reflection paper on a tailored clinical approach in biosimilar development. 2023. https://www.ema.europa.eu/en/documents/other/concept-paper-development-reflection-paper-tailored-clinical-approach-biosimilar-development_en.pdf. Accessed 8 June 2024.

Luke MC. Equivalence of locally acting drug products. 2017. https://www.fda.gov/media/105890/download. Accessed 8 June 2024.

Novakovic J, Szirtes J, Fields A, Tsang YC. Clinical endpoint bioequivalence studies are not sensitive: A perspective from generic drugs. Clin Pharmacol Ther. 2019;105(2):295–7.

Article  PubMed  Google Scholar 

Usmani OS, Molimard M, Gaur V, Gogtay J, Singh GJP, Malhotra G, et al. Scientific rationale for determining the bioequivalence of inhaled drugs. Clin Pharmacokinet. 2017;56(10):1139–54.

Article  CAS  PubMed  Google Scholar 

Kosaka M, Ozaki A, Kaneda Y, Saito H, Yamashita E, Murayama A, et al. Generic drug crisis in Japan and changes leading to the collapse of universal health insurance established in 1961: the case of Kobayashi Kako Co. Ltd. Cost Eff Resour Alloc. 2023;21(1):35.

Article  PubMed  PubMed Central  Google Scholar 

AnswersNews. The number of generics on the market has reached a new low this year. https://answers.ten-navi.com/pharmanews/26905/. Accessed 17 Sept 2024 (In Japanese).

Fuji Keizai Group. No. 22060. https://www.fuji-keizai.co.jp/press/detail.html?cid=22060&view_type=2&la=ja. Accessed 8 June 2024 (In Japanese).

AnswersNews. How to provide a stable supply of biosimilars…Consider domestic manufacturing and demand forecasts. https://answers.ten-navi.com/pharmanews/27629/. Accessed 8 June 2024 (In Japanese).

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