{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,10,9]],"date-time":"2026-10-09T19:52:06Z","timestamp":1791575526837,"version":"4.3.4"},"reference-count":39,"publisher":"Springer Science and Business Media LLC","issue":"7","license":[{"start":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T00:00:00Z","timestamp":1739491200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"},{"start":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T00:00:00Z","timestamp":1739491200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/www.springernature.com\/gp\/researchers\/text-and-data-mining"}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Naunyn-Schmiedeberg's Arch Pharmacol"],"published-print":{"date-parts":[[2025,7]]},"DOI":"10.1007\/s00210-025-03874-w","type":"journal-article","created":{"date-parts":[[2025,2,14]],"date-time":"2025-02-14T04:32:49Z","timestamp":1739507569000},"page":"9357-9365","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":3,"title":["Efforts of the Pharmaceuticals and Medical Devices Agency of Japanese regulatory agency in supporting biosimilar development and disseminate information"],"prefix":"10.1007","volume":"398","author":[{"ORCID":"https:\/\/orcid.org\/0000-0002-6778-7114","authenticated-orcid":false,"given":"Ryosuke","family":"Kuribayashi","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Aya","family":"Hariu","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Yuka","family":"Saino","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"Kayo","family":"Shinohara","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]}],"member":"297","published-online":{"date-parts":[[2025,2,14]]},"reference":[{"key":"3874_CR1","doi-asserted-by":"publisher","first-page":"1188368","DOI":"10.3389\/fphar.2023.1188368","volume":"14","author":"KA Alnaqbi","year":"2023","unstructured":"Alnaqbi KA, Bellanger A, Brill A, Casta\u00f1eda-Hern\u00e1ndez G, Clop\u00e9s Estela A, Delgado S\u00e1nchez O et al (2023) An international comparative analysis and roadmap to sustainable biosimilar markets. Front Pharmacol 14:1188368. https:\/\/doi.org\/10.3389\/fphar.2023.1188368","journal-title":"Front Pharmacol"},{"issue":"6","key":"3874_CR2","doi-asserted-by":"publisher","first-page":"783","DOI":"10.1007\/s40259-020-00452-9","volume":"34","author":"L Barbier","year":"2020","unstructured":"Barbier L, Simoens S, Vulto AG, Huys I (2020a) European stakeholder learnings regarding biosimilars: part I\u2014improving biosimilar understanding and adoption. BioDrugs 34(6):783\u2013796. https:\/\/doi.org\/10.1007\/s40259-020-00452-9","journal-title":"BioDrugs"},{"issue":"6","key":"3874_CR3","doi-asserted-by":"publisher","first-page":"797","DOI":"10.1007\/s40259-020-00440-z","volume":"34","author":"L Barbier","year":"2020","unstructured":"Barbier L, Simoens S, Vulto AG, Huys I (2020b) European stakeholder learnings regarding biosimilars: part II\u2014improving biosimilar use in clinical practice. BioDrugs 34(6):797\u2013808. https:\/\/doi.org\/10.1007\/s40259-020-00440-z","journal-title":"BioDrugs"},{"key":"3874_CR4","doi-asserted-by":"publisher","first-page":"820755","DOI":"10.3389\/fmed.2022.820755","volume":"9","author":"L Barbier","year":"2022","unstructured":"Barbier L, Mbuaki A, Simoens S, Declerck P, Vulto AG, Huys I (2022) Regulatory information and guidance on biosimilars and their use across Europe: a call for strengthened one voice messaging. Front Med (Lausanne) 9:820755. https:\/\/doi.org\/10.3389\/fmed.2022.820755","journal-title":"Front Med (Lausanne)"},{"issue":"12","key":"3874_CR5","doi-asserted-by":"publisher","first-page":"e575","DOI":"10.1016\/S1470-2045(20)30485-X","volume":"21","author":"CL Bennett","year":"2020","unstructured":"Bennett CL, Schoen MW, Hoque S, Witherspoon BJ, Aboulafia DM, Hwang CS et al (2020) Improving oncology biosimilar launches in the EU, the USA, and Japan: an updated policy review from the Southern Network on Adverse Reactions. Lancet Oncol 21(12):e575\u2013e588. https:\/\/doi.org\/10.1016\/S1470-2045(20)30485-X","journal-title":"Lancet Oncol"},{"key":"3874_CR6","unstructured":"Biospace (2024)\u00a0Biosimilars market size poised to hit USD 150.26 billion by 2033. https:\/\/www.biospace.com\/biosimilars-market-size-poised-to-hit-usd-150-26-billion-by-2033. Accessed 28 Dec 2024"},{"issue":"3_suppl","key":"3874_CR7","doi-asserted-by":"publisher","first-page":"11","DOI":"10.1177\/1078155219898510","volume":"26","author":"A Chan","year":"2020","unstructured":"Chan A, Patel H, Siderov J, Bubalo J, Foreman E (2020) Assessing biosimilar education needs among oncology pharmacy practitioners worldwide: an ISOPP membership survey. J Oncol Pharm Pract 26(3_suppl):11\u201321. https:\/\/doi.org\/10.1177\/1078155219898510","journal-title":"J Oncol Pharm Pract"},{"key":"3874_CR8","unstructured":"EMA (2023a) Statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU. 2023. https:\/\/www.ema.europa.eu\/en\/documents\/public-statement\/statement-scientific-rationale-supporting-interchangeability-biosimilar-medicines-eu_en.pdf. Accessed 28 Dec 2024"},{"key":"3874_CR9","unstructured":"EMA (2023b) Q&A on the statement on the scientific rationale supporting interchangeability of biosimilar medicines in the EU. 2023. https:\/\/www.ema.europa.eu\/en\/documents\/other\/qa-statement-scientific-rationale-supporting-interchangeability-biosimilar-medicines-eu_en.pdf. Accessed 28 Dec 2024"},{"key":"3874_CR10","unstructured":"EMA (2024a) Biosimilar medicines: overview. https:\/\/www.ema.europa.eu\/en\/human-regulatory-overview\/biosimilar-medicines-overview. Accessed 28 Dec 2024"},{"key":"3874_CR11","unstructured":"EMA (2024b) What is a biosimilar? https:\/\/www.youtube.com\/watch?v=adM6Qpy0KYc. Accessed 28 Dec 2024"},{"key":"3874_CR12","unstructured":"EMA (2024c) An information guide for patients \u201cWhat I need to know about biosimilar medicines.\u201d\u00a0https:\/\/ec.europa.eu\/docsroom\/documents\/26643. Accessed 28 Dec 2024"},{"key":"3874_CR13","unstructured":"EMA (2024d) Biosimilars in the EU Information guide for healthcare professionals. https:\/\/www.ema.europa.eu\/en\/documents\/leaflet\/biosimilars-eu-information-guide-healthcare-professionals_en.pdf. Accessed 28 Dec 2024"},{"key":"3874_CR14","unstructured":"Fuji Keizai Group (2024) No. 22060. https:\/\/www.fuji-keizai.co.jp\/press\/detail.html?cid=22060&view_type=2&la=ja. Accessed 12 Sept 2024 (In Japanese)"},{"key":"3874_CR15","unstructured":"IQVIA (2024) Biosimilars in the United States 2023\u20132027. https:\/\/www.iqvia.com\/-\/media\/iqvia\/pdfs\/institute-reports\/biosimilars-in-the-united-states-2023-2027\/iqvia-institute-biosimilars-in-the-united-states-2023-usl-orb3393.pdf. Accessed 12 Sept 2024"},{"key":"3874_CR16","doi-asserted-by":"publisher","first-page":"443","DOI":"10.1007\/s40259-023-00605-6","volume":"37","author":"R Kuribayashi","year":"2023","unstructured":"Kuribayashi R, Nakano A, Hariu A et al (2023) Historical overview of regulatory approvals and PMDA\u2019s assessments for biosimilar products in Japan during 2009\u20132022. BioDrugs 37:443\u2013451. https:\/\/doi.org\/10.1007\/s40259-023-00605-6","journal-title":"BioDrugs"},{"key":"3874_CR17","unstructured":"MHLW (2020) Guideline for ensuring quality, safety, and efficacy of biosimilars. https:\/\/www.pmda.go.jp\/files\/000267479.pdf. Accessed 12 Sept 2024"},{"key":"3874_CR18","unstructured":"MHLW (2024a) Government policy for biosimilar in Japan. https:\/\/www.mhlw.go.jp\/content\/001095684.pdf. Accessed 12 Sept 2024 (In Japanese)"},{"key":"3874_CR19","unstructured":"MHLW (2024b) Questions and answers (Q&A) on guideline for ensuring the quality, safety, and efficacy of biosimilars. https:\/\/www.pmda.go.jp\/files\/000267480.pdf. Accessed 15 Sept 2024"},{"key":"3874_CR20","unstructured":"MHLW (2024c) Lectures on biopharmaceuticals and biosimilars. https:\/\/www.mhlw.go.jp\/stf\/seisakunitsuite\/bunya\/0000132762_00005.html. Accessed 15 Sept 2024 (In Japanese)"},{"key":"3874_CR21","unstructured":"News (2024) \u201cIncrease biosimilars with over 80% market share to 60%\u201d new goal to promote biosimilars in Japan. https:\/\/idec-inc.com\/blog\/2023\/06\/19\/new-goal-to-promote-biosimilars-in-japan\/. Accessed 12 Sept 2024"},{"key":"3874_CR22","unstructured":"Nihon Keizai Shimbun (2024) News. https:\/\/www.nikkei.com\/article\/DGXZQOUA13CG90T10C24A2000000\/. Accessed 12 Sept 2024 (In Japanese)"},{"key":"3874_CR23","unstructured":"Nippon (2024) Japan\u2019s senior population falls for the first time on record. https:\/\/www.nippon.com\/en\/japan-data\/h01796\/. Accessed 3 Oct 2024"},{"issue":"4","key":"3874_CR24","doi-asserted-by":"publisher","first-page":"215","DOI":"10.1007\/s40290-021-00396-7","volume":"35","author":"ST Oskouei","year":"2021","unstructured":"Oskouei ST, Kusmierczyk AR (2021) Biosimilar uptake: the importance of healthcare provider education. Pharmaceut Med 35(4):215\u2013224. https:\/\/doi.org\/10.1007\/s40290-021-00396-7","journal-title":"Pharmaceut Med"},{"key":"3874_CR25","unstructured":"PMDA (2024a) PMDA Website for biosimilars (Japanese version). https:\/\/www.pmda.go.jp\/review-services\/drug-reviews\/about-reviews\/p-drugs\/0034.html. Accessed 12 Sept 2024 (In Japanese)"},{"key":"3874_CR26","unstructured":"PMDA (2024b) PMDA website for biosimilars (English version). https:\/\/www.pmda.go.jp\/english\/review-services\/reviews\/0005.html. Accessed 12 Sept 2024"},{"key":"3874_CR27","unstructured":"PMDA (2024c) List of approved products. https:\/\/www.pmda.go.jp\/english\/review-services\/reviews\/approved-information\/drugs\/0002.html. Accessed 2 Oct 2024"},{"key":"3874_CR28","unstructured":"PMDA website for biosimilars. Learning videos: review for biosimilars. https:\/\/www.youtube.com\/watch?v=YTsN6ARbn5w. Accessed 15 Sept 2024"},{"issue":"1","key":"3874_CR29","doi-asserted-by":"publisher","first-page":"37","DOI":"10.1002\/cpt.2765","volume":"113","author":"S Shubow","year":"2023","unstructured":"Shubow S, Sun Q, Nguyen Phan AL, Hammell DC, Kane M, Lyman GH et al (2023) Prescriber perspectives on biosimilar adoption and potential role of clinical pharmacology: a workshop summary. Clin Pharmacol Ther 113(1):37\u201349. https:\/\/doi.org\/10.1002\/cpt.2765","journal-title":"Clin Pharmacol Ther"},{"issue":"2","key":"3874_CR30","doi-asserted-by":"publisher","first-page":"529","DOI":"10.1016\/j.japh.2022.11.001","volume":"63","author":"JG Stevenson","year":"2023","unstructured":"Stevenson JG, McCabe D, McGrath M, McBride A (2023) Pharmacist biosimilar survey reveals knowledge gaps. J Am Pharm Assoc 63(2):529\u2013537. https:\/\/doi.org\/10.1016\/j.japh.2022.11.001","journal-title":"J Am Pharm Assoc"},{"key":"3874_CR31","unstructured":"US FDA (2023) Biosimilars basics for patients. https:\/\/www.fda.gov\/drugs\/biosimilars\/biosimilars-basics-patients. Accessed 21 Sept 2024"},{"key":"3874_CR32","unstructured":"US FDA (2024a) Biosimilar product information. https:\/\/www.fda.gov\/drugs\/biosimilars\/biosimilar-product-information. Accessed 12 Sept 2024"},{"key":"3874_CR33","unstructured":"US FDA (2024b) Education efforts to help increase biosimilar understanding and acceptance. https:\/\/www.fda.gov\/drugs\/our-perspective\/education-efforts-help-increase-biosimilar-understanding-and-acceptance. Accessed 21 Sept 2024"},{"key":"3874_CR34","unstructured":"US FDA (2024c) Biosimilars action plan. https:\/\/www.fda.gov\/drugs\/biosimilars\/biosimilars-action-plan. Accessed 3 Oct 2024"},{"key":"3874_CR35","unstructured":"US FDA (2024d) Industry information and guidance. https:\/\/www.fda.gov\/drugs\/biosimilars\/industry-information-and-guidance#industry. Accessed 21 Sept 2024"},{"key":"3874_CR36","unstructured":"US FDA (2024e) Overview for health care professionals. https:\/\/www.fda.gov\/drugs\/biosimilars\/overview-health-care-professionals. Accessed 21 Sept 2024"},{"key":"3874_CR37","unstructured":"US FDA (2024f) Multimedia education materials. https:\/\/www.fda.gov\/drugs\/biosimilars\/multimedia-education-materials-biosimilars#For%20Patients. Accessed 21 Sept 2024"},{"key":"3874_CR38","unstructured":"US FDA (2024g) Considerations in demonstrating interchangeability with a reference product: update. https:\/\/www.fda.gov\/media\/179456\/download. Accessed 28 Dec 2024"},{"key":"3874_CR39","unstructured":"US FDA (2024h) A milestone in facilitating the development of safe and effective biosimilars. https:\/\/www.fda.gov\/news-events\/fda-voices\/milestone-facilitating-development-safe-and-effective-biosimilars. Accessed 3 Oct 2024"}],"container-title":["Naunyn-Schmiedeberg's Archives of Pharmacology"],"original-title":[],"language":"en","link":[{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00210-025-03874-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/article\/10.1007\/s00210-025-03874-w\/fulltext.html","content-type":"text\/html","content-version":"vor","intended-application":"text-mining"},{"URL":"https:\/\/link.springer.com\/content\/pdf\/10.1007\/s00210-025-03874-w.pdf","content-type":"application\/pdf","content-version":"vor","intended-application":"similarity-checking"}],"deposited":{"date-parts":[[2025,7,15]],"date-time":"2025-07-15T04:52:54Z","timestamp":1752555174000},"score":1,"resource":{"primary":{"URL":"https:\/\/link.springer.com\/10.1007\/s00210-025-03874-w"}},"subtitle":[],"short-title":[],"issued":{"date-parts":[[2025,2,14]]},"references-count":39,"journal-issue":{"issue":"7","published-print":{"date-parts":[[2025,7]]}},"alternative-id":["3874"],"URL":"https:\/\/doi.org\/10.1007\/s00210-025-03874-w","relation":{},"ISSN":["0028-1298","1432-1912"],"issn-type":[{"value":"0028-1298","type":"print"},{"value":"1432-1912","type":"electronic"}],"subject":[],"published":{"date-parts":[[2025,2,14]]},"assertion":[{"value":"15 November 2024","order":1,"name":"received","label":"Received","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"2 February 2025","order":2,"name":"accepted","label":"Accepted","group":{"name":"ArticleHistory","label":"Article History"}},{"value":"14 February 2025","order":3,"name":"first_online","label":"First Online","group":{"name":"ArticleHistory","label":"Article History"}},{"order":1,"name":"Ethics","group":{"name":"EthicsHeading","label":"Declarations"}},{"value":"Not applicable.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Ethics approval and consent to participate"}},{"value":"All authors consent for publication.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Consent for publication"}},{"value":"The authors declare no competing interests.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Competing interests"}},{"value":"The views expressed in this article are those of the authors and do not necessarily reflect the official views of the Pharmaceuticals and Medical Devices Agency.","order":5,"name":"Ethics","group":{"name":"EthicsHeading","label":"Disclaimer"}}]}}