各国生物类似药立法发展现状和批准产品的研究进展
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摘要
通过对美国、欧盟、日本、韩国及我国生物类似药的立法发展及法规进行梳理,了解我国生物类似药法规方面存在的主要差异。通过对美国、欧盟、日本、韩国及我国生物类似药的批准及在研情况进行梳理,摸清国内外生物类似药的上市及研发现状,为我国生物类似药法规体系研究奠定基础。主要综述了各国生物类似药立法发展现状和批准产品的研究进展。
Through reviewing the legislative development and regulations of bio-similar drugs in the United States, European Union,Japan, Korea, and China, the main differences in bio-similar drugs laws and regulations in China are understood. Through reviewing the approval and research status of bio-similar drugs in the United States, the European Union, Japan, Korea, and China, the status quo of domestic and foreign bio-similar drugs' marketing and research are found out, and lay a foundation for the research of bio-similar drugs regulatory system in China. The current situation of bio-similar drug legislation and approved products in various countries are reviewed in this paper.
Through reviewing the legislative development and regulations of bio-similar drugs in the United States, European Union,Japan, Korea, and China, the main differences in bio-similar drugs laws and regulations in China are understood. Through reviewing the approval and research status of bio-similar drugs in the United States, the European Union, Japan, Korea, and China, the status quo of domestic and foreign bio-similar drugs' marketing and research are found out, and lay a foundation for the research of bio-similar drugs regulatory system in China. The current situation of bio-similar drug legislation and approved products in various countries are reviewed in this paper.
引文
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[2]Public Health Services Act.PHSA[EB/OL].(1944-07-08)[2019-01-29].https://legcounsel.house.gov/Comps/PHSA-merged.pdf.
[3]FDA.Biologics price competition and innovation act[EB/OL].[2018-05-12].https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ucm627824.htm.
[4]FDA.Affordable care act(ACA 6004).[EB/OL].(2010-03-23)[2018-05-12].https://www.fda.gov/Drugs/Guidance ComplianceRegulatoryInformation/ucm292040.htm.
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[6]FDA.Biosimilars action plan:balancing innovation and competition[EB/OL].(2018-07-20)[2018-08-18].https://www.fda.gov/ucm/groups/fdagov-public/@fdagovdrugsgen/documents/document/ucm613761.pdf.
[7]European medicines agency:similar biological medicinal products(overarching guideline).CHMP/437/04 Rev.1[EB/OL].(2005-10-30)[2018-04-26].https://www.ema.europa.eu/documents/scientific-guideline/guideline-similarbiological-medicinal-products_en.pdf.
[8]JETRO.JETRO invest Japan report 2015[EB/OL].(2017-05-31)[2018-04-26].https://www.jetro.go.jp/ext_images/_.
[9]从四家公司看生物类似药的发展.[EB/OL].(2017-02-16)[2018-04-26].https://mp.weixin.qq.com/s/7-kpl NRJnimvMfXsLx1oMw?
[10]2020世界制药原料韩国展-CPhI Korea 2020[EB/OL].(2016-10-08)[2017-05-16].https://www.bestb2b.com/prod_55483100.htm.
[11]国家药品监督管理局.生物类似药研发与评价技术指导原则(试行)[EB/OL].(2015-02-28)[2018-04-26].http://www.cde.org.cn/zdyz.do?method=large Page&id=243.
[12]国家药品监督管理局.药品注册管理办法(修订稿)[EB/OL].(2017-10-23)[2018-09-11].http://samr.cfda.gov.cn/WS01/CL0778/178900.html.
[13]国家药品监督管理局药品审评中心.关于贝伐珠单抗注射液生物类似药临床研究设计及审评的考虑[EB/OL].[2017-07-18].http://www.cde.org.cn/dzkw.do?method=largePage&id=313923.
[14]国家药品监督管理局药品审评中心.关于征求“注射用曲妥珠单抗生物类似药临床研究设计及审评考虑要点”意见的通知[EB/OL].[2017-10-31].http://www.cde.org.cn/news.do?method=largeInfo&id=314090.
[15]国家药品审评中心.阿达木生物类似药临床研究设计要点考虑(征求意见稿)(2018-09-18)[2018-10-11].http://www.cde.org.cn/news.do?method=largeInfo&id=314704.
[16]FDA.Biosimilar product information[EB/OL].(2015-03)[2019-01].https://www.fda.gov/Drugs/DevelopmentApproval Process/HowDrugsareDevelopedandApproved/Approval Applications/Therapeutic Biologic Applications/Biosimilars/ucm580432.htm.
[17]FDA.Biosimilars action plan:balancing innovation and competition[EB/OL].[2018-07].https://www.fda.gov/downloads/Drugs/DevelopmentApprovalProcess/HowDru gsareDevelopedandApproved/ApprovalApplications/Ther apeutic Biologic Applications/Biosimilars/UCM613761.pdf.
[18]EMA.Europen public assessment reports[EB/OL].(2016-12)[2018-06].http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/landing/epar_search.jsp&mid=WC0b01ac058001d124&searchTab=searchByAuthType&keyword=Enterkeywords&searchType=name&alreadyLoaded=true&status=Authorised&jsenabled=false&search GenericType=biosimilars&orderBy=activeSubstance&pa geNo=1.
[19]EU.EU clinical trials register[EB/OL].(2009-11-18)[2018-07-16].https://www.clinicaltrialsregister.eu/ctr-search/search?query=biosimilar.
[20]PMDA.List of approved products[EB/OL].(2009-06)[2018-10].http://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0002.html.
[21]MFDS.MFDS has approved biosimilar products[EB/OL].(2012-07)[2017-11].http://www.mfds.go.kr/eng/index.do?nMenuCode=183.
[22]马玉琴,张象麟.韩国生物类似药的研究进展[J].现代药物与临床,2018,33(6):1291-1294.
[23]JPMA.バイオ製品及びバイオシミラーの現状_日韓医療製品規制に関するシンポジウム[EB/OL].[2017-07].http://www.jpma.or.jp/about/issue/gratis/newsletter/archive_after2014/80t4.pdf.
[24]行业新闻.中国生物类似药发展概述[EB/OL].[2018-05-28].http://www.360doc.com/content/18/0528/08/77611_757594441.shtml.