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国际生物类似药实施经验教训:创新扩散模型的应用。

Lessons from International Experience with Biosimilar Implementation: An Application of the Diffusion of Innovations Model.

机构信息

Faculty of Pharmacy and Pharmaceutical Sciences, University of Alberta, Edmonton, AB.

Social Sciences Lead, The Office of Lifelong Learning and the Physician Learning Program, Faculty of Medicine and Dentistry, University of Alberta, Edmonton, AB.

出版信息

Healthc Policy. 2020 Feb;15(3):16-27. doi: 10.12927/hcpol.2020.26133.

DOI:10.12927/hcpol.2020.26133
PMID:32176608
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7075443/
Abstract

Although biosimilars offer cost savings in Canadian healthcare, uptake is low. We discuss the literature on international experiences with biosimilar adoption in the context of the Diffusion of Innovations model. We highlight potential challenges with biosimilar implementation and gaps in research needed to inform implementation efforts. We observe a lack of systematic description of implementation design and evaluation and a paucity of in-depth and engaged research to understand stakeholders' pragmatic considerations and the knowledge, messages and meanings that shape clinician and patient decisions to choose biosimilars.

摘要

尽管生物类似药为加拿大的医疗保健带来了成本节约,但采用率却很低。我们在创新扩散模型的背景下讨论了国际上生物类似药采用经验的文献。我们强调了生物类似药实施中潜在的挑战以及为实施工作提供信息所需的研究空白。我们观察到缺乏对实施设计和评估的系统描述,以及缺乏深入和参与性的研究来了解利益相关者的实际考虑因素以及塑造临床医生和患者选择生物类似药的决策的知识、信息和意义。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dac/7075443/95e3bdf5d608/policy-15-016-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dac/7075443/95e3bdf5d608/policy-15-016-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/1dac/7075443/95e3bdf5d608/policy-15-016-g001.jpg

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本文引用的文献

1
The surge in biosimilars: considerations for effective pharmacovigilance and EU regulation.生物类似药的激增:有效药物警戒及欧盟监管的考量
Ther Adv Drug Saf. 2018 Aug 3;9(10):601-608. doi: 10.1177/2042098618790442. eCollection 2018 Oct.
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Perception of Originator Biologics and Biosimilars: A Survey Among Belgian Rheumatoid Arthritis Patients and Rheumatologists.原研生物制剂和生物类似药的认知:一项在比利时类风湿关节炎患者和风湿病学家中的调查。
BioDrugs. 2017 Oct;31(5):447-459. doi: 10.1007/s40259-017-0244-3.
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Assessing gastroenterologist and patient acceptance of biosimilars in ulcerative colitis and Crohn's disease across Germany.
从生物制剂转换为生物类似药:来自综合医疗保健系统的洞察。
BioDrugs. 2022 Jan;36(1):1-11. doi: 10.1007/s40259-021-00510-w. Epub 2021 Nov 24.
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A Look at the History of Biosimilar Adoption: Characteristics of Early and Late Adopters of Infliximab and Etanercept Biosimilars in Subregions of England, Scotland and Wales - A Mixed Methods Study.审视生物类似药的采用历程:英国、苏格兰和威尔士各地区英夫利昔单抗和依那西普生物类似药早期和晚期采用者的特征——一项混合方法研究。
BioDrugs. 2021 Jan;35(1):75-87. doi: 10.1007/s40259-020-00456-5.
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Kicking Off the 2020s with Healthcare Policy.开启 2020 年代的医疗政策。
Healthc Policy. 2020 Feb;15(3):6-11. doi: 10.12927/hcpol.2020.26135.
评估德国各地胃肠病学家和患者对溃疡性结肠炎和克罗恩病生物类似药的接受度。
PLoS One. 2017 Apr 14;12(4):e0175826. doi: 10.1371/journal.pone.0175826. eCollection 2017.
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Policy objective of generic medicines from the investment perspective: The case of clopidogrel.从投资角度看仿制药的政策目标:以氯吡格雷为例
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5
Assessing physician and patient acceptance of infliximab biosimilars in rheumatoid arthritis, ankylosing spondyloarthritis and psoriatic arthritis across Germany.评估德国各地医生和患者对类风湿性关节炎、强直性脊柱炎和银屑病关节炎中英夫利昔单抗生物类似药的接受度。
Patient Prefer Adherence. 2017 Mar 13;11:519-530. doi: 10.2147/PPA.S129333. eCollection 2017.
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Awareness, Knowledge, and Perceptions of Biosimilars Among Specialty Physicians.专科医生对生物类似药的认知、了解及看法。
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Br J Gen Pract. 2016 Aug;66(649):402-3. doi: 10.3399/bjgp16X686221.
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