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Clinical trial and 'real-world' data support switching from a bio-originator to its biosimilar.

作者信息

Kay Jonathan, Dörner Thomas, Emery Paul, Kvien Tore K, Breedveld Ferdinand C

机构信息

Division of Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, Massachusetts, USA

Department of Medicine/Rheumatology and Clinical Immunology, Charité Universitätsmedizin and Deutsches Rheumaforschungszentrum (DRFZ), Berlin, Germany.

出版信息

Ann Rheum Dis. 2020 Apr;79(4):e44. doi: 10.1136/annrheumdis-2018-214994. Epub 2019 Jan 18.

DOI:10.1136/annrheumdis-2018-214994
PMID:30659047
Abstract
摘要

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Clinical trial and 'real-world' data support switching from a bio-originator to its biosimilar.临床试验和“真实世界”数据支持从生物原研药转换为其生物类似药。
Ann Rheum Dis. 2020 Apr;79(4):e44. doi: 10.1136/annrheumdis-2018-214994. Epub 2019 Jan 18.
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Long-term follow-up after switching from originator infliximab to its biosimilar CT-P13: the weight of nocebo effect.从原研英夫利昔单抗转换为其生物类似药CT-P13后的长期随访:无安慰剂效应的影响
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Recurrence Rates of Inflammation after Switching from the Originator Infliximab to Biosimilar Infliximab-abda for Noninfectious Uveitis.非感染性葡萄膜炎患者从原研英夫利昔单抗转换为英夫利昔单抗-abda 生物类似药后的炎症复发率。
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Regulatory Framework for Supporting the Integration and Use of Biosimilars in the Private Healthcare System of the United Arab Emirates (UAE).支持生物类似药在阿拉伯联合酋长国(阿联酋)私立医疗系统中整合与使用的监管框架。
Cureus. 2024 Nov 27;16(11):e74581. doi: 10.7759/cureus.74581. eCollection 2024 Nov.
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BMJ Open. 2023 Nov 21;13(11):e077454. doi: 10.1136/bmjopen-2023-077454.
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Maximizing the benefits of using biosimilars in Egypt.
在埃及实现生物类似药使用效益的最大化。
J Pharm Policy Pract. 2023 Jun 26;16(1):79. doi: 10.1186/s40545-023-00581-w.
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Real-world use of an etanercept biosimilar including selective automatic substitution in inflammatory arthritis patients: a UK-based electronic health records study.英夫利昔单抗生物类似药在现实世界中的应用,包括在炎性关节炎患者中的选择性自动替换:一项基于英国电子健康记录的研究。
Rheumatol Adv Pract. 2022 Jul 27;6(2):rkac056. doi: 10.1093/rap/rkac056. eCollection 2022.
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Biosimilar-to-Biosimilar Switching: What is the Rationale and Current Experience?生物类似药与生物类似药的转换:其原理和当前经验是什么?
Drugs. 2021 Nov;81(16):1859-1879. doi: 10.1007/s40265-021-01610-1. Epub 2021 Oct 27.
6
Treatment retention of infliximab and etanercept originators versus their corresponding biosimilars: Nordic collaborative observational study of 2334 biologics naïve patients with spondyloarthritis.英夫利昔单抗和依那西普原研药与相应生物类似药治疗保留率:北欧协作观察性研究 2334 例生物制剂初治的脊柱关节炎患者。
RMD Open. 2019 Oct 23;5(2):e001079. doi: 10.1136/rmdopen-2019-001079. eCollection 2019.
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Does a mandatory non-medical switch from originator to biosimilar etanercept lead to increase in healthcare use and costs? A Danish register-based study of patients with inflammatory arthritis.从原研药到生物类似药依那西普的强制性非医学转换是否会导致炎症性关节炎患者的医疗保健使用和成本增加?一项丹麦基于登记的研究。
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