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生物类似药的临床和监管关注:文献综述。

Clinical and Regulatory Concerns of Biosimilars: A Review of Literature.

机构信息

Faculty of Pharmacy, University Ss. Cyril and Methodius, 1000 Skopje, North Macedonia.

Department of Pharmacy, Faculty of Medicine, University of Prishtina, 10000 Prishtina, Kosovo.

出版信息

Int J Environ Res Public Health. 2020 Aug 11;17(16):5800. doi: 10.3390/ijerph17165800.

DOI:10.3390/ijerph17165800
PMID:32796549
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC7460311/
Abstract

Although biosimilars have been part of clinical practice for more than a decade, healthcare professionals (HCPs) do not fully accept them. This is because of the perception that biosimilars may not be like their originators in terms of quality, safety, and efficacy. This study aims to evaluate the current knowledge and attitudes of healthcare professionals toward biosimilar prescription, and to elaborate on their concerns. We reviewed the literature using PubMed, Cochrane Library, and Science Direct electronic databases in the period from 2018 to 2020. The knowledge and confidence of healthcare professionals vary between countries, between clinical profiles and between studies. Although most of the healthcare professionals had a positive attitude to prescribing biosimilars, they would still prefer to prescribe them in initial treatment. Generally, HCPs were against multiple switches and substitution of biosimilars at the pharmacy level. HCP's key concern was interchangeability, with eventual consequences on the clinical outcome of patients. HCPs still approach biosimilars with caution and stigma. HCPs need to have an unbiased coherent understanding of biosimilars at clinical, molecular and regulatory levels. It was also observed that most of their concerns are more theoretical than science-based. Physicians are in an excellent position to accept biosimilars, but they need the additional support of regulatory authorities to approve and take into consideration the available scientific data regarding biosimilars.

摘要

尽管生物类似药已经在临床实践中应用了十余年,但医疗保健专业人员(HCPs)并未完全接受它们。这是因为人们认为生物类似药在质量、安全性和疗效方面可能与原创药不同。本研究旨在评估医疗保健专业人员对生物类似药处方的现有知识和态度,并详细说明他们的关注点。我们使用 PubMed、Cochrane Library 和 Science Direct 电子数据库在 2018 年至 2020 年期间对文献进行了回顾。医疗保健专业人员的知识和信心在国家之间、临床专业之间和研究之间存在差异。尽管大多数医疗保健专业人员对开具生物类似药持积极态度,但他们仍更愿意在初始治疗中开具此类药物。一般来说,HCPs 反对在药房层面进行多次转换和替代生物类似药。HCP 最关心的是可互换性,这可能会对患者的临床结果产生影响。医疗保健专业人员仍然对生物类似药持谨慎和歧视态度。HCPs 需要在临床、分子和监管层面上对生物类似物有一个公正、连贯的理解。还观察到,他们的大多数担忧更多的是理论上的,而不是基于科学的。医生在接受生物类似药方面处于有利地位,但他们需要监管机构的额外支持来批准并考虑有关生物类似药的现有科学数据。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4126/7460311/35373d1745cf/ijerph-17-05800-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4126/7460311/35373d1745cf/ijerph-17-05800-g001.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/4126/7460311/35373d1745cf/ijerph-17-05800-g001.jpg

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