Hemmington Amy, Dalbeth Nicola, Jarrett Paul, Fraser Alan G, Broom Reuben, Browett Peter, Petrie Keith J
Department of Psychological Medicine, University of Auckland, New Zealand.
Department of Medicine, Auckland and Department of Dermatology Middlemore Hospital, University of Auckland, New Zealand.
Pharmacoepidemiol Drug Saf. 2017 May;26(5):570-577. doi: 10.1002/pds.4186. Epub 2017 Feb 24.
Biosimilars are a cost-effective alternative to biologics that could improve patients' access to expensive biological medicines. Currently, there are little data on doctors' perceptions of biosimilars and in what situations they are comfortable prescribing biosimilars. In this study, we investigated medical specialists' perceptions of biosimilars and the factors associated with the acceptance of biosimilars.
A national sample of 110 of 327 medical specialists working in the areas of rheumatology, dermatology, gastroenterology, oncology and haematology completed an online questionnaire examining attitudes towards prescribing biosimilars, indication extrapolation and switching patients to a biosimilar.
Most specialists held positive views of biosimilars, with between 54 and 74% confident in the safety, efficacy, manufacturing and pharmacovigilance of biosimilars. Seventy-one percent of specialists agreed that they would prescribe biosimilars for all or some conditions meeting relevant clinical criteria. Specialists were less confident about indication extrapolation and switching patients from an existing biologic. Acceptance of biosimilars was significantly associated with a lower perceived time to explain a biosimilar to a patient and lower number of weekly patient appointments. The most common situations that they would not prescribe a biosimilar was where there was a lack of clinical data supporting efficacy (32%), or evidence of adverse effects (17%).
Medical specialists held generally positive attitudes towards biosimilars but were less confident in indication extrapolation and switching patients from a biologic. Providing clinicians with guidance on how to explain biosimilars to patients and written patient material may help overcome some of the barriers to the use of biosimilars. Copyright © 2017 John Wiley & Sons, Ltd.
生物类似药是生物制品的一种具有成本效益的替代方案，可改善患者获得昂贵生物药物的机会。目前，关于医生对生物类似药的看法以及他们在何种情况下愿意开具生物类似药的数据很少。在本研究中，我们调查了医学专家对生物类似药的看法以及与生物类似药接受度相关的因素。
从327名从事风湿病学、皮肤病学、胃肠病学、肿瘤学和血液学领域工作的医学专家中抽取110名作为全国样本，完成一份在线问卷，该问卷调查了对开具生物类似药的态度、适应症外推以及将患者转换为生物类似药的情况。
大多数专家对生物类似药持积极看法，54%至74%的专家对生物类似药的安全性、有效性、生产和药物警戒有信心。71%的专家同意，他们会为所有或某些符合相关临床标准的病症开具生物类似药。专家对适应症外推以及将现有生物制剂的患者转换用药的信心较低。对生物类似药的接受度与向患者解释生物类似药所需的感知时间较短以及每周患者预约数量较少显著相关。他们最常见的不开具生物类似药的情况是缺乏支持疗效的临床数据（32%），或有不良反应的证据（17%）。
医学专家对生物类似药总体持积极态度，但对适应症外推以及将患者从生物制剂转换用药的信心较低。为临床医生提供如何向患者解释生物类似药的指导以及书面患者资料可能有助于克服使用生物类似药的一些障碍。版权所有©2017约翰·威利父子有限公司。
