Faculty of Medicine, University of Queensland, Brisbane, Australia.
Faculty of Medicine, School of Public Health, University of Queensland, Brisbane, Australia.
BioDrugs. 2024 Jul;38(4):541-555. doi: 10.1007/s40259-024-00659-0. Epub 2024 Jun 15.
Biosimilars represent an opportunity to realise savings against the costs of innovative medicines. Despite efforts made by stakeholders, there are numerous barriers to the uptake of biosimilars. To realise the promise of biosimilars reducing costs, barriers must be identified, understood, and overcome, and enablers magnified. The aim of this systematic review is to summarise the enablers and barriers affecting uptake of biosimilars through the application of a classification system to organise them into healthcare professional (HCP), patient, or systemic categories.
A systematic literature search was performed in PubMed, Scopus, CINAHL, eConlit, and Embase. Included were primary research studies published in English between Jan 2017 through June 2023 focused on enablers and barriers affecting uptake of biosimilars. Excluded studies comprised comparisons of biosimilar efficacy and safety versus the reference biologic. One reviewer extracted data that included classification of barriers or enablers, the sub-classification, and the identification of the degree of agency associated with the actor through their role and associations as a mediator within their network, through the application of Actor Network Theory. The data were validated by a second reviewer (PV).
Of the 94 studies included, 59 were cross-sectional, 20 were qualitative research, 12 were cohort studies, and three were economic evaluations. Within the review, 51 of the studies included HCP populations and 35 included patients. Policies and guidelines were the most cited group of enablers, overall. Systemic enablers were addressed in 29 studies. For patients, the most frequently cited enabler was positive framing of a biosimilar, while for HCPs, cost benefit was the most frequently noted enabler. The most frequently discussed systemic barrier to biosimilar acceptance was lack of effective policies or guidelines, followed by lack of financial incentives, while the most significant barriers for HCPs and patients, respectively, were their lack of general knowledge about biosimilars and concerns about safety and efficacy. Systemic actors and HCPs most frequently acted with broad degree of agency as mediators, while patient most frequently acted with a narrow degree of agency as mediators within their networks.
Barriers and enablers affecting uptake of biosimilars are interconnected within networks, and can be divided into systemic, HCP, and patient categories. Understanding the agency of actors within networks may allow for more comprehensive and effective approaches. Systemic enablers in the form of policies appear to be the most effective overall levers in affecting uptake of biosimilars, with policy makers advised to give careful consideration to appropriately educating HCPs and positively framing biosimilars for patients.
生物类似药为降低创新药物成本提供了机会。尽管利益相关者做出了努力，但生物类似药的采用仍存在诸多障碍。为了实现生物类似药降低成本的承诺，必须识别、理解和克服障碍，并放大促进因素。本系统评价的目的是通过应用分类系统将影响生物类似药采用的促进因素和障碍组织到医疗保健专业人员（HCP）、患者或系统类别中，总结影响生物类似药采用的促进因素和障碍。
在 PubMed、Scopus、CINAHL、eConlit 和 Embase 中进行了系统的文献检索。纳入了 2017 年 1 月至 2023 年 6 月期间以英语发表的主要研究，重点关注影响生物类似药采用的促进因素和障碍。排除了比较生物类似药疗效和安全性与参考生物制剂的研究。一位审查员提取了数据，包括障碍或促进因素的分类、子分类以及通过应用 Actor Network Theory 识别与角色相关的参与者的代理程度。第二位审查员（PV）对数据进行了验证。
在纳入的 94 项研究中，59 项为横断面研究，20 项为定性研究，12 项为队列研究，3 项为经济评估。在本次审查中，51 项研究纳入了 HCP 人群，35 项研究纳入了患者。总体而言，政策和指南是最常被引用的促进因素群体。29 项研究涉及系统促进因素。对于患者，最常被引用的促进因素是对生物类似药的积极描述，而对于 HCP，成本效益是最常被提及的促进因素。生物类似药接受度的最常见系统障碍是缺乏有效的政策或指南，其次是缺乏财务激励，而 HCP 和患者的最大障碍分别是他们对生物类似药的一般知识缺乏和对安全性和疗效的担忧。系统参与者和 HCP 作为中介，最常具有广泛的代理程度，而患者作为中介，最常具有狭窄的代理程度。
影响生物类似药采用的障碍和促进因素在网络中相互关联，并可分为系统、HCP 和患者类别。了解网络中参与者的代理程度可能会允许更全面和有效的方法。以政策形式出现的系统促进因素总体上似乎是影响生物类似药采用的最有效杠杆，建议政策制定者仔细考虑如何适当教育 HCP，并积极为患者描述生物类似药。
