Medical Affairs, Viatris, Inc., Canonsburg, PA, USA.
Harrison School of Pharmacy, Auburn University, Auburn, AL, USA.
J Clin Pharm Ther. 2021 Dec;46(6):1489-1497. doi: 10.1111/jcpt.13426. Epub 2021 Apr 8.
Despite the large body of evidence demonstrating equivalent efficacy and safety for branded drugs and their generic counterparts, some patients and providers have the perception that generics may be less safe and effective than branded agents. Authorized generics (AGs) are a category of generic drugs defined by the United States Food and Drug Administration (FDA) as being the same as the brand-name drug without the brand's name on the label and which may have minor differences, such as tablet or capsule markings for identification. Studies in which AGs are considered along with other generics may increase our understanding of factors that may influence perceptions about generics and shed light on areas where education may be impactful. The objectives of this paper are to provide information about AGs, review studies in which they have been evaluated and explore the role that AGs may fill in the individualized treatment of patients.
A literature review was conducted on 30 September 2019 with follow-up search on 4 March 2020. The search was focussed on published papers and meeting abstracts that provided information on AGs with respect to medical and health outcomes of therapy as well as switching in individuals receiving branded, AG, or other generic agents. Information about patients' perceptions of generic medications and adherence to therapy was also included. Additional information, including relevant government sources, such as the FDA website and the Federal Trade Commission Report, was included as appropriate.
The literature specific to AGs is limited, but available data clearly highlight the importance of patient perception of generics as well as medication appearance as factors that may affect adherence and potentially more frequent switchbacks to branded agents from generics or AGs.
To our knowledge, this is the first narrative review to provide a summary of the published evidence about AGs with respect to clinical and health outcomes and switching. There is a need for more research and education regarding the use of AGs in clinical practice if they are to become more recognized as a potential treatment choice for patients. Generic medications play an important role in the healthcare system, and AGs may be able to provide an option to meet the specific needs of individual patients.
尽管有大量证据表明品牌药物及其仿制药具有同等的疗效和安全性，但一些患者和提供者认为仿制药可能不如品牌药物安全有效。授权仿制药（AG）是美国食品和药物管理局（FDA）定义的一种仿制药类别，与品牌药物相同，但标签上没有品牌名称，并且可能存在微小差异，例如用于识别的片剂或胶囊标记。在考虑 AG 与其他仿制药的研究中，我们可能会更深入地了解可能影响对仿制药看法的因素，并阐明教育可能产生影响的领域。本文的目的是提供有关 AG 的信息，回顾已评估 AG 的研究，并探讨 AG 在患者个体化治疗中可能发挥的作用。
于 2019 年 9 月 30 日进行文献综述，并于 2020 年 3 月 4 日进行后续搜索。搜索重点是关于 AG 的已发表论文和会议摘要，这些论文和摘要提供了关于医疗和健康结果以及接受品牌、AG 或其他仿制药的个体换药方面的信息。还包括有关患者对仿制药的看法和对治疗的依从性的信息。根据需要，包括了其他信息，例如相关政府来源，如 FDA 网站和联邦贸易委员会报告。
专门针对 AG 的文献有限，但现有数据清楚地强调了患者对仿制药的看法以及药物外观作为可能影响依从性并可能更频繁地从仿制药或 AG 换回品牌药物的因素的重要性。
据我们所知，这是第一篇关于 AG 的综述，总结了关于 AG 的临床和健康结果以及换药的已发表证据。如果 AG 要成为患者潜在的治疗选择之一，那么在临床实践中使用 AG 需要更多的研究和教育。仿制药在医疗保健系统中发挥着重要作用，AG 可能能够提供满足个体患者特定需求的选择。
