Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies,BioDrugs

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Switching from One Biosimilar to Another Biosimilar of the Same Reference Biologic: A Systematic Review of Studies
BioDrugs ( IF 5.4 ) Pub Date : 2022-07-26 , DOI: 10.1007/s40259-022-00546-6
Hillel P Cohen ₁ , Sohaib Hachaichi ₂ , Wolfram Bodenmueller ₂ , Tore K Kvien ₃ , Silvio Danese ₄ , Andrew Blauvelt ₅

Affiliation

Background

Multiple switches (transitions) between biosimilars of the same reference biologic are now a reality, and they are expected to become more common in the future as more biosimilars enter the market. Switching between two biosimilars of the same reference biologic is generally driven by affordability, formulary requirements, or the relocation/travel of the patient. Evidence of whether switching between biosimilars of the same reference biologic provides similar safety and efficacy profiles is reviewed here.

Methods

A systematic search was undertaken using electronic databases (to December 2021): Biosis, Embase, MEDLINE, and EBM Reviews/Cochrane Database of Systematic Reviews via Ovid. Publications were evaluated for effectiveness and/or safety data linked to switching from one biosimilar to another.

Results

The systematic search yielded 982 citations. After eliminating duplicates, 626 citations remained for the initial title/abstract screening phase. Following the initial screening, 240 records were chosen; more thorough examination yielded 35 citations. After comprehensive screening and expert advice, 23 studies were selected, of which 13 were published in peer-reviewed journals; the remainder have been published as abstracts. Overall, 3657 patients were included in these studies. All studies were observational in nature; no randomized clinical trials were identified. The studies were heterogeneous in size, design, and endpoints. Across the studies, data are provided on safety, effectiveness, immunogenicity, pharmacokinetics, patient retention, patient and physician perceptions, and drug-use patterns. The majority of studies examined switches between biosimilar infliximabs, although switches between biosimilar adalimumabs, etanercepts, and rituximabs were also identified. Two use-pattern studies and one case report were also detected and are discussed.

Conclusion

Within the limitations of this systematic review, available data suggests that biosimilar-to-biosimilar switching is a safe and effective clinical practice, although it is not covered by current health authority regulations or guidance. No reduction in effectiveness or increase in adverse events was detected in biosimilar-to-biosimilar switching studies conducted to date.

中文翻译：

从一种生物仿制药切换到相同参考生物制剂的另一种生物仿制药：研究的系统回顾

背景

同一参考生物制剂的生物仿制药之间的多次转换（转换）现已成为现实，并且随着更多的生物仿制药进入市场，预计它们在未来将变得更加普遍。相同参考生物制剂的两种生物仿制药之间的转换通常是由负担能力、处方要求或患者的搬迁/旅行驱动的。本文综述了相同参考生物制剂的生物仿制药之间的转换是否提供相似的安全性和有效性特征的证据。

方法

使用电子数据库（截至 2021 年 12 月）进行系统检索：Biosis、Embase、MEDLINE 和 EBM Reviews/Cochrane 系统评价数据库（通过 Ovid）。对出版物进行了与从一种生物仿制药转换为另一种生物仿制药相关的有效性和/或安全性数据的评估。

结果

系统检索共获得 982 次引用。消除重复后，初始标题/摘要筛选阶段仍保留 626 条引用。经过初步筛选，共选出 240 条记录；更彻底的检查产生了 35 次引用。经过全面筛选和专家建议，评选出23项研究，其中13项在同行评审期刊上发表；其余部分已作为摘要发表。总体而言，这些研究纳入了 3657 名患者。所有研究本质上都是观察性的；没有发现随机临床试验。这些研究在规模、设计和终点方面各不相同。在所有研究中，提供了有关安全性、有效性、免疫原性、药代动力学、患者保留率、患者和医生认知以及药物使用模式的数据。大多数研究检查了生物仿制药英夫利昔单抗之间的转换，尽管也确定了生物仿制药阿达木单抗、依那西普和利妥昔单抗之间的转换。还发现并讨论了两项使用模式研究和一份案例报告。