To date, no consensus exists among stakeholders about switching patients between reference biological products (RPs) and biosimilars, which may have been curbing the implementation of biosimilars in clinical practice. This study synthesizes the available data on switching and assesses whether switching patients from a RP to its biosimilar or vice versa affects efficacy, safety, or immunogenicity outcomes. A total of 178 studies, in which switch outcomes from a RP to a biosimilar were reported, was identified. Data were derived from both randomized controlled trials and real‐world evidence. Despite the limitations stemming from a lack of a robust design for most of the studies, the available switching data do not indicate that switching from a RP to a biosimilar is associated with any major efficacy, safety, or immunogenicity issues. Some open‐label and observational studies reported increased discontinuation rates after switching, which were mainly attributed to nocebo effects. Involvement of the prescriber in any decision to switch should remain and attention should be paid to the mitigation of a potential nocebo effect.

中文翻译：

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参考生物制药和生物仿制药之间切换的功效、安全性和免疫原性：系统评价。

迄今为止，利益相关者之间对于参考生物制品（RP）和生物仿制药之间的转换尚未达成共识，这可能限制了生物仿制药在临床实践中的实施。这项研究综合了有关转换的可用数据，并评估将患者从 RP 转换为其生物仿制药或反之亦然是否会影响疗效、安全性或免疫原性结果。总共有 178 项研究报告了从 RP 到生物仿制药的转换结果。数据来自随机对照试验和现实世界的证据。尽管大多数研究由于缺乏稳健的设计而存在局限性，但现有的转换数据并不表明从 RP 转换为生物仿制药与任何主要的功效、安全性或免疫原性问题相关。一些开放标签和观察性研究报告称，转换后停药率增加，这主要归因于反安慰剂效应。处方者应继续参与任何转换决定，并应注意减轻潜在的反安慰剂效应。