随着生物仿制药的日益普及,由于非医学原因,在鼻祖生物制剂和类似生物仿制药之间切换治疗的做法变得越来越普遍.支持这种做法的证据主要来自单开关随机对照试验(RCT)和真实世界(RW)证据研究。然而,随着同一鼻祖的更多生物仿制药进入市场,发起人和生物仿制药之间的多个切换事件正在成为现实,尽管支持这种做法的有效性和安全性的证据有限。一些国家已经制定了指导方针,政策,或有关互换性和/或自动替代的法律,而其他人则使这些做法不受医疗保健系统其他组件的监管或控制。总的来说,关于单一非医疗转换的指导方针往往含糊不清,对多个非医疗转换的关注更少,这种做法大多不受管制。这篇叙述性综述将首先讨论当前对非医疗转换的监管观点以及与转换疗法相关的挑战,特别是多种生物仿制药的可用性。然后,我们将根据临床实践中目前发生的三种不同的多切换场景,回顾RCT和RW研究的当前证据:在发起人和单个生物类似菌之间切换,在同一鼻祖的生物仿制药之间切换,以及切换回发起人的临床实践(即,切换)在最初的非医疗切换到类似生物仿制药失败后。
With the increasing availability of biosimilars, the practice of switching therapies for non-medical reasons between an
originator biologic and an analogous biosimilar has become more common. The evidence to support this practice mostly comes from single-switch randomized controlled trials (RCTs) and real-world (RW) evidence studies. However, as more biosimilars of the same
originator enter the market, multiple switching events between originators and biosimilars is becoming a reality, despite limited evidence to support the efficacy and safety of such practice. Some countries have established guidelines, policies, or laws related to interchangeability and/or automatic substitution, whereas others have left these practices unregulated or controlled by other components of the healthcare system. Collectively, guidelines on single non-medical switching are often vague, with even less focus given to multiple non-medical switching, leaving this practice mostly unregulated. This narrative
review will first discuss the current regulatory perspectives on non-medical switching and challenges associated with switching therapies, particularly with the availability of multiple biosimilars. We will then
review the current evidence from RCTs and RW studies in the light of three different multiple-switch scenarios currently taking place in clinical practice: switching between an
originator and a single biosimilar, switching between biosimilars of the same originator, and the clinical practice of switching back to the originator (i.e., switchbacks) after a failure of the initial non-medical switch to the analogous biosimilar.