In their correspondence, Cantini and Benucci1 voice concern regarding the recommendation of our international multidisciplinary task force on biosimilars that ‘a single switch from a bio-originator to one of its biosimilars is safe and effective.’2 This recommendation was based on consistent evidence from randomised controlled trials comparing biosimilars to their respective reference products in patients with rheumatologic diseases, in which subjects treated with a reference product were subsequently transitioned to treatment with its biosimilar. In all such studies that have been published to date, there has been no significant loss of efficacy or increase in the incidence of adverse events or of antidrug antibodies following such a change. This has been demonstrated not only for biosimilars of infliximab3–6 and etanercept,7 but also for biosimilars of adalimumab.8 9 The NOR-SWITCH study met its primary endpoint at 52 weeks, thereby demonstrating non-inferiority of changing treatment from bio-originator infliximab to biosimilar infliximab CT-P13 (infliximab-dyyb) to continued treatment with bio-originator infliximab in patients with any of the six inflammatory diseases for which infliximab is indicated who had exhibited stable disease activity over the previous 6 months.10 It is important to recognise that this prospective, double-blind, randomised controlled trial was powered to demonstrate non-inferiority of changing to the biosimilar to continued treatment with the bio-originator in the aggregated population of patients with the six inflammatory diseases; it was not designed to assess non-inferiority of this treatment strategy in any individual disease. As Cantini and Benucci point out, 248 (51.6%) of the 481 subjects enrolled in NOR-SWITCH had inflammatory …

中文翻译：

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临床试验和“真实世界”数据支持从生物原研药转向生物仿制药

在他们的通信中，Cantini 和 Benucci1 对我们关于生物仿制药的国际多学科工作组的建议表示担忧，即“从生物仿制药单一转换到其生物仿制药之一是安全有效的。”2 该建议基于来自以下方面的一致证据在风湿病患者中比较生物仿制药与其各自参考产品的随机对照试验，其中接受参考产品治疗的受试者随后转变为使用其生物仿制药进行治疗。在迄今为止已发表的所有此类研究中，在这种变化后，没有显着的疗效损失或不良事件或抗药物抗体的发生率增加。这不仅在英夫利昔单抗 3-6 和依那西普的生物仿制药中得到证实，7 但也适用于阿达木单抗的生物仿制药。8 9 NOR-SWITCH 研究在 52 周时达到了主要终点，从而证明了将治疗从生物原研药英夫利昔单抗改为生物仿制药英夫利昔单抗 CT-P13（英夫利昔单抗-dyyb）到继续治疗的非劣效性在过去 6 个月内疾病活动稳定的六种炎症性疾病患者中使用生物源英夫利昔单抗进行治疗。 10 重要的是要认识到这项前瞻性、双盲、随机对照试验的效力证明在六种炎症性疾病患者的总体人群中，使用生物仿制药继续治疗的非劣效性；它并非旨在评估该治疗策略在任何个体疾病中的非劣效性。