We read with great interest Cantini and Benucci’s response to our letter.1 However, we would like to add some points to the debate. To date and to our knowledge, every single clinical trial investigating efficacy and safety of biosimilars in rheumatology using a double-blinded design has failed to report any clinical difference with the original biologic. The double-blinded controlled trial NOR-SWITCH as well as open-label extension studies such as PLANETRA investigating efficacy and safety of the switch from original to biosimilar infliximab also failed to report any difference.2 3 These studies unequivocally condone the grade 1b recommendation 6 regarding the efficacy and safety of the switch published …

中文翻译：

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对信件的其他回应：“从生物起源转向生物仿制药：推荐这个程序是否为时过早？” 通过 Cantini 和 Bennuci

我们怀着极大的兴趣阅读了坎蒂尼和贝努奇对我们来信的回应。1 然而，我们想在辩论中添加一些要点。迄今为止，据我们所知，每一项使用双盲设计研究风湿病生物仿制药的有效性和安全性的临床试验都未能报告与原始生物仿制药的任何临床差异。双盲对照试验 NOR-SWITCH 以及开放标签扩展研究（如 PLANETRA 调查从原研药转为生物仿制药英夫利昔单抗的有效性和安全性）也没有报告任何差异。2 3 这些研究明确同意 1b 级建议 6关于已发布的开关的有效性和安全性……