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首页> 外文期刊>Expert opinion on biological therapy >The design of clinical trials to support the switching and alternation of biosimilars
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The design of clinical trials to support the switching and alternation of biosimilars

机译：支持生物仿制药转换和替代的临床试验设计

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Introduction: Loss of exclusivity for biological therapeutics opens the door for biosimilar development. Biosimilars must demonstrate structural, functional, and clinical similarity with a currently approved biological originator product. A therapeutic alternative for biologic-naive patients, a single switch from an originator to biosimilar has also been studied in clinically stable patients; further, switching therapy multiple times (alternating) between an originator and a biosimilar has been investigated. Because biosimilars are not identical to originators and no robust clinical data have convincingly demonstrated that switching or alternating therapy of stable patients is safe and efficacious, there is an imperative need to understand the characteristics of well-designed clinical trials to support these practices.
机译：简介：生物疗法失去排他性为生物仿制药的发展打开了大门。生物仿制药必须证明与目前批准的生物原始产品的结构，功能和临床相似性。对于初生生物患者的治疗替代方案，也已经在临床稳定的患者中研究了从始发者到仿制药的单一转换。此外，已经研究了在始发者和生物仿制药之间多次切换治疗（交替）的方法。由于生物仿制药与原始药物并不相同，并且没有可靠的临床数据令人信服地证明稳定患者的转用或交替治疗是安全有效的，因此迫切需要了解设计良好的临床试验的特征以支持这些实践。

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