Introduction: Many tumor necrosis factor (TNF)-alpha 'biosimilar' agents have been approved for the treatment of psoriasis and other autoinflammatory conditions. These biosimilars have the same structure as the originator biologic and have been shown to be equivalent in terms of safety and efficacy. However, given the method by which biosimilars are manufactured, they are not exact replicas of the originator, unlike generic forms of non-biologic medications. Therefore, there is controversy regarding whether these agents should be considered interchangeable with their originator biologics.Areas covered: The objective of this review is to summarize the safety data for each of the approved TNF-alpha biosimilars to determine whether or not these agents have appropriate safety profiles to replace their originator biologics.Expert opinion: Based on extrapolation of phase III investigations in patients with rheumatologic diseases, each of the approved anti-TNF agents have comparable efficacy, tolerability, and safety profiles to their originators. Studies in patients with psoriasis are more limited. Transitioning from a biologic to its biosimilar has also been shown to be similarly safe and immunogenetic compared to maintenance therapy with the originator. More post-marketing studies are needed to demonstrate the long-term safety in patients with psoriasis.

译文

:简介:许多肿瘤坏死因子(TNF)-α“生物仿制药”药物已被批准用于治疗牛皮癣和其他自体炎症。这些生物仿制药与原始生物仿制药具有相同的结构,并已被证明在安全性和功效上是等效的。但是,给定制造生物仿制药的方法,与非生物药物的一般形式不同,它们不是原始仿制药的精确复制品。因此,关于这些药物是否应与其原始生物制剂互换使用存在争议。研究范围:本综述的目的是总结每种批准的TNF-α生物仿制药的安全性数据,以确定这些药物是否具有适当的适用性。专家意见:根据对风湿病患者进行的III期研究的推断,每种批准的抗TNF药物均具有与其始发者相当的功效,耐受性和安全性。银屑病患者的研究更为有限。与使用始发者进行的维持治疗相比,从生物制剂过渡到其生物仿制药也已被证明具有相似的安全性和免疫遗传性。需要更多的上市后研究来证明牛皮癣患者的长期安全性。

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