As of mid-2017, 10 tumour necrosis factor inhibitors (four for etanercept and three each for adalimumab and infliximab) and a first rituximab biosimilar are on the market, and a considerable number more are in various stages of development. The clinical trials of biosimilars, which have included long term extensions, have used various designs to look at switching between originator and biosimilar products, with reassuring results for clinical practice. For the infliximab biosimilar CT-P13 in particular, several studies have examined non-medical switching in real world practice. The results suggest that switching does not compromise safety, efficacy, or immunogenicity. However, additional data from clinical and real world switching studies, especially of switching between two or more biosimilars, are needed, as is continuing pharmacovigilance with larger databases to fill remaining gaps in the evidence. As biosimilar development continues, innovations in formulation and drug delivery technology may become of increasing interest.

中文翻译：

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生物仿制药已获批准并正在开发中

截至 2017 年年中，已有 10 种肿瘤坏死因子抑制剂（依那西普 4 种，阿达木单抗和英夫利昔单抗各 3 种）和第一个利妥昔单抗生物仿制药上市，还有相当多的药物处于不同的开发阶段。生物仿制药的临床试验（包括长期扩展）使用了各种设计来研究原研药和生物仿制药产品之间的转换，并为临床实践带来了令人放心的结果。特别是对于英夫利昔单抗生物仿制药 CT-P13，一些研究已经检验了现实世界实践中的非医疗转换。结果表明，转换不会损害安全性、有效性或免疫原性。然而，需要来自临床和现实世界转换研究的额外数据，尤其是在两种或多种生物仿制药之间转换的数据，继续使用更大的数据库进行药物警戒以填补证据中的剩余空白。随着生物仿制药的继续发展，配方和药物输送技术的创新可能会引起越来越多的关注。