aClinical Professor of Internal Medicine, UT Southwestern Medical School bMedical Director, Metroplex Clinical Research Center, Dallas, Texas cDirector of Clinical Research, Rheumatology Division, Professor of Medicine and Timothy S. and Elaine L. Peterson Chair in Rheumatology, Department of Medicine, UMass Memorial Medical Center and University of Massachusetts Medical School, Worcester, Massachusetts, USA.
Curr Opin Rheumatol. 2017 May;29(3):260-268. doi: 10.1097/BOR.0000000000000379.
Abbreviated pathways for the approval of biosimilars have been established in the European Union (EU), the United States, and other countries. Biosimilar TNF inhibitors have been available in South Korea and the EU since 2012 and 2013, respectively, and the first biosimilar infliximab was introduced to the clinic in the United States in November 2016. Five TNF inhibitor biosimilars have now been approved, and many other biosimilars to treat rheumatoid arthritis and other inflammatory diseases are in development.
Over the last 18 months, published results of randomized clinical trials (RCTs) have shown equivalent efficacy and comparable safety and immunogenicity of biosimilars with their reference products. 'Real world' experience with biosimilars in the EU continues to increase and provides evidence regarding the efficacy and safety of using biosimilars in the clinic and of switching from bio-originators to their biosimilars.
Cost implications of using biosimilars and extrapolation of their use to treat diseases in which they were not tested in RCTs are of great interest. We review the results of RCTs and available experience with biosimilars in the clinic.
在欧盟（EU）、美国和其他国家已经建立了生物类似药的简化审批途径。自 2012 年和 2013 年以来，韩国和欧盟分别已经有生物类似 TNF 抑制剂上市，2016 年 11 月，第一个生物类似物英夫利昔单抗被引入美国临床应用。目前已经有 5 种 TNF 抑制剂生物类似药获得批准，还有许多其他用于治疗类风湿关节炎和其他炎症性疾病的生物类似药正在研发中。
在过去的 18 个月中，已发表的随机临床试验（RCT）的结果表明，生物类似药与其参比制剂具有等效的疗效、相当的安全性和免疫原性。欧盟中生物类似药的“真实世界”经验不断增加，为临床使用生物类似药以及从生物原研药转换为生物类似药的疗效和安全性提供了证据。
使用生物类似药的成本影响以及将其使用范围外推至 RCT 未测试的疾病的问题引起了极大的关注。我们综述了 RCT 的结果以及生物类似药在临床中的应用经验。
