Wiland Piotr, Batko Bogdan, Brzosko Marek, Kucharz Eugeniusz J, Samborski Włodzimierz, Świerkot Jerzy, Więsik-Szewczyk Ewa, Feldman Julia
Department of Rheumatology and Internal Medicine, Wrocław Medical University, Jan Mikulicz-Radecki University Teaching Hospital in Wrocław, Poland.
Rheumatology Unit, Józef Dietl Specialist Hospital in Kraków, Poland.
Reumatologia. 2018;56(4):234-242. doi: 10.5114/reum.2018.77975. Epub 2018 Aug 31.
Evidence from over 10 years of clinical experience demonstrates that biosimilar medicines approved in the European Union can be used for all their registered indications as safely as their originators and with no negative impact on therapeutic efficacy. The debate on the use of biosimilars in rheumatology focuses specifically on the safety of switching between biosimilars and reference products. Studies conducted to date, including randomised double-blind and open-label extension trials, have not demonstrated any significant differences in therapeutic efficacy or safety between patients switched from one medicine to another and those who were continued on a single medicine. According to the latest recommendations for the use of biosimilars in rheumatic diseases, developed by an international task force in 2017, there is no clinical evidence that a single switch from an originator to a biosimilar medicine is associated with any significant risk for patient safety or reduction in therapeutic efficacy.
超过10年的临床经验证据表明，在欧盟获批的生物类似药可用于其所有注册适应症，其安全性与原研药相当，且对治疗效果无负面影响。关于生物类似药在风湿病学中的应用的争论特别集中在生物类似药与参比产品之间转换的安全性上。迄今为止进行的研究，包括随机双盲和开放标签扩展试验，均未显示从一种药物转换至另一种药物的患者与持续使用单一药物的患者在治疗效果或安全性上有任何显著差异。根据一个国际特别工作组在2017年制定的关于生物类似药在风湿性疾病中应用的最新建议，没有临床证据表明从原研药单次转换为生物类似药会给患者安全带来任何重大风险或降低治疗效果。
