Škvor Jaroslav
Vnitr Lek. 2015 Mar;61(3):207-8.
Biosimilar drugs or drugs which are similar to reference biological drugs represent a new treatment option within the biological treatment. They are already the standard biotherapeutics option in some fields of medicine, in others as in diabetology, remain to be evaluated. The article presents the definition of biosimilar drugs and summarizes the therapeutic benefits and attitudes of agencies for drug control in the United States and Europe.
生物类似药或与参比生物药相似的药物是生物治疗中的一种新的治疗选择。它们在某些医学领域已经是标准的生物治疗选择,而在其他领域,如糖尿病学领域,仍有待评估。本文介绍了生物类似药的定义,并总结了美国和欧洲药品监管机构对其的治疗益处及态度。