Paramsothy Sudarshan, Cleveland Noa Krugliak, Zmeter Nada, Rubin David T
Dr Paramsothy is an advanced IBD fellow, Dr Krugliak Cleveland is an internal medicine resident, Dr Zmeter is a clinical research coordinator, and Dr Rubin is a professor of medicine at the Inflammatory Bowel Disease Center at the University of Chicago Medicine in Chicago, Illinois.
Gastroenterol Hepatol (N Y). 2016 Dec;12(12):741-751.
Monoclonal antibody biologic therapies, introduced nearly 20 years ago, revolutionized the treatment of inflammatory bowel disease (IBD) and are now well established as the most effective agents available. As the first of these biologic agents starts to come off patent, biosimilar agents have emerged as alternatives to originator drugs. The unique drug development and manufacturing processes involved in the creation of biologic agents pose distinct regulatory challenges compared to generic formulations of conventional medications. Reductions in medication costs have been proposed to be a major benefit of biosimilar therapies; however, there are concerns regarding the adequacy of the existing regulatory process and data requirements for biosimilar therapy approval, as well as the true bioequivalence of these agents. Infliximab biosimilars for the treatment of IBD have been available in Europe and Asia for a few years and are expected to become available in the United States within the next 1 to 2 years. This article reviews biosimilar therapies and the current data with respect to IBD.
单克隆抗体生物疗法于近20年前问世，彻底改变了炎症性肠病（IBD）的治疗方式，如今已被公认为现有最有效的药物。随着首批这类生物制剂开始专利到期，生物类似药已成为原研药的替代选择。与传统药物的仿制药制剂相比，生物制剂研发和生产过程的独特性带来了截然不同的监管挑战。降低药物成本被认为是生物类似药疗法的主要益处；然而，人们对现有生物类似药疗法审批的监管流程和数据要求是否充分，以及这些药物的真正生物等效性存在担忧。用于治疗IBD的英夫利昔单抗生物类似药在欧洲和亚洲已上市数年，预计未来1至2年内将在美国上市。本文综述了生物类似药疗法以及目前关于IBD的相关数据。
