Department of Pharmacy, Cleveland Clinic Foundation, Cleveland, OH, USA.
Digestive Disease Institute, Cleveland Clinic Foundation, Cleveland, OH, USA.
Curr Gastroenterol Rep. 2024 Mar;26(3):77-85. doi: 10.1007/s11894-023-00913-5. Epub 2024 Jan 20.
Biosimilars were introduced to decrease biologic-related expenditures, but their uptake in inflammatory bowel disease (IBD) remains suboptimal. Herein, we review biosimilar concepts, current products available for IBD treatment, and resources to support biosimilar utilization.
Although a cornerstone of IBD treatment, biologics are costly due to their development. Biosimilars, which are biologic products highly similar to a reference product, aim to decrease these expenditures. Infliximab, adalimumab, and ustekinumab biosimilars are approved for IBD, but uptake remains low due to biosimilar efficacy and safety concerns and delayed market entry. Clinicians can effectively address some of these barriers and help patients and healthcare systems reap the benefits of decreased costs and increased treatment access. Data shows comparable efficacy and safety outcomes with biosimilars in IBD. Several biosimilar products are available and in the pipeline, but efforts are needed from various stakeholders to bolster utilization and generate benefits.
生物类似药的引入旨在降低生物制剂相关费用，但在炎症性肠病（IBD）中的应用仍不理想。本文综述了生物类似药的概念、目前可用于治疗 IBD 的产品以及支持生物类似药应用的资源。
生物制剂是 IBD 治疗的基石，但由于其开发成本高昂。生物类似药是与参照产品高度相似的生物制剂，旨在降低这些费用。英夫利昔单抗、阿达木单抗和乌司奴单抗的生物类似药已获准用于治疗 IBD，但由于对生物类似药疗效和安全性的担忧以及市场准入延迟，其应用仍不理想。临床医生可以有效地解决其中一些障碍，并帮助患者和医疗系统从降低成本和增加治疗机会中获益。数据表明，生物类似药在 IBD 中的疗效和安全性相当。有几种生物类似药产品已经上市或正在研发中，但需要各利益相关者共同努力，以提高其利用率并产生效益。
