Bhat Shubha, Kane Sunanda V
Digestive Disease and Surgery Institute and Department of Pharmacy, Cleveland Clinic, Cleveland, Ohio.
Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.
Gastroenterol Hepatol (N Y). 2024 Jul;20(7):376-382.
Annual out-of-pocket expenditures for patients with inflammatory bowel disease (IBD) are estimated to be as high as $41,000, with medications, such as biologics, being one of the main cost contributors. Although biologics have revolutionized IBD management, these medications are costly owing to their molecular makeup and manufacturing processes. Biosimilars, which are biologic medications that are highly similar to the US Food and Drug Administration (FDA)-approved reference product with no clinically meaningful differences in safety, purity, or potency, offer the same therapeutic benefits at a reduced cost. Other additional benefits offered with biosimilars include increased treatment access and fostered development of new therapeutic options. Despite the expansion of biosimilars in IBD, their adoption and utilization have been suboptimal in the United States. This article provides an overview of the biosimilar landscape in IBD, including FDA-approved biosimilars available, and a clinical guide to navigate switching to biosimilars in various clinical scenarios based on current evidence.
炎症性肠病（IBD）患者的年度自付费用估计高达41,000美元，其中生物制剂等药物是主要成本贡献因素之一。尽管生物制剂彻底改变了IBD的治疗方式，但由于其分子构成和生产工艺，这些药物成本高昂。生物类似药是与美国食品药品监督管理局（FDA）批准的参比产品高度相似、在安全性、纯度或效力方面无临床意义差异的生物药物，能以降低的成本提供相同的治疗益处。生物类似药还带来其他额外益处，包括增加治疗可及性以及促进新治疗选择的开发。尽管生物类似药在IBD领域有所扩展，但在美国其采用和使用情况仍不理想。本文概述了IBD领域的生物类似药情况，包括已获FDA批准的生物类似药，并根据现有证据提供了一份临床指南，指导在各种临床场景中转换使用生物类似药。
