Park Sang Hyoung, Park Jae Cheol, Lukas Milan, Kolar Martin, Loftus Edward V
Department of Gastroenterology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
IBD Clinical and Research Centre, ISCARE Lighthouse and First Faculty of Medicine, Charles University, Prague, Czech Republic.
Intest Res. 2020 Jan;18(1):34-44. doi: 10.5217/ir.2019.09147. Epub 2020 Jan 30.
The inflammatory bowel diseases (IBD), which consist of Crohn's disease and ulcerative colitis, are chronic, incurable immunemediated inflammatory disorders of the intestine. As IBD incidence continues to increase globally and its mortality is low, prevalent cases of IBD are rapidly increasing, thereby leading to a substantial increase in health care costs. Although the introduction of biologic agents for IBD management has revolutionized the armamentarium of IBD therapy, the high cost of this therapy is concerning. With the expirations of patents for existing biologic agents (originals), biosimilars with cheaper costs have been highlighted in the field of IBD. Despite concerns regarding their short- and long-term efficacy, safety, immunogenicity, and interchangeability, increasing evidence via prospective observations and phase III or IV clinical trials, which aim to prove the "biosimilarity" of biosimilars to originals, has partly confirmed their efficacy, safety, and interchangeability. Additionally, although patients and physicians are reluctant to use biosimilars, a positive budget impact has been reported owing to their use in different countries. In the near future, multiple biosimilars with lower costs, and efficacy and safety profile similar to originals, could be used to treat IBD; thus, further consideration and knowledge dissemination are warranted in this new era of biosimilars.
炎症性肠病（IBD）包括克罗恩病和溃疡性结肠炎，是一种慢性、无法治愈的肠道免疫介导性炎症性疾病。由于IBD在全球的发病率持续上升，且死亡率较低，IBD的普遍病例正在迅速增加，从而导致医疗保健成本大幅上升。尽管引入生物制剂用于IBD的治疗已经彻底改变了IBD治疗的手段，但这种治疗的高成本令人担忧。随着现有生物制剂（原研药）专利的到期，成本较低的生物类似药在IBD领域受到了关注。尽管人们对其短期和长期疗效、安全性、免疫原性和可互换性存在担忧，但通过旨在证明生物类似药与原研药“生物相似性”的前瞻性观察以及III期或IV期临床试验，越来越多的证据部分证实了它们的疗效、安全性和可互换性。此外，尽管患者和医生不愿使用生物类似药，但据报道，在不同国家使用生物类似药对预算有积极影响。在不久的将来，多种成本更低、疗效和安全性与原研药相似的生物类似药可用于治疗IBD；因此，在这个生物类似药的新时代，有必要进行进一步的思考和知识传播。
