a Department of Gastroenterology and Hepatology , Amsterdam UMC , Amsterdam , The Netherlands.
b Department of Gastroenterology , University Hospital Southampton , Southampton , UK.
Expert Rev Gastroenterol Hepatol. 2019 Feb;13(2):143-155. doi: 10.1080/17474124.2019.1553617. Epub 2019 Jan 17.
The patent expiration of some biologics used in chronic conditions such as inflammatory bowel disease (IBD) has led to the development of biosimilar monoclonal antibodies. The tailored regulatory approval route for biosimilar development ensures that approved biosimilars show similarity to their originators in terms of efficacy and safety, and avoids unnecessary repetition of clinical trials carried out with the originator product. However, some patients may still have concerns about using biosimilars and it is the responsibility of healthcare professionals (HCPs) to alleviate these concerns. Areas covered: This review highlights clinical and real-world evidence supporting efficacy and safety of biosimilars in patients with IBD. Moreover, based on international surveys, potential patient concerns are highlighted, along with possible actions HCPs can take to address these concerns. Expert commentary: The rising use of biosimilars in IBD is expected to have a positive impact on the availability of biologics and healthcare costs. Several biosimilars have been approved for use and more are likely to come to the market in the future; however, transitioning patients to biosimilars could pose an unexpected challenge without the help and support of HCPs.
一些用于慢性疾病（如炎症性肠病[IBD]）的生物制剂的专利到期，导致了生物类似药的开发。生物类似药开发的定制监管审批途径确保了已批准的生物类似药在疗效和安全性方面与原研药相似，并避免了对原研产品进行不必要的临床试验重复。然而，一些患者可能仍然对使用生物类似药存在担忧，减轻这些担忧是医疗保健专业人员（HCPs）的责任。
本综述强调了支持 IBD 患者使用生物类似药的疗效和安全性的临床和真实世界证据。此外，基于国际调查，突出了潜在的患者关注点，以及 HCPs 可以采取哪些措施来解决这些关注点。
生物类似药在 IBD 中的使用增加预计将对生物制剂的可及性和医疗保健成本产生积极影响。已经批准了几种生物类似药的使用，并且未来可能会有更多的生物类似药进入市场；然而，如果没有 HCPs 的帮助和支持，将患者过渡到生物类似药可能会带来意想不到的挑战。
