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.

中文翻译：

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炎症性肠病的生物仿制药：医护人员如何帮助解决患者的担忧？

某些用于慢性疾病的生物制剂（例如炎症性肠病（IBD））的专利到期导致了生物仿制单克隆抗体的开发。针对生物仿制药开发的量身定制的监管批准途径可确保已批准的生物仿制药在功效和安全性方面与其原始药物相似，并避免不必要地重复使用原始药物进行的临床试验。但是，某些患者可能仍对使用生物仿制药感到担忧，医护人员（HCP）有责任减轻这些担忧。涵盖的领域：本综述重点介绍了支持IBD患者使用生物仿制药的有效性和安全性的临床和现实证据。此外，根据国际调查，突出了潜在的患者担忧，HCP可以采取可能的措施来解决这些问题。专家评论：在IBD中越来越多地使用生物仿制药将对生物制剂的可获得性和医疗费用产生积极影响。几种生物仿制药已获批准使用，将来可能会更多地投放市场。但是，如果没有HCP的帮助和支持，将患者转入生物仿制药可能会带来意想不到的挑战。