NIHR Clinical Research Facility, University Hospital Southampton NHS Foundation Trust , Southampton , UK.
Dermatology Department, 2nd Medical faculty, Charles University and Na Bulovce Hospital , Prague , Czech Republic.
Expert Opin Biol Ther. 2019 Oct;19(10):1001-1014. doi: 10.1080/14712598.2019.1610381. Epub 2019 May 6.
: The expiry of patents for biologics has led to the introduction of biosimilars for the treatment of immune-mediated inflammatory diseases (IMIDs). These treatment alternatives may allow earlier and wider access to appropriate therapy for patients without increasing the economic burden on health-care systems. Prescription of biosimilars to treatment-naïve patients is well accepted; however, additional considerations must be taken into account when switching clinically stable patients from reference products to biosimilars. : We discuss the current considerations related to switching from reference products to biosimilars from a physician and patient perspective. We review the clinical data and real-life experience on switching patients with IMIDs, present the position of the relevant medical societies, and discuss the importance of patient-physician communication and need for shared decision-making. : The introduction of biosimilars provides an opportunity to expand access to treatment for patients with IMIDs across Europe and support the financial sustainability of health-care systems. We anticipate that as the real-world evidence base grows, confirming the results of clinical trials, there will be a corresponding increase in physician and patient acceptance, not only to initiating treatment with a biosimilar, but also to switching medication from a reference product to a biosimilar.
: 生物制品专利的到期导致了生物类似药的出现，用于治疗免疫介导的炎症性疾病（IMIDs）。这些治疗选择可以让更多的患者更早地获得合适的治疗，而不会增加医疗保健系统的经济负担。对于治疗初治患者，处方生物类似药已被广泛接受；然而，在将临床稳定的患者从参比产品转换为生物类似药时，必须考虑额外的因素。 : 我们从医生和患者的角度讨论了从参比产品转换为生物类似药的当前注意事项。我们回顾了关于转换免疫介导的炎症性疾病患者的临床数据和实际经验，介绍了相关医学协会的立场，并讨论了患者-医生沟通的重要性和共同决策的需求。 : 生物类似药的引入为欧洲的 IMIDs 患者扩大治疗机会提供了机会，并支持医疗保健系统的财务可持续性。我们预计，随着真实世界证据基础的增长，临床试验结果得到证实，医生和患者的接受程度将相应提高，不仅是开始使用生物类似药，而且是将药物从参比产品转换为生物类似药。
