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首页> 外文期刊>Journal of Internal Medicine >Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody
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Biosimilars in immune-mediated inflammatory diseases: initial lessons from the first approved biosimilar anti-tumour necrosis factor monoclonal antibody

机译：免疫介导的炎性疾病中的生物仿制药：首个获批的生物仿制药抗肿瘤坏死因子单克隆抗体的初步经验

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The introduction of targeted biological therapies has revolutionised the management of immune-mediated inflammatory diseases (IMIDs) such as rheumatoid arthritis, ankylosing spondylitis, psoriasis and inflammatory bowel disease. Following treatment with these therapies, many patients experience significant improvements in different aspects of their disease, including symptoms, work productivity and other outcomes relevant for individuals and society. However, due to the complexity of biological drug development and manufacturing processes, the costs of these therapies are relatively high. Indeed, the financial burden on healthcare systems due to biological therapies is considerable and lack of patient access to effective treatment remains a concern in many parts of the world. As many reference biological therapies have now reached or are near to patent expiry, a number of biosimilar' drugs have been developed for use in various clinical settings, and some of these drugs are already in use in several countries. While the potential pharmacoeconomic benefits of cost-effective biosimilars seem clear, several issues have been raised regarding, for example, the definition of biosimilarity and the validity of indication extrapolation, as well as the switchability' and relative immunogenicity of biosimilars and their reference drugs. In this review, these issues will be discussed with reference to CT-P13, a biosimilar of the anti-tumour necrosis factor monoclonal antibody infliximab, which is approved in Europe and elsewhere for the treatment of various IMIDs. Other important issues, including those related to data collection during nonclinical and clinical development of biosimilars, are also discussed.
机译：靶向生物疗法的引入彻底改变了免疫介导的炎性疾病（IMID）的管理，例如类风湿性关节炎，强直性脊柱炎，牛皮癣和炎性肠病。使用这些疗法进行治疗后，许多患者在疾病的各个方面都经历了重大改善，包括症状，工作效率以及与个人和社会相关的其他结果。然而，由于生物药物开发和制造过程的复杂性，这些疗法的成本相对较高。确实，由于生物疗法而给医疗保健系统带来的经济负担是相当大的，并且患者缺乏获得有效治疗的机会仍然是世界许多地方的关注点。随着许多参考生物疗法已经达到或接近专利到期，已经开发出了多种生物仿制药用于各种临床环境，其中一些药物已经在多个国家使用。尽管具有成本效益的生物仿制药的潜在药理经济效益似乎很明显，但已提出了一些问题，例如，生物仿制药的定义和适应症外推的有效性，以及生物仿制药及其参考药物的可转换性和相对免疫原性。在这篇综述中，将参考CT-P13讨论这些问题，CT-P13是抗肿瘤坏死因子单克隆抗体英夫利昔单抗的生物仿制药，该药已在欧洲和其他地方获准用于治疗各种IMID。还讨论了其他重要问题，包括与生物仿制药非临床和临床开发过程中的数据收集有关的问题。

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