Institute of Life Course and Medical Sciences, University of Liverpool, 3rd Floor Clinical Sciences Centre, Aintree Hospital , Liverpool, UK.
Department of Rheumatology, Aintree Hospital, Liverpool University Hospitals NHS Foundation Trust Liverpool, UK.
Expert Opin Biol Ther. 2021 Jan;21(1):29-36. doi: 10.1080/14712598.2020.1802421. Epub 2020 Aug 12.
Tumor necrosis factor inhibitors (TNFi) have revolutionized the treatment of rheumatic diseases. Whilst extremely efficacious, the original TNFi also carried a high acquisition cost that limited their use. 'Biosimilar' TNFi's, developed on expiry of the patents for the biooriginators, have comparable efficacy and safety, are less expensive and provide the potential to improve access to these effective therapies in a more cost-effective manner.
The background and development of TNFis, their biosimilars and follow on 'copycat' drugs are discussed, together with their use in both developed and developing countries, focusing on the potential to enhance access to effective targeted therapies.
Bridging the economic gap to facilitate universal access to anti-TNF biosimilars has been largely unsuccessful, driving the development of copycat mimics in developing countries. Meanwhile, the more recent introduction of targeted synthetic disease-modifying drugs has provided cheaper, equally effective treatments for rheumatic diseases that are conveniently delivered by mouth. We review the TNF biosimilars in rheumatic diseases, their role in a rapidly evolving treatment landscape, and speculate about the future for this iconic therapeutic class.
肿瘤坏死因子抑制剂(TNFi)彻底改变了风湿性疾病的治疗方法。虽然这些药物极其有效,但最初的 TNFi 也具有很高的获得成本,限制了它们的使用。在生物原创药的专利到期后开发的“生物类似药”在疗效和安全性方面相当,价格更低,并有可能以更具成本效益的方式改善对这些有效治疗方法的获取。
讨论了 TNFis 的背景和发展、它们的生物类似药和后续的“仿制药”,以及它们在发达国家和发展中国家的使用情况,重点是提高获得有效靶向治疗的机会。
在发展中国家,弥合经济差距以促进普遍获得抗 TNF 生物类似药的努力在很大程度上没有成功,这推动了仿制药的发展。与此同时,最近引入的靶向合成疾病修正药物为风湿性疾病提供了更便宜、同样有效的治疗方法,这些药物通过口服给药。我们回顾了风湿性疾病中的 TNF 生物类似药,及其在快速发展的治疗领域中的作用,并对这一标志性治疗类别的未来进行了推测。