我们准备好在参考产品和生物仿制药之间进行多重切换了吗?

Q2 Medicine Arquivos de Gastroenterologia Pub Date : 2024-07-19 eCollection Date: 2024-01-01 DOI:10.1590/S0004-2803.24612024-046
Fabio Vieira Teixeira, Laurent Peyrin-Biroulet, Silvio Danese
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引用次数: 0

摘要

就直接和间接医疗成本而言,炎症性肠病(IBD)目前给社会造成了巨大的社会和经济负担。这些疾病无法治愈且具有进展性,因此患者终生都无法避免花费。二十多年前,英夫利西单抗的问世彻底改变了 IBD 的治疗。如今,虽然生物制剂药物为患者提供了多种重要的治疗选择,但它们也会给医疗系统带来巨大的成本。生物仿制药最重要的好处是能大幅降低成本,增加获得先进疗法的机会。生物仿制药还可以治疗新确诊的患者,并为有需要的患者优化剂量。生物制剂治疗的价格与需求之间存在反比关系。要想更大幅度地降低成本,就必须更多地使用生物仿制药。为此,不仅要在新患者中使用生物仿制药,而且要让已经开始使用参考生物制剂治疗的患者转用生物仿制药。目前,随机研究和观察性研究已证明了推荐在参比产品和生物仿制药之间进行单一转换的有效性和安全性,反之亦然。本手稿旨在回顾文献并讨论科学证据是否足以支持 IBD 患者多次切换生物制剂和生物仿制药。
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ARE WE READY FOR MULTIPLE SWITCHES BETWEEN REFERENCE PRODUCTS AND BIOSIMILARS?

Inflammatory bowel diseases (IBD) currently impose an immense social and economic burden on society in terms of both direct and indirect healthcare costs. Their incurable and progressive nature results in an unavoidable lifetime expense. The introduction of infliximab more than two decades ago had revolutionized IBD treatment. Nowadays, while biologic drugs comprise various vital therapeutic options for patients, they can be associated to significant costs to healthcare systems. The most crucial benefit of biosimilars is that they bring more significant cost reduction and increase access to advanced therapies. They also allow the treatment of newly diagnosed patients and dose optimization for those who need it. There is an inverse relationship between price and demand for treatment with biologics. For a more significant reduction in cost to be possible, greater use of biosimilars is necessary. For this to occur, it is imperative not only to use biosimilars in naïve patients but also to switch to biosimilars in those patients who have started therapy with reference biologics. At present, randomized and observational studies have demonstrated effectiveness and safety results in recommending a single switch between a reference product and a biosimilar, and vice versa. The purpose of this manuscript is to review the literature and discuss whether scientific evidence is enough to support multiple switches of biologics and biosimilars in IBD patients.

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来源期刊
Arquivos de Gastroenterologia
Arquivos de Gastroenterologia Medicine-Gastroenterology
CiteScore
2.00
自引率
0.00%
发文量
109
审稿时长
9 weeks
期刊介绍: The journal Arquivos de Gastroenterologia (Archives of Gastroenterology), a quarterly journal, is the Official Publication of the Instituto Brasileiro de Estudos e Pesquisas de Gastroenterologia IBEPEGE (Brazilian Institute for Studies and Research in Gastroenterology), Colégio Brasileiro de Cirurgia Digestiva - CBCD (Brazilian College of Digestive Surgery) and of the Sociedade Brasileira de Motilidade Digestiva - SBMD (Brazilian Digestive Motility Society). It is dedicated to the publishing of scientific papers by national and foreign researchers who are in agreement with the aim of the journal as well as with its editorial policies.
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