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超越成本:真实世界中生物类似药的临床及患者获益观察

Beyond Cost: Observations on Clinical and Patient Benefits of Biosimilars in Real-World Settings.

作者信息

Kvien Tore K, Betteridge Neil, Brückmann Ines, Bodenmüller Wolfram, Bryn Galyna, Danese Silvio, Gonçalves João, Maravic Zorana, Thorne Carter, Wingate Laura, Cornes Paul

机构信息

REMEDY Center for Treatment of Rheumatic and Musculoskeletal Diseases, Diakonhjemmet Hospital, Oslo, Norway.

Faculty of Medicine, University of Oslo, Oslo, Norway.

出版信息

BioDrugs. 2025 Jul;39(4):537-553. doi: 10.1007/s40259-025-00727-z. Epub 2025 Jun 5.

Abstract

The introduction of biosimilars into healthcare systems globally is recognized by many as a healthcare success. Despite this, questions have been raised about whether biosimilars can deliver sufficient value to patients and healthcare professionals, as well as sufficient cost saving, for their use in treatment to be worthwhile. In this review, we discuss how the increasing financial burden of complex therapeutic medicines, such as biologics, can be ameliorated by off-patent biosimilar medicines, particularly with increasing worldwide incidences of cancer and other chronic diseases. We then describe real-world cases that demonstrate the significant direct and indirect benefits of biosimilars to patients and healthcare systems beyond costs. Healthcare sustainability is crucial to ensuring that healthcare systems can continue to deliver high-quality care to patients. The savings realized from the introduction of biosimilars have expanded treatment options and improved access to therapies across a spectrum of diseases. Cost savings from biosimilar use have also led to changes in treatment guidelines, increasing the availability of biologic medicines for earlier lines of therapy. This expansion of access can have a positive impact on the overall patient experience and can reduce the overall disease burden. However, the adoption of biosimilars has not been universally successful, and faces challenges in the current healthcare landscape and in the pharmaceutical development pipeline.

摘要

全球医疗体系引入生物类似药被许多人视为医疗领域的一项成就。尽管如此,对于生物类似药能否为患者和医疗专业人员带来足够价值,以及能否节省足够成本以使治疗使用具有价值,人们仍存在疑问。在本综述中,我们讨论了非专利生物类似药如何缓解复杂治疗药物(如生物制剂)日益增加的经济负担问题,特别是考虑到全球癌症和其他慢性病发病率不断上升的情况。然后,我们描述了一些实际案例,这些案例表明生物类似药除了成本节约外,还能为患者和医疗体系带来显著的直接和间接益处。医疗可持续性对于确保医疗体系能够持续为患者提供高质量护理至关重要。引入生物类似药所实现的成本节约扩大了治疗选择范围,并改善了各类疾病的治疗可及性。使用生物类似药节省的成本还导致了治疗指南的变化,增加了早期治疗线中生物制剂药物的可及性。这种可及性的扩大对患者的整体体验可能产生积极影响,并可减轻整体疾病负担。然而,生物类似药的采用并非普遍成功,在当前医疗环境和药物研发流程中面临挑战。

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