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视网膜疾病的临床与社会经济负担:生物类似药能否增添价值?一篇叙述性综述。

Clinical and Socioeconomic Burden of Retinal Diseases: Can Biosimilars Add Value? A Narrative Review.

作者信息

Hariprasad Seenu M, Holz Frank G, Asche Carl V, Issa Amine, Mora Oriol, Keady Simon, Rezk Mourad F, Sarocco Phil, Simoens Steven

机构信息

Department of Ophthalmology and Visual Science, The University of Chicago Medicine and Biological Sciences, 5841 S. Maryland Avenue, MC2114: Room S-438, Chicago, IL, 60637, USA.

Department of Ophthalmology, University of Bonn, Bonn, Germany.

出版信息

Ophthalmol Ther. 2025 Apr;14(4):621-641. doi: 10.1007/s40123-025-01104-3. Epub 2025 Feb 26.

DOI:10.1007/s40123-025-01104-3
PMID:40009268
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC11920568/
Abstract

Retinal diseases, such as neovascular age-related macular degeneration, diabetic retinopathy, and retinal vein occlusion, pose a significant global burden on individuals, families, and healthcare systems. Intravitreal anti-vascular endothelial growth factor (anti-VEGF) therapy has become the standard treatment for retinal diseases, improving clinical outcomes, while delaying disease progression. Although effective, biologics are associated with high costs, which can lead to underutilisation and, consequently, suboptimal patient treatment outcomes, further contributing to healthcare costs. Additionally, the expansion in the elderly population is predicted to significantly increase costs and burden on healthcare systems due to retinal diseases, requiring effective strategies and the utilisation of emerging technologies that are crucial public health priorities for tackling global vision impairment. Recently, anti-VEGF biosimilars have been approved and are expected to provide a cost-effective alternative, while providing equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetic profiles as the reference product. The entry of biosimilars holds the promise of meeting some of these unmet needs, giving physicians and patients access to sustainable treatments that can provide cost-effective therapy, enabling savings to be reinvested into healthcare facilities. This article aims to review the impact of retinal diseases on clinical, social, and financial aspects of patient care, emphasising the potential value of biosimilars in ophthalmology.

摘要

视网膜疾病,如新生血管性年龄相关性黄斑变性、糖尿病视网膜病变和视网膜静脉阻塞,给个人、家庭和医疗保健系统带来了巨大的全球负担。玻璃体内抗血管内皮生长因子(抗VEGF)治疗已成为视网膜疾病的标准治疗方法,可改善临床结果,同时延缓疾病进展。尽管生物制剂有效,但它们成本高昂,可能导致使用不足,进而导致患者治疗效果不理想,进一步增加医疗成本。此外,预计老年人口的增加将因视网膜疾病而显著增加医疗保健系统的成本和负担,这就需要有效的策略并利用新兴技术,这是应对全球视力损害的关键公共卫生优先事项。最近,抗VEGF生物类似药已获批准,预计将提供一种具有成本效益的替代方案,同时提供与参比产品等效的疗效以及可比的安全性、免疫原性和药代动力学特征。生物类似药的进入有望满足其中一些未满足的需求,使医生和患者能够获得可持续的治疗方法,从而提供具有成本效益的治疗,使节省下来的资金能够重新投入到医疗设施中。本文旨在综述视网膜疾病对患者护理的临床、社会和财务方面的影响,强调生物类似药在眼科中的潜在价值。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d361/11920568/034d1fa08881/40123_2025_1104_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d361/11920568/034d1fa08881/40123_2025_1104_Fig1_HTML.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/d361/11920568/034d1fa08881/40123_2025_1104_Fig1_HTML.jpg

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本文引用的文献

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Surv Ophthalmol. 2024 Jul-Aug;69(4):521-538. doi: 10.1016/j.survophthal.2024.03.009. Epub 2024 Mar 21.
2
Diabetic Retinopathy and Quality of Life: A Systematic Review and Meta-Analysis.糖尿病视网膜病变与生活质量:一项系统评价与荟萃分析
JAMA Ophthalmol. 2024 Mar 1;142(3):199-207. doi: 10.1001/jamaophthalmol.2023.6435.
3
A Systematic Literature Review of Gaps and Challenges in Value Assessment of Biosimilars: An ISPOR Special Interest Group Report.
《生物类似药价值评估差距与挑战的系统文献回顾:ISPOR 特别兴趣小组报告》
Value Health. 2023 Aug;26(8):1137-1144. doi: 10.1016/j.jval.2023.04.007.
4
Preparing for the next decade of anti-VEGF biosimilars for retinal diseases: a focus on South Asia.为下一个十年用于治疗视网膜疾病的抗 VEGF 生物类似药做准备:关注南亚。
Expert Opin Biol Ther. 2023 Jul-Dec;23(8):689-692. doi: 10.1080/14712598.2023.2239706. Epub 2023 Jul 24.
5
Incidence and prevalence of neovascular age-related macular degeneration: 15-year epidemiological study in a population-based cohort in Finland.新生血管性年龄相关性黄斑变性的发病率和患病率:芬兰基于人群队列的 15 年流行病学研究。
Ann Med. 2023 Dec;55(1):2222545. doi: 10.1080/07853890.2023.2222545.
6
The Broader Economic Value of Treatment for Diabetic Macular Edema.糖尿病性黄斑水肿治疗的更广泛经济价值。
Diabetes Care. 2023 Jun 1;46(6):1196-1203. doi: 10.2337/dc22-2527.
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Emerging therapeutic strategies for unmet need in neovascular age-related macular degeneration.治疗新生血管性年龄相关性黄斑变性未满足需求的新兴策略。
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