治疗眼科疾病的抗血管内皮生长因子生物仿制药:综述。

IF 5.1 2区 医学 Q1 OPHTHALMOLOGY
Neil M. Bressler , Peter K. Kaiser , Diana V. Do , Quan Dong Nguyen , Kyu Hyung Park , Se Joon Woo , Min Sagong , Mario Bradvica , Mercy Yeeun Kim , Seungkee Kim , SriniVas R. Sadda
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引用次数: 0

摘要

针对血管内皮生长因子(VEGF)的玻璃体内注射生物制剂(生物制剂)的开发大大改善了常见血管内皮生长因子驱动的视网膜疾病患者的临床治疗效果。然而,品牌药物的成本相对较高,这对大多数医疗系统和患者来说都是一个经济负担,很可能导致一些患者无法获得治疗,临床疗效也较差。生物类似药(生物仿制药)是临床效果等同、潜在经济的参照产品替代品。主要卫生机构批准的生物仿制药已在全面的可比性研究中被证明与参比产品相似,产生了支持分析、临床前和临床生物相似性所需的全部证据。抗血管内皮生长因子(Anti-VEGF)生物仿制药自 2022 年起开始进入美国眼科领域。我们回顾了生物仿制药的监管和科学概念、眼科领域的生物仿制药开发情况(特别关注抗血管内皮生长因子生物仿制药),并讨论了生物仿制药的应用所面临的机遇和挑战。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Biosimilars of anti-vascular endothelial growth factor for ophthalmic diseases: A review

The development of intravitreally injected biologic medicines (biologics) acting against vascular endothelial growth factor (VEGF) substantially improved the clinical outcomes of patients with common VEGF-driven retinal diseases. The relatively high cost of branded agents, however, represents a financial burden for most healthcare systems and patients, likely resulting in impaired access to treatment and poorer clinical outcomes for some patients. Biosimilar medicines (biosimilars) are clinically equivalent, potentially economic alternatives to reference products. Biosimilars approved by leading health authorities have been demonstrated to be similar to the reference product in a comprehensive comparability exercise, generating the totality of evidence necessary to support analytical, pre-clinical, and clinical biosimilarity. Anti-VEGF biosimilars have been entering the field of ophthalmology in the US since 2022. We review regulatory and scientific concepts of biosimilars, the biosimilar development landscape in ophthalmology, with a specific focus on anti-VEGF biosimilars, and discuss opportunities and challenges facing the uptake of biosimilars.

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来源期刊
Survey of ophthalmology
Survey of ophthalmology 医学-眼科学
CiteScore
10.30
自引率
2.00%
发文量
138
审稿时长
14.8 weeks
期刊介绍: Survey of Ophthalmology is a clinically oriented review journal designed to keep ophthalmologists up to date. Comprehensive major review articles, written by experts and stringently refereed, integrate the literature on subjects selected for their clinical importance. Survey also includes feature articles, section reviews, book reviews, and abstracts.
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