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Neovascular age-related macular degeneration (nAMD) is the advanced form of AMD, affecting 20% of patients but causing irreversible vision loss in more than 80% of AMD patients [1, 2]. Intravitreal anti-vascular endothelial growth factor (anti-VEGF) agents have been shown to successfully preserve or improve visual acuity for at least one year [3].

新生血管性年龄相关性黄斑变性（nAMD）是AMD的晚期形式，影响20%的患者，但在80%以上的AMD患者中导致不可逆的视力丧失[1，2]。。

However, uncertainty in the injection frequency and the overall treatment duration beyond 12–24 months has imposed tremendous time and financial burden to patients and their families due to the need for continual monitoring and follow-up visits [4].Biosimilars are biological products that have chemical structure and biological function comparable to previously patented anti-VEGF agents (the reference drug) [5].

然而，由于需要持续监测和随访，注射频率和12-24个月以上的总体治疗持续时间的不确定性给患者及其家属带来了巨大的时间和经济负担。生物仿制药是具有与先前专利的抗VEGF剂（参考药物）相当的化学结构和生物学功能的生物制品。

Due to their much-reduced prices, biosimilars provide a greater accessibility than the reference drug to patients with nAMD, especially in the middle- and low-income countries [6]. Biosimilar development relies on a comprehensive head-to-head comparison of the biosimilar and the reference drug. The European Medicine Agency (EMA) conceives comparability as a stepwise process that is tailor-made for each product, with the aim of ruling out differences in clinical efficacy or safety between the biosimilar and the reference drug.

由于其价格大大降低，生物仿制药为nAMD患者提供了比参考药物更大的可及性，特别是在中低收入国家（6）。生物仿制药的开发依赖于生物仿制药和参考药物的全面头对头比较。欧洲药品管理局（EMA）将可比性视为针对每种产品量身定制的逐步过程，目的是排除生物仿制药和参考药物之间临床疗效或安全性的差异。

The US Food and Drug Administration (FDA) approves biosimilars through an abbreviated pathway [7]. FDA may also approve a biosimilar for an indication (or a specific population) without requiring direct evidence from new trials when safety and efficacy have been confirmed for the original indication.

美国食品和药物管理局（FDA）通过缩写途径批准生物仿制药（7）。当原始适应症的安全性和有效性得到确认时，FDA也可以批准生物仿制药用于适应症（或特定人群），而不需要新试验的直接证据。

Moreover, switching studies are typically conducted to achieve interchangeability with the original reference drug [8]. Despite these rigorous requirements by regulatory agencies [9,10,11], physicians .

此外，通常进行转换研究以实现与原始参考药物的互换性（8）。尽管监管机构[9，10，11]对医生提出了严格的要求。

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Download referencesFundingFundingSL reported a grant UG1EY020522 from the National Eye Institute, National Institutes of Health, USA; payment to institution. GV reported none.Author informationAuthors and AffiliationsDepartment of Ophthalmology, University of Colorado Anschutz Medical Campus, Aurora, CO, USASu-Hsun LiuDepartment of Epidemiology, University of Colorado Anschutz Medical Campus, Aurora, CO, USASu-Hsun LiuIRCCS-Fondazione Bietti, Rome, ItalyGianni VirgiliDipartimento Neurofarba, University of Florence, Florence, ItalyGianni VirgiliAuthorsSu-Hsun LiuView author publicationsYou can also search for this author in.

下载参考文献FundingFundingsL报告了美国国立卫生研究院国家眼科研究所的拨款UG1EY020522；向机构付款。GV报告没有。作者信息作者和附属机构科罗拉多大学安舒茨医学院眼科，科罗拉多州奥罗拉，USASu Hsun Liu科罗拉多大学安舒茨医学院流行病学系，科罗拉多州奥罗拉，USASu Hsun LiuIRCCS Fondazione Bietti，罗马，意大利维吉尼亚州维吉尼亚州神经法巴，佛罗伦萨大学，意大利维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼亚州维吉尼。

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Additional informationPublisher’s note Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.Rights and permissionsReprints and permissionsAbout this articleCite this articleLiu, SH., Virgili, G. Cochrane Corner: Anti-vascular endothelial growth factor biosimilar for macular degeneration..

Additional informationPublisher的注释Springer Nature在已发布的地图和机构隶属关系中的管辖权主张方面保持中立。权利和许可打印和许可本文引用本文Liu，SH.，Virgili，G。Cochrane Corner：抗血管内皮生长因子生物仿制药治疗黄斑变性。。

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