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美国用于治疗视网膜疾病的生物类似药。

Biosimilars in the Treatment of Retinal Disease in the United States.

出版信息

Ophthalmic Surg Lasers Imaging Retina. 2023 Jun;54(6):362-366. doi: 10.3928/23258160-20230508-01. Epub 2023 Jan 5.

Abstract

Biosimilars have recently emerged into the vitreoretinal pharmaceutical market. This review defines biosimilars, discusses the approval process, and reviews the benefits, risks, and controversies regarding biosimilars. This review also discusses ranibizumab biosimilars that have recently received United States Food and Drug Administration approval in the United States and discusses anti-vascular endothelial growth factor biosimilars that are in development. .

摘要

生物类似药最近已进入眼内视网膜制药市场。本文定义了生物类似药,讨论了其审批流程,并综述了生物类似药的获益、风险和争议。本文还讨论了最近在美国获得美国食品药品监督管理局批准的雷珠单抗生物类似药,并讨论了正在研发中的抗血管内皮生长因子生物类似药。

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