视网膜疾病的生物类似药：最新进展
Biosimilars for Retinal Diseases: An Update.
作者信息
Sharma Ashish, Kumar Nilesh, Parachuri Nikulaa, Bandello Francesco, Kuppermann Baruch D, Loewenstein Anat
机构信息
Lotus Eye Hospital and Institute, Coimbatore, Tamil Nadu, India.
Lotus Eye Hospital and Institute, Coimbatore, Tamil Nadu, India.
出版信息
Am J Ophthalmol. 2021 Apr;224:36-42. doi: 10.1016/j.ajo.2020.11.017. Epub 2020 Dec 9.
PURPOSE
To review the biosimilars of anti-vascular endothelial growth factor agents for retinal diseases and provide an update about their development.
DESIGN
Literature review.
METHODS
A comprehensive literature review was performed for scientific articles, clinical trials, and press releases for the development of biosimilars in ophthalmology.
RESULTS
To date, Razumab (Intas Pharmaceuticals Ltd, Ahmedabad, GJ, India) is the only approved biosimilar for ophthalmic use, but the landscape will rapidly change in the future with multiple biosimilar candidates, which are currently in phase 3 trials, showing promising early results.
CONCLUSION
Biosimilars hold the potential to reduce the financial burden of the highly efficacious biologic therapy in retinal pathologies. However, the off-label bevacizumab may differentiate the success of biosimilars in different geographic regions.
目的
回顾用于视网膜疾病的抗血管内皮生长因子药物生物类似药，并提供其研发进展的最新情况。
设计
文献综述。
方法
对眼科生物类似药研发的科学文章、临床试验和新闻稿进行全面的文献综述。
结果
迄今为止，雷珠单抗（印度艾哈迈达巴德英塔斯制药有限公司）是唯一获批用于眼科的生物类似药，但随着多个目前处于3期试验的生物类似药候选药物显示出有希望的早期结果，未来情况将迅速改变。
结论
生物类似药有可能减轻视网膜疾病中高效生物治疗的经济负担。然而，未获批准的贝伐单抗可能会使生物类似药在不同地理区域的成功情况有所不同。
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