Lotus Eye Hospital and Institute, Coimbatore, Tamilnadu, India
Lotus Eye Hospital and Institute, Coimbatore, Tamilnadu, India.
Br J Ophthalmol. 2020 Jan;104(1):2-7. doi: 10.1136/bjophthalmol-2019-314443. Epub 2019 Jul 17.
This article aims to analyse the key regulatory guidelines across the globe concerning biosimilars.
Review of the current literature.
Biosimilars are well regulated with the majority of regulators having enforced the guidelines for the development and approval, and new biosimilar drugs are appearing on the horizon to provide a therapeutic option to a wider population base because of its cost-effectiveness and proven safety. Due to their extensive analytical data, clinical data and pharmacovigilance studies, their development should not be considered similar to generic drugs.
This review discusses the biosimilars, their regulation globally and their difference from generics from ophthalmic perspective.
本文旨在分析全球范围内关于生物类似药的关键监管指南。
对当前文献进行综述。
生物类似药受到了很好的监管，大多数监管机构都执行了开发和批准的指导方针，新的生物类似药即将面世，由于其成本效益和安全性已得到证实，将为更广泛的人群提供治疗选择。由于其广泛的分析数据、临床数据和药物警戒研究，其开发不应被视为与仿制药相似。
本文从眼科角度讨论了生物类似药、它们在全球的监管情况及其与仿制药的区别。
