Understanding biosimilars and its regulatory aspects across the globe: an ophthalmology perspective.

Abstract

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.