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

PURPOSE: This article aims to analyse the key regulatory guidelines across the globe concerning biosimilars.
MATERIALS AND METHODS: Review of the current literature.
RESULTS: 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.
CONCLUSION: This review discusses the biosimilars, their regulation globally and their difference from generics from ophthalmic perspective. © Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.