RT Journal Article
SR Electronic
T1 Understanding biosimilars and its regulatory aspects across the globe: an ophthalmology perspective
JF British Journal of Ophthalmology
JO Br J Ophthalmol
FD BMJ Publishing Group Ltd.
SP 2
OP 7
DO 10.1136/bjophthalmol-2019-314443
VO 104
IS 1
A1 Ashish Sharma
A1 Nilesh Kumar
A1 Baruch D Kuppermann
A1 Francesco Bandello
A1 Anat Loewenstein
YR 2020
UL http://bjo.bmj.com/content/104/1/2.abstract
AB 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.