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Understanding biosimilars and its regulatory aspects across the globe: an ophthalmology perspective
Ashish Sharma1, Nilesh Kumar2, Baruch D Kuppermann3
1Lotus Eye Hospital and Institute, Coimbatore, Tamilnadu, India drashish79@hotmail.com.
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.
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