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

Ashish Sharma, Nilesh Kumar, Baruch D. Kuppermann, Francesco Bandello, Anat Loewenstein

Research output: Contribution to journalReview articlepeer-review


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.

Original languageEnglish
Pages (from-to)2-7
Number of pages6
JournalBritish Journal of Ophthalmology
Issue number1
Publication statusPublished - Jan 1 2020


  • agencies regulation
  • biosimilars
  • ophthalmology
  • regulation

ASJC Scopus subject areas

  • Ophthalmology
  • Sensory Systems
  • Cellular and Molecular Neuroscience


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