Article Text

other Versions

Download PDFPDF
Understanding biosimilars and its regulatory aspects across the globe: an ophthalmology perspective
  1. Ashish Sharma1,
  2. Nilesh Kumar1,
  3. Baruch D Kuppermann2,
  4. Francesco Bandello3,
  5. Anat Loewenstein4,5
  1. 1Lotus Eye Hospital and Institute, Coimbatore, Tamilnadu, India
  2. 2Gavin Herbert Eye Institute, University of California, Irvine, California, USA
  3. 3University Vita Salute Hospital San Raffaele, Milano, Italy
  4. 4Department of Ophthalmology, Tel Aviv Medical Centre and Sackler Faculty of Medicine, Sidney Fox Chair of Ophthalmology, Tel Aviv University, Israel
  5. 5Israel
  1. Correspondence to Dr Ashish Sharma, Vitreoretina, Lotus Eye Care Hospital, Coimbatore 641014, India; drashish79{at}


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.

  • biosimilars
  • regulation
  • ophthalmology
  • agencies regulation

Statistics from

Request Permissions

If you wish to reuse any or all of this article please use the link below which will take you to the Copyright Clearance Center’s RightsLink service. You will be able to get a quick price and instant permission to reuse the content in many different ways.


  • Funding The authors have not declared a specific grant for this research from any funding agency in the public, commercial or not-for-profit sectors.

  • Competing interests None declared.

  • Patient consent for publication Not required.

  • Provenance and peer review Not commissioned; externally peer reviewed.