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Review
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. 1 Lotus Eye Hospital and Institute, Coimbatore, Tamilnadu, India
  2. 2 Gavin Herbert Eye Institute, University of California, Irvine, California, USA
  3. 3 University Vita Salute Hospital San Raffaele, Milano, Italy
  4. 4 Department of Ophthalmology, Tel Aviv Medical Centre and Sackler Faculty of Medicine, Sidney Fox Chair of Ophthalmology, Tel Aviv University, Israel
  5. 5 Israel
  1. Correspondence to Dr Ashish Sharma, Vitreoretina, Lotus Eye Care Hospital, Coimbatore 641014, India; drashish79{at}hotmail.com

Abstract

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

https://doi.org/10.1136/bjophthalmol-2019-314443

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    Footnotes

    • 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.