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Review
Generic medications in ophthalmology
  1. Matt Zore1,
  2. Alon Harris1,
  3. Leslie Abrams Tobe1,
  4. Brent Siesky1,
  5. Ingrida Januleviciene2,
  6. Jennifer Behzadi1,
  7. Annahita Amireskandari1,
  8. Patrick Egan1,
  9. Kevin Garff3,
  10. Barbara Wirostko3
  1. 1Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana, USA
  2. 2Eye Clinic, Kaunas University of Medicine, Kaunas, Lithuania
  3. 3Moran Eye Center, University of Utah, Salt Lake City, Utah, USA
  1. Correspondence to Professor Alon Harris, Lois Letzter Professor of Ophthalmology, Professor of Cellular and Integrative Physiology, Department of Ophthalmology, Indiana University School of Medicine, 1160 West Michigan Street, Indianapolis, IN 46202, USA; alharris{at}indiana.edu

Abstract

The purpose of this review is to discuss the process of genericisation of medications in the US and Europe with a focus on ophthalmic drugs. Regulatory guidelines of the US Food and Drug Administration and the European Medicines Agency will be discussed, and the advantages and concerns of genericisation will be explored. We will look at various studies concerning the safety and efficacy of generic drugs compared to their branded counterparts. In particular, the challenges of assuring bioequivalence and therapeutic equivalence in topical ophthalmic drugs will be examined.

  • Drugs
  • Treatment Medical
  • Pharmacology
  • Glaucoma

https://doi.org/10.1136/bjophthalmol-2012-302245

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