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Review
. 2013 Mar;97(3):253-7.
doi: 10.1136/bjophthalmol-2012-302245. Epub 2012 Nov 9.

Generic medications in ophthalmology

Matt Zore  1 , Alon Harris, Leslie Abrams Tobe, Brent Siesky, Ingrida Januleviciene, Jennifer Behzadi, Annahita Amireskandari, Patrick Egan, Kevin Garff, Barbara Wirostko
Affiliations
Review

Generic medications in ophthalmology

Matt Zore et al. Br J Ophthalmol. 2013 Mar.

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.

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Comment in

  • Authors' response: generic medications in ophthalmology.
    Connor AJ, Fraser S. Connor AJ, et al. Br J Ophthalmol. 2013 Jun;97(6):795. doi: 10.1136/bjophthalmol-2013-303159. Epub 2013 Mar 7. Br J Ophthalmol. 2013. PMID: 23471822 No abstract available.
  • Authors' response.
    Harris A, Siesky B, Januleviciene I, Tobe LA, Zore M, Amireskandari A, Geffen N, Wirostko B. Harris A, et al. Br J Ophthalmol. 2013 Jun;97(6):795-6. doi: 10.1136/bjophthalmol-2013-303307. Epub 2013 Mar 15. Br J Ophthalmol. 2013. PMID: 23505302 No abstract available.