Generic medications in ophthalmology.

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

Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA.

The British journal of ophthalmology 2013 Mar

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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.

Citation

Matt Zore, Alon Harris, Leslie Abrams Tobe, Brent Siesky, Ingrida Januleviciene, Jennifer Behzadi, Annahita Amireskandari, Patrick Egan, Kevin Garff, Barbara Wirostko. Generic medications in ophthalmology. The British journal of ophthalmology. 2013 Mar;97(3):253-7