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

doi:10.1136/bjophthalmol-2012-302245

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

Research output: Contribution to journal › Review article › peer-review

22 Scopus citations

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.

Original language	English
Pages (from-to)	253-257
Number of pages	5
Journal	British Journal of Ophthalmology
Volume	97
Issue number	3
DOIs	https://doi.org/10.1136/bjophthalmol-2012-302245
State	Published - Mar 2013
Externally published	Yes

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10.1136/bjophthalmol-2012-302245

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title = "Generic medications in ophthalmology",

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.",

author = "Matt Zore and Alon Harris and Tobe, \{Leslie Abrams\} and Brent Siesky and Ingrida Januleviciene and Jennifer Behzadi and Annahita Amireskandari and Patrick Egan and Kevin Garff and Barbara Wirostko",

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AU - Harris, Alon

AU - Tobe, Leslie Abrams

AU - Siesky, Brent

AU - Januleviciene, Ingrida

AU - Behzadi, Jennifer

AU - Amireskandari, Annahita

AU - Egan, Patrick

AU - Garff, Kevin

AU - Wirostko, Barbara

PY - 2013/3

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AB - 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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U2 - 10.1136/bjophthalmol-2012-302245

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ER -

Generic medications in ophthalmology

Abstract

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