Generic medications in ophthalmology. Issue 3 (9th November 2012)

• Record Type: Journal Article
• Authors: Zore, Matt; Harris, Alon; Tobe, Leslie Abrams; Siesky, Brent; Januleviciene, Ingrida; Behzadi, Jennifer; Amireskandari, Annahita; Egan, Patrick; Garff, Kevin; Wirostko, Barbara
• Is Part Of: British journal of ophthalmology. Volume 97:Issue 3(2013)
• Page Start: 253
• Page End: 257
• Publication Date: 2012-11-09
• Subjects: Drugs -- Treatment Medical -- Pharmacology -- Glaucoma; Ophthalmology -- Periodicals; 617.7
• DOI: 10.1136/bjophthalmol-2012-302245
• Languages: English
• ISSNs: 0007-1161

Abstract

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.