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.
authors.affiliation: Department of Ophthalmology, Indiana University School of Medicine, Indianapolis, Indiana 46202, USA.
authors.forename: Matt
authors.initials: M
authors.lastname: Zore
authors.forename: Alon
authors.initials: A
authors.lastname: Harris
authors.forename: Leslie Abrams
authors.initials: LA
authors.lastname: Tobe
authors.forename: Brent
authors.initials: B
authors.lastname: Siesky
authors.forename: Ingrida
authors.initials: I
authors.lastname: Januleviciene
authors.forename: Jennifer
authors.initials: J
authors.lastname: Behzadi
authors.forename: Annahita
authors.initials: A
authors.lastname: Amireskandari
authors.forename: Patrick
authors.initials: P
authors.lastname: Egan
authors.forename: Kevin
authors.initials: K
authors.lastname: Garff
authors.forename: Barbara
authors.initials: B
authors.lastname: Wirostko
mesh_terms: D016568:Drugs, Generic / Q000627:therapeutic use*; D005128:Eye Diseases / Q000188:drug therapy*; D006801:Humans; D009885:Ophthalmology
chemical_list: D016568:Drugs, Generic