title: Generic drugs for the treatment of ocular conditions: changing the treatment landscape.
abstract: As global spending on medicinal products continues to rise, the availability of lower-cost generic substitutes is increasingly driving health care decision-making. US FDA does not require strict demonstration of human bioequivalence and/or therapeutic studies for the approval of generic ophthalmic compounds. Bioequivalence between generic and innovator compounds is presumed on the basis of matching active and inactive ingredient profiles. Generic compounds may differ from innovator agents with regards to performance under environmental stress, relative acidity and bottle size/rigidity. Matching ingredient profiles may therefore not result in consistently comparable drug compositions and clinical effects.
authors: University of Illinois Eye and Ear Infirmary, Chicago, IL, USA.
authors: Ahmad A
authors: AA
authors: Aref
mesh_terms: D003657:Decision Making; D017277:Drug Approval; D016527:Drug Costs; D057915:Drug Substitution; D016568:Drugs, Generic / Q000008:administration & dosage / Q000191:economics / Q000627:therapeutic use*; D005128:Eye Diseases / Q000188:drug therapy*; D006801:Humans; D013810:Therapeutic Equivalency; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D016568:Drugs, Generic
keywords: generics; glaucoma; intraocular pressure; ocular; ophthalmology; pharmaceuticals