title: Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.
abstract: Authorized generics are identical in formulation to brand drugs, manufactured by the brand company but marketed as a generic. Generics, marketed by generic manufacturers, are required to demonstrate pharmaceutical and bioequivalence to the brand drug, but repetition of clinical trials is not required. This retrospective cohort study compared outcomes for generics and authorized generics, which serves as a generic vs. brand proxy that minimizes bias against generics. For the seven drugs studied between 1999 and 2014, 5,234 unique patients were on brand drugs prior to generic entry and 4,900 (93.6%) switched to a generic. During the 12 months following the brand-to-generic switch, patients using generics vs. authorized generics were similar in terms of outpatient visits, urgent care visits, hospitalizations, and medication discontinuation. The likelihood of emergency department (ED) visits was slightly higher for authorized generics compared with generics. These data suggest that generics were clinically no worse than their proxy brand comparators.
authors.affiliation: Auburn University, Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, Auburn, Alabama, USA.
authors.forename: R A
authors.initials: RA
authors.lastname: Hansen
authors.affiliation: Auburn University, Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, Auburn, Alabama, USA.
authors.forename: J
authors.initials: J
authors.lastname: Qian
authors.affiliation: Marshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin, USA.
authors.forename: R L
authors.initials: RL
authors.lastname: Berg
authors.affiliation: Marshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin, USA.
authors.forename: J G
authors.initials: JG
authors.lastname: Linneman
authors.affiliation: Massachusetts College of Pharmacy and Health Sciences, International Center for Pharmaceutical Economics and Policy, Boston, Massachusetts, USA.
authors.forename: E
authors.initials: E
authors.lastname: Seoane-Vazquez
authors.affiliation: US Food and Drug Administration, Office of Generic Drugs, Silver Spring, Maryland, USA.
authors.forename: S
authors.initials: S
authors.lastname: Dutcher
authors.affiliation: US Food and Drug Administration, Office of Generic Drugs, Silver Spring, Maryland, USA.
authors.forename: S
authors.initials: S
authors.lastname: Raofi
authors.affiliation: University of Wisconsin, School of Medicine and Public Health, Department of Biostatistics and Medical Informatics, and Department of Computer Science, Madison, Wisconsin, USA.
authors.forename: C D
authors.initials: CD
authors.lastname: Page
authors.affiliation: Marshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin, USA.
authors.forename: P L
authors.initials: PL
authors.lastname: Peissig
mesh_terms: D000067575:Administrative Claims, Healthcare; D000328:Adult; D000368:Aged; D000553:Ambulatory Care; D057225:Data Mining / Q000379:methods; D057915:Drug Substitution / Q000009:adverse effects; D064420:Drug-Related Side Effects and Adverse Reactions / Q000175:diagnosis / Q000209:etiology* / Q000628:therapy; D016568:Drugs, Generic / Q000009:adverse effects / Q000627:therapeutic use*; D057286:Electronic Health Records; D004636:Emergency Service, Hospital; D019317:Evidence-Based Medicine / Q000379:methods; D005260:Female; D006760:Hospitalization; D006801:Humans; D008297:Male; D008875:Middle Aged; D061214:Patient Safety; D011358:Product Surveillance, Postmarketing; D012189:Retrospective Studies; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors
chemical_list: D016568:Drugs, Generic