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Clin Pharmacol Ther. 2018 Feb;103(2):310-317. doi: 10.1002/cpt.591. Epub 2017 Oct 10.

Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug.

Author information

Auburn University, Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, Auburn, Alabama, USA.
Marshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin, USA.
Massachusetts College of Pharmacy and Health Sciences, International Center for Pharmaceutical Economics and Policy, Boston, Massachusetts, USA.
US Food and Drug Administration, Office of Generic Drugs, Silver Spring, Maryland, USA.
University of Wisconsin, School of Medicine and Public Health, Department of Biostatistics and Medical Informatics, and Department of Computer Science, Madison, Wisconsin, USA.


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.

[Indexed for MEDLINE]
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