Volume 103, Issue 2 p. 310-317
Articles

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

RA Hansen

Corresponding Author

RA Hansen

Auburn University, Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, Auburn, Alabama, USA

Correspondence: RA Hansen ([email protected])Search for more papers by this author
J Qian

J Qian

Auburn University, Harrison School of Pharmacy, Department of Health Outcomes Research and Policy, Auburn, Alabama, USA

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RL Berg

RL Berg

Marshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin, USA

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JG Linneman

JG Linneman

Marshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin, USA

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E Seoane-Vazquez

E Seoane-Vazquez

Massachusetts College of Pharmacy and Health Sciences, International Center for Pharmaceutical Economics and Policy, Boston, Massachusetts, USA

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S Dutcher

S Dutcher

US Food and Drug Administration, Office of Generic Drugs, Silver Spring, Maryland, USA

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S Raofi

S Raofi

US Food and Drug Administration, Office of Generic Drugs, Silver Spring, Maryland, USA

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CD Page

CD Page

University of Wisconsin, School of Medicine and Public Health, Department of Biostatistics and Medical Informatics, and Department of Computer Science, Madison, Wisconsin, USA

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PL Peissig

PL Peissig

Marshfield Clinic Research Foundation, Biomedical Informatics Research Center, Marshfield, Wisconsin, USA

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First published: 16 December 2016
Citations: 17

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.

CONFLICT OF INTEREST

In the past 3 years, Richard Hansen has provided expert testimony for Boehringer Ingelheim. No other authors declare a potential conflict of interest. Funding was made possible by the US Food and Drug Administration through grant U01FD005272. Views expressed in written materials or publications and by speakers do not necessarily reflect the official policies of the Department of Health and Human Services; nor does any mention of trade names, commercial practices, or organization imply endorsement by the United States Government.