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

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 require...

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Bibliographic Details
Published in:Clinical pharmacology and therapeutics 2018-02, Vol.103 (2), p.310-317
Main Authors: Hansen, RA, Qian, J, Berg, RL, Linneman, JG, Seoane‐Vazquez, E, Dutcher, S, Raofi, S, Page, CD, Peissig, PL
Format: Article
Language:English
Subjects:
Administrative Claims, Healthcare
Adult
Aged
Ambulatory Care
Data Mining - methods
Drug Substitution - adverse effects
Drug-Related Side Effects and Adverse Reactions - diagnosis
Drug-Related Side Effects and Adverse Reactions - etiology
Drug-Related Side Effects and Adverse Reactions - therapy
Drugs, Generic - adverse effects
Drugs, Generic - therapeutic use
Electronic Health Records
Emergency Service, Hospital
Evidence-Based Medicine - methods
Female
Hospitalization
Humans
Male
Middle Aged
Patient Safety
Product Surveillance, Postmarketing
Retrospective Studies
Risk Assessment
Risk Factors
Time Factors
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Summary: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.
ISSN:0009-9236
1532-6535
DOI:10.1002/cpt.591