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Comparison of Outcomes Following a Switch From a Brand to an Authorized Versus Independent Generic Drug
Author(s) -
Hansen RA,
Qian J,
Berg RL,
Linneman JG,
SeoaneVazquez E,
Dutcher S,
Raofi S,
Page CD,
Peissig PL
Publication year - 2018
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.591
Subject(s) - generic drug , medicine , brand names , discontinuation , proxy (statistics) , bioequivalence , advertising , drug , family medicine , pharmacology , business , computer science , machine learning , bioavailability
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.