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

Journal Article (Journal Article)

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.

Full Text

Duke Authors

Cited Authors

  • Hansen, RA; Qian, J; Berg, RL; Linneman, JG; Seoane-Vazquez, E; Dutcher, S; Raofi, S; Page, CD; Peissig, PL

Published Date

  • February 2018

Published In

Volume / Issue

  • 103 / 2

Start / End Page

  • 310 - 317

PubMed ID

  • 27981563

Pubmed Central ID

  • PMC5860648

Electronic International Standard Serial Number (EISSN)

  • 1532-6535

Digital Object Identifier (DOI)

  • 10.1002/cpt.591


  • eng

Conference Location

  • United States