Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence

Gagne, Joshua J.; Jiang, Wenlei; Dutcher, Sarah K.; Xie, Jing; Lii, Joyce; Fulchino, Lisa A.; Kesselheim, Aaron S.

doi:10.1002/pds.4009

Cited by 5 publications

(9 citation statements)

References 12 publications

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“…Future studies might expand on our work through a focus on narrow therapeutic index drugs because the efficacy and tolerability between generic and brand narrow therapeutic index drugs may be perceived differently. Another future area for study may be to examine switching patterns for authorized versus ANDA‐approved generics approved via product‐specific testing procedures, using an approach similar to a 2016 study …”

Section: Discussionmentioning

confidence: 99%

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Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs

et al. 2017

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Background While generic drugs are therapeutically equivalent to brand drugs, some patients and healthcare providers remain uncertain about whether they produce identical outcomes. Authorized generics, which are identical in formulation to corresponding brand drugs but marketed as a generic, provide a unique post-marketing opportunity to study whether utilization patterns are influenced by perceptions of generic drugs. Objectives To compare generic-to-brand switchback rates between generics and authorized generics. Methods A retrospective cohort study was conducted using claims and electronic health records data from a regional U.S. healthcare system. Ten drugs with authorized generics and generics marketed between 1999 and 2014 were evaluated. Eligible adult patients received a brand drug during the 6 months preceding generic entry, and then switched to a generic or authorized generic. Patients in this cohort were followed for up to 30 months from the index switch date to evaluate occurrence of generic-to-brand switchbacks. Switchback rates were compared between patients on authorized generics versus generics using Kaplan-Meier curves and Cox proportional hazards models, controlling for individual drug effects, age, sex, Charlson comorbidity score, pre-index drug use characteristics, and pre-index healthcare utilization. Results Among 5,542 unique patients that switched from brand-to-generic or brand-to-authorized generic, 264 (4.8%) switched back to the brand drug. Overall switchback rates were similar for authorized generics compared with generics (HR=0.86; 95% CI 0.65-1.15). The likelihood of switchback was higher for alendronate (HR=1.64; 95% CI 1.20-2.23) and simvastatin (HR=1.81; 95% CI 1.30-2.54) and lower for amlodipine (HR=0.27; 95% CI 0.17-0.42) compared with other drugs in the cohort. Conclusions Overall switchback rates were similar between authorized generic and generic drug users, indirectly supporting similar efficacy and tolerability profiles for brand and generic drugs. Reasons for differences in switchback rates among specific products need to be further explored.

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Section: Discussionmentioning

confidence: 99%

“…Another future area for study may be to examine switching patterns for authorized versus ANDAapproved generics approved via product-specific testing procedures, using an approach similar to a 2016 study. 26…”

Section: Discussionmentioning

confidence: 99%

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs

et al. 2017

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“…However, other pharmacoepidemiologic studies of these drugs used large claims databases found no differences in switchbacks between these products and matched comparators. [ 46 ] Further research on the details regarding the sources of concern about generic drugs could provide insight into improving physicians’ views of generic drugs and confidence in the generic drug approval process.…”

Section: Discussionmentioning

confidence: 99%

Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval

et al. 2016

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BackgroundGeneric drugs are cost-effective versions of brand-name drugs approved by the Food and Drug Administration (FDA) following proof of pharmaceutical equivalence and bioequivalence. Generic drugs are widely prescribed by physicians, although there is disagreement over the clinical comparability of generic drugs to brand-name drugs within the physician community. The objective of this survey was to assess physicians' perceptions of generic drugs and the generic drug approval process.Methods and FindingsA survey was administered to a national sample of primary care internists and specialists between August 2014 and January 2015. In total, 1,152 physicians comprising of internists with no reported specialty certification and those with specialty certification in hematology, infectious diseases, and endocrinology were surveyed. The survey assessed physicians’ perceptions of the FDA’s generic drug approval process, as well as their experiences prescribing six generic drugs approved between 2008 and 2012 using product-specific approval pathways and selected comparator drugs. Among 718 respondents (62% response rate), a majority were comfortable with the FDA’s process in ensuring the safety and effectiveness of generic drugs overall (91%) and with letting the FDA determine which tests were necessary to determine bioequivalence in a particular drug (92%). A minority (13–26%) still reported being uncomfortable prescribing generic drugs approved using product-specific pathways. Overall, few physicians heard reports of concerns about generic versions of the study drugs or their comparators, with no differences between the two groups. Physicians tended to hear about concerns about the safety or effectiveness of generic drugs from patients, pharmacists, and physician colleagues.ConclusionsPhysicians hold largely positive views of the FDA's generic drug approval process even when some questioned the performance of certain generic drugs in comparison to brand-name drugs. Better education about the generic drug approval process and standards may alleviate concerns among the physician community and support the delivery of cost-effective health care.

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“…Postmarketing surveillance of "real-world data" using rigorous methodologies could be used as an alternative approach to identify switching between brand to generic medications as a proxy for lack of therapeutic equivalence. [17][18][19][20] A high "switch-to-brand" rate, the number of patients switching from generic to a brand over a period of time, in real-world settings could support the need to further investigate a specific generic manufacturer under the assumption that cost incentives would likely cause patients to prefer a generic product if it demonstrates effectiveness. Our objective was to estimate the prevalence and to identify clinical and demographic predictors for generic to brand switch for escitalopram, duloxetine, and venlafaxine extended release (ER).…”

Section: Evaluation Of Switch-to-brand Rates As a Potential Signal For Therapeutic Equivalency Of Generic Antidepressants: A Real-world Rmentioning

confidence: 99%

“…In a previous study using the Optum Lifesciences Research Database and a 1-year follow-up period, venlafaxine ER was found to have a switch-to-brand prevalence of ~ 2%. 17 In a study of the Security Health Plan database, a regional insurance provider, the unadjusted switch-to-brand prevalence following a 30-month observation period for citalopram, paroxetine, and sertraline were ~ 6%, 5%, and 4%, respectively. 18 Furthermore, an analysis of escitalopram and sertraline products in a large US commercial health insurance database reported a switch-to-brand prevalence of 9% and 7%, respectively.…”

Section: Likelihood Of Switch-to-brandmentioning

confidence: 99%

Evaluation of Switch‐to‐Brand Rates as a Potential Signal for Therapeutic Equivalency of Generic Antidepressants: A Real‐World Retrospective Cohort Study

Kalaria

Spence

Hong

et al. 2021

Clin Pharma and Therapeutics

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Switch-backs associated with generic drugs approved using product-specific determinations of therapeutic equivalence

Abstract: As compared to control drugs, patients were not more likely to systematically switch back from generic to brand-name versions of the four study drugs. Copyright © 2016 John Wiley & Sons, Ltd.

Cited by 5 publications

References 12 publications

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs

Comparison of Generic-to-Brand Switchback Rates Between Generic and Authorized Generic Drugs

Physicians’ Trust in the FDA’s Use of Product-Specific Pathways for Generic Drug Approval

Evaluation of Switch‐to‐Brand Rates as a Potential Signal for Therapeutic Equivalency of Generic Antidepressants: A Real‐World Retrospective Cohort Study

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