GENERIC INITIATION OR SUBSTITUTION VERSUS BRAND-NAME MEDICATIONS : A SYSTEMATIC REVIEW
Author(s)
Monira Alwhaibi, PhD1, Yazed Alruthia, BSc, PharmD, PhD2.
1Professor, King Saud University, Riyadh, Saudi Arabia, 2King Saud University, Riyadh, Saudi Arabia.
1Professor, King Saud University, Riyadh, Saudi Arabia, 2King Saud University, Riyadh, Saudi Arabia.
OBJECTIVES: Generic initiation/substitution is a common practice worldwide to contain the rising healthcare cost. However, there is a persistent concern among patients and healthcare providers that generic initiation/substitution may negatively impact different health outcomes. Therefore, the purpose of this systematic review was to evaluate the existing evidence about the impact of generic initiation/substitution on economic and clinical health outcomes.
METHODS: A systematic literature search was conducted using MEDLINE and CINAHL via EBSCO, EMBASE, and Cochrane Database of Systematic Reviews via OVID. Studies evaluating the economic, and clinical health outcomes of generic substitution that were published in peer-reviewed journals in English from inception to April 2026 were included in this review.
RESULTS: Out of the 380 identified articles, 86 studies were eligible and have been included in this review (eight clinical trials and seventy-eight observational studies). Findings regarding economic outcomes were mixed; approximately half of the studies reported no overall cost savings associated with generic initiation/substitution, whereas the remaining studies reported significant differences favoring generic products.. Regarding clinical outcomes, most of the seventy included studies (n = 43) reported no significant differences between generic and brand-name medications in terms of efficacy/effectiveness, hospitalization rates, emergency department visits, mortality, or safety following initiation or substitution with generic
CONCLUSIONS: current evidence suggests that generic initiation/substitution generally results in clinical outcomes comparable to those of brand-name medications across multiple therapeutic areas. However, evidence regarding economic outcomes remains inconsistent. Additional high-quality studies evaluating both clinical and economic outcomes are needed to better inform healthcare policy and prescribing practices related to generic initiation/substitution
METHODS: A systematic literature search was conducted using MEDLINE and CINAHL via EBSCO, EMBASE, and Cochrane Database of Systematic Reviews via OVID. Studies evaluating the economic, and clinical health outcomes of generic substitution that were published in peer-reviewed journals in English from inception to April 2026 were included in this review.
RESULTS: Out of the 380 identified articles, 86 studies were eligible and have been included in this review (eight clinical trials and seventy-eight observational studies). Findings regarding economic outcomes were mixed; approximately half of the studies reported no overall cost savings associated with generic initiation/substitution, whereas the remaining studies reported significant differences favoring generic products.. Regarding clinical outcomes, most of the seventy included studies (n = 43) reported no significant differences between generic and brand-name medications in terms of efficacy/effectiveness, hospitalization rates, emergency department visits, mortality, or safety following initiation or substitution with generic
CONCLUSIONS: current evidence suggests that generic initiation/substitution generally results in clinical outcomes comparable to those of brand-name medications across multiple therapeutic areas. However, evidence regarding economic outcomes remains inconsistent. Additional high-quality studies evaluating both clinical and economic outcomes are needed to better inform healthcare policy and prescribing practices related to generic initiation/substitution
Conference/Value in Health Info
2026-11, ISPOR Europe 2026, Vienna, Austria
Value in Health, Volume 29, Issue 12S
Code
CO188
Topic
Clinical Outcomes, Economic Evaluation, Health Policy & Regulatory
Topic Subcategory
Clinical Outcomes Assessment, Comparative Effectiveness or Efficacy
Disease
Cardiovascular Disorders (including MI, Stroke, Circulatory), Infectious Disease (non-vaccine), Neurological Disorders