• William B Feldman, Aaron S Kesselheim, Jerry Avorn, Massimiliano Russo, and Shirley V Wang.
• Program on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Division of Pulmonary and Critical Care Medicine, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, Massachusetts (W.B.F.).
• Ann. Intern. Med. 2023 Aug 1; 176 (8): 104710561047-1056.

BackgroundIn 2019, the U.S. Food and Drug Administration (FDA) approved the first generic maintenance inhaler for asthma and chronic obstructive pulmonary disease (COPD). The inhaler, Wixela Inhub (fluticasone-salmeterol; Viatris), is a substitutable version of the dry powder inhaler Advair Diskus (fluticasone-salmeterol; GlaxoSmithKline). When approving complex generic products like inhalers, the FDA applies a special "weight-of-evidence" approach. In this case, manufacturers were required to perform a randomized controlled trial in patients with asthma but not COPD, although the product received approval for both indications.ObjectiveTo compare the effectiveness and safety of generic (Wixela Inhub) and brand-name (Advair Diskus) fluticasone-salmeterol among patients with COPD treated in routine care.DesignA 1:1 propensity score-matched cohort study.SettingA large, longitudinal health care database.PatientsAdults older than 40 years with a diagnosis of COPD.MeasurementsIncidence of first moderate or severe COPD exacerbation (effectiveness outcome) and incidence of first pneumonia hospitalization (safety outcome) in the 365 days after cohort entry.ResultsAmong 45 369 patients (27 305 Advair Diskus users and 18 064 Wixela Inhub users), 10 012 matched pairs were identified for the primary analysis. Compared with Advair Diskus use, Wixela Inhub use was associated with a nearly identical incidence of first moderate or severe COPD exacerbation (hazard ratio [HR], 0.97 [95% CI, 0.90 to 1.04]) and first pneumonia hospitalization (HR, 0.99 [CI, 0.86 to 1.15]).LimitationsFollow-up times were short, reflecting real-world clinical practice. The possibility of residual confounding cannot be completely excluded.ConclusionUse of generic and brand-name fluticasone-salmeterol was associated with similar outcomes among patients with COPD treated in routine practice.Primary Funding SourceNational Heart, Lung, and Blood Institute.

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