The use of the first generic maintenance inhaler approved for asthma and chronic obstructive pulmonary disease (COPD) produced outcomes similar to those with the original brand-name product in patients with COPD treated in routine practice. Using a special “weight-of-evidence” approach, the FDA approved the inhaler, Wixela Inhub (fluticasone–salmeterol; Viatris) in 2019 as a substitutable version of the dry powder inhaler Advair Diskus (fluticasone–salmeterol; GlaxoSmithKline). The generic product was required to be tested in patients with asthma but not with COPD.
In a propensity score-matched cohort study of a large, longitudinal healthcare database, records of adults older than 40 years with COPD were examined for the incidence of first moderate or severe COPD exacerbation (effectiveness outcome) and incidence of first pneumonia hospitalization (safety outcome) in the 365 days after cohort entry.
“Among 45,369 patients (27,305 Advair Diskus users and 18,064 Wixela Inhub users), 10,012 matched pairs were identified for the primary analysis,” the authors write. “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]).”