Generic fluticasone-salmeterol as effective as brand-name version, study finds

A propensity score-matched cohort study of patients treated for chronic obstructive pulmonary disease (COPD) in routine practice found that the use of generic and brand-name fluticasone–salmeterol was associated with similar outcomes. The findings are published in Annals of Internal Medicine.

In 2019, the U.S. Food and Drug Administration (FDA) approved the first generic maintenance inhaler for asthma and 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.

Researchers from Brigham and Women's Hospital and Harvard Medical School conducted a propensity score–matched cohort study of 10,012 matched pairs using either generic or brand-name fluticasone–salmeterol for COPD. The authors found that compared with brand-name use, generic use was associated with a nearly identical incidence of first moderate or severe COPD exacerbation. They also report that use of generic fluticasone-salmeterol was associated with similar rates of first pneumonia hospitalization as the brand-name reference drug.

According to the authors, their study adds important new data supporting the clinical equivalence of generic and brand-name fluticasone–salmeterol in a group of patients who were not included in clinical trials leading to generic version approval.