Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary Disease
Authors: Andrew Clerman, Markham Luke
Journal: Annals of Internal Medicine (2024)

LettersJanuary 2024Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary DiseaseAndrew Clerman, MD, PhD, and Markham Luke, MD, PhDAndrew Clerman, MD, PhDU.S. Food and Drug Administration Office of Generic Drugs, Silver Spring, MarylandSearch for more papers by this author, and Markham Luke, MD, PhDU.S. Food and Drug Administration Office of Generic Drugs, Silver Spring, MarylandSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L23-0428 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail TO THE EDITOR: We commend Feldman and colleagues (1) on their rigorous postmarket real-world evidence investigation of the comparative effectiveness and safety of generic and brand-name fluticasone propionate and salmeterol inhalation powder. As noted by the authors, the bioequivalence assessment of orally inhaled drug products (OIDPs) presents a unique challenge because of formulation, device performance, local drug delivery, and variability in indicated patient populations (2). In addition, as the authors have previously shown, device patents on brand-name OIDPs serve as an additional barrier to the development of generic versions (3).Despite these challenges, approvals of generic OIDPs are accelerating, as ...References1. Feldman WB, Kesselheim AS, Avorn J, et al. Comparative effectiveness and safety of generic versus brand-name fluticasone–salmeterol to treat chronic obstructive pulmonary disease. Ann Intern Med. 2023;176:1047-1056. [PMID: 37549393] doi:10.7326/M23-0615 LinkGoogle Scholar2. Newman B, Witzmann K. Addressing the regulatory and scientific challenges with generic orally inhaled drug products. Pharmaceut Med. 2020;34:93-102. [PMID: 32112304] doi:10.1007/s40290-020-00327-y CrossrefMedlineGoogle Scholar3. Demkowicz BJ, Tu SS, Kesselheim AS, et al. Patenting strategies on inhaler delivery devices. Chest. 2023;164:450-460. [PMID: 36842533] doi:10.1016/j.chest.2023.02.031 CrossrefMedlineGoogle Scholar4. Lee J, Feng K, Conti DS, et al. Considerations for the forced expiratory volume in 1 second–based comparative clinical endpoint bioequivalence studies for orally inhaled drug products. Clin Pharmacol Ther. 2022;112:982-989. [PMID: 35133652] doi:10.1002/cpt.2553 CrossrefMedlineGoogle Scholar5. Walenga RL, Butler C, Craven BA, et al. Mechanistic modeling of generic orally inhaled drug products: a workshop summary report. CPT Pharmacometrics Syst Pharmacol. 2023;12:560-574. [PMID: 36330693] doi:10.1002/psp4.12889 CrossrefMedlineGoogle Scholar Author, Article, and Disclosure InformationAuthors: Andrew Clerman, MD, PhD; Markham Luke, MD, PhDAffiliations: U.S. Food and Drug Administration Office of Generic Drugs, Silver Spring, MarylandDisclosures: Authors have reported no disclosures of interest. Forms can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L23-0428. PreviousarticleNextarticle Advertisement FiguresReferencesRelatedDetailsSee AlsoComparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary Disease William B. Feldman , Aaron S. Kesselheim , Jerry Avorn , Massimiliano Russo , and Shirley V. Wang Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary Disease William B. Feldman , Aaron S. Kesselheim , Jerry Avorn , Massimiliano Russo , Shirley V. Wang Metrics Current Issue January 2024Volume 177, Issue 1 Keywords Asthma Chronic obstructive pulmonary disease Confidence intervals COVID-19 Food and Drug Administration Hazard ratio Hospitalizations Inhalation Pneumonia Safety ePublished: 16 January 2024 Issue Published: January 2024 PDF downloadLoading ...