Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary Disease
Authors: William B. Feldman, Aaron S. Kesselheim, Jerry Avorn, Massimiliano Russo, Shirley V. Wang
Journal: Annals of Internal Medicine (2024)

LettersJanuary 2024Comparative Effectiveness and Safety of Generic Versus Brand-Name Fluticasone–Salmeterol to Treat Chronic Obstructive Pulmonary DiseaseWilliam B. Feldman, MD, DPhil, MPH, Aaron S. Kesselheim, MD, JD, MPH, Jerry Avorn, MD, Massimiliano Russo, PhD, Shirley V. Wang, PhDWilliam B. Feldman, MD, DPhil, MPHProgram 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, MassachusettsSearch for more papers by this author, Aaron S. Kesselheim, MD, JD, MPHProgram on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MassachusettsSearch for more papers by this author, Jerry Avorn, MDProgram on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MassachusettsSearch for more papers by this author, Massimiliano Russo, PhDDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MassachusettsSearch for more papers by this author, Shirley V. Wang, PhDDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MassachusettsSearch for more papers by this authorAuthor, Article, and Disclosure Informationhttps://doi.org/10.7326/L23-0429 SectionsAboutFull TextPDF ToolsAdd to favoritesDownload CitationsTrack CitationsPermissions ShareFacebookTwitterLinkedInRedditEmail IN RESPONSE: We believe that the FDA's approach to bioequivalence described by Drs. Clerman and Luke is sensible. The FDA requires wide-ranging in vitro and in vivo testing when approving complex generic drug–device combinations, such as inhalers. The large suite of required studies using a range of methods to test generic drug–device combinations helps to ensure that patients receiving these products will have similar disease control as those receiving brand-name versions.In the case of fluticasone–salmeterol, the FDA required a clinical trial in patients with asthma but not chronic obstructive pulmonary disease because current standards for bioequivalence do not mandate ...References1. Ng D, Kerwin EM, White MV, et al. Clinical bioequivalence of Wixela Inhub and Advair Diskus in adults with asthma. J Aerosol Med Pulm Drug Deliv. 2020;33:99-107. [PMID: 31634023] doi:10.1089/jamp.2019.1547 CrossrefMedlineGoogle Scholar2. Feldman WB, Bloomfield D, Beall RF, et al. Patents and regulatory exclusivities on inhalers for asthma and COPD, 1986-2020. Health Aff (Millwood). 2022;41:787-796. [PMID: 35579925] doi:10.1377/hlthaff.2021.01874 CrossrefMedlineGoogle Scholar3. Reddy S, Beall RF, Tu SS, et al. Patent challenges and litigation on inhalers for asthma and COPD. Health Aff (Millwood). 2023;42:398-406. [PMID: 36877911] doi:10.1377/hlthaff.2022.00873 CrossrefMedlineGoogle Scholar4. U.S. Food and Drug Administration. Summary of FY 2024 legislative proposals. 13 March 2023. Accessed at www.fda.gov/media/166049/download on 10 October 2023. Google Scholar Author, Article, and Disclosure InformationAuthors: William B. Feldman, MD, DPhil, MPH; Aaron S. Kesselheim, MD, JD, MPH; Jerry Avorn, MD; Massimiliano Russo, PhD; Shirley V. Wang, PhDAffiliations: 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, MassachusettsProgram on Regulation, Therapeutics, and Law, Division of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MassachusettsDivision of Pharmacoepidemiology and Pharmacoeconomics, Department of Medicine, Brigham and Women's Hospital, and Harvard Medical School, Boston, MassachusettsDisclosures: Disclosures can be viewed at www.acponline.org/authors/icmje/ConflictOfInterestForms.do?msNum=L23-0429. 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 Andrew Clerman , and Markham Luke 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 Copyright & PermissionsCopyright © 2024 by American College of Physicians. All Rights Reserved.PDF downloadLoading ...