Safety outcomes when switching between biosimilars and reference biologics: A systematic review and meta-analysis

• Thomas M. Herndon ,

  Roles Conceptualization, Data curation, Investigation, Methodology, Validation, Visualization, Writing – original draft, Writing – review & editing

  * E-mail: thomas.herndon@fda.hhs.gov

  Affiliation Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

  https://orcid.org/0009-0009-2677-9255

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• Cristina Ausin,

  Roles Conceptualization, Data curation, Investigation, Methodology, Validation, Visualization, Writing – review & editing

  Affiliation Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Nina N. Brahme,

  Roles Conceptualization, Data curation, Investigation, Methodology, Validation, Visualization, Writing – review & editing

  Affiliation Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Sarah J. Schrieber,

  Roles Conceptualization, Data curation, Investigation, Methodology, Validation, Visualization, Writing – original draft, Writing – review & editing

  Affiliation Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Michelle Luo,

  Roles Conceptualization, Data curation, Investigation, Methodology, Validation, Visualization, Writing – review & editing

  Affiliation Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Frances C. Andrada,

  Roles Data curation, Investigation, Validation, Visualization, Writing – review & editing

  Affiliation Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Carol Kim,

  Roles Data curation, Validation, Writing – review & editing

  Affiliation Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Wanjie Sun,

  Roles Data curation, Formal analysis, Visualization, Writing – review & editing

  Affiliation Division of Biometrics VIII, Office of Biostatistics, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Lingjie Zhou,

  Roles Data curation, Formal analysis, Visualization, Writing – review & editing

  Affiliation Division of Biometrics VIII, Office of Biostatistics, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Stella Grosser,

  Roles Writing – review & editing

  Affiliation Division of Biometrics VIII, Office of Biostatistics, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

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• Sarah Yim,

  Roles Conceptualization, Supervision, Writing – review & editing

  Affiliation Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

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• M. Stacey Ricci

  Roles Conceptualization, Supervision, Writing – original draft, Writing – review & editing

  Affiliation Office of Therapeutic Biologics and Biosimilars, Office of New Drugs, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Silver Spring, Maryland, United States of America

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