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Analysis and Regulation of Biologics, Including Biosimilars

  • Karen M. Nagel
Chapter
Part of the AAPS Introductions in the Pharmaceutical Sciences book series (AAPSINSTR)

Abstract

Biologics represent an increasingly important segment of the pharmaceutical market, and were 25% of the worldwide total prescription and OTC sales in 2017. EvaluatePharma predicts that by 2024, 9 of the top 15 pharmaceuticals by sales in the United States, and 10 worldwide will be monoclonal antibodies or fusion proteins. Many of these products have patents that have already or soon will expire. Due to the complex nature of biologics, they are typically expensive to produce, and until recently, the United States had no defined process for approving biosimilar equivalents of biotechnology-derived drugs.

Keywords

Biosimilarity Interchangeable biosimilar Totality of the evidence Biologics License Application Biosimilar product switching Biosimilar product naming Extrapolation of data 

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Copyright information

© American Association of Pharmaceutical Scientists 2018

Authors and Affiliations

  • Karen M. Nagel
    • 1
  1. 1.Chicago College of PharmacyMidwestern UniversityDowners GroveUSA

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