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Biopharmaceuticals Are Not Chemical Drugs

  • John Geigert
Chapter

Abstract

Biopharmaceuticals are definitely different from chemical drugs. This is not a perception, but a reality, and it is reflected by the statements on regulatory authority websites and in the wording of the regulatory guidances that they issue. Also, as is shown in this chapter, the four major CMC differences between biopharmaceuticals and chemical drugs are discussed: (1) how the products are synthesized, (2) impact of the process on the manufactured product, (3) complexity of the manufactured product, and (4) biosimilars are not bio-generics.

Keywords

Biologics Recombinant proteins Monoclonal antibodies CGTPs ATMPSs Biosimilars Generics Interchangeability INN 

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Copyright information

© Springer Nature Switzerland AG 2019

Authors and Affiliations

  • John Geigert
    • 1
  1. 1.BioPharmaceutical Quality SolutionsCarlsbadUSA

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