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Regulatory Approach for Non-Biological Complex Drugs

  • At: 2012 FIP Congress in Amsterdam (the Netherlands)
  • Type: Poster
  • By: BORCHARD, Gerrit (University of Geneva, School of Pharmacy Geneva-Lausanne, Geneva, Switzerland)
  • Co-author(s): Flühmann, B. (Vifor Fresenius Medical Care Renal Pharma Ltd., St. Gallen, Switzerland)
    Mühlebach, S. (Vifor Fresenius Medical Care Renal Pharma Ltd., St. Gallen, Switzerland)
  • Abstract:

    In the European Union,
    intended


    copies

    of originator medicinal products are categorized either as generics or biosimilars and two distinct regulatory pathways have been established for marketing authorization. The major difference between the two product classes refers to the fact that complex biological molecules cannot be fully characterized and

    ..

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Last update 4 October 2019

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