Biosimilar Activities

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On this page you can download the following documents:

 

  • Reflection Paper on Extrapolation of Indications in Authorisation of Biosimilar Products
  • Training Manual on the Basic of Analytical Comparability of Biosimilar Monoclonal Antibodies (English, Spanish, Russian)
  • Nonclinical Comparability Exercise of Biosimilar Monoclonal Antibody for Regulatory Reviewers
  • Training Manual on the Basics of the Clinical Comparability Exercise for Biosimilar Monoclonal Antibodies

 

You can also access the following page:

 

Type
Simple basic page