Biosimilar Activities


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
  • Primer on Biosimilar-Related Regulatory Topics for Regulatory Reviewers


You can also access the following page:


Simple basic page