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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
- Primer on Biosimilar-Related Regulatory Topics for Regulatory Reviewers
- Workshop Summary Report: Increasing the Efficiency of Biosimilar Development Programs — Reevaluating the Need for Comparative Clinical Efficacy Studies
You can also access the following page:
Files
Type
Simple basic page