Biosimilar Activities

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Description
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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
Date
File
BWG Reflection Paper, dated 25 September 2017 (1.58 MB)
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File
Quality Training Manual - Spanish, dated 26 November 2018 (2.54 MB)
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File
Quality Training Manual - English, dated 17 December 2018 (8.41 MB)
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File
Quality Training Manual - Russian, dated 26 November 2018 (6.12 MB)
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File
Nonclinical Training Manual - English, dated 17 December 2019 (711.74 KB)
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File
Clinical Comparability Training Manual, dated 20 December 2020 (1.83 MB)
Date
File
Primer on Biosimilar-Related Regulatory Topics for Regulatory Reviewers, dated 9 January 2022 (1.57 MB)
Date
File
Workshop Summary Report: Increasing the Efficiency of Biosimilar Development Programs, dated 6 May 2024 (621.46 KB)
Type
Simple basic page
Related links
Public Assessment Summary Information for Biosimilar (PASIB)
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