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Biosimilars Regulation International

Global Regulators Issue Advice On Clinical Comparability Of Biosimilar MAbs

Comparative Clinical Studies Should Support Demonstration Of Biosimilarity

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Executive Summary

The International Pharmaceutical Regulators Programme has documented various approaches currently being used for the clinical comparability of biosimilar monoclonal antibodies in different jurisdictions.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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