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Biosimilar Sponsors Say Pharmacokinetic Bridging Studies Should Be The Exception, Not The Norm

Executive Summary

US FDA guidance runs risk of creating de facto requirement for bridging studies when a biosimilar applicant seeks to use comparative data involving a foreign reference product, Novartis says; IGBA, AAM urge agency adopt a ‘global comparator’ approach that would eliminate the need for clinical bridging studies between US and foreign reference biologics.

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