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Streamlined European Pathway Needed For Biosimilars To Hit Smaller Targets

Development Costs Are Currently Too High For Smaller-Value Biologics To Be Viable

Executive Summary

A more streamlined European regulatory pathway for biosimilars – potentially removing the requirement for confirmatory efficacy trials – is needed for the industry to be able to feasibly offer competition to smaller-value biologic brands, heard delegates to Medicines for Europe’s 18th Biosimilar Medicines Conference.

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