Streamlined European Pathway Needed For Biosimilars To Hit Smaller Targets
Development Costs Are Currently Too High For Smaller-Value Biologics To Be Viable
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.