A more streamlined European regulatory pathway for biosimilars, eliminating the requirement for confirmatory Phase III efficacy trials, is needed for smaller-value biologic brands to become viable targets for biosimilar competition, according to European biosimilar industry leaders.
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.
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