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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

 
• By Dave Wallace

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.

Medicines for Europe 18th biosimilars conference
Adrian van den Hoven, Esa Heinonen and Isabell Remus (from center to right) discussed the need for a streamlined European pathway for biosimilars • Source: Medicines for Europe

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.

Speaking at European off-patent industry association Medicines for Europe’s 18th Biosimilar Medicines Conference in Brussels, Belgium, in early October, the body’s director general Adrian van den Hoven underlined that “we want

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