Streamlined European Pathway Needed For Biosimilars To Hit Smaller Targets

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

17 Oct 2022

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...