In a website posting, the International Generic and Biosimilar medicines Association (IGBA) has commended the General Assembly of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonization of "Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs."
This significant development, which took place at the recent ICH meeting in Madrid, Spain, marks the introduction of a new ICH Multidisciplinary Guideline, which aims to further strengthen consensus and harmonization among ICH members regarding reducing or eliminating routine for Comparative Efficacy Studies (CES) for biosimilar medicines. These efforts build upon the advancements in analytical technologies, the nearly three decade long experience with biosimilar development and regulation and existing harmonization initiatives found in the context of the ICH Q5E guideline that describes factors that may influence when additional clinical data is needed.
The trade group said that harmonization of the criteria for determining the need for CES in biosimilar development programs will help to avoid conducting CES which do not provide meaningful data for regulatory decision making, increase efficiency in biosimilar development and therefore ultimately increase the availability and accessibility of important biologic therapies for patients. By providing a unified scientific framework to justify when such studies are not routinely required, this guideline will help reduce the cost and duration of biosimilar development - ultimately benefiting patients around the world.
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