IGBA Welcomes ICH New Topic for Harmonisation: Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs (May 2025)
The International Generic and Biosimilar medicines Association (IGBA) commends the General Assembly of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) for its adoption of a new topic focused on the harmonisation of "Framework for Determining Utility of Comparative Efficacy Studies in Biosimilar Development Programs."