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." 

The International Generic and Biosimilar medicines Association (IGBA) appreciates the opportunity to contribute to this consultation and seeks to specifically highlight aspects related to the prevention of drug shortages and the preservation of widespread access to safe, affordable medicines. A resilient and reliable generic medicines supply chain is vital for safeguarding patient health, strengthening the U.S. healthcare system and achieving U.S. national security objectives. In response to the Notice of Request for Public Comments on Section 232 National Security Investigation of Imports of Pharmaceuticals and Pharmaceutical Ingredients, the IGBA seeks to provide insights informed by our experience and engagement with international supply chains. The IGBA will focus on questions (iii), (viii), (ix), and (x) with the aim of contributing constructively to the discussion on mitigating potential impacts on drug availability and ensuring continued access to affordable treatments for U.S. patients. Read IGBA’s submission here

IGBA Statement as new member of the Coalition for Access to NCD Medicines and Products.