IGBA identifies streamlined development through reduced comparative clinical studies and appropriate use of global comparator product as key to greater biosimilar access (July 2024)
The mandate to conduct routine comparative clinical efficacy studies for biosimilar medicines, compounded by duplicative regional requirements, serves as a barrier to greater medicine access for patients. The International Generic and Biosimilar Medicines Association (IGBA) has issued two position papers; the first proposing streamlined development through reduced clinical studies and the second proposing use of the same comparator product across jurisdictions.