IGBA identifies streamlined development process

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, said the trade group International Generic and Biosimilar Medicines Association (IGBA).

The 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. Avoiding scientifically unnecessary studies, and their repetition using locally sourced reference materials, does not compromise the quality, safety and efficacy of the approved biosimilar medicines. This can facilitate more efficient development of more affordable medicines, enabling biosimilar access for more patients in more jurisdictions (see IQVIA Biosimilar Void report).

Importance of educating all stakeholders