While noting that full regulatory harmonization may be out of reach, Suzette Kox, secretary general of the IGBA this week called for further convergence among stringent regulators in the biosimilar space, particularly on the acceptance of foreign-sourced reference products. Kox, speaking at the Association for Accessible Medicines’ GRx+Biosim conference in Bethesda, MD, explained how a global framework for “truly global biosimilar development” is necessary to avoid repetitive, and therefore unethical, clinical studies. She also called for more regulators to share unredacted biosimilar assessment reports, although not publicly, especially as FDA often shares such reports with the WHO. Learn More