Harmonizing bioequivalence: advancing global access to generic medicines

The 3rd Bioequivalence Conference, co-hosted by the International Generic and Biosimilar Medicines Association (IGBA) and Medicines for Europe, concluded yesterday in the Netherlands. This landmark event brought together experts from regulatory authorities, industry, and academia to discuss the evolving bioequivalence landscape and its critical role in improving global access to medicines.

According to the IGBA, the conference took place at a pivotal time, with the ICH M13 guideline series advancing global harmonization efforts. These developments aim to streamline generic medicine development, reduce duplication of studies, and accelerate access to affordable, quality-assured treatments for patients worldwide.

Attendees engaged in in-depth discussions on key topics, including development of ICH M13 guideline series and essential issues, such as the single global development of generic medicines, model-informed approaches supporting bioequivalence, and compliance and oversight in bioequivalence studies.