Importance of Single Global Regulatory Standards for the Assessment of Generic and Biosimilar Medicines to Advance Patient Access

Generic and biosimilar medicines are foundational to sustainable healthcare, enabling broader patient access globally through high-quality, cost-effective alternatives. However, their market access is hindered by regulatory fragmentation across major authorities, where regulatory expectations are not always clearly aligned across jurisdictions or transparently justified, introducing additional complexity and potential delays in development and approval. This study integrates structured interviews with representatives from generic and biosimilar companies, alongside comprehensive literature and regulatory database reviews, to assess the impact of these regulatory inconsistencies. Analysis of 52 pharmaceutical products across four categories identified several key challenges including duplicated clinical studies across jurisdictions, inconsistent reference product (RP) requirements, and divergent manufacturing standards, potentially contributing to increased development costs and delayed market entry. These challenges disproportionately affect complex generics and orphan drugs, affecting global patient access to critical medicines. Despite promising international harmonization initiatives, substantial obstacles remain. The findings highlight key areas for greater regulatory alignment, including acceptance of foreign RPs, harmonization of technical standards, streamlined development pathways, and enhanced collaboration among regulatory agencies. Such measures are critical to facilitate global development of generic and biosimilar medicines, ensuring timely patient access without compromising safety or efficacy.