Expanding Global Biosimilar Access: Converging Regulatory Approaches with Analytical Insights

This session presents key findings from extensive consultations with National Regulatory Authorities, companies, and organizations across LATAM, APAC, India, and MENA regions. The discussion examines critical challenges in biosimilar approval and lifecycle quality control, focusing on the development of reference standards, analytical characterization tools, and opportunities for global regulatory convergence. Through real-world case studies, participants will explore how advanced analytical technologies are transforming regulatory decision-making, including potential pathways for clinical trial waivers based on analytical similarity data. Public standards create a shared scientific foundation that enables trust across the global medicines supply chain, from manufacturers to regulators to healthcare providers. The session offers practical guidance for navigating diverse regulatory requirements and implementing effective quality control strategies across different regions.

Panelists will discuss critical challenges in biosimilar approval and lifecycle quality control focusing on 1) the need for new product-level documentary and physical reference standards, 2) analytical characterization tools and technologies, and 3) opportunities for global regulatory convergence.