Biosimilar Regulatory Standards in the ICH Regions: Implications for Global Biosimilar Development

Key advantage of biosimilar products is their cost-effectiveness, which in turn can increase patient access to biologic therapeutics that otherwise may be unaffordable. Therefore, demand for biosimilars is rapidly growing across both established and emerging regions. Regulatory frameworks for biosimilar development are relatively new and quickly evolving. EU pioneered regulations for biosimilar medicines only 20 years ago, which since then served as a reference for other regulatory agencies’ biosimilar frameworks. US had a significant lag in establishing biosimilar regulations, but nevertheless, its current biosimilar landscape is advancing at a much faster pace compared to EU. This session will compare the CMC, nonclinical, clinical, and regulatory approval criteria for biosimilars in the ICH regions and point to key differences between the regulatory practices that may accelerate or impede biosimilar development in various regions. In addition, relevant case studies will be presented to demonstrate different approaches to regulatory approval of biosimilars between the ICH regions. This talk aims to assist the sponsors and regulatory professionals in developing the most optimal strategies to bring biosimilar products on a global market.