Changing global regulatory requirements for biosimilars: FDA and emerging international perspectives

FDA uses a science-based totality-of-the-evidence approach to evaluate biosimilar products, with comparative analytical assessment serving as the foundation of a biosimilar development program. This presentation will describe how comprehensive structural and functional comparisons between a proposed biosimilar and its reference product drive development decisions and inform the need for additional studies.

In this webinar, Dr. Sarah Yim will discuss the role of clinical studies, including comparative clinical pharmacology and, when appropriate, comparative efficacy and safety studies, in supporting the conclusion that there are no clinically meaningful differences between a biosimilar and its reference product. The complementary roles of analytical and clinical data within FDA's regulatory framework will be highlighted.

Finally, Dr. Yim will review how the growing body of scientific evidence and FDA's regulatory experience support streamlined scientific expectations for demonstrating biosimilarity and interchangeability. She will also highlight the evolving global regulatory landscape for biosimilars and refer to published guidance updates from relevant regulatory authorities. Attendees will gain an understanding of FDA's current approach to biosimilar evaluation and how advances in science continue to enable efficient, evidence-based development programs while maintaining FDA's rigorous standards for safety, purity, and potency.