Learning Tracks

As biosimilar use continues to expand, effective pharmacovigilance remains a key component of ensuring patient safety and maintaining confidence in these products. This session will examine the practical implementation of FDA’s biological product naming convention and the role of product identification in post-market safety monitoring. Speakers from industry, academia, and FDA will discuss real-world experience with suffix-based naming, lessons learned from adverse event reporting systems, and considerations for the future of biosimilar surveillance.

Learning Objectives
• Explain FDA’s approach to nonproprietary naming for biological products and the rationale behind its use in pharmacovigilance.
• Evaluate real-world data and reporting trends related to product identification in adverse event reporting and safety monitoring activities.
• Discuss how product naming and identification intersect with broader pharmacovigilance tools and surveillance programs, including implications for the continued monitoring of biosimilar safety and effectiveness.