Back to Agenda
Session 3: Enhancing Patient Access by Streamlining the Development of Safe, Effective, and High Quality Biosimilars
Session Chair(s)
Jessica Greenbaum
Director, Regulatory Affairs Policy U.S.
Sandoz Inc., United States
Breaking the clinical comparative efficacy study barrier will redefine the trajectory for the development of safe, effective, and high quality biosimilars, providing a critical tool for addressing the “biosimilar void” and enhancing patient access. Global regulatory authorities are increasingly recognizing that a robust biosimilarity program can be supported by comprehensive analytical and pharmacokinetic studies, with comparative efficacy studies—the least sensitive tool for detecting differences—as scientifically unnecessary. Beyond comparative efficacy studies, there exist additional opportunities to enhance development and review efficiencies, without any compromise to safety, effectiveness, or quality, such as shifting towards a global comparator, or, at minimum, an “analytical only” bridge to justify the use of foreign comparators.
Learning Objective : - Identify the scientific rationale for eliminating the need for comparative efficacy trials as well as other strategies to streamline biosimilar development
- Evaluate regulatory perspectives on streamlining development
- Analyze how streamlining development can reduce development costs and address the biosimilar void, thereby enhancing patient access to safe, effective, and high quality biosimilars
Speaker(s)
Speaker
Representative Invited
AGES, Austria
Speaker
Representative Invited
US FDA, United States
Speaker
João Tavares Neto
Brazilian Health Regulatory Agency (ANVISA), Brazil
Have an account?