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An Overview of Biosimilar Extrapolation During FDA Approval

Opinion
Video

Specialists define and discuss extrapolation, along with the importance of strong data in specific disease states.

This is a video synopsis/summary of a panel discussion involving Ryan Haumschild, PharmD, MS, MBA; Alice B. Gottlieb, MD, PhD; Bincy Abraham, MD, MS; Jamie T. Brogan, APRN; and Vibeke Strand, MD.

Strand provides significant insights into the intricate landscape of biosimilars, specifically addressing the concept of biosimilar indication extrapolation. She elucidates that biosimilar indication extrapolation is employed in the FDA approval process to streamline the development program, aiming for efficiency and cost-effectiveness. The rationale is that if a biosimilar demonstrates equivalent efficacy, safety, and immunogenicity in one FDA-approved indication of the reference product, it can be extrapolated to other indications.

She emphasizes that although extrapolation might be convincing, having indication-specific data is crucial for reinforcing confidence, particularly in diverse diseases with distinct patient populations, outcome measures, and characteristics. Strand draws attention to the challenges faced in diseases like gastrointestinal conditions and dermatologic diseases, highlighting the need for comprehensive clinical trials. She stresses that extrapolation, although beneficial, may not provide the same level of reassurance as having data specific to each indication.

The discussion touches on the importance of understanding the limitations of extrapolation, particularly in diseases with variations in efficacy and safety profiles. Strand sheds light on the complexities involved in navigating the biosimilar landscape, ensuring a nuanced understanding of how extrapolation influences the approval and acceptance of biosimilars in various medical fields.

Video synopsis is AI-generated and reviewed by AJMCÒ editorial staff.

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