An Overview of Biosimilar Extrapolation During FDA Approval

EP: 1.Utilizing Recently Approved Biosimilars in Clinical Practice

EP: 2.Transitioning to Biosimilars: Considerations for Providers and Payers

EP: 3.Navigating Challenges Associated with Biosimilars Across Various Disease States

EP: 4.Provider Acceptance Driving Confidence in Biosimilar Therapy

EP: 5.Decision-Making Process Surrounding Biosimilar Implementation

EP: 6.Biosimilar Administration Considerations Impacting Patient Experience

EP: 7.Initiating Biosimilar Treatment in Patients Without Previous Reference Biologic Experience

EP: 8.Switching Patients from Reference Product to Biosimilar

EP: 9.Defining Interchangeability and Switching in Biologics

EP: 10.Evolution of Auto-Substitution in Biosimilar Landscape

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EP: 11.An Overview of Biosimilar Extrapolation During FDA Approval

EP: 12.Harnessing Indication-Specific Data on Biosimilars

EP: 13.Cost Savings Related to Biosimilars

EP: 14.Payers and PBMs Impacted by Biosimilar Integration

EP: 15.Payer Support Driving Lowering of Biosimilar-Related Health Care Costs

EP: 16.Patient Conversations: Managing Patient Expectations Regarding Biosimilars

EP: 17.Key Points of Emphasis Regarding Biosimilar Integration

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.