Defining Interchangeability and Switching in Biologics

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

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EP: 9.Defining Interchangeability and Switching in Biologics

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

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 esteemed experts Ryan Haumschild, PharmD, MS, MBA; Alice B. Gottlieb, MD, PhD; Bincy Abraham, MD, MS; and Vibeke Strand, MD. The focus of this segment is on the crucial topic of interchangeability in biosimilars, shedding light on the FDA’s criteria and the implications for clinicians.

Strand introduces the concept of interchangeability, emphasizing its importance as a designation. Currently, only 1 biosimilar, adalimumab-adbm (Cyltezo), has received this designation, signifying that it has undergone switching studies in which patients alternated between the biosimilar and the reference product without compromising efficacy or safety. This is particularly significant for immunogenicity, a crucial consideration with biologics like adalimumab (Humira). Strand underscores the reassurance provided by interchangeability, preventing disruptions in treatment that could lead to complications.

Brogan delves deeper into the requirements for interchangeability from the FDA. To achieve this designation, a biosimilar must prove that it can be switched multiple times between the reference product and the biosimilar without increased risks such as loss of response, safety events, or immunogenicity. This necessitates rigorous switching studies, exemplified by trials like NOR-SWITCH (NCT02148640) and the VOLTAIRE studies, demonstrating the safety and efficacy of multiple switches.

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