Medical experts discuss interchangeability designation requirements for biosimilars.
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 editorial staff.