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Cutting Through The Confusion On US Biosimilar Interchangeability

Experts Offer Clarity Amid Misunderstandings Over US FDA Designation

 
• By Dave Wallace

Amid ongoing confusion around the US interchangeability designation for biosimilars, Joseph Park and Gillian Woollett of Samsung Bioepis talk to Generics Bulletin about the risks of misinformation, the importance of educational efforts, and how language is shaping certain misunderstandings around biosimilars.

Question mark cards in a jar
Confusion remains over aspects of the US FDA interchangeability designation • Source: Shutterstock

With the first three interchangeability designations having been granted for biosimilars by the US Food and Drug Administration and one of them being an interchangeable Humira (adalimumab) biosimilar, plus multiple adalimumab biosimilars lined up for launch in 2023, the US interchangeability designation is attracting more and more attention among industry stakeholders.

However, with confusion persisting over interchangeability in the US – including the misleading implication that biosimilars without the designation are inferior to those with it, as well as the FDA’s designation of interchangeability differing from how similar language is used to describe biosimilars in other global

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