Cutting Through The Confusion On US Biosimilar Interchangeability

Experts Offer Clarity Amid Misunderstandings Over US FDA Designation

 
• By David Wallace
  
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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.

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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...

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An abbreviated licensure pathway for biologics was created by the 2009 Biologics Price Competition and Innovation Act. Biologics demonstrated to be biosimilar to or interchangeable with FDA-approved products can use the 351(k) biologics license application pathway. Biosimilars BLAs submitted under the 351(k) pathway have a 12 month user fee goal for FDA action. Updated weekly.

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