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From Interchangeability To Invisibility: FDA Wipes Designation From Biosimilar Labels

New Draft Guidance Urges Removal Of Interchangeability Designation From Biosimilar Labeling

 
• By Dave Wallace

Amid continuing stakeholder confusion over the meaning and significance of the US FDA’s interchangeability designation for biosimilars, the agency has now recommended omitting altogether details of interchangeability from biosimilar labels.

Three vials with blank white labels, syringe in background
FDA: biosimilar labels should not include interchangeability details • Source: Shutterstock

Ever since its introduction, the US Food and Drug Administration’s interchangeability designation for biosimilars has been a much-debated topic among industry stakeholders. But now, the latest FDA draft guidance has recommended removing the designation from biosimilar labels altogether.

Key Takeaways:

  • New US FDA draft guidance has recommended removing details of interchangeability from biosimilar labels

  • The FDA suggested the interchangeability designation had been a source of confusion for prescribers

  • The agency said prescribers could be

Citing the difficultly of appropriately labeling interchangeable biosimilars and updating labeling “without causing undue confusion” – as well as suggesting that a labeling statement indicating interchangeability and explaining the designation is “not likely to be useful to prescribers” – the FDA made the move as part of its

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