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Generics Bulletin Explains: Removing Interchangeability Information From US Biosimilar Labels

Biosimilars Industry Backs Latest FDA Labeling Guidance – But Originators Disagree

 
• By Dave Wallace

A clear divide between the biosimilars sector and the brand industry has been demonstrated by responses to a consultation over FDA draft guidance recommending that biosimilar labels remove information on interchangeability. Generics Bulletin explains the opposing positions.

Tug Of War In Silhouette - Fighting Over Chasm, Divide
The off-patent and brand industries are split over US biosimilar labeling • Source: Shutterstock

A clear split between the biosimilars industry and the branded biologics sector has emerged in comments submitted to the US Food and Drug Administration over draft guidance around biosimilar labeling and interchangeability.

Key Takeaways

  • The AAM’s Biosimilars Council and the Biosimilars Forum industry associations are supportive of draft FDA guidance recommending that details of interchangeability designations be removed from biosimilar labels.

  • Several biosimilars firms also responded individually, also backing the FDA’s suggestion and pointing out unintended negative consequences caused by the interchangeability designation

The FDA recently issued revised draft guidance that recommended removing details of the designation

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