Generics Bulletin Explains: Removing Interchangeability Information From US Biosimilar Labels

Biosimilars Industry Backs Latest FDA Labeling Guidance – But Originators Disagree

 
• By David Wallace
  
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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between the biosimilars sector and the brand industry has been demonstrated by responses to a consultation over FDA draft guidance recommending that biosimilar labels remove information on interchangeability.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industry and the branded biologics sector has emerged in comments submitted to the US Food and Drug Administration over draft guidance around biosimilar labeling and interchangeability.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.

The FDA recently issued revised draft guidance that recommended removing details of the designation from biosimilar labels altogether.

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US Biosimilars

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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