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FDA Officially Recommends Removal Of Interchangeability Designation From Biosimilar Labels

Agency Previously Floated The Idea In Draft Guidance In September

 
• By Chloe Kent

The US Food and Drug Administration has recommended that biosimilar drugs all use the same biosimilarity statement on their product information. Interchangeable products currently employ a separate interchangeability statement.

Pharmacist serving a patient at the counter
Interchangability relates to pharmacy-level substitution, meaning the information may be more suitable in the Purple Book rather than on labeling • Source: Shutterstock

The US Food and Drug Administration has recommended that the prescribing information for all biosimilar drugs marketed in the country display a uniform biosimilarity statement, including interchangeable biosimilars which currently display an interchangeability statement instead.

Key takeaways:

  • Product labeling for biosimilars in the US currently states whether the product “is biosimilar to” or “is interchangeable to” the reference drug.

The agency floated removing interchangeability designation from biosimilar labels as part of draft guidance in September. (Also see "From...

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