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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Agency Previously Floated The Idea In Draft Guidance In September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 FDA has now recommended that all products state which reference product they are “biosimilar” to, doing away with the interchangeability statement.

  • It previously floated removing interchangeability designation from biosimilar labels in draft guidance published in September

The agency floated removing interchangeability designation from biosimilar labels as part of draft guidance in September

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