The FDA has released draft industry guidance for biosimilar and interchangeable biosimilar product labeling. The guidance includes proposed recommended approaches for:
- product identification, including when to use the biosimilar or interchangeable biosimilar product name, reference product name;
- content presentation; and
- specific sections of labeling, including prescribing information, indications, usage (including specific populations and paediatrics) and clinical pharmacology.
The draft document is open for comments by 17 November 2023.