← FDA GUIDANCE
FDA GUIDANCE · FINALDecember 9, 2025

Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers: Guidance for Industry

What this record is not

Guidance details are published by the U.S. FDA; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA. The authoritative text is on fda.gov.

Status
Final
Topic
Advertising
Issue date
December 9, 2025
CHECKING ACCESS

Checking your access…

READ THE FULL GUIDANCE

The complete guidance document — every recommendation and its scope — is published by the FDA. SPEQ surfaces and indexes it for reference; the authoritative text lives on fda.gov.

View on fda.gov →