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

Source: https://www.keypedia.com/guidances/guidance-document/promotional-labeling-and-advertising-considerations-for-prescription-biological-reference-products-biosimilar-products-and-interchangeable-biosimilar-products-questions-and-answers-guidance-for-industry/98d122b6-0f73-480f-9605-fbb17a6e6e72

> FDA guidance document: Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers:  Guidance for Industry. Issue date: December 09, 2025. Get complete insights and analysis.

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## Details

- Title: Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers:  Guidance for Industry
- Communication Type: Guidance Document
- Product Type: biologics
- Office Name: Center for Drug Evaluation and Research
- Office URL: /offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c
- Issue Date: 2025-12-09
- Last Changed: 2025-12-09
- Docket Number: <a href="https://www.regulations.gov/docket/FDA-2019-D-5473">FDA-2019-D-5473</a>

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