Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products

The U.S. Food and Drug Administration (FDA) has issued the final guidance titled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers.” The guidance addresses common questions and Regulatory considerations when creating promotional labeling and advertising for:

• Reference biological products
• Biosimilar products
• Interchangeable biosimilar products

Key Considerations Covered

While not exhaustive in this summary, the guidance broadly helps stakeholders understand:

• Accuracy and truthfulness standards for promotional communications under FDA regulations.
• How claims regarding biosimilarity or interchangeability should be presented to avoid misleading implications.
• Regulatory expectations and examples clarifying appropriate vs. inappropriate promotional practices.

Regulatory Commitment and Context

The final guidance represents FDA’s continued commitment to:

• Support adoption and uptake of biosimilars in the U.S. market.
• Prevent false or misleading promotional statements about biological products.
• Provide industry clarity on advertising practices in accordance with Regulatory standards.

This finalization completes an FDA commitment under the BsUFA III performance goals to issue guidance in this area. For additional Regulatory information and resources on biosimilars, stakeholders are directed to the FDA biosimilars page.