FDA revises industry guidance on biologics promotion and advertising

On Wednesday, the US Food and Drug Administration (FDA) announced a revised draft guidance to answer questions biologics companies may have when developing promotional communications for prescription biologics including reference products, biosimilars, and interchangeable biosimilars.

The revised draft guidance, “ Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” discusses considerations for presenting data and information about reference products or biosimilar products, including interchangeable biosimilars, in promotional communications to help ensure they are accurate, truthful, and non-misleading.

This revised draft guidance fulfills the Biosimilar User Fee Amendments of 2022 commitment to publish draft guidance on promotional labeling and advertising considerations for interchangeable biosimilar products and replaces the 2020 draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products: Questions and Answers.”