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

Docket Number: FDA-2019-D-5473 Issued by: Guidance Issuing Office Center for Drug Evaluation and Research Center for Biologics Evaluation and Research This guidance addresses questions that manufacturers, packers, distributors, and their representatives (firms) may have when developing FDA-regulated promotional labeling and advertisements (promotional communications) for prescription reference products, biosimilar products, and interchangeable biosimilar products licensed under the Public Health Service Act. The guidance discusses considerations for presenting data and information about reference products or biosimilar products in promotional communications to help ensure that they are accurate, truthful, and non-misleading. Submit Comments Submit Comments Online You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5)) If unable to submit comments online, please mail written comments to: Dockets Management Food and Drug Administration 5630 Fishers Lane, Rm 1061 Rockville, MD 20852 All written comments should be identified with this document's docket number: FDA-2019-D-5473.