Lexology July 8, 2024
In April 2024, the U.S. Food and Drug Administration (“FDA”) issued revised draft guidance, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference Products, Biosimilar Products, and Interchangeable Biosimilar Products: Questions and Answers,” (the “Draft Guidance”) intended to address common questions that arise during the process of developing promotional communications for prescription reference products and biosimilar products, including interchangeable biosimilar products licensed under the Public Health Service Act (the “PHS Act”).
More specifically, the revised Draft Guidance outlines considerations for presenting data and information about such products in promotional communications to ensure they are truthful, non‑misleading and accurate—standards that apply to the advertising and promotion of all prescription drugs.
Background
The FDA issued an initial draft guidance in February 2020...
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