USA – FDA drafts guidance for biosimilar, reference product labels

The FDA released its draft guidance this week, “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products—Questions and Answers.”

The 10-page guidance is intended for manufacturers, packers, distributors and others, offering considerations for developing labels and promotional materials for prescription reference and biosimilar products.

The Agency notes that goal of the guidance document is to ensure that data and information about these products is “truthful and non-misleading as required under the Federal Food, Drug, and Cosmetic Act and FDA’s implementing regulations…