FDA releases Final Guidance on biosimilar labelling

Today, FDA finalized the guidance for industry “Labeling for Biosimilar Products.” This guidance provides an overview of FDA’s recommendations for biosimilar product labeling and is intended to assist industry in developing labeling for submission in proposed biosimilar product applications.   A biosimilar product is a biological product that is approved based on a demonstration that it is highly similar to an FDA-approved biological product, known as a reference product. The biosimilar also must be shown to have no clinically meaningful differences in terms of safety and effectiveness from the reference product. 

Today’s final guidance on biosimilar labeling is another step that the FDA is taking to provide increased regulatory certainty for stakeholders, including applicants engaged in the development of biosimilar products. Biosimilar products create competition and can improve access and lower the costs to patients of important treatments.