FDA's new draft guidance on biosimilars labeling

While the US medicines regulator has been granting approvals for biosimilar version of branded medicine for some time, it is only in the last year or so that they have been coming onto the market due to originators’ strong patent positions.

In a move that will help encourage biosimilars uptake, on Friday, the US Food and Drug Administration (FDA) issued its new draft guidance “ Labeling for Biosimilar and Interchangeable Biosimilar Products” and corresponding  Notice of Availability ( OA).

In this draft guidance, the FDA outlines its recommendations for biosimilar and interchangeable biosimilar product labeling. The FDA notes that it has now approved 42 biosimilar products, including four interchangeable biosimilars, and has gained valuable experience about labeling considerations for biosimilar and interchangeable biosimilar products. This guidance considers that experience and includes recommendations on labeling for interchangeable biosimilar products and other topics.