This guidance is intended to help applicants develop draft labeling for proposed biosimilar and interchangeable biosimilar products2 18 for submission in an application under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)) (351(k) application). The recommendations for biosimilar and interchangeable biosimilar product labeling in this guidance pertain only to the Prescribing Information, except for certain recommendations in section V, FDA-Approved Patient Labeling of Biosimilar and Interchangeable Biosimilar Products, pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication giuide, Instructions for Use)
When finalized, this guidance will revise and replace the guidance for industry Labeling for Biosimilar Products (July 2018). Significant changes from the July 2018 guidance include recommendations on the following topics:
• Labeling for interchangeable biosimilar products
• Product identification when the reference product labeling describes a clinical study conducted with a non-U.S.-approved biological product
• Pediatric use statements
• Incorporating relevant immunogenicity data and information from the reference product labeling in the biosimilar or interchangeable biosimilar product labeling
In general, FDA’s guidance documents do not establish legally enforceable responsibilities.
Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.