This guidance is intended to help applicants develop draft labeling for proposed biosimilar and interchangeable biosimilar products 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 Guide, Instructions for Use).