This guidance is intended to assist applicants in developing draft labeling for submission in applications for proposed biosimilar products under section 351(k) of the Public Health Service Act (PHS Act) (42 U.S.C. 262(k)). The recommendations for prescription drug labeling in this guidance pertain only to the prescribing information (commonly referred to as the package insert), except for recommendations in section V pertaining to FDA-approved patient labeling (e.g., Patient Information, Medication Guide, and Instructions for Use). Specific labeling recommendations for interchangeable biological products are not provided in this guidance (see section VIII of this guidance)


Posted on the FDA website on 31 March 2016