This guidance provides stakeholders information regarding FDA’s implementation of the Biosimilar User Fee Amendments of 2017 (BsUFA II) under Title IV of the FDA Reauthorization Act of 2017. Because BsUFA II created changes to the user fee program, this guidance serves to provide an explanation about the new fee structure and types of fees for which entities are responsible.

This guidance describes the types of user fees authorized by BsUFA II, the process for submitting payments to FDA, the consequences for failing to pay BsUFA fees, and the process for requesting a reconsideration of a user fee assessment. This guidance also describes how FDA determines which products are subject to a fee and discusses certain changes to FDA’s policies under the new law. This guidance does not address how FDA determines and adjusts fees each fiscal year; nor does it address FDA’s implementation of other user fee programs (e.g., Prescription Drug User Fee Amendments, Generic Drug User Fee Amendments). Throughout this guidance, references to user fees or the user-fee program are to the user fee program for biosimilar biological products under section 744H of the Federal Food, Drug, and Cosmetic Act (FD&C Act).