FDA Draft Guidance Explains Assessment of User Fees Under BsUFA

The FDA recently released a draft guidance document entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.” The guidance is meant to address various industry inquiries around the implementation of the Biosimilar User Fee Amendments II (BsUFA II). Specifically, the document addresses the changes to the user fee program and provides an explanation about the new fee structure and types of fees that entities are responsible to pay.

The Biosimilar User Fee Act of 2012 (BsUFA I) authorized the FDA to collect user fees for a 5-year period from biosimilar developers. Such fees help to fund the review process of biosimilar product applications and have played an important role in expediting the process. BsUFA II extended the FDA’s authority to collect user fees from fiscal year 2018 through fiscal year 2022 and revised the required fees and how they are collected.

The BsUFA II sanctioned the collection of 3 types of fees:

• Biosimilar biological product development program fees (BDP fees)
• Biosimilar biological product application fees
• Biosimilar biological product program fees

These fees differ from the BsUFA I because they eliminated fees required for supplements as well as biosimilar biological product establishment fees. In addition, the BsUFA II also removed the reduction of an application fee by the cumulative amount of fees paid by the applicant under the BDP.

The guidance provides an overview of when these fees are incurred and the process by which applicants must submit payments. Should a developer fail to pay the required fees, the document also addresses the consequences and the means for submitting reconsideration and appeal requests.

According to the FDA, if an applicant has failed to pay any BDP fee (initial, annual, or reactivation) for a product, the FDA will not host a BDP meeting relating to the product for which fees are owed, consider an investigational new drug submitted for the product if the FDA determines the investigation is intended to support a biosimilar biological product application, or allow the sponsor of a clinical investigation from continuing the investigation if the FDA determines it is to support a biosimilar biological product application.

The FDA has noted that this guidance does not include any substantive changes from the previous draft guidance. Industry members and other stakeholders are able to submit comments on the guidance to the Federal Register.