The FDA recently released a draft guidance document entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.”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).
The FDA recently released a draft guidance document entitled “Assessing User Fees Under the Biosimilar User Fee Amendments of 2017.”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:
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The FDA has noted that this guidance does not include any substantive changes from the previous draft guidance.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.
Julie Reed: Why 2024 Is Important for Biosimilars
April 17th 2024Julie Reed, executive director of the Biosimilars Forum, showcases how the biosimilar industry is expected to develop throughout 2024, including major policy changes and hope for continued improvement in market share for adalimumab biosimilars.
Exploring the Biosimilar Horizon: Julie Reed's Predictions for 2024
February 18th 2024On this episode of Not So Different, Julie Reed, executive director of the Biosimilars Forum, returns to discuss her predictions for the biosimilar industry for 2024 and beyond as well as the impact that the Forum's 4 new members will have on the organization's mission.
BioRationality: Removing the Misconceptions Surrounding Interchangeability
April 15th 2024Sarfaraz K. Niazi, PhD, outlines the current state of interchangeable biosimilars in the US and policy changes needed to clear up misconceptions surrounding the meaning behind interchangeability designations.
A New Chapter: How 2023 Will Shape the US Biosimilar Space for 2024 and Beyond
December 31st 2023On this episode of Not So Different, Cencora's Brian Biehn and Corey Ford take a look back at major policy and regulatory advancements in 2023 and how these changes will alter the space going forward.
Biosimilars Council: PBM Rebate Schemes Cost Americans, Payers $6 Billion
April 10th 2024A report from the Biosimilars Council evaluating IQVIA data found that rebate schemes orchestrated by pharmacy benefit managers (PBMs) are costing US patients and payers billions of dollars by suppressing biosimilar adoption.
Rising Biosimilar Adoption for an Italian Payer Will Benefit National Health Care System, Patients
April 9th 2024Data from 2021 and 2022 indicates increasing biosimilar use in an Italian health care company, with potential for full adoption in the future, benefiting both the National Health System and citizens through efficient and sustainable health care policies.