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Biden Authorizes Update to the Biosimilar User Fee Act Through 2027


After months of pressure and calls for action, President Biden reauthorized the Biosimilar User Fee Act, which will allow the FDA to assess and collect fees for biosimilars for the next 5 years.

By signing the FDA User Fee Reauthorization Act of 2022, President Biden also reauthorized the Biosimilar User Fee Act, also known as BsUFA III. The reauthorization will enable the FDA to assess and collect fees for biosimilars from October 2022 to September 2027.

“The new law ensures that FDA will continue to receive a source of stable and consistent funding during fiscal years 2023-2027…. Biosimilar biological products represent an important public health benefit, with the potential to offer life-saving or life-altering benefits at reduced cost to the patient,” the FDA commented on its website.

For several months, advocates and industry leaders have been calling on the administration to advance BsUFA III, including representatives from the Biosimilars Forum, the Biosimilars Council, and the Association for Accessible Medicines.

“We are committed to developing a robust biosimilar industry in the US, and to help the BsUFA program further develop over the next five years. We are at a critical inflection point for the biosimilars industry and we believe that enhancing the process for biosimilar development, review and educating the public of the importance of biosimilars is critically important to sustaining and cementing the biosimilar pathway for years to come,” said Juliana (Julie) M. Reed, executive director of the Biosimilars Forum in an April 2022 letter to the Senate Committee on Health, Education, Labor and Pensions encouraging the progression of BsUFA III.

The bill for BsUFA III was originally introduced to Congress in February 2022 by Representative Angie Craig (D-Minnesota). It passed in the House on March 31 and passed in the Senate on September 29 with an amendment.

When collecting user fees for biosimilars, the FDA applies them to “expediting the process for the review of biosimilar biological product applications, including postmarket safety activities.” According to the FDA, BsUFA assists biosimilar development and expedites the development process to get these products to the American public sooner.

The original BsUFA became law in 2012 and it was last reauthorized in 2017. Between March 2021 and June 2021, the FDA developed the changes for BsUFA III through collaboration with drug industry representatives. In November 2021, the FDA held a virtual BsUFA III Reauthorization Proposed Enhancements Public Meeting, during which members of the public were invited to hear opening remarks, background on BsUFA III, and overview of recommendations for reauthorization, industry perspectives, and public comment. A similar meeting also occurred in November 2020. The enhancements that FDA developed as a result of these meetings and consultations were referred to Congress in January 2022 as part of Title IV of the FDA User Fee Reauthorization Act.

The FDA released a commitment letter for BsUFA III that outlined the performance goals and procedures for the act for the next 5 years. The letter highlighted the FDA’s commitment to using BsUFA III to:

  • Ensure the effectiveness of the Biosimilar Biological Product Review Program
  • Enhancing the development of biosimilars and interchangeable products
  • Continuing to enhance user fee resource management
  • Improve FDA hiring and retention of review staff
  • Monitor and modernize data collection and technological tools for biosimilar development
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