Biosimilar User Fee Act reauthorization

Biosimilars/General | Posted 23/09/2016 post-comment0 Post your comment

On 16 September 2016, the US Food and Drug Administration (FDA) released the Biosimilar User Fee Act II (BsUFA II) performance goals letter, attracting support from industry associations.

User Fee V13H23

Representatives from the Biotechnology Innovation Organization (BIO), Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biosimilars Forum all took part in the technical negotiations for the reauthorization of BsUFA.

‘The goals and commitments outlined in the BsUFA II goals letter will expand and build upon the initial success of BsUFA I by ensuring that the FDA has the resources necessary to review biosimilars in an efficient and timely manner’, according to BIO. They added that the BsUFA II should also maintain ‘the agency’s high standards for safety and efficacy by making structural modifications that will enhance the operation of the biosimilars user fee program’.

The BsUFA calls for biosimilars makers to pay fees annually to FDA in the same way as brand-name drugmakers do [1]. This funding is supplemental to what the US Congress appropriates to FDA each year and is intended to enable FDA to hire more staff, improve systems and establish a better managed biosimilars review process to make biosimilar therapies available to patients sooner without compromising review quality. BsUFA lasts for a five-year period. The current version (BsUFA I) will expire on 30 September 2017 and the new version (BsUFA II) will cover fiscal years 2018 to 2022.

Enhancements to the biosimilars review process envisioned in the BsUFA II goals letter include the establishment of a programme for enhanced communications during the biosimilars review process, similar to that which already exists as part of Prescription Drug User Fee Act (PDUFA). A new time reporting system will also be implemented and financial transparency will be enhanced. FDA has also committed to improving recruitment, hiring and retention of staff, a necessity, according to BIO, in order to accomplish the goals of the biosimilars programme.

Key provisions of BsUFA II include:
• Continue to improve the efficiency of the science-based FDA review process for biosimilars
• Establish dedicated staff capacity for key functions, such as facilitating scientific coordination, policy development, operations management, programme governance, internal training, educational outreach, and communication
• Help ensure the long-term sustainability of BsUFA activities through modernized time reporting and capacity planning
• Promote more informative engagement between FDA and biosimilar sponsors during development and review of biosimilar products, for example, by helping to ensure feedback is provided in a timely manner

These provisions, according to PhRMA, will, through the BsUFA II agreement, ‘help provide FDA with the resources needed to enhance the science-based review of new biosimilars, which will help increase competition in the marketplace to the benefit of patients’.

On 12 August 2016, FDA also sent the FY2017 annual BsUFA invoices. The BsUFA fees for FY2017 for biological product development, product, establishment and reactivation have been set as US$203,810, US$97,750, US$512,200 and US$407,620, respectively. For an application containing clinical data the fees are US$2,038,100 and US$1,019,050 for an application without clinical data.

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1. GaBI Online - Generics and Biosimilars Initiative. Generic and biosimilar user fee recommendations sent to Congress []. Mol, Belgium: Pro Pharma Communications International; [cited 2016 Sep 23]. Available from:

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Source: BIO, FDA, PhRMA

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