FDA to hold public meeting on reauthorization of BsUFA

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The US Food and Drug Administration (FDA) is seeking specific suggestions on potential changes to the Biosimilar User Fee Act (BsUFA) performance goals ahead of negotiations to reauthorize the law.

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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 hoped will 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. The BsUFA lasts for a five-year period. The current version will expire on 30 September 2017 and the new version will cover fiscal years 2018 to 2022. Without new legislation, FDA will no longer be able to collect user fees to fund the biosimilars review process.

In a Federal Register notice published on 28 September 2015, FDA announced that it would hold a public meeting on 18 December 2015 at the agency’s White Oak Campus, New Hampshire, Vermont, USA to discuss the reauthorization of the BsUFA.

At the meeting in December 2015, FDA is seeking input from stakeholders and is particularly interested in responses to the following questions:

  • What is your assessment of the overall performance of the BsUFA programme to date?
  • What aspects of BsUFA performance goals should be retained, changed or discontinued to further strengthen and improve the programme?

Persons interested in participating in the meeting should register by 18 November 2015. Electronic and written comments will be accepted until 19 January 2016.

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1.  GaBI Online - Generics and Biosimilars Initiative. Generic and biosimilar user fee recommendations sent to Congress [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2015 Oct 16]. Available from: www.gabionline.net/Generics/News/Generic-and-biosimilar-user-fee-recommendations-sent-to-Congress

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Source: US FDA,Federal Register

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