FDA asks for comments on reauthorization of BsUFA

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The US Food and Drug Administration (FDA) is seeking public comment on the statement of work for an assessment of the Program for Enhanced Review Transparency and Communication (Program) for original biologics license applications (BLAs). The program is part of the FDA’s commitments under the proposed reauthorization of the Biosimilar User Fee Act (BsUFA).


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.

As part of this Program, FDA is proposing that there be additional communication between FDA review teams and biosimilar applicants. This additional communication will take the form of BPD Type 4 (pre-351(k) application) meetings, mid-cycle communications and late-cycle meetings. The agency will also agree with the biosimilar applicant on a formal communication plan (FCP). As a result of these extra communications, FDA is proposing that its review clock will only begin after a 60-day administrative filing review period.

The goal of the additional communication is to improve the quality and completeness of submissions before the applicant submits an application and to provide applicants with opportunities during the review process to clarify previous submissions and provide additional data and analyses that are readily available, potentially avoiding the need for an additional review cycle.

FDA has released the statement of work for a comment period of 30 days, i.e. until 31 July 2017. Comments can be posted to the Dockets Management Staff under Docket No. FDA-2017-N-3199. This can be done via the website www.regulations.gov or written comments can be mailed to Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.

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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 2017 Jul 7]. Available from: www.gabionline.net/Generics/News/Generic-and-biosimilar-user-fee-recommendations-sent-to-Congress

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Source: Federal register, GPO, US FDA

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