Source: http://www.fdalawblog.net/2011/12/fda-proposes-biosimilar-and-interchangeable-biological-product-user-fee-system-and-performance-goals/
Timestamp: 2019-04-22 08:12:49+00:00

Document:
On December 7, 2011, FDA will publish a Federal Register notice – a prepublication version of which is available here – announcing a December 16th public meeting and comment period (Docket No. FDA-2011-N-0326) to discuss the Agency’s proposed recommendations for a user fee program for biosimilar biological products for Fiscal Years (“FYs”) 2013 through 2017. The meeting and comment period is required by the Biologics Price Competition and Innovation Act of 2009 (“BPCIA”), which was enacted on March 23, 2010 as part of the Affordable Care Act, and which created, under new section 351(k) of the Public Health Service Act (“PHS Act”), a route to obtain approval of biosimilar and interchangeable versions of a reference product licensed under PHS Act § 351(a). The December announcement follows a May 2011 notice (see our previous post here) FDA held with public and industry stakeholders regarding the development of a § 351(k) application user fee program for FYs 2013-2017.
FDA’s notice includes both a discussion of the proposed user fees, and the Agency’s proposed performance goals and procedures for the next five FYs. Each topic is discussed below.
Proposed User Fees. FDA proposes the establishment of four types of biosimilars user fees. Three of the fees – the one-time application fee, and the annual product and establishment fees – are well known to industry and would be set equal to the rates established under the Prescription Drug User Fee Act (“PDUFA”) for a particular FY. For FY 2012, the PDUFA fees are $1,841,500 (application), $520,100 (establishment), and $98,970 (product) – see our previous post here.
Proposed Performance Goals and Procedures. FDA’s notice includes a summary of the proposed performance goals for a number of items, including proprietary name review, major dispute resolution, clinical holds, special protocol assessments, first cycle performance goals, and, as discussed below, review performance goals and meeting management goals. The full description of FDA’s proposed performance goals and procedures for the biosimilars user fee program are in the draft biosimilars user fee commitment letter that is hot off the presses.
FDA’s proposed review performance goals include goals for biosimilar biological product application submissions and resubmissions, supplements with clinical data, and original manufacturing supplements. As with the initial iteration of PDUFA, FDA takes a step-wise approach over the first few FYs to reach a goal of 90% for original and resubmitted § 351(k) applications. This is depicted in the tables below.
Biosimilar Initial Advisory Meeting – This is an initial assessment meeting limited to a general discussion regarding the feasibility of licensure under PHS Act § 351(k), and general advice on the expected content of the development program if the § 351(k) route is feasible.
BPD Type 2 Meeting – This is a meeting for the sponsor and FDA to discuss a specific issue, such as a proposed study design or endpoints, or to discuss questions seeking targeted advice from FDA regarding an ongoing development program.
BPD Type 4 Meeting – This is a meeting to discuss the format and content of a § 351(k) application or supplement.
FDA’s target timeframes for the various meeting types are shown below. FDA’s performance goals for the meetings begin with 70% in FY2013 and progress to 90% by FY2017.
After the December 16th public meeting, will finalize its user fee and performance goal proposals, revising them as necessary in response to comments or concerns raised at the public meeting and in docket comments. Under § 7001(f)(1) of the Affordable Care Act, FDA must transmit its recommendations to Congress by January 15, 2012.

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