By Donald Zuhn --
On Monday, the U.S. Food and Drug Administration published a notice in the Federal Register (76 Fed. Reg. 27062) requesting comments related to the development of a user fee program for biosimilar and interchangeable biological products under the approval pathway for biosimilar biological products established by the Patient Protection and Affordable Care Act (PPACA). In a press release, the FDA noted that the PPACA mandates that the agency develop recommendations for a user fee program for fiscal years 2013-2017, and that such recommendations must be presented to Congress by January 15, 2012.
In the Federal Register notice, the FDA states that the fee for a biologics license application (BLA) is currently the same regardless of whether the application is submitted under the new 351(k) approval pathway created by the PPACA or the preexisting 351(a) approval pathway. In working towards a user fee program for the 351(k) approval pathway, the FDA's notice outlines the agency's principles for developing the program, its proposal for a user fee program, and proposed performance goals for 351(k) applications for FY 2013-2017.
With regard to the FDA's principles for developing a user fee program, the agency seeks comment regarding the following proposed guiding principles:
(1) A user fee program must provide the FDA with sufficient review capacity in order to prevent unnecessary delays in the development and approval of biosimilar and interchangeable biologics.
(2) At least between 2013 and 2107, 351(k) user fees should remain comparable to 351(a) user fees. The notice explains that "at least initially, review to determine biosimilarity or interchangeability of a proposed product in a 351(k) application is expected to be comparably complex, technically demanding, and resource-intensive as review of a proposed 351(a) application."
(3) The 351(k) user fee program should provide funding to support activities that occur early in the biosimilar and interchangeable product development cycle.
(4) Because the same expert scientific teams at the FDA that conduct review of 351(a) applications will typically be involved in the review of 351(k) applications, the 351(k) user fee program should ensure adequate resources for the review of 351(k) applications, so that critical resources for 351(a) review are not redirected from innovator drug review to biosimilar products.
Based on the above principles, the FDA has proposed a user fee program consisting of two fees for 351(k) applications in the premarket phase (i.e., Biosimilar Product Development and 351(k) Marketing Application fees) and two fees for marketed 351(k) products (i.e., Establishment and Product fees). A detailed discussion of these fees can be found in the FDA's Federal Register notice. With regard to the premarket phase fees, the notice indicates that "the FY 2013 annual Biosimilar Product Development fee amount would be on the order of $150,000," and that the 351(k) Marketing Application fee would be set equal to the 351(a) marketing application fee (from which accrued annual Biosimilar Product Development fees would be deducted).
In the third section of its notice, the FDA describes two categories of 351(k) applications (noting that the biosimilars approval pathway prohibits applications from being submitted until 4 years after the reference product was first licensed, and prohibits the FDA from approving such applications until 12 years after the reference product was first licensed). The two categories include: (1) applications submitted 10 or more years after the date of first licensure of the reference product, which would be eligible for approval in 2 years or less, and (2) applications submitted between 4 and 10 years after the date of first licensure of the reference product. While the notice sets forth performance goals for the first category of applications, the FDA, noting that the agency "is concerned about committing resources to meet performance goals that might ready an application for approval years before it could be approved, necessitating updating of the application, new reviews, and new inspections of facilities shortly before the application becomes eligible for approval under the section 351(k)(7)," seeks public input regarding the second category of applications. To guide public comment on the latter category, the FDA poses several questions on page 27066 of the Federal Register notice.
In addition to soliciting public comment regarding user fees, the FDA states that it plans to hold public meetings with public and industry stakeholders on the issue. Those interested in participating in the public meetings should send their complete contact information to BiosimilarsUserFeeProgram@ fda.hhs.gov by June 3, 2011. Written comments are due by June 9, 2011, and can be submitted by regular mail addressed to the Division of Dockets Management (HFA–305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, or electronically at http://www.regulations.gov. Additional information regarding the public meetings and submission of written comments can be found in the FDA's Federal Register notice.
In other biosimilar news, according to reports by Reuters and FierceBiotech, the director of the Center for Drug Evaluation and Research at the FDA, Dr. Janet Woodcock, has indicated that a full set of biosimilar guidelines will be released by the FDA later this year.