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Aug. 4 — The Food and Drug Administration Aug. 4 released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved under Section 351(a) of the Public Health Service Act (PHS Act).
A notice announcing the draft guidance will be published in the Aug. 5 Federal Register.
The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) amended the PHS Act and other statutes to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed biologic reference product. Section 351(k)(7) of the PHS Act describes reference product exclusivity, during which a 351(k) sponsor isn't permitted to submit and the FDA isn't permitted to license a 351(k) application that references a reference product, the agency said.
Under this section, approval of a 351(k) application may not take effect until 12 years after the date of first licensure of the reference product, the FDA said. A 351(k) application for a biosimilar or interchangeable biological product cannot be submitted for review until four years after the date on which the reference product was first licensed.
The FDA said 351(k) applicants may provide information to the agency to assist with its analysis of the date of first licensure for a biological product.
The agency said in the draft guidance that it is reviewing options for making information publicly available regarding reference product exclusivity and dates of first licensure. The FDA said that once a method is determined, it plans to communicate this information on its website.
In the draft guidance, the FDA recommended that sponsors provide the following information to help with evaluating the date of first licensure:
The agency said that any other information and data that would assist in making a determination regarding the date of first licensure also should be included.
The FDA said it estimates that it will receive a total of approximately 10 requests annually for determining the date of first licensure. The agency also said the average burden per response will be 150 hours, for a total estimated reporting burden of 1,500 hours.
The agency asked that comments on the draft guidance, identified by Docket No. FDA-2013-D-1165, be submitted by Oct. 6.
A spokeswoman for the Biotechnology Industry Organization (BIO) told Bloomberg BNA Aug. 4 that BIO is reviewing the draft guidance.
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The draft guidance is at http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM407844.pdf and the Federal Register notice is at http://op.bna.com/hl.nsf/r?Open=bdmr-9mnlbs.
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