Stay ahead of developments in federal and state health care law, regulation and transactions with timely, expert news and analysis.
Aug. 4 — The Food and Drug Administration Aug. 4 released a draft guidance to assist sponsors and other interested parties in providing information that will help the agency determine the exclusivity period for biologics approved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A notice announcing the draft guidance will be published in the Aug. 5 Federal Register.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The agency said in the draft guidance that it is reviewing options for making information publicly available regarding reference product exclusivity and dates of first licensure.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In the draft guidance, the FDA recommended that sponsors provide the following information to help with evaluating the date of first licensure: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The agency asked that comments on the draft guidance, identified by Docket No. FDA-2013-D-1165, be submitted by Oct. 6.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.
To contact the reporter on this story: Bronwyn Mixter in Washington at firstname.lastname@example.org
To contact the editor responsible for this story: Lee Barnes at email@example.com
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.
All Bloomberg BNA treatises are available on standing order, which ensures you will always receive the most current edition of the book or supplement of the title you have ordered from Bloomberg BNA’s book division. As soon as a new supplement or edition is published (usually annually) for a title you’ve previously purchased and requested to be placed on standing order, we’ll ship it to you to review for 30 days without any obligation. During this period, you can either (a) honor the invoice and receive a 5% discount (in addition to any other discounts you may qualify for) off the then-current price of the update, plus shipping and handling or (b) return the book(s), in which case, your invoice will be cancelled upon receipt of the book(s). Call us for a prepaid UPS label for your return. It’s as simple and easy as that. Most importantly, standing orders mean you will never have to worry about the timeliness of the information you’re relying on. And, you may discontinue standing orders at any time by contacting us at 1.800.960.1220 or by sending an email to firstname.lastname@example.org.
Put me on standing order at a 5% discount off list price of all future updates, in addition to any other discounts I may quality for. (Returnable within 30 days.)
Notify me when updates are available (No standing order will be created).
This Bloomberg BNA report is available on standing order, which ensures you will all receive the latest edition. This report is updated annually and we will send you the latest edition once it has been published. By signing up for standing order you will never have to worry about the timeliness of the information you need. And, you may discontinue standing orders at any time by contacting us at 1.800.372.1033, option 5, or by sending us an email to email@example.com.
Put me on standing order
Notify me when new releases are available (no standing order will be created)