FDA Seeks Comments on Interim Biosimilars Report

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By Bronwyn Mixter

Sept. 24 — The FDA is seeking comments on the interim results of a study on the workload and costs associated with the review of biosimilar product applications, according to a notice published Sept. 24 in the Federal Register (80 Fed. Reg. 57,621).

The interim report said that as of March 31, the Food and Drug Administration had received a total of 52 investigational new drug applications and pre-investigational new drug applications, participated in 102 biosimilar product development meetings of all types and received five biologics license applications for biosimilar products.

The FDA spent $23.6 million in fiscal year 2013, $21.4 million in FY 2014 and $20.9 million in the first two quarters of FY 2015 for biosimilar-related work, the report said. In total, the FDA has spent $65.9 million over the first 2.5 fiscal years of the program.

The study was conducted by an independent consulting firm, Eastern Research Group of Lexington, Mass., and it fulfills a statutory requirement under the first authorization of the Biosimilar User Fee Act of 2012 (BsUFA), which enables the FDA to collect user fees from companies for the review of biosimilar applications for fiscal years 2013 to 2017, the notice said.

The Affordable Care Act (Pub. L. 111-148) amended the Public Health Service Act to create an abbreviated licensure pathway for biological products that are demonstrated to be “biosimilar” to or “interchangeable” with an FDA-licensed biological product. The agency approved the first, and so far only, biosimilar for the U.S. in March. That biosimilar, Zarxio, is a Sandoz product that is biosimilar to Amgen's cancer drug Neupogen; and Sandoz (part of Novartis) began selling it in September.

BsUFA, part of the FDA Safety and Innovation Act (Pub. L. No. 112-144), authorizes the FDA to assess and collect fees for biosimilar products. The agency uses these fees to expedite the review process for these products.

At a Sept. 17 Senate hearing, an FDA official said there are 57 biosimilars in development and the agency is meeting with the sponsors of those products and has issued three final guidance documents. However, at that hearing, lawmakers criticized the agency for not issuing guidance on topics such as biosimilar labeling and interchangeability.

Comments on the interim report are due Oct. 26 (Docket No. FDA–2015–N–3155).

To contact the reporter on this story: Bronwyn Mixter in Washington at bmixter@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

The interim report is at http://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM459686.pdf.

The Federal Register notice is at http://www.gpo.gov/fdsys/pkg/FR-2015-09-24/pdf/2015-24227.pdf.