Monday, August 20, 2012

Approved FDA User Fees for Biosimilars

Today's guest post is authored by Amy M. Belton, PhD, Research Associate, Johns Hopkins University School of Medicine.

The FDA has recently released the 2013 User Fees for Biosimilars, which outlines the fees charged to companies that are seeking FDA approval of their biosimilar therapies. The fee schedule is in effect October 1, 2012 to September 30, 2013. The sponsor is responsible for paying fees associated with biological product development (BPD) of a biosimilar product. The biosimilar biological product application fees can be either $979,440 or $1,958,800 depending upon whether clinical data is included. The fees are necessary throughout the development process so that the FDA can review applications in a timely manner

The FDA charges user fees in an effort to supplement the current budget which helps pay for the review of medical devices, drugs and now biosimilar applications. Each area has its own fees associated with reviewing applications. Charging user fees also requires the FDA to abide by time tables agreed upon by industry and the FDA in order to expedite the review of applications. The user fee system for biosimilars was adopted from the Prescription Drug User Fee Act which requires sponsors to pay fees in order to assure timely review of applications submitted to the FDA. User fees have significantly decreased the approval time for new therapies. This important for patients suffering from diseases in which these therapies are intended to treat.

The 13th Annual Biosimilars and Generic Drugs Meeting it will be important for generic drug manufacturers to share with biosimilar manufacturers the history of the user fee program and to give insight into what biosimilar sponsors will need to be aware of as they begin to secure FDA approval of a biosimilar.  For more information on the event, download the agenda.  If you'd like to join me in Boston, register today and mention code XP1786BLOG and save 25% off the standard rate!

Do you agree that the FDA should charge companies user fees? Do you think these fees will be a deterrent for some biosimilar manufacturers in these tough economic times?  Based on the current pipeline of development which sponsor do you think will secure the first USFDA approved biosimilar?

The complete FDA user fee notice can be found here.

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