Regulatory Focus™ > News Articles > FDA Unveils Higher PDUFA, Lower BsUFA Fees for FY 2018

FDA Unveils Higher PDUFA, Lower BsUFA Fees for FY 2018

Posted 14 September 2017 | By Zachary Brennan 

FDA Unveils Higher PDUFA, Lower BsUFA Fees for FY 2018

With the new user fee deals signed into law, the US Food and Drug Administration (FDA) on Wednesday unveiled the revamped fee amounts that will apply from 1 October 2017 to 30 September 2018 for prescription drug and biosimilar application and programs.

For prescription drugs requiring clinical data, the price for FY 2018 will be about $2.4 million, which is nearly $400,000 more than in 2017. For prescription drugs not requiring clinical data, the fee will be about $1.2 million, which is about $192,000 more than 2017.

Orphan products will still be exempt from paying fees and FDA says it approximates that about 37 program fees will be exempted in FY 2018.

"The FY 2018 revenue amount may be adjusted further, if necessary, to provide for sufficient operating reserves of carryover user fees," FDA said in a Federal Register notice. "Finally, the amount is adjusted to provide for additional direct costs to fund PDUFA VI initiatives. Fee amounts are to be established each year so that revenues from application fees provide 20 percent of the total revenue, and prescription drug program fees provide 80 percent of the total revenue."


On the biosimilar side, which was aligned with fees from the Prescription Drug User Fee Act (PDUFA) in the last agreement but now has its own formula, fee rates for FY 2018 include:

  • Initial biosimilar biological product development (BPD) fee: $227,213
  • Annual BPD fee: $227,213
  • Reactivation (a fee to resume participation in a discontinued program): $454,426
  • Applications requiring clinical data: $1,746,745 (which is about $292,000 less than 2017)
  • Applications not requiring clinical data: $873,373 (which is about $146,000 less than 2017)
  • Program fees: $304,162

"The initial BPD fee for a product is due when the sponsor submits an IND that FDA determines is intended to support a biosimilar biological product application for the product or within 5 calendar days after FDA grants the first BPD meeting for the product, whichever occurs first," FDA said in a notice.

But while BsUFA fees are lower, companies note that they will no longer deduct the annual BPD fees from the BsUFA application fee upon filing, which can add up considering biosimilar products are in the BPD program for four or more years.

In late August, FDA also unveiled the medical device and generic drug user fees.

Editor's note: Updated 9/15/17 on the annual BPD fee deduction.

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