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Regulatory Focus™ > News Articles > Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017

Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017

Posted 27 July 2016 | By Zachary Brennan 

Prescription Drug and Biosimilar User Fees to See Major Discounts in 2017

As an increasing number of new drug applications (NDAs) and biologic license applications (BLAs) are expected to be submitted in 2017, the US Food and Drug Administration (FDA) has lowered some of the application fees by more than $300,000.

For 2017, the fee for an NDA requiring clinical data or a biosimilar application requiring clinical data will be $2,038,100, which is $336,100 less than the $2.37 million fee from 2016.

For an NDA not requiring clinical data or a supplement requiring clinical data, or a biosimilar biological product supplement with clinical data, the user fee is $1,019,050, which is $168,050 less than the fee for 2016. Establishment fees for 2017 will amount to $512,200, which is $73,000 less than 2016, and the 2017 fee for a new prescription drug or biosimilar product is $97,750, which is $16,700 less than 2016’s fee rate and more than $6,000 less than the fee for 2014.

If a prescription drug or biosimilar company paid one of each of these fees in 2017, it would see a total of $593,850 in savings when compared to 2016.

These fees are effective on 1 October 2016 and will remain in effect through 30 September 2017, when the Prescription Drug User Fee Act (PDUFA) and the Biosimilar User Fee Act (BsUFA) will be re-authorized.

Calculation of Fees

FDA notes that at the beginning of 2016, the establishment fee was based on an estimate that 485 establishments would be subject to and would pay fees, and by the end of FY 2016, FDA estimates that 523 establishments will have been billed for establishment fees, before all decisions on requests for waivers or reductions are made.

FDA also estimates that it will either waive or reduce fees for 16 establishments and that another 16 establishment fees will be exempted this year because of an orphan drug exemption, meaning FDA is expecting a net of 491 fee-paying establishments.

The FY 2017 product fee rate ($97,750) is determined by dividing the adjusted total fee revenue to be derived from product fees ($251,508,000) by an estimated 2,573 products.

And similar to the Generic Drug User Fee Act (GDUFA) fees unveiled on Tuesday, FDA says that after running analyses on the status of PDUFA’s operating reserves and its estimated balance as of the beginning of FY 2018, FDA estimates that the PDUFA program will have sufficient funds for the operating reserves so it will not be performing a final year adjustment as such an adjustment, was deemed to be unnecessary.

Other BsUFA Fees

In addition to the user fees that are the same for biosimilar and new drug applications, for FY 2017 initial and annual Biological Product Development (BPD) fees will be $203,810, which is $33,610 less than 2016’s fee. The BPD reactivation fee for 2017 will be $407,620, which is $67,220 less than 2016’s fee.

However, FDA notes that if a sponsor submitting a biosimilar application has previously paid an initial BPD fee, annual BPD fee(s) and/or reactivation fee(s) for the product that is the subject of the application, the fee for the application is reduced by the cumulative amount of these previously paid fees. 

Invoices for establishment and product fees for FY 2017 will be issued in August 2016 using the new fee schedule, FDA added.

Biosimilar Fee Schedule for FY 2017

Initial BPD $203,810

Annual BPD $203,810

Reactivation $407,620

Applications Requiring clinical data $2,038,100

Not requiring clinical data $1,019,050

Supplement requiring clinical data $1,019,050

Establishment $512,200

Product $97,750

Prescription Drug User Fee Rates for Fiscal Year 2017

Biosimilar User Fee Rates for Fiscal Year 2017


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