User Fees to increase for NDAs, BLAs and ANDAs in Fiscal 2016

August 6, 2015

Manufacturers of new drugs and biologics, generics and biosimilars, as well as outsourcing facilities, will pay higher user fees for their applications starting Oct. 1, according to figures released last week by the FDA.

In all, the agency expects to collect $1.2 billion in user fees in fiscal 2016: $851.5 million from PDUFA drugs, $318.7 million from generic drugs and $815,479 from outsourcing facilities. Target revenue estimates for biosimilars were not included in the FDA’s notice.

User fees for NDAs and BLAs that require clinical data will be $2.37 million in fiscal year 2016, up slightly from $2.34 million this year. Applications that don’t require clinical data will be $1.19 million, again up slightly from $1.17 million. Manufacturers will pay an annual establishment fee of $585,200 for each facility, up from $569,200, and $114,450 for each product, up from $110,370.

ANDA filers will pay nearly $20,000 more per application next year — $76,030 versus the current $58,730. However, facility fees will be lower — $243,905 for domestic drug manufacturing plants, down from $247,717, and $258,905 for foreign plants, down from $262,717. Drug master file fees will be rise to $42,867 from this year’s $26,720.

The annual fee for biosimilar product development programs, the precursor to an actual biosimilar application, will increase from $233,520 this year to $237,420 next year. Submitting a biosimilar application requiring clinical data will cost drugmakers $2.37 million, the same as for an original NDA or BLA. The fee for a biosimilar product supplement with clinical data is $1.19 million.

The FDA also announced fee rates for outsourcing facilities. Small business outsourcing facilities will pay $5,203, up from $5,103 in fiscal 2015, while non-small businesses will pay $16,465, up from $16,442. All outsourcing facilities will pay the same fee for a reinspection — $15,610, up from $15,308.

Notices outlining the new user fees for PDUFA, GDUFA, biosimilars and outsourcing facilities can be found here: www.fdanews.com/7-15-PDUFA.pdf, www.fdanews.com/7-15-GDUFA.pdf, www.fdanews.com/7-15-BioFees.pdf, www.fdanews.com/7-15-FacilityFees.pdf. —Jonathon Shacat