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BsUFA Fees to Surge for Fiscal 2017

August 2, 2016

Biosimilar user fees under BsUFA will climb across the board starting Oct. 1.

Fees for BLA filings requiring clinical data in fiscal 2017 will increase $168,050 to $1.19 million while those without clinical data will rise $336,100 to $2.37 million.

The FDA’s announced fee schedule also shows supplemental filings that incorporate clinical data will climb to $1.02 million, while a supplement requiring clinical data will be double that: $2.04 million.

Product fees and establishment fees also saw an uptick, with product fees rising $16,700 to $114,450 and establishment fees rising $73,000 per establishment to $585,200.

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