The Biosimilar User Fee Act of 2012 (BsUFA) authorizes the FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development (BPD). These user fees are intended to expedite the review process of biosimilar products, and are amended on an annual basis to account for inflation and to ensure that the Agency’s needs are being met.
Late last week, FDA announced its rates for fiscal year 2017, which have significantly decreased from the Agency’s 2016 rates. FDA’s fiscal year 2017 biosimilar user fee rates are as follows:
|Fee Category||FY 2017 Fee Rates|
|Applications Requiring Clinical Data||$2,038,100|
|Applications Not Requiring Clinical Data||$1,019,050|
|Supplement Requiring Clinical Data||$1,019,050|
In addition to providing the updated rates, FDA’s notice states the following:
In some situations, the FDA states that it may grant a small business waiver from its first biosimilar biological product application fee. These rates will kick-in on October 1st and will remain in effect until September 30, 2017.
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