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.
|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:
- “The initial BPD fee for a product is due when the sponsor submits an investigational new drug (IND) application that FDA determines is intended to support a biosimilar biological product application or within 5 calendar days after FDA grants the first BPD meeting, whichever occurs first. A sponsor who has paid the initial BPD fee is considered to be participating in FDA’s BPD program for that product.”
- “Once a sponsor has paid the initial BPD fee for a product, the annual BPD fee is assessed beginning with the next fiscal year.”
- “if a sponsor has discontinued participation in FDA’s BPD program and wants to re-engage with FDA on development of the product, the sponsor must pay a reactivation fee to resume participation in the program.”
- However, FDA also states that the reactivation fee must be paid either within five days of FDA granting the sponsor’s request for a BPD meeting for that product, OR “upon the date of submission of an IND describing an investigation that FDA determines is intended to support a biosimilar biological product application.”
- “Under BsUFA, the initial and annual BPD fee rates for a fiscal year are equal to 10 percent of the fee rate established under the Prescription Drug User Fee Act (PDUFA) for an application requiring clinical data for that fiscal year.”
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.