The FDA recently announced a notice of public meeting and request for comments in the Federal Register regarding proposed recommendations for a user fee program for biosimilar biological products for fiscal years 2013 through 2017. The Federal Register notice describes the FDA’s proposed user fee program, as well as FDA’s proposed performance goals and procedures.
The public meeting will be held on Friday, December 16, 2011, from 9 a.m. to 1 p.m at FDA’s White Oak Campus in Silver Spring, MD. Registration to attend the meeting must be received by December 14, 2011. The FDA requests that electronic or written comments be submitted by January 6, 2012. Further details on how to register or submit comments can be found here.
The proposed recommendations include four types of fees, including biosimilar product development (BPD) fees, marketing application fees, and establishment and product fees, which are summarized briefly below.
The FDA proposed biosimilar product development fees include an initial BPD (Biosimilar Product Development) fee for each product and an annual BPD fee. Sponsors are required to pay only a single initial BPD fee for each product no matter how many indications are proposed for the product. The initial BPD fee for each fiscal year from 2013 to 2017 is proposed to be 10 percent of the human drug application fee established under PDUFA for that fiscal year. Each year thereafter an annual BPD fee is due on or before October 1 until a marketing application that is submitted by the sponsor is accepted for filing or the sponsor stops participating in the BPD program.
The FDA proposed that the marketing application fee be equivalent to the human drug application fee established under the Prescription Drug User Fee Act (PDUFA), less any cumulative BPD fees already paid for the biologic product. The FDA also proposed that the product establishment and product fees be equivalent to the establishment and product fees established under PDUFA for any given fiscal year.