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FDA Biosimilar User Fee Rates: Fiscal Year 2016

August 7, 2015

In order to expedite the review process of biosimilar biological products, FDA is authorized to assess and collect fees from sponsors. The fees are collected for various activities related to biosimilar biological product development (BPD), including:

  • Initial and annual BPD fees;
  • Reactivation fees; and
  • Biosimilar biological product application, establishment, and product fees.

User fee rates are amended on an annual basis to account for inflation and to ensure the needs of the Agency are being met. Rates for fiscal year 2016 are as follows:

 

Fee Category

Fee Rates for FY 2016
Initial BPD

$237,420
Annual BPD

$237,420
Reactivation

$474,840
Applications:
Requiring Clinical Data

$2,374,200
Not Requiring Clinical Data

$1,187,100
Supplement Requiring Clinical Data

$1,187,100
Establishment

$585,200
Product

$114,450

 

Need help with your biosimilar biological product application? With filing fees as high as they are, we know how important it is for your application to be done correctly the first time around; as such we are focused on working with you to achieve positive outcomes at FDA. Because of this focus, our clients have an outstanding rate of success when working with us. For details about our unique approach and information on how we can help get your product approved by FDA faster and cheaper, please contact us. 
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