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 Rates for FY 2016
Requiring Clinical Data
Not Requiring Clinical Data
Supplement Requiring Clinical Data
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.