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FDA Finalizes Guidance on Biosimilar User Fees Under BsUFA II

Posted 28 June 2018 | By Michael Mezher 

FDA Finalizes Guidance on Biosimilar User Fees Under BsUFA II

The US Food and Drug Administration (FDA) on Thursday finalized guidance explaining changes to its user fee program for biosimilar products and the fees it charges industry under the Biosimilar User Fee Amendments of 2017 (BsUFA II).

FDA says the final guidance does not include any substantive changes from the draft version issued in November 2017.

For the second iteration of its user fee program for biosimilars, FDA and industry negotiated a number of changes that affect the types of fees industry pays and how those fees are collected.
Under BsUFA II, sponsors are assessed three types of fees:
  • Initial and annual biosimilar biological product development program (BPD) fees
  • Biosimilar biological product application fees
  • Biosimilar program fees
For BPD fees, sponsors are assessed a fee when they enter the biosimilar biological product development program within five calendar days of FDA granting the first BPD meeting for the product or when the sponsor submits an investigational new drug (IND) application for the product.

Sponsors are also required to pay an annual BDP fee at the start of each fiscal year while their product is still in active development. Sponsors are also assessed a reactivation fee equal to twice the amount of the annual BPD fee if they wish to resume development of a biosimilar after halting development.

As with BsUFA I, biosimilars are assessed an application fee upon submission to FDA. The fee for applications that do not require clinical data for safety and effectiveness is half that for those that do.

Once a sponsor has an approved biosimilar, they will be assessed a biosimilar program fee annually for each of their approved biosimilars. In a change from BsUFA I, FDA has capped the number of program fees at a maximum of five per company each year, though there are currently no sponsors with five or more approved biosimilars in the US.

In a change from BsUFA I, biosimilar developers are no longer assessed supplemental fees or establishment fees.

Guidance, Federal Register Notice

Categories: Regulatory News

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