FDA Releases BsUFA Fee Rates, Performance Goals for 2018

The FDA has published its Biosimilar User Fee Act (BsUFA) rates for 2018. The Biosimilar User Fee Amendments of 2017 (BsUFA II) authorize the agency to assess and collect fees from applicants for biosimilar products from October 2017 to September 2022. The FDA uses the fees to expedite the review process for biosimilars.

Some of the 2018 rates represent substantial increases from those charged in 2017:

• Initial biological product development (BPD) fees will increase from $203,810 in 2017 to $227,213 in 2018
• Annual BPD fees will increase from $203,810 to $227,213
• Reactivation fees will increase from $407,620 to $454,426

However, application fees will see some reductions:

• Fees for applications requiring clinical data will drop to $1,746,745 from $2,038,100
• Applications not requiring clinical data will drop to $873,373 from $1,019,050

The 2018 fees include a new program fee of $304,162, but eliminates 2 fee categories: product fees ($97,750) and establishment fees ($512,200).

The agency also released its performance goals for the coming year. The agency plans to review and act on:

• 90% of original biosimilar biological product application submissions within 10 months of the 60-day filing date
• 90% of resubmitted original biosimilar biological product applications within 6 months of the receipt date
• 90% of original supplements with clinical data in 10 months of receipt
• 90% of resubmitted supplements with clinical data within 6 months of receipt

The agency also has plans to improve its performance with respect to original manufacturing supplements. In 2018, its goal is to review and act on 70% of manufacturing supplements requiring prior approval within 4 months of receipt. That percentage will increase by 5% per year until 2022, when the FDA plans to act on 90% of such supplements within the same timeframe. Manufacturing supplements that do not require prior approval will be reviewed, across all years from 2018 to 2022, within 6 months of receipt.

The FDA will also implement its program for enhanced review transparency and communication for original 351 Biologics License Applications. According to the FDA, the program is designed to promote efficiency and effectiveness of the first review cycle process for biosimilars, and to minimize the number of review cycles needed for an approval. Under the program, the FDA review team and the biosimilar applicant may follow a standard communication approach, or may reach a mutual agreement on the timing and nature of interaction and the information exchange between the 2 parties.

Under a standard approach, the agency will hold a presubmission meeting with the applicant to discuss the planned content of the application, the applicant will submit an original application, and the FDA will communicate substantive review issues in its Day 74 letter (or notify the applicant if no substantive review issues were identified). The BsUFA review period will begin at the end of the 60-day filing review period beginning on the day of the FDA’s receipt of the original submission. The FDA will communicate with the applicant mid-cycle in the review process to provide an update on the review’s status, and will also meet with the applicant late in the cycle. For applications that will be subject to an advisory committee meeting, the FDA plans to convene meetings not later than 2 months prior to the BsUFA goal date. The FDA plans to complete all inspections for applications in each program within 10 months of having received an application.