By Nitisha Pyndiah, Ph.D.

 

The BPD/Program Fee invoices for FY2019 were emailed on August 27, 2018. As a follow-up to my previous blog post on the BsUFA II fees, I will list the BsUFA fees since FY 2015 and use two case studies to help you understand the changes in your Biosimilar User Fees.

In our previous blog post, we described the user fee types for biosimilars: Biosimilar Biological Product Development (BPD) Fees, Application fees and Program fees. We highlighted a major change which eliminated the reduction of an application fee by the cumulative amount of fees paid by the applicant under the BPD program. For certain biosimilar developers that have been in the program for a long time it means an important budget change as there would be no deduction to their application fees. This increase in the fees will be used to expedite the review process for biosimilars, enhance review transparency and communication. According to the Agency, in the BsUFA II Five-year Financial Plan: “During BsUFA I, FDA received fewer original biosimilar biological product application submissions than the Agency had initially expected to receive, which resulted in the collection of relatively more BPD fees than expected and fewer application, establishment, and product fees […] FDA anticipates that many of the development programs started in BsUFA I will convert to original submissions early in BsUFA II, which would contribute to an increase in application review work relative to BsUFA I.”

As a biosimilar developer, you should be aware of these changes to plan appropriately your drug development and maybe realign your budget.

To understand better the change in fees, the user type fees from FY2015 to FY2019, have been listed in the table below.

In green, no reduction on the application fee.

Table 1: Overview of the BsUFA fees from FY 2015 to FY 2019.

Case Study 1

In June 2017, a company A submitted their BLA for their Biosimilar product. Company A had been in the program for three years and would have paid $ 891,660 in BPD fees ($ 216,910 initial BPD fees in 2014 and the annual fees until FY 2017, see table 1). Under BsUFA I, Company A was able to reduce their application fee by deducting the amount paid in BPD fees from the application fee due when the BLA was submitted on June 2017. This company A paid $1,146,440 at the time of the marketing application submission. ($2,038,100 – $891,660= $1,146,440)

•  The total amount of BsUFA fees paid until after submission of the application: $1,146,440

Please note that company A would have paid an establishment fee of $512,200 and a product fee of $ 97,750 once the submission was approved.

Case Study 2

Our second example is company B wishing to submit their BLA for their Biosimilar Product in December 2018. Company B has been in the program for over four years and has paid $ 1,304,282 in BPD fees ($ 216,910 initial BPD fees in 2014 and the annual fees until FY 2019, see table 1).

Company B, initially thought (when they entered the program) that they would be able to reduce their application fee with the amount paid in BPD fees but under BsUFA II they will have no reduction in their application fee at the time of marketing application submission.

Here is the economic impact on the product development of their biosimilar product:

If company B submits the application in December 2018, it means that company B would have to pay the full application fee (w/clinical data) $ 1,746,745 and would have also paid $ 1,304,282 in BPD fees. Although the company is submitting the application in December 2018, they will still have to pay the BPD fees for FY2019 as these are due on the first business day on or after October 1 of each fiscal year.

•  Total amount of BsUFA fees paid until after submission of the application: $1,304,282+$1,746,745=$ 3,051,027

Please note that company B would have to pay an annual program fee of $304,162 for each biosimilar biological product identified in the application (applicants will not be assessed more than 5 program fees per FY) once the product is approved.

for further information, please see “BsUFA II fees—are you aware of the major changes?” here.

 

Nitisha Pyndiah - Biotech Consulting Services

Nitisha Pyndiah, PhD, is a Consultant where she provides advice for the development of biological, biotechnological, and biosimilar products.

Nitisha provides expertise in the areas of virology, molecular biology, microbiology, immunology, immunogenicity, quality control, GLP and GMP. She prepares and evaluates CMC sections, including FDA meeting documents; and conducts scientific and regulatory gap analyses. She supports technical, strategic, and operational regulatory affairs for recombinant proteins, monoclonal antibodies, and vaccines.