By Nitisha Pyndiah, PhD
The FDA guidance document Assessing User Fees Under the Biosimilar User Fee Amendments of 2017 explains the changes, but let’s review the most important items.
The Biosimilar User Fee Act of 2012 (BsUFA I) added sections to the FD&C Act, authorizing FDA to collect user fees for a 5-year period from developers of biosimilar biological products. BsUFA was reauthorized in 2017 for a 5-year period under Title IV of the FDA Reauthorization Act of 2017 (BsUFA II) and fees have increased. Read on to understand those changes.
What are the main differences between BsUFA I and BsUFA II?
There are three types of fees under BsUFA II that are set each fiscal year:
Biosimilar biological product development program fees (BPD fees)
Biosimilar biological product application fees (application fees)
Biosimilar biological product program fees (program fees)
This means that the fees for supplements and for establishments have been eliminated.
A very important aspect is that BsUFA II also eliminates the reduction of an application fee by the cumulative amount of fees paid by the applicant under the BPD program meaning that the full application fee will be due at the time of submission for BLAs with clinical data required to support safety and efficacy.
For example, if an applicant submits their BLA in December 2018, the BPD annual fees for FY2019 will be due on October 1, 2018 and will not be refunded or deducted.
The fees for FY2019 (October 1, 2018 to September 30, 2019) will be published in August 2018.
Let’s describe further those BSUFA II fees
Initial BPD fee
One-time fee assessed to a sponsor to enter a BPD program (the sponsor enters the program by submitting a meeting request for a BPD meeting for a product or submits a clinical protocol for an investigational new drug application (IND) describing an investigation to support a biosimilar biological product application)
Annual BPD fee
An annual fee that the sponsor has to pay the next fiscal year after paying the initial BPD fee. This amount is due on or after October 1 of each fiscal year.
As this part can be confusing, some further clarifications: If a person submits a BLA for a biosimilar before October 1 of the fiscal year and the application is accepted for filling on or after October 1 of that fiscal year, the applicant may request a refund of the annual BPD fee paid.
A sponsor may also wish to discontinue the participation in a BPD program but need to keep in mind that to resume participation in the BPD program (by requesting a BPD meeting or submitting a clinical protocol to an IND) the sponsor will have to pay a reactivation fee within 5 calendar days of FDA granting a meeting or upon submission of the IND. That reactivation fee is twice the amount of the annual BPD fee established for that fiscal year.
From FY 2018, each person that submits an application (BLA for biosimilar) is assessed an application fee:
Full application fees for a biosimilar BLA for which clinical data with respect to safety or effectiveness are required for approval
Half of the full application fees for a biosimilar BLA for which clinical data with respect to safety and effectiveness are not required for approval
Exception to the application fees
If a biosimilar BLA:
was submitted by a person that paid the fee for the application,
was accepted for filing, and
was not approved or was withdrawn (without a waiver)
Refund of the application fee
If an application is refused for filing or is withdrawn without a waiver before filing, FDA will refund 75% of the application fee paid. An application that was withdrawn before filing or refused for filing will be subject to the full application fee when resubmitted, unless a waiver applies.
Waiver of the application fees
Small business submitting its first biosimilar biological product application to the FDA and does not have another product that has been approved under a human drug application or a biosimilar.
A fee for approved applications
Program fees are assessed to each person who is named as the applicant in a biosimilar biological product application for each biosimilar biological product identified in an approved biosimilar biological product application as of October 1 of the fiscal year.
Important note: Program fees for liquid parenteral biosimilar biological products. The definition of biosimilar biological product was reviewed under BsUFA II to mean a ‘specific strength of a biological product in final dosage form for which a biosimilar biological product application has been approved’. E.g an autoinjector with the same strength or potency in final dosage form as a prefilled syringe or vial will be assessed a separate program fee.
There is a limit of five program fees to be paid for biosimilar biological products identified in each approved application.
What happens if you fail to pay the fees?
A BPD meeting related to a product for which fees have not been paid, will not be granted by FDA
FDA will not consider an IND submitted for the product to have been received under section 505(i)(2) of the FD&C Act if FDA determines that the investigation is intended to support a biosimilar biological product application
FDA shall prohibit the sponsor of a clinical investigation from continuing the investigation (‘financial hold’) if FDA determines that the investigation is intended to support a biosimilar biological product application.
Stay tuned for our next blog post on this topic where we will provide you with the detailed costs for the development of a biosimilar biological product.
Do you need help with the development of your biosimilar product or determining what fees you have to pay?
Are you in the process of developing a biosimilar biological product? Do you need help preparing and submitting your IND or BLA to the FDA? Or perhaps you need to request a Biosimilar Initial Advisory Meeting or a Biosimilar Product Development (BPD) Meeting. We can help. Contact us today to learn more about our services and how we can help you advance our product with the FDA.
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.