The schedules for the 2024 Biosimilar User Fees (BsUFA) (here) and Medical Device User Fees (MDUFA) (here) have been posted on the Federal Register prepublication page and are scheduled for final publication on August 28, 2024. 

BsUFA Fees 

The Biosimilar User Fee Amendments of 2022 (BsUFA III) authorize the FDA to assess and collect user fees for certain activities in connection with biosimilar biological product development, review of certain applications for approval of biosimilar biological products, and each biosimilar biological product approved in a biosimilar biological product application.  BsUFA III directs the FDA to establish, before the beginning of each fiscal year, the amount of initial and annual biosimilar biological product development (BPD) fees, the reactivation fee, and the biosimilar biological product application and program fees for such year.  These fees apply for the period from October 1, 2023, through September 30, 2024. 

Here are the fees for FY 2024: 

BsUFA Fees for FY 2024 

Fee Category  FY 2023
Fee Rate 		 FY 2024
Fee Rate 		 Change 
Initial BPD  $47,325  $10,000  -$37,325 
Annual BPD  $47,325  $10,000  -$37,325 
Reactivation  $94,650  $20,000  -$74,650 
Applications 
  Requiring clinical data  $1,746,745  $1,018,753  -$727,992 
  Not requiring clinical data  $873,373  $509,377  -$363,996 
Program Fee  $304,162  $177,397  -$126,765 

This must come as a welcome surprise and shows what happens when the biosimilar pathway is utilized to become a welltrafficked highway: The price for each unit of service comes down dramatically.  I don’t believe we have ever seen a drop in fees of this magnitude in any of the other UFA programs.  This drop is clearly a marker of the success of the biosimilar program as more and more biosimilars gain approval and make it to market.  As the success of biosimilars takes off, so do the number of players in the field.  With the pressure on smallmolecule drug prices, the BsUFA program has even more of an allure for those wishing to tackle the more complex “generic”type biologic products. 

MDUFA Fees 

As for MDUFA, we note that all of the many fees rose for FY 2024.  I wonder how CDRH keeps track of all these fees. 

It may be helpful to review the FR notices cited at the beginning of this blog for further information on the assumptions that the FDA uses to reach these new fees.  These fees will go into effect on October 1, 2023 and remain in effect until September 30, 2024, after which the new fiscal year will begin. 

MDUFA Fees for FY 2024 

Application Fee Type  FY 2023 Fee Standard  FY 2023 Small Business Fee  FY 2024 Fee Standard  FY 2024 Small Business Fee 
Premarket application (a PMA submitted under section 515(c)(1) of the FD&C Act (21 U.S.C. 360e(c)(1)), a PDP submitted under section 515(f) of the FD&C Act, or a BLA submitted under section 351 of the Public Health Service Act (the PHS Act) (42 U.S.C. 262))  $441,547  $110,387  $483,560  $120,890 
Premarket report (submitted under section 515(c)(2) of the FD&C Act)  $441,547  $110,387  $483,560  $120,890 
Efficacy supplement (to an approved BLA under section 351 of the PHS Act)  $441,547  $110,387  $483,560  $120,890 
Panel-track supplement  $353,238  $88,309  $386,848  $96,712 
De novo classification request  $132,464  $33,116  $145,068  $36,267 
180-day supplement  $66,232  $16,558  $72,534  $18,134 
Real-time supplement  $30,908  $7,727  $33,849  $8,462 
510(k) premarket notification submission  $19,870  $4,967  $21,760  $5,440 
30-day notice  $7,065  $3,532  $7,737  $3,869 
513(g) request for classification information  $5,961  $2,980  $6,528  $3,264 
Annual Fee Type 
Annual fee for periodic reporting on a class III device  $15,454  $3,864  $16,925  $4,231 
Annual establishment registration fee  $6,493  $6,493  $7,653  $7,653