The Food and Drug Administration announced yesterday that the Biosimilar User Fee (BsUFA) program invoices for Fiscal Year (FY) 2019 were emailed to sponsors on August 27, 2018.  Sponsors should expect to receive their invoices by August 29, 2018.  This follows the PDUFA FY 2019 PDUFA program fee invoices which were emailed on August 15, 2018.  Full payment of annual fees is due on October 1, 2018.

The FY 2019 BsUFA fee rates, published in the Federal Register on July 31, 2018, are below.

  FY 2018 FY 2019
BPD Initial $227,213 $185,409
Annual $227,213 $185,409
Reactivation $454,426 $370,818
Application w/ Clinical Data $1,746,745 $1,746,745
w/o Clinical Data $873,379 $873,379
Program $304,162 $304,162

 

As a reminder, although generic sponsors will not receive an invoice for the program fee, the fee is also due on October 1, 2018 (along with the annual facility fee).  For those sponsors who have not withdrawn or transferred ownership of their applications, the fee will be due for all approved ANDAs owned by the sponsor on October 1, 2018.  The FY 2019 GDUFA fee rates are below.

User Fee Type FY 2019 FY 2018
Program Large Size:

≥ 20 ANDAs

  $       1,862,167  $       1,590,792
Medium Size:

Between 16-19 ANDAs

  $           744,867  $          636,317
Small Size:

≤ 5 ANDAs

  $           186,217  $          159,079
Facility Domestic API  $             44,226  $             45,367
Foreign API  $             59,226  $             60,367
Domestic FDF  $           211,305  $          211,087
Foreign FDF  $           226,305  $          226,087
Domestic CMO  $             70,435  $             70,362
Foreign CMO  $             85,435  $             85,362