The FDA has announced the rates for biosimilar user fees for the 2017 Fiscal Year:
FY17 BsUFA Fees
| Biological Product Development | Initial | $203,810 |
|---|---|---|
| Annual | $203,810 | |
| Application | w/Clinical Data | $2,038,100 |
| w/o Clinical Data | $1,019,050 | |
| Supplement | w/Clinical Data | $1,019,050 |
| Product | $97,750 | |
| Establishment | $512,200 | |
| Reactivation | $407,620 | |
The biosimilar user fees for a given fiscal year are calculated as a percentage of the fee rate established under the Prescription Drug User Fee Act (PDUFA) for that fiscal year. Interestingly, the rates for FY17 are lower than the current rates:
FY16 BsUFA Fees
| Biological Product Development | Initial | $237,420 |
|---|---|---|
| Annual | $237,420 | |
| Application | w/Clinical Data | $2,374,200 |
| w/o Clinical Data | $1,187,100 | |
| Supplement | w/Clinical Data | $1,187,100 |
| Product | $114,450 | |
| Establishment | $585,200 | |
| Reactivation | $474,840 | |
The new rates will take effect on October 1, 2016.