FDA Outlines BsUFA II Fee Structure in Draft Guidance

The FDA published a draft guidance explaining the new biosimilar fee structure under BsUFA II and the types of fees that took effect Oct. 1. The draft also covers how to submit payments to the agency, the consequences for failing to pay and how to request reconsiderations of fee assessments.

The second generation of the fee program authorizes fees for development programs, for applications and for ongoing product programs. Fees for filing prior-approval supplements and for establishments were eliminated under the five-year authorization. BsUFA II also dropped a previous provision allowing cumulative development fees to count toward the application fee.

If fees are not paid, the FDA will not consider an investigational new drug application for the product for which a fee is due and it will stop any clinical trials under way for the product.