As part of BsUFA, FDA was required to contract with an independent accounting or consulting firm to study the workload volume and full costs associated with the process for the review of biosimilar biological product applications. More information about the requirements for the reports are described in section 744I(d) of the FD&C Act (21 U.S.C. 379j-53(d)), as amended by the Food and Drug Administration Safety and Innovation Act enacted in 2012.
- Interim Results of Study of Workload Volume and Full Costs Associated With Review of Biosimilar Biological Product Applications
- Review of Biosimilar Biologic Product Applications: Study of Workload Volume and Full Costs-Interim Report
- Review of Biosimilar Biologic Product Applications: Study of Workload Volume and Full Costs-Final Report