The Biosimilar User Fee Act (BsUFA) requires FDA 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. On February 24, 2016, the FDA released the Final Results Report of its Study of Workload Volume and Full Costs, prepared in conjunction with Eastern Research Group, Inc. (ERG).
ERG’s calculations cover the first three years of the FDA biosimilars program (FY13-15), and include estimates for several components, including biosimilar development program activities, 351(k) BLA reviews, science and research, training, and outreach. ERG’s calculations were based on interviews, email requests for time estimates associated with work on BLAs, CDER time reporting data, 2013-2015 FDA BsUFA financial reports, and volume numbers for sponsors, meetings, meeting requests, and other data that is tracked by FDA.
ERG’s data has been collected in tables at the beginning of the report. While the number of total biologics submissions has increased every year from 33 in FY13 to 57 in FY15, and total workload has increased from about 86 FTEs (Full-Time Equivalents) in FY13 to about 126 FTEs in FY15, some aspects, such as the amount of time spent by FDA on Science and Research, and Training, have gone down. Overall, ERG estimates that FDA has spent a total of $81.7 million on biosimilars-related work over the first three fiscal years of the program.
Read the full report here.
Stay tuned to Big Molecule Watch for more biosimilar news as it develops.