In the first two and a half years of the US Food and Drug Administration (FDA)’s biosimilars review program, the agency is only recently starting to ramp up spending and manpower, according to an interim report from Eastern Research Group (ERG) released Wednesday.
Under the Biosimilar User Fee Act (BsUFA), enacted by Congress in 2012, FDA was required to contract with an independent consulting firm to develop an estimate of the workload volume and full costs associated with the process for the review of biosimilar applications, and the agency chose ERG to develop these estimates.
ERG says the goal of the report is to estimate the volume of biosimilars review program work components and the workload and costs. ERG also interviewed a number of FDA staff, including the 55 employees working on the 351(k) biologic license applications (BLAs). Interviews were performed from March to May 2015.
The interim ERG report finds that although FDA received only five 351(k) BLAs for biosimilars between FY 2013 and 31 March 2015, three of those applications came in the first quarter of 2015. FDA’s Center for Drug Evaluation and Research (CDER) Director Janet Woodcock, however, said recently in a Senate hearing that there are 57 biosimilars in development for the US market. She also said that FDA is working to release long-awaited biosimilars guidance on interchangeability, labeling and statistical approaches to the evaluation of analytical similarity data.
That uptick in applications in FY 2015 has translated into FDA spending (in total costs associated with biosimilars) about $20.9 million in the first two quarters of this fiscal year, which compares with $23.6 million in all of FY2013 and $21.4 million in all of FY2014.
“The largest category of work for FDA has been in performing IND [investigational new drug] and pre-IND work, including BPD [biosimilars product development] meetings (55.8 FTEs [full-time employees]). Policy work (23.7 FTEs) and then science and research work (21.0 FTEs) were the second and third largest categories of work,” ERG says.
In comparison to FDA’s findings in its BsUFA financial reporting, ERG says its total cost estimates are slightly lower than FDA's.
Interestingly, the report also notes that the vast majority of the biosimilars work performed by FDA through 31 March has been performed by CDER. And while the interim report focuses on work performed by CDER, and FDA-provided estimates of work from the Center for Biologics Evaluation and Research (CBER), FDA Office of the Commissioner and Office of Regulatory Affairs (ORA), ERG says the final report will include its own estimates for work from the later three divisions.
The final report is due for release by September 2016 and it’s expected to expand on and update this interim report. ERG adds that it will include more information on time spent for clinical inspections during 351(k) BLA reviews in the final report.
ERG Study of Workload Volume and Full Costs