Report: FDA Zeroes in on Biosimilar Review

Participation in biosimilar development program activities with the FDA has seen a steady uptick over the past three fiscal years — from 33 in fiscal 2013 to 57 last year — according to an analysis by independent consulting firm Eastern Research Group.

In the analysis, which is intended to provide an independent study of the workload and costs associated with the biosimilar program, ERG estimates that agency has spent $81.7 million on biosimilar-related activities since fiscal 2013.

ERG also found that labor costs associated with reviews rose from $13.5 million to $21.4 million last year, for a total of about $48 million.