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# Biosimilar Costs at FDA Jumped 40% Last Year
- URL: https://www.fdaweb.com/biosimilar-costs-at-fda-jumped-40-last-year/
- Published: 2016-03-14T12:00:00.000Z
- Updated: 2026-09-15T02:43:26.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5135065

> FDA’s costs for implementing its biosimilars program jumped almost 40% last year after the first application was reviewed and approved, according to a [new independent report](http://www.fda.gov/downloads/ForIndustry/UserFees/BiosimilarUserFeeActBsUFA/UCM488846.pdf?ref=fdaweb.com) commissioned by the agency. The report was mandated by the biosimilars user fee program to study the workload volume and full costs associated with the process for reviewing biosimilar biological product applications. During FY 2015, the agency spent $32.3 million on the biosimilars program, a 39% increase (about $9 million) compared to the $23.5 million spent in 2014, it says.  
>  
> According to the report, there are 57 products registered under the biosimilars program and a total of 7 applications have been submitted for review. So far, the agency has approved one product — Sandoz’ Zarxio (filgrastim-sndz), a biosimilar equivalent to Amgen’s Neupogen.  
>  
> Full-time equivalent (FTE) staff also increased significantly last year, the report notes. At the end of FY 2015, there were 127 FTE assigned to biosimilars, which was a 55% increase over the 82 assigned the previous year.