FDA Spent $65.9 Million on Biosimilars Actitivies Since 2013: Report

An interim report shows that the FDA has conducted nearly 90 meetings with more than 50 drug companies interested in producing biosimilar products since 2013 at a cost of $65.9 million.

The report, ordered by Congress, showed the agency met with and reviewed potential IND applications with 33 drugmakers in 2013, 48 in 2014 and added four more in 2015.

The FDA has accepted five BLAs for biosimilars, two in fiscal year 2014 and three since December. Of the two BLAs accepted in 2014, only Sandoz’s Zarxio was at the mid-way point of the application process by the end of the year.

A senate panel grilled CDER Director Janet Woodcock last week over the FDA’s lack of biosimilar protocols when compared to Canada and Europe. Woodcock told the lawmakers that the agency’s one-on-one meetings with drugmakers are taking up a great deal of time, as there are 57 proposed biosimilars in the pipeline.

Consulting firm Eastern Research Group estimates that the FDA spent $23.6 million in 2013, $21.4 million in 2014 and $20.9 million in the first two quarters of 2015. ERG developed the estimates through interviews and surveys with FDA staff involved in biosimilars review work.

The FDA must publish a final report by September 2016. Read the interim report here www.fdanews.com/09-24-15-BiosimilarReport.pdf. — Kellen Owings