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FDA Responds to Senate Pressure Over Biosimilar Protocols


September 30, 2015.

FDA News reports that FDA has conducted meetings with more than 50 drug companies interested in producing biosimilar products since 2013 at a cost of $65.9 million.

The agency has released the figures after CDER Director Janet Woodcock was questioned by a senate panel last week over the FDA’s lack of biosimilar protocols when compared to Canada and Europe. Woodcock said that the Agency’s one-on-one meetings with drugmakers take up a great deal of time, as there are 57 proposed biosimilars in the pipeline.

The agency 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. According to FDA News,onsulting firm Eastern Research Group estimates that the agency spent $23.6 million in 2013, $21.4 million in 2014 and $20.9 million in the first two quarters of 2015. 

Congress has called on FDA to publish a report on its biosimilar activities by September 2016.

The interim report can be viewed here: www.fdanews.com/09-24-15-BiosimilarReport.pdf

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