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FDA Expecting 10 Biosimilar Applications Submitted By End Of FY 2015

 
• By Derrick Gingery

The agency says it expects to receive three biosimilar marketing applications in fiscal year 2014 and another seven in FY 2015, as well as much more in program revenue.

FDA expects to have received as many as 10 biosimilar applications by the end of FY 2015, indicating Sandoz Inc. is unlikely to be the only sponsor to publicly disclose an application filing for long. 

The additional applications should boost user fee revenue for the fledgling program, which in FY 2013 did not spend any of its collections.

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