FDA Sets Biosimilar Application Fees, But Is Silent On Volume Projections
This article was originally published in The Pink Sheet Daily
A Federal Register notice outlines the new user fee amounts and suggests that President Obama’s budget projections anticipated as many as 10 marketing applications, but the mix of INDs and full applications is unknown.
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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.
The agency changes its rhetoric on the subject, inviting speculation about whether a marketing application has been received.
Halfway through the first year of the biosimilar user fee program, fee payments have not lived up to the expectation in President Obama’s FY 2013 budget request. Initial meetings continue to grow but at a slow pace, suggesting sponsors may remain hesitant about the pathway.