FDA Sets Biosimilar Application Fees, But Is Silent On Volume Projections

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.

The FY 2013 biosimilar user fee amounts imply that the president’s budget proposal was accounting for a maximum of 10 marketing applications that year.

It is more likely that there will be fewer than 10 filed however, given that some candidates will reach the...