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.
FDA’s biosimilar user fee program does not appear to be generating revenue very quickly, which may affect the pace of the emerging field.
The agency still has not received a biosimilar marketing application six months after its Oct. 1, 2012 launch, but has...