Biosimilars: Does Low BsUFA Fee Revenue Suggest Sponsor Interest Has Stalled?
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.
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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.
Guidance is “emerging” that will allow sponsors to use data from products not licensed in their respective regions in applications.
Color remains a mystery, but publication may come in handy soon as biosimilar sponsors are nearing the marketing application stage.