Curious Biosimilar Issues: More Workload, But Fewer US FDA Staff Needed
The US FDA’s capacity planning formula indicates a smaller biosimilar program than a year ago, but says supplement, meeting and other work continue to increase.
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The agency reissued the user fee notice, saying fewer dollars were needed for new staff.
US FDA’s first decision on biosimilars interchangeability might have less meaning for two insulin products, but payer and prescriber responses to interchangeable biosimilars for adalimumab, which are further out on the horizon, may be more instructive regarding the importance of interchangeability status.
Revenue increases are expected in FY 2021 over pre-pandemic estimates, in part because the US FDA believes sponsors may have applications that were delayed by COVID-19.