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Curious Biosimilar Issues: More Workload, But Fewer US FDA Staff Needed

 
• By Derrick Gingery

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.

Workload
Meetings and manufacturing supplements are estimated to rise in FY 2022, while one less biosimilar application is expected, compared to the current fiscal year. • Source: Alamy

Biosimilar program projections from the US Food and Drug Administration suggest fewer staff are needed than a year ago, even as several workload metrics continue to increase.

The agency’s capacity planning adjustment predictably estimated that funding for more full-time equivalent paid staff is necessary for the biosimilar user fee program in fiscal year 2022, according to the announcement of new user fee rates

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