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US FDA Rebates Biosimilar Fees, Limits Generic Fee Hike In FY 2022

 
• By Derrick Gingery

The generic drug user fee could have jumped substantially to ensure operating reserves were sufficient, but the FDA decided against it, and biosimilar program reserves were too high, so the agency reduced the amount it will need.

Fees up and down
Many generic and outsourcer user fees will increase in FY 2022, while biosimilar fees will remain steady or decrease. • Source: Alamy

Generic drug sponsors will receive a user fee break of sorts after the agency decided against hiking fiscal year 2022 rates as much as legally allowed.

At the same time, biosimilar sponsors will get a rare user fee rebate, although it did not translate into lower...

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US FDA Skips User Fee Increase For More Staff Amid Exodus, Hiring Difficulties

 
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A calculation used to determine whether the FDA has the staff to handle its workload also was not included in the description of prescription drug user fee calculations.

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A list of EU biosimilar filings, CHMP opinions and EU marketing authorizations, including details of the biosimilar company, the brand name/INN, indication(s), the reference product/company, and the date and type of event.

EMA Backs Gilead’s Yeytuo And 13 Other Drugs For EU Approval But Rejects Three

 
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More from Biosimilars & Generics

Generic Drugs And AI: Maximum Daily Dose Tool Could Help US FDA Be ‘At The Forefront’

 
• By Michael McCaughan

The FDA is testing a new artificial intelligence tool to help generic drug developers automate maximum daily dose calculations.

Repurposed Generics For Rare Diseases: Janet Woodcock Proposes Shortcut

 
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No Surprise Here: Foreign Drug Facilities Should Expect Surprise Inspections, US FDA Says

 
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