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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

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