Key FDA Officials From Generics And Biosimilars User Fee Programs Laid Off, Said AAM

A Major Wave Of Layoffs Across Multiple FDA Departments Happened On 1 April

Off-patent drug trade groups expressed their concerns that personnel and expertise cuts will affect the agency’s ability to review and approve generics and biosimilars.

Concept of layoffs. People walking in a line down a red path — (Shutterstock)

Mass staff layoff upheaval at the US Food and Drug Administration has also affected the off-patent drug offices on 1 April, warned trade group the Association for Accessible Medicines.

“AAM is deeply concerned by reports that key officials within the FDA’s generic drug and biosimilar programs and officials responsible...

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Iron Sucrose Competition Expands With Viatris and Amphastar FDA Approvals

12 Aug 2025

• By Dean Rudge

Viatris and Amphastar are expanding their complex generic portfolios with the planned launches of FDA-approved versions of Vifor Pharma/Daiichi Sankyo’s Venofer (iron sucrose). The FDA’s database also show Sandoz holds an approval for generic Venofer, though it has not disclosed launch plans.