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Biosimilars: US FDA Ends FY 2019 With Record Number Of Approvals, One Complete Response Letter

 
• By Sue Sutter

Agency approved 11 biosimilars from six sponsors with only one publicly disclosed complete response letter (Tanvex’s filgrastim). Pink Sheet infographic shows 351(k) application submission, approval and CRL rates over the life of the user fee program.  

silhouette image of ribbon at finish line with kids winner crossing it.(focus on ribbon)) - Image
Six biosimilar sponsors brought 11 products across the US FDA's finish line in FY 2019. • Source: Shutterstock

The US Food and Drug Administration’s biosimilars user fee program closed out fiscal year 2019 with a banner number of approvals and only one publicly disclosed complete response letter, the lowest number since 2014, according to data compiled by the Pink Sheet.

At least three 351(k) applications were known to be under review as of 30 September, including one, Sandoz Inc.’s pegfilgrastim candidate (LA-EP2006), for which the user fee date now appears to have passed without action. (See the Pink Sheet

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