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

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