Biosimilars: US FDA Ends FY 2019 With Record Number Of Approvals, One Complete Response Letter
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.
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The latest drug development news and highlights from our US FDA Performance Tracker include a Neulasta biosimilar approval for Sandoz, novel approvals for Celgene's Reblozyl and Giskit B.V.'s ExEm Foam, and a submission for Regeneron's Ebola candidate.
A lower-than-expected number of fee-paying application submissions in FY 2018 resulted in the agency spending approximately $9.7m more than anticipated from its user fee carryover balance, leading to a reset of spend-down targets for the remainder of BsUFA II.
US FDA met more biosimilar user fee program meeting performance goals in FY 2018 compared to prior year but still fell short in scheduling for three of five types of meetings. Office of New Drugs reorganization, once completed, should address some logistical scheduling issues.