Biosimilars: Sandoz Pegfilgrastim Review, Amgen Adalimumab Launch Extended To 2018
Sandoz needs to do another study to satisfy FDA, while Amgen says it faces a slow pace of patent litigation with AbbVie.
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Keeping Track: Biosimilars, Novel Approvals, And Ebola
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.
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.
Complex Products At US FDA: Adamis' Epi-Pen Alternative OKed; Sandoz Advair ANDA Accepted
The latest regulatory news on new versions of complex products and delivery systems from our FDA Performance Tracker.