Zarxio Clinical Development Timeline
Chronicle of the development and review of Sandoz’s filgrastim-sndz, a biosimilar to Amgen’s Neupogen.
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A listing of the Drug Review Profile series articles published in the Pink Sheet.
Growing number of products participating in BsUFA program, coupled with budgetary challenges, have made FDA attainment of some early goals under the Biosimilar User Fee Act difficult.
FDA review documents for Sandoz’s filgrastim-sndz suggest that biosimilar sponsors need to consider how differences in delivery device from the reference product will play out under the 351(k) pathway, including whether new device designs and human factors data will be needed to secure interchangeability.