Zarxio Clinical Development Timeline
Executive Summary
Chronicle of the development and review of Sandoz’s filgrastim-sndz, a biosimilar to Amgen’s Neupogen.
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Behind The Approval Letter: Drug Review Profiles
A listing of the Drug Review Profile series articles published in the Pink Sheet.
As Biosimilar Meeting Requests Rise, So Do FDA's Performance Goal Challenges
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.
Zarxio Syringe’s Limitations May Delay Decision On Neupogen Interchangeability
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.