Zarxio Reviewers
Executive Summary
FDA staff that participated in the 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.
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.
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.