Sandoz’s Biosimilar Data-Bridging Plans For Zarxio Faced FDA Doubts
FDA 'strongly encouraged' Sandoz to conduct three-way clinical PK/PD study comparing its Zarxio biosimilar to the EU- and U.S.-approved versions of Amgen’s Neupogen; however, the firm succeeded in using only analytical data to justify relevance of studies using the European reference product.
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Regulatory framework for biosimilars is still a work in progress, especially on the analytical and labeling issues that featured in the Pink Sheet's Drug Review Profile of Zarxio.
A listing of the Drug Review Profile series articles published in the Pink Sheet.
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.