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Will Fortune Favor The Brave? Biosimilar Sponsors Need High Tolerance For Uncertainty

Executive Summary

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.

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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.

FDA’s Inaugural Biosimilar Review Bumpier Than First Appeared

How agency handled issues around protein content differences, statistical analyses of quality data and immunogenicity testing for Sandoz’s Zarxio may prove instructive for future 351(k) applicants.

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