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.

A biosimilar sponsor’s ability to secure an interchangeability determination may be complicated by performance and design differences in the delivery devices for the biosimilar and reference product, FDA review documents for Sandoz Inc.’s Zarxio (filgrastim-sndz) suggest.

In its review of Sandoz's 351(k) application, the agency raised concerns about the ability of patients and caregivers to administer...

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