Biosimilars: What Will The Second Advisory Committee Tell Us?
This article was originally published in The Pink Sheet Daily
Celltrion will have the most at stake next week, but future sponsors – and FDA itself – could learn a lot about how reviews of these new products work.
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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.
First quarter submission volume is the second lowest of the GDUFA era, in part because of BE study problems caused by the pandemic.