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Will FDA Answer The Big Biosimilars Questions?

This article was originally published in SRA

Executive Summary

AbbVie is hoping that US lawmakers will get to the bottom of why the Food and Drug Administration did not require Sandoz to identify in the labeling of Zarxio (filgrastim-sndz) that the product is a biosimilar or clearly state the drug had not been found to be interchangeable – something regulators had earlier said in a draft guidance was "necessary" to declare.