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The Big Biosimilars Questions: Will Senate Get Answers?

This article was originally published in Scrip

Executive Summary

When a Senate subcommittee of the Health, Education, Labor and Pensions (HELP) panel calls Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research, to testify on Sept. 17, AbbVie is hoping lawmakers will get to the bottom of why the agency did not require Novartis and its Sandoz unit to identify in the labeling of Zarxio (filgrastim-sndz) the product is a biosimilar and did not clearly state the drug had not been found to be interchangeable – something regulators had earlier said in a draft guidance was "necessary" to declare.


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