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AbbVie: Hearing Needed On Biosimilars Interchangeability

This article was originally published in Scrip

Executive Summary

While the FDA had pledged to provide biosimilar makers a guidance this year outlining what is needed for products to demonstrate interchangeability – a promise now unlikely to be kept, given 2015 is nearly over and there's no sign of the document – AbbVie Inc. is arguing a public hearing is needed before the agency acts on that vow.