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AbbVie Calls For US FDA Hearing On Biosimilars Interchangeability

This article was originally published in SRA

Executive Summary

While the US Food and Drug Administration had pledged to provide biosimilar makers with guidance in 2015 outlining what is needed for products to demonstrate interchangeability - a promise that it failed to keep - AbbVie is arguing a public hearing is needed before the agency acts on that vow1.