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Biosimilars Among 100+ Guidances FDA Plans For 2016

This article was originally published in Scrip

Executive Summary

After missing its goal last year to issue much-anticipated guidances for biosimilar makers about interchangeability, labeling and statistical approaches to analytical similarity, the FDA said it's going to give it another go and try to get them done before the end of 2016, although the agency didn't provide a specific timeline.