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Naming of biosimilars a confidence game on a deadline

By Mari Serebrov
Washington Editor

Thursday, February 6, 2014

With the FDA expected to approve its first biosimilar within a year or two, how to name the follow-on biologics has passed from an academic debate to a must-do proposition. Since sponsors must include the name in the dossier when they submit a biosimilar application, those that are getting close to filing need to know pretty quickly how the drugs are to be named, Sumant Ramachandra, senior vice president and chief scientific officer at Hospira Inc., told BioWorld Today.

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