FDA Releases Long-Awaited Draft Guidance on Biosimilar Labeling
By Zachary Brennan -
Published 31 March 2016
The US Food and Drug Administration (FDA) on Thursday unveiled draft guidance on biosimilar labels, which will rely heavily on their reference products’ labels, though the biologics industry will likely be happy that the labels must make certain clarifications about the biosimilar and reference product.
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Tags: biosimilar labels, biosimilar approval, reference product labeling