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Biosimilars Regulation Biologics

Biosimilar Labeling: US FDA’s Final Guidance Means Status Quo For Sponsors

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Executive Summary

Advice document, little changed from a March 2016 draft, continues to reflect agency’s view that clinical studies supporting a demonstration of biosimilarity should not be included in labeling.

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This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

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