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BioPharmaceutical United States Regulation

What Will Biosimilar Labeling Look Like? Stakeholders Await FDA Guidance, Approvals

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Executive Summary

Unknowns include whether labeling will include reference product’s clinical data, and how absence of data for particular indications or populations will be handled; labeling decisions for 351(k) approvals will have important ramifications for advertising and promotion of both the biosimilar and reference product.

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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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