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BioPharmaceutical United States Regulation

FDA Biosimilars Guidances Address Immunogenicity Studies, European Bridge Data, Analytics

This article was originally published in The Pink Sheet Daily

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Executive Summary

The agency’s first three draft guidances on biosimilar product development describe how to characterize biosimilar and reference products and extrapolate data on one condition of use to another. FDA says interchangeability is difficult to determine now and will require a switching study.

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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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