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BioPharmaceutical United States Drug Approval Standards

Sandoz Pushing FDA To Make Biosimilar Interchangeability Decisions

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Executive Summary

Absent guidance, the company says it is submitting proposals for trial designs it believes could demonstrate biosimilar interchangeability.

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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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