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Biosimilar Interchangeability: Stakeholders Want More FDA Guidance, Fewer Hurdles

Executive Summary

The limited discussion of interchangeability in FDA’s initial biosimilar draft guidances has left some stakeholders clamoring for more details. Others say the agency’s demand for a “higher standard” of evidence to show interchangeability is misplaced and will inhibit use of the 351(k) pathway.

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