Another Brick in the Wall: The FDA Releases Draft Clinical Pharmacology Guideline for Biosimilar Development

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By Robert G. Bell

Robert Bell

In May, the FDA released its new draft guidance Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product. The draft guidance addresses pharmacokinetic (PK) and pharmacodynamic (PD) comparisons of biosimilars to reference biologic products required as part of a stepwise approach to developing the data and information (totality of evidence) necessary to support biosimilarity. The clinical pharmacology assessment may be an important component of the scientific justification supporting extrapolation of clinical data to one or more additional conditions of use.

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