FDA: Draft Guidance - Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

This draft guidance is intended to assist spon sors with the design and use of clinical pharmacology studies to support a decision that a proposed therapeutic biological product is biosimilar to its reference product. This guidance pertains to those products — such as therapeutic biological products — for which pharmacokinetic (PK) and pharmacodynamic (PD) data are required as part of a stepwise approach to developing the data and information necessary to support a demonstration of biosimilarity.