Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product

Clinical Pharmacology Data to Support a Demonstration of Biosimilarity to a Reference Product is the final version of a draft guidance for industry originally released in 2014. It is intended to assist sponsors with the design and use of clinical pharmacokinetic and pharmacodynamic studies to support a demonstration that a proposed therapeutic biological product is biosimilar to its reference product.

As explained in the guidance, clinical pharmacology studies play a critical role in the stepwise process for demonstrating biosimilarity. They may:

  • Support a demonstration that there are no clinically meaningful differences between a proposed biosimilar product and a reference product.
  • Address residual uncertainties that remain after the analytical evaluation.
  • Add to the totality of the evidence supporting a demonstration of biosimilarity.
  • Support a selective and targeted approach to the design of any recommended subsequent clinical studies.

The guidance discusses some of the overarching concepts related to clinical pharmacology testing for biosimilar products, approaches for developing the appropriate clinical pharmacology database, and the utility of modeling and simulation for designing clinical trials.

The full document is available on the FDA website.