The US Food and Drug Administration (FDA) has finalised guidance on the clinical pharmacology requirements for a biosimilar. The guidance addresses the design and use of clinical pharmacology studies to support a decision that a proposed biological product is biosimilar to its reference product.
The guidance contains four main sections: The role of clinical pharmacology studies in the demonstration of biosimilarity, critical considerations in the use of clinical pharmacology studies to support biosimilarity, developing clinical pharmacology data for supporting a demonstration of biosimilarity and the utility of simulation tools in study design and data analysis.
Clinical pharmacology studies are a vital component in the development of biosimilar products. These studies should be part of a stepwise process for demonstrating that a proposed biological product and its reference product are biosimilar. These studies may support the conclusion that there are no clinically meaningful differences between the products. The studies may address residual uncertainties following analytical evaluation, may contribute to the evidence supporting a demonstration of biosimilarity, and may also assist with a selective and targeted approach to the design of subsequent clinical studies conducted to help demonstrate biosimilarity.