Clinical pharmacology of biological medicines

Biological medicines encompass a wide group of therapeutic agents that are manufactured by living organisms and include monoclonal antibodies, peptides (e.g. insulin), vaccines, blood products, RNA targeting therapies and gene and cellular therapies. Here, we focus on the clinical pharmacology of monoclonal antibodies, which occupy an increasing share of the market for a diverse set of indications. Their large size, complex structure and ability to bind to highly specific target sites, and the heterogeneity imparted by the nature of their production, mean that monoclonal antibodies exhibit unique and specific pharmacokinetic and pharmacodynamic characteristics.