The emerging role of pharmacogenomics in biologics.

Biologics can be seen as "designer" drugs whose mode of action in a specific disease mechanism is frequently well understood, making it often possible to predict better efficacy and safety profiles for biologics when compared with small molecule drugs. Biologics have been approved for the treatment of major disease classes, such as inflammatory disease, cardiovascular disease, and cancer. However, as it is true for small molecule drugs, often only a fraction of the treated population responds to biologics, and clinical markers for prediction of efficacy are seldom available. It is reasonable to expect that the use of genetic or genomic markers will contribute to improving the prediction of safety and efficacy of both biologics and small molecule drugs. In this paper, we will review the differences between biologics and small molecule drugs, focusing on studies highlighting the relevance of genetic and genomic information on safety and efficacy issues in therapies with biologics. The potential impact of these studies on the promotion of personalized medicine and on regulatory decisions will also be discussed.