title: The emerging role of pharmacogenomics in biologics.
abstract: 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.
authors: Office of Biotechnology Products, Division of Therapeutic Proteins, Center for Drugs Evaluation and Research, Bethesda, Maryland, USA.
authors: E
authors: E
authors: Lacaná
authors: S
authors: S
authors: Amur
authors: P
authors: P
authors: Mummanneni
authors: H
authors: H
authors: Zhao
authors: F W
authors: FW
authors: Frueh
mesh_terms: D000893:Anti-Inflammatory Agents / Q000627:therapeutic use; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents / Q000627:therapeutic use; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D015415:Biomarkers / Q000032:analysis*; D000068818:Cetuximab; D003257:Consumer Product Safety; D004348:Drug Labeling; D004358:Drug Therapy / Q000639:trends*; D064420:Drug-Related Side Effects and Adverse Reactions; D005819:Genetic Markers; D005838:Genotype; D006801:Humans; D007880:Legislation, Drug; D018579:Patient Selection; D010597:Pharmacogenetics / Q000331:legislation & jurisprudence / Q000639:trends*; D010641:Phenotype; D011110:Polymorphism, Genetic; D018570:Risk Assessment; D000068878:Trastuzumab; D014409:Tumor Necrosis Factor-alpha / Q000037:antagonists & inhibitors / Q000235:genetics
chemical_list: D000893:Anti-Inflammatory Agents; D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D000970:Antineoplastic Agents; D001688:Biological Products; D015415:Biomarkers; D005819:Genetic Markers; D014409:Tumor Necrosis Factor-alpha; D000068878:Trastuzumab; D000068818:Cetuximab