Biologics (also known as biological products) are complex therapeutic molecules derived from living cells or organisms — including proteins, nucleic acids, cells, and tissues — used to treat, prevent, or diagnose disease. Unlike small-molecule drugs, biologics are characterized by their high molecular complexity, structural heterogeneity, and sensitivity to manufacturing conditions. They include monoclonal antibodies (mAbs), recombinant proteins, vaccines, cell therapies, and gene therapies, and are subject to strict regulatory oversight by agencies such as the European Medicines Agency (EMA) and Food and Drug Administration (FDA)..
