title: An overview of FDA-approved biologics medicines.
abstract: Recombinant DNA technologies revolutionized medicine. Herein, the approvals and mechanistic basis of biologics-based medicines are analyzed. The overall and relative rate of FDA approvals for recombinant proteins grew from the 1980s through the first half-decade of the new millennium. Over time, the number of biologics gaining approval for an orphan indication has climbed to more than 50% in the current decade. The field has been dynamic in terms of the types of biologics, indications targeted and the mechanistic basis of drug activity. Despite impressive increases in recombinant-protein-based medicine, the rate of new biologics approvals could have leveled out.
authors.affiliation: Washington University in St Louis, St Louis, MO 63110, USA. Electronic address: michael.kinch@wustl.edu.
authors.forename: Michael S
authors.initials: MS
authors.lastname: Kinch
mesh_terms: D000818:Animals; D000911:Antibodies, Monoclonal / Q000627:therapeutic use; D001688:Biological Products / Q000009:adverse effects / Q000627:therapeutic use*; D017277:Drug Approval; D057487:Enzyme Therapy; D006801:Humans; D061214:Patient Safety; D011956:Receptors, Cell Surface / Q000187:drug effects; D018160:Receptors, Cytoplasmic and Nuclear / Q000187:drug effects; D018570:Risk Assessment; D012307:Risk Factors; D016896:Treatment Outcome; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000911:Antibodies, Monoclonal; D001688:Biological Products; D011956:Receptors, Cell Surface; D018160:Receptors, Cytoplasmic and Nuclear