title: Licensed monoclonal antibodies and associated challenges.
abstract: Monoclonal antibodies (mAbs) are the leading class of targeted therapeutics and remarkably effective in addressing autoimmune diseases, inflammations, infections, and various types of cancer. Several mAbs approved by US food and drug administration (FDA), are available on the market and a number are pending for approval. Luckily, FDA approved mAbs have played a pivotal role in the treatment and prevention of lethal diseases. However, claiming that licensed mAbs are 100% safe is still debatable, because infections, malignancies, anaphylactoid, and anaphylactic reactions are the more frequently associated adverse events. To evaluate benefit to risk ratio of mAbs, it is important for the clinical research staff or physicians to monitor and follow-up the patients who are receiving mAbs dozes. It is recommended that patients, physicians, biopharmaceutical companies, and researchers should keep in touch to highlight and resolve antibody-based adverse events. In this review we underscore the associated challenges of mAbs, approved by FDA from 2007-2014.
authors.forename: Amjad Hayat
authors.initials: AH
authors.lastname: Khan
authors.forename: Esmaeil
authors.initials: E
authors.lastname: Sadroddiny
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D001327:Autoimmune Diseases / Q000473:pathology / Q000628:therapy*; D017277:Drug Approval / Q000331:legislation & jurisprudence; D006801:Humans; D007155:Immunologic Factors / Q000627:therapeutic use*; D007249:Inflammation; D008004:Licensure / Q000331:legislation & jurisprudence; D061214:Patient Safety / Q000331:legislation & jurisprudence; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D000911:Antibodies, Monoclonal; D007155:Immunologic Factors
keywords: FDA approved mAbs; adverse events of mAbs; antibody-based therapeutics; licensed mAbs and associated challenges; safety and risks of mAbs