Affiliations: Department of Medical Biotechnology, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, International Campus (TUMS-IC), Tehran, Iran
Correspondence:
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Corresponding author: Esmaeil Sadroddiny, Department of Medical Biotechnology, School of Advanced Technologies in Medicine, Tehran University of Medical Sciences, No 88 Italia st., Tehran, Iran. PO Box. 1417755469, Tel.: +98 21 88991118 24; Fax: +98 21 88991117; E-mail:[email protected]
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.
Keywords: FDA approved mAbs, adverse events of mAbs, antibody-based therapeutics, safety and risks of mAbs, licensed mAbs and associated challenges
