Monoclonal antibodies are antibodies made of identical immune cells which are clones of a unique parent cell and bind to the same epitope or multiple epitopes depending upon its type. Since the approval of the first FDA approved therapeutic Mab,Muromonab CD3 a murine mAb in 1986 there was a decline in the further applications butthe number of monoclonal antibodies (mAbs) have significantly increased over the last three decades for various therapeutic applications like cardiovascular, respiratory, hematology, kidney, immunology and oncology, orphan diseases or indications such as paroxysmal nocturnal hemoglobinuria as well as cancers and multiple sclerosis and even breast cancer, asthma and rheumatoid arthritis. The rate of approval of monoclonal antibodies in the market for the treatment of various diseases has increased intenselywith the approval by licensing authorities of chimeric, humanized and then fully human monoclonal antibodies.In 2018, a record number of 11 mAbs were approved, which comprise almost 20% of all drugs approved by the FDA in 2018. Thisnumber surpasses the registered moieties in 2016 and 2017 (7 and 9, respectively), leading to the approvalof 27 antibody-based newer drugs over these three years. In 2018, the approved mAbs are Erenumab (Aimovig), Femanezumab (Ajovy), Galcanezumab (Emgality), Gurosumab (Crysvita), Lanadelumab (Takhzyro), Mogamulizumab (Poteligeo), Moxetumomab pasudodox (Lumoxiti), Cemiplimab (Libtayo), Ibalizumab (Trogarzo), Tildrakizumab (Ilumetri, Ilumya), Ema- palumab (Gamifant)) which treat a wide variety of diseases. It is expected that the number of approvals of monoclonal antibodies would exceed in 2019.
Keywords: Monoclonal antibodies (mAbs), Therapeutic application, FDA approvals, Cancer, Chimeric, Orphan disorders.