Background: Over the last three decades, monoclonal antibodies (MAbs) have made a
striking transformation from scientific tools to powerful human therapeutics. Muromonab CD3 a
murine MAb was the first FDA approved therapeutic MAb for the prevention of kidney transplant
rejection. Since its approval in 1986, there has been a decline in further application and approvals
until the late 1990s when the first chimeric Mab, Rituximab was approved for the treatment of lowgrade
B cell lymphoma in 1997. With the approval by licensing authorities of chimeric, followed by
humanized and then fully human monoclonal antibodies, the rate of approval and monoclonal antibodies
available in the market for the treatment of various diseases has increased dramatically. As
of March 2017, FDA has approved approximately 60 therapeutic MAbs which are currently under
evaluation in various phases of clinical trials.
Objective: MAbs are approved for the treatment of diseases belonging to various systems like cardiovascular,
respiratory, hematology, kidney, immunology and oncology. MAbs are approved for
the treatment of orphan diseases or indications such as paroxysmal nocturnal hemoglobinuria as
well as cancers and multiple sclerosis where hundreds of patients are treated and even diseases such
as breast cancer, asthma and rheumatoid arthritis where millions are being treated. This review focuses
briefly on types, molecular targets, mechanism of actions and therapeutic indications of FDA
approved MAb products that are currently available in the market.
Conclusion: With the advent of fully human MAbs, the efficacy and safety have improved in the
treatment of various cardiovascular, cancer, respiratory, hematology, autoimmune diseases and
infections. The introduction of biosimilars will increase the affordability and utilization of MAbs in
the treatment of various diseases.