What is Humira?
Adalimumab, trade names Humira ("human monoclonal antibody in rheumatoid arthritis") and Exemptia are TNF inhibiting anti-inflammatory drug manufactured by AbbVie and Zydus Cadila respectively.
Adalimumab binds to tumor necrosis factor-alpha (TNFα). TNFα normally binds to TNFα receptors, which leads to the inflammatory response of autoimmune diseases. By binding to TNFα, adalimumab reduces this inflammatory response. Adalimumab has been approved in the United States for rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn's disease, ulcerative colitis, moderate to severe chronic psoriasis and juvenile idiopathic arthritis.
In rheumatoid arthritis, adalimumab has a response rate similar to methotrexate, and in combination nearly doubles the response rate of methotrexate alone.
Because TNFα is part of the immune system that protects the body from infection, treatment with adalimumab may increase the risk of infections.
It is marketed in 0.8 mL vials, preloaded 0.8 mL syringes and also in preloaded pen devices (called Humira Pen), injected subcutaneously, typically by the patient at home. It cannot be administered orally because the digestive system would destroy the drug.
Adalimumab was the first fully human monoclonal antibody drug approved by the FDA. It was derived from phage display, and was discovered through a collaboration between BASF Bioresearch Corporation (Worcester, Massachusetts, a unit of BASF) and Cambridge Antibody Technology as D2E7, then further manufactured at BASF Bioresearch Corporation and developed by BASF Knoll (BASF Pharma) and, ultimately, manufactured and marketed by Abbott Laboratories after the acquisition of BASF Pharma by Abbott. On January 1, 2013 Abbott split into two companies, one retaining the Abbott name and the other named AbbVie. Humira is now owned by AbbVie.
Humira costs approximately $3,100 per month, like the TNF-alpha inhibitor etanercept (Enbrel).
In 2012, Humira had $4.3 billion of sales in the US, and $9.3 billion worldwide.
In December 2014, Cadila Healthcare Ltd., launched in India the first Adalimumab biosimilar, under the name '''Exemptia''', at a price of $200 a vial. Humira's U.S. patent will expire in 2016.