PNS Pharma recently released a report titled “Humira Biosimilars Clinical Trial Insight” that includes clinical data on 33 potential new drugs that have a similar action to Humira (adalimumab), an approved and prescribed therapy for rheumatoid arthritis (RA) in Europe and the U.S.
The patent protecting Humira ends this year in the U.S. and in 2018 in Europe, and of the 33 biosimilars that are under evaluation as possible new drugs, more than 10 have progressed into Phase 3 studies and are expected to be commercialized in the next five to eight years.
Several molecules are known to be involved in RA development. One is TNF-alpha, an inflammatory protein produced by immune cells. TNF-alpha promotes inflammation by binding to its receptors, located at the cells’ surface. In RA patients, this protein has been found in increased levels in the synovial fluids (joint fluid), and its mediated inflammation contributes to joint destruction.
Humira is an antibody targeting TNF-alpha that was designed to treat several inflammatory diseases, such as RA, psoriatic arthritis, Crohn’s disease and ulcerative colitis. In RA patients, Humira has been shown to have a similar effectiveness as Rheumatrex (methotrexate).
When Humira binds to TNF-alpha, the protein is no longer able to bind to its natural receptors on cell surfaces and trigger the activation of inflammatory processes. Thus, Humira has the ability to specifically interfere with the activation of TNF-alpha and block inflammation, thereby improving RA symptoms and disease progression.
The antibody was originally produced by the Bioresearch Center in Massachusetts (BASF) in collaboration with the Cambridge Antibody Technologies in England, and is currently produced by Abbot Laboratories.
The dosing schedule and improved tolerance of Humira compared to existing drugs launched it to the top of best-selling pharmaceutical products from 2012 to 2015. In 2015, Humira reached $14 billion in sales worldwide. Abbott also has plans to expand the use of Humira to psoriasis, Crohn’s disease, and juvenile idiopathic arthritis, all of which have in common the activation of TNF-alpha as a promotor of inflammation.
Biosimilars to Humira have already been launched on the market. In 2014, Cadila Healthcare, an Indian pharmaceutical, introduced Exemptia at a price five times cheaper than Humira. Also, Adfrar and Amgens, other Humira biosimilars, were released in 2016. Amgens has been approved in the U.S. under the name Amjevita.
According to the U.S. Food and Drug Administration (FDA), “A biosimilar product is a biological product that is approved based on a showing that it is highly similar to an FDA-approved biological product, known as a reference product, and has no clinically meaningful differences in terms of safety and effectiveness from the reference product.
“FDA requires licensed biosimilar and interchangeable biological products to meet the agency’s rigorous standards of safety and efficacy. That means patients and healthcare professionals will be able to rely upon the safety and effectiveness of the biosimilar or interchangeable product, just as they would the reference product.”