La rheumatoid arthritis It is a disease in which the joints become inflamed, causing pain, deformity and difficulty in movement, although it can also affect other parts of the body. In addition, this condition is chronic despite the fact that with adequate treatment good control of the disease is achieved in most cases.
According to Spanish Society of Rheumatology (SER), rheumatoid arthritis is common. Only in Spain there are some 200.000 affected, being more frequent in women and presenting with a higher incidence between 45 and 55 years of age.
The triggering cause of the rheumatoid arthritis It is unknown. It is known that there are alterations of the immune system and that the inflation that occurs in the joints is the consequence of the invasion of the synovial membrane by immune cells that damage the joint.
Regarding treatment, since the authorization of the first biotech drug in rheumatology, whose active ingredient is infliximab, this medical specialty, together with oncology, has seen the growth of biological therapies grow the most. In addition to infliximab, two other molecules, adalimumab and etanercept, work by neutralizing a factor, called TNF, which is known to have a pro-inflammatory effect in rheumatic patients. They are effective drugs for the control of inflammation and pain in a variable percentage of patients with rheumatoid arthritis and are generally well tolerated but their price is very high.
In September 2013, the European Commission approved the marketing of Inflectra and Remsima (infliximab), two biosimilars whose active ingredient is infliximab, a biosimilar monoclonal antibody to treat inflammatory diseases such as rheumatoid arthritis, ankylosing spondylitis and psoriatic arthritis.
The approval of biosimilars with infliximab was a milestone because it constituted the first authorization in Europe of a biosimilar of a second-generation drug with particular structural and functional complexities. However, the marketing licensees accredited a very high structural and functional equivalence, which together with the comparative clinical studies led to its authorization. In a double-blind, randomized, phase III study, its therapeutic equivalence to Remicade, the original product of reference. Specifically, in the analysis, 73,4% of patients who received the biosimilar achieved a greater than 20% improvement in rheumatoid arthritis symptoms after 30 weeks of treatment (using the ACR20 scoring system), compared with 69,7% of those treated with Remicade.
In addition, this 'green light' for biosimilars with infliximab in Europe It has been extended at the beginning of this month of April to the United States, where one of them has already been approved. There, the North American Drug Agency (FDA) has approved Inflectra (infliximab) for all indications of Remicade, becoming the first biosimilar monoclonal antibody approved in the North American country.