Biologics in autoimmune disease

11^th European Biosimilars Congress

April 26-27, 2018 Rome, Italy

Sandra Simic

Ewopharma d.o.o, Croatia

Posters & Accepted Abstracts: J Bioanal Biomed

Abstract :

Biologics that target autoimmune responses and inflammatory injury pathways have a marked beneficial impact on the management of many chronic diseases, including rheumatoid arthritis, psoriasis, inflammatory bowel disease, and ankylosing spondylitis. The use of biologic therapies for the treatment of autoimmune diseases is rapidly expanding, owing to the good efficacy and safety profiles of these drugs, and the better understanding of the initial targets of altered immune regulation and activity in various diseases. The major targets of most biologic therapies are cytokines, B cells, and co-stimulation molecules. Anti-cytokines include anti-tumor necrosis factor (TNF)-�±, anti-interleukin (IL)-1, and anti-IL-6 molecules. B-cell depletion includes use of anti-CD20 antibodies and B cell receptor (BCR) modulation by the B-lymphocyte stimulator (BLyS). Although some of the biologic therapies have been found to be useful in more than one disease, others are specific for a single disease. The last two decades have witnessed a revolution in the treatment of autoimmune diseases due to the introduction of biological agents which, although now included as standard treatment in patients with autoimmune rheumatological, dermatological and gastrointestinal diseases. The use of biological agents is associated with greater costs compared with the mainly anti-inflammatory and immunosuppressant drugs used in the pre-biological era. Biosimilars are a classification of biologic medicines that are similar to currently available biologic therapies known as originators. They provide significant savings to hospitals budget and enable higher number of patientsâ�� availability of biologic treatment. Biosimilars are highly similar copies of biological drugs, but not identical to approved â��referenceâ�� agents. Biological agents are complex proteins involved in the immune response and their exact replicas are extremely difficult, if not impossible, to obtain. Three scenarios have converged to provide a specific opportunity for biosimilars in autoimmune diseases: growing demand for biologics due to successful clinical use; the nearing of patent expiry for the four top-selling biological brands; and the search to reduce health costs due to the financial crisis. s.simic@ewopharma.hr