New version of etanercept drug made available in Europe
Data from a 52-week study of 596 patients with moderate to severe rheumatoid arthritis has been used to support an application for a new, affordable biosimilar anti-TNF drug developed by Samsung Bioepis, called Benepali to be made available in Europe.
Biosimilars are biological therapies that are designed to function almost identically to an existing licensed treatment and deliver the same proven safety and effectiveness, but at a considerably lower price than the older drugs.
Benepali is a new biosimilar version of the anti-TNF therapy etanercept, with trades under the name Enbrel. People with rheumatoid arthritis or other inflammatory diseases, overproduce a protein called TNF, which causes inflammation and damage to the bones, cartilage and tissue. Anti-TNF drugs block the action of TNF proteins, reducing the inflammation, but they can be very costly.
Results from the study showed that this new biosimilar offered equivalent efficacy to the older Enbrel and it has now been granted marketing authorisation as a treatment for adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis.
Prof Peter Taylor, professor of musculoskeletal sciences at the University of Oxford’s Kennedy Institute of Rheumatology, says, “For more than 15 years, anti-TNF therapies have revolutionised the care and outlook of patients living with chronic inflammatory diseases such as rheumatoid arthritis.
“However, access to these highly-effective treatments have been restricted by high costs. The development of biosimilar drugs is a welcome solution to help alleviate some challenges to access.”
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