New biosimilar version of etanercept approved in Europe
Published on 19 January 2016
An affordable new treatment for various types of arthritis is to be made available in Europe following the approval of the drug Benepali.
The new biosimilar version of the anti-TNF therapy etanercept has been granted marketing authorisation in the EU for the treatment of adults with moderate to severe rheumatoid arthritis, psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis.
Developed by Samsung Bioepis, the drug is the first etanercept biosimilar to be based on the licensed product Enbrel, and will become the first subcutaneous anti-TNF biosimilar to be launched in Europe.
Biosimilars are biological therapies that are designed to function almost identically to an existing licensed treatment, delivering the same proven safety and effectiveness for a fraction of the older drug's price.
Data from a 52-week study of 596 patients with moderate to severe rheumatoid arthritis was used to support the application for Benepali's approval, with results from this trial showing that the new biosimilar offered equivalent efficacy to the older Enbrel.
Professor Peter Taylor, professor of musculoskeletal sciences at the University of Oxford's Kennedy Institute of Rheumatology, said: "For more than 15 years, anti-TNF therapies have revolutionised the care and outlook for patients living with chronic inflammatory diseases such as rheumatoid arthritis.
"However, access to these highly-effective treatments has been restricted by high costs. The development of biosimilar drugs is a welcome solution to help alleviate some challenges with access."