The European Commission has approved marketing authorization for biosimilar drug Benepali for the treatment of adults with moderate to severe rheumatoid arthritis (RA), psoriatic arthritis, non-radiographic axial spondyloarthritis and plaque psoriasis.
A joint venture between U.S. biotech company Biogen and South Korea’s Samsung BioLogics conglomerate, Benepali is the first etanercept biosimilar referencing Enbrel to be approved in the European Union.
“The approval of Benepali is a significant step forward for patients and physicians -- and an important milestone for Biogen, as we bring to market the first product from our biosimilar pipeline,” Dr. Alpna Seth, global head of Biogen's biosimilars business unit, said. “As a biotechnology pioneer, Biogen is proud to translate our heritage and expertise in biologics to biosimilars. Benepali, as the first etanercept biosimilar referencing Enbrel approved in the EU, can help expand access to treatment options for people affected by chronic inflammatory conditions.”
Approval for the biosimilar drug was based on data collected from Samsung Bioepis’ 52 weeks of head-to-head Phase I and double-blind Phase III clinical trials that compared Benepali to Enbrel, its reference drug.
“For more than 15 years, anti-TNF therapies have revolutionized the care and outlook for patients living with chronic inflammatory diseases such as RA,” Peter Taylor, Norman Collisson professor of musculoskeletal sciences at Oxford University and Kennedy Institute of Rheumatology, said. “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. The newly approved treatment Benepali has similar quality, efficacy and a comparable safety and immunogenicity profile to Enbrel.”
