EU nod for Samsung Bioepis’ Remicade Biosimilar
Samsung Bioepis’ biosimilar of J&J’s blockbuster anti-inflammatory, infliximab, has won regulatory approval in Europe, which could potentially expand access to anti-TNF therapies in the region.
Like its reference product, Flixabi has been cleared by the EU Commission for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
The decision was made based on data from 54-week, Phase III clinical study in which Flixabi showed comparable safety and equivalent efficacy to infliximab (marketed as Remicade), with an ACR20 response rate of 65.3 percent versus 69.2 percent, respectively.
“With this approval, we are taking another important step in broadening affordable, high-quality biologic treatment options across Europe,” said Christopher Hansung Ko, president and chief executive of Samsung Bioepis.
Bioepis is a joint venture between Samsung Biologics and Biogen, which will lead the commercialisation and distribution of the drug in the EU and European Economic Area member states.
Earlier this year, the JV bagged clearance for Benepali, the first biosimilar version of Pfizer/Amgen’s multi-billion-dollar anti-TNF drug etancerpt (sold as Enbrel), for the treatment of rheumatoid arthritis, psoriatic arthritis, axial spondyloarthritis and plaque psoriasis.
At the time, Hansung Ko noted that availability of the drug “will drive down healthcare costs and increase patient access to one of the most widely used treatment options for immunological diseases across Europe.”