Biogen has launched Flixabi - a biosimilar of Johnson & Johnson's blockbuster infliximab - across the UK for use in a range of chronic inflammatory conditions.
The drug won approval in May this year for adults with Crohn's disease, adult ulcerative colitis, rheumatoid arthritis (RA), ankylosing spondylitis, psoriatic arthritis, and psoriasis. It can also be used to treat children and adolescents aged six to 17 years with severe, active paediatric Crohn's disease or severely active paediatric ulcerative colitis.
Clearance came on the back of data from a 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.
According to Biogen, the conditions Flixabi is marketed for are estimated to affect more than 600,000 people in the UK and can cost the NHS up to £470 million every year.
Flixabi is the second anti-TNF biosimilar to be marketed in UK by the company, which says its availability will help expand access to cost-effective biologic therapies available to physicians and patients.
"Anti-TNF therapies cost EU healthcare budgets an estimated $10Bn a year; biosimilars offer physicians and healthcare systems high-quality alternatives at a lower cost," said Darren Clarkson, Regional Director, Biosimilars UK/Ire/NL at Biogen.
"With the launch of Flixabi, we further our commitment to increasing patient choice and expanding access while helping to reduce the burden on healthcare systems."