1 April 2016 - The CHMP has issued a positive opinion for the marketing authorization of Flixabi (infliximab). Previously known as SB2, Flixabi is an infliximab biosimilar candidate referencing Remicade, which was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen.

The positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU). If approved by the EC, Flixabi could be prescribed in the same indications as Remicade. This includes treatment of adults with rheumatoid arthritis (RA), Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. FLIXABI could also be used in patients six to 17 years old with severe, active Crohn’s disease or severely active ulcerative colitis.

The positive CHMP opinion comes shortly after marketing authorization was granted for Benepali (etanercept), a biosimilar referencing Enbrel. Both Flixabi and Benepali are anti-TNF therapies, a treatment class which accounts for the largest prescribed segment of the global biologics market.

“The positive CHMP opinion for Flixabi marks another important milestone for our biosimilars business this year. We are excited to harness this positive momentum as we prepare to bring our second biosimilar treatment to patients in the EU,” said Alpna Seth, Ph.D., Senior Vice President and Global Head of the Biosimilars Business Unit at Biogen. “Biogen is building upon its deep expertise in manufacturing and commercializing biologics for immunological conditions by bringing forth these important therapies. Biosimilars will increase choice and access for patients in the EU, while providing potential cost savings to healthcare systems.”

For more details, go to: http://media.biogen.com/press-release/autoimmune-diseases/flixabi-infliximab-biosimilar-candidate-referencing-remicade-recei