WESTON (dpa-AFX) - The European Commission has granted marketing authorization in the European Union for FLIXABI, an infliximab biosimilar referencing Remicade.
FLIXABI was developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen (BIIB). FLIXABI is indicated for the treatment of adults with rheumatoid arthritis (RA), Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Additionally, FLIXABI can be used in patients 6 to 17 years old with severe, active Crohn's disease or severely active ulcerative colitis.
FLIXABI will be the second anti-TNF biosimilar to be manufactured and commercialized by Biogen in the EU. Earlier this year, Samsung Bioepis received approval for BENEPALI (etanercept), a biosimilar referencing Enbrel. Biogen has since launched BENEPALI in several countries across the EU.
As part of the submission, Samsung Bioepis provided a robust preclinical and clinical data package from head-to-head Phase 1 and Phase 3 clinical trials comparing FLIXABI with the reference product Remicade. Following biosimilar approval guidelines from the European Medicines Agency, the Phase 3 clinical trial for FLIXABI was performed to confirm equivalent efficacy, and to compare safety and immunogenicity with Remicade. The 54-week, double-blind, Phase 3 study was conducted in patients with moderate to severe RA despite methotrexate therapy. The primary end point was the American College of Rheumatology 20% (ACR20) response at week 30 in the per-protocol set (PPS). The primary end point for the study was met, with data showing that patients taking FLIXABI had an equivalent ACR20 response and a comparable safety profile to those taking Remicade.
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