CHMP Issues Positive Opinion on Samsung Bioepis’ Flixabi, a Biosimilar Treatment for IBD

CHMP Issues Positive Opinion on Samsung Bioepis’ Flixabi, a Biosimilar Treatment for IBD
The Committee for Medicinal Products for Human Use (CHMP), the scientific board of European Medicines Agency, has issued a positive opinion on Samsung Bioepis’ Flixabi for the treatment of ulcerative colitis (UC) and Crohn’s disease, and for rheumatoid arthritis, ankylosing spondylitis, psoriasis, and psoriatic arthritis. Flixabi (SB2) is a biological product similar to the reference product Remicade (infliximab), and the second anti-TNF-α drug developed by the company receiving a positive opinion for approval in Europe. The active substance of Flixabi is infliximab, an immunosuppressant. Infliximab is a chimeric human-murine monoclonal antibody that binds with high affinity to both soluble and transmembrane forms of the tumor necrosis factor α (TNFα), but not to lymphotoxin α (TNFβ). The European Commission (EC) will now review CHMP’s opinion, and issue a final decision concerning marketing authorization for Flixabi. If the EC grants approval, Flixabi will be marketed in the European Union by Biogen as a 100 mg powder concentrate solution for infusion. “The CHMP's positive opinion on Flixabi brings us a step closer to broadening affordable, high-quality treatment options for autoimmune patients across Europe,” said Christopher Hansung Ko, president and CEO of Samsung Bioepis in a press release. “We will continue to leverage our strengths in product development and quality assurance, so that we can increase patient access to a wide
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