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Biogen receives marketing authorization in the EU for infliximab biosimilar
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Biogen announced the European Commission granted marketing authorization in the European Union for Flixabi, a biosimilar to infliximab indicated for the treatment of adults with rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and psoriasis.
Developed by Samsung Bioepis, the joint venture between Samsung BioLogics and Biogen, Flixabi will be the second anti-tumor necrosis factor (TNF) biosimilar to be manufactured and commercialized by Biogen in the European Union, according to a company press release. The release noted that in a phase 3 randomized clinical trial of 584 patients, researchers found equivalence of Flixabi to infliximab (Remicade, Janssen Biotech) in the ACR20 response rate at week 30 and week 54 in the per-protocol set and in the ACR20 response in the full analysis set at week 30 and week 54.
Alpna Seth
“The approval of Flixabi marks a major step forward for both Samsung Bioepis and Biogen. It expands our anti-TNF portfolio and furthers Biogen’s commitment to commercializing biosimilars of advanced biologics, while expanding cost-effective treatment options for patients living with chronic inflammatory conditions, such as Crohn’s disease and ulcerative colitis,” Alpna Seth, PhD, senior vice president and global head of the Biosimilars Business Unit at Biogen, said in the release. “We are delighted to be the first company to bring two anti-TNF biosimilars to patients and physicians across Europe.”
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