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Flixabi Biosimilar to Infliximab Gains Positive CHMP Opinion
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The Committee for Medicinal Products for Human Use has issued a positive opinion for the marketing authorization of Flixabi, formerly known as SB2, a biosimilar to infliximab. The biosimilar is developed by Samsung Bioepis, a joint venture between Biogen and Samsung BioLogics.
The positive opinion will be referred to the European Commission, and, if approved, Flixabi could be prescribed for the same indications as the originator infliximab product (Remicade, Janssen) which is approved for rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, psoriasis, Crohn’s disease and ulcerative colitis.
“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 [European Union] EU,” Alpna Seth, PhD, senior vice president and global head of the Biosimilars Business Unit at Biogen, said in a press release from 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 health care systems.”
According to the release, the positive opinion from the Committee for Medicinal Products for Human Use follows the submission of phase 1 and phase 3 clinical trial data by Samsung Bioepis comparing Flixabi to the originator infliximab. The phase 3 study involved 584 patients with moderate to severe rheumatoid arthritis treated during 54 weeks, and comparable ACR20 responses were observed with both originator infliximab and Flixabi.
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