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 wider choice of life-enhancing medications.”
CHMP’s opinion was based on data derived from Phase 1 and 3 clinical trials assessing Flixabi as a biological medicinal product similar to Remicade. Results from the 54-week Phase 3 randomized trial, involving 584 patients with moderate to severe rheumatoid arthritis across 73 sites in 11 countries, found equivalent efficacy and comparable safety.
Samsung Bioepis currently holds a portfolio of 13 biosimilar products, covering the therapeutic areas of oncology, immunology, and diabetes:
- SB4, a biological medicinal product similar to Enbrel (etanercept)
- SB2, a biological medicinal product similar to Remicade (infliximab)
- SB5, a biological medicinal product similar to Humira (adalimumab)
- SB9 (MK-1293), a biological medicinal product similar to Lantus (insulin glargine)
- SB3, a biological medicinal product similar to Herceptin (trastuzumab)
- SB8, a biological medicinal product similar to Avastin (bevacizumab)
Upon approval, Samsung Bioepis’ biosimilar products will be marketed by Biogen and Merck, under commercialization agreements between the companies.