Samsung Bioepis’ Flixabi (infliximab biosimilar) recommended for approval in the European Union

April 10, 2016 12:52 PM

Samsung Bioepis Co., Ltd. announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion on Flixabi – a biosimilar version of Remicade (infliximab).

The product was also known as SB2 – for the treatment of rheumatoid arthritis, Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis. Flixabi® is the second anti-TNF-alfa biosimilar developed by Samsung Bioepis to receive a positive recommendation for approval in Europe.

The CHMP’s positive opinion will now be referred to the European Commission (EC) which will review and decide on the grant of a marketing authorization for Flixabi. If a marketing authorization is granted, Flixabi will be commercialized in the European Union by Biogen.

“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 & CEO of Samsung Bioepis. “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.”

The positive CHMP opinion on Flixabi was based on Phase 1 and Phase 3 clinical studies that tested the biosimilarity of Flixabi to Remicade®. In a 54-week Phase 3 clinical study, Flixabi showed comparable safety and equivalent efficacy to Remicade, as evidenced in ACR20 response rate of 65.3% in the Flixabi arm versus 69.2% in the Remicade arm at Week 54, fully supporting the 30-week study results of 64.1% and 66.0%, respectively. The Flixabi study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries.

Samsung Bioepis Biosimilar Pipeline
Samsung Bioepis continues to advance a pipeline of 13 biosimilar candidates, which includes the following six “first wave” product candidates that cover the therapeutic areas of immunology, oncology and diabetes:

  • SB4 biosimilar candidate referencing Enbrel® (etanercept)
  • SB2 biosimilar candidate referencing Remicade® (infliximab)
  • SB5 biosimilar candidate referencing Humira® (adalimumab)
  • SB9 (MK-1293) biosimilar candidate referencing Lantus® (insulin glargine)
  • SB3 biosimilar candidate referencing Herceptin® (trastuzumab)
  • SB8 biosimilar candidate referencing Avastin® (bevacizumab)

Source: Samsung Bioepis

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