Samsung Bioepis Becomes First to Obtain European Commission Approval for Second Anti-TNF-α Biosimilar with Flixabi®
Samsung Bioepis Co., Ltd. today announced the European Commission's (EC) approval of Flixabi® – a biosimilar version of Remicade® (infliximab), also known as SB2 – for the treatment of rheumatoid arthritis, Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and psoriasis.
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Christopher Hansung Ko, President & CEO of Samsung Bioepis (Photo: Business Wire)
"With this approval, we are taking another important step in broadening affordable, high-quality biologic treatment options across Europe," said Christopher Hansung Ko, President & CEO of Samsung Bioepis. "The focused dedication of everyone at Samsung Bioepis has now yielded in the European approval for another biosimilar referencing a most widely used biologic medicine. Our commitment to quality and speed has brought us this far in just over four years, and our relentless drive for healthcare innovation will continue as we further advance one of the industry's largest biosimilar pipelines."
The EC approval of Flixabi® applies to all 28 European Union (EU) member states as well as the European Economic Area (EEA) member states of Norway, Iceland and Liechtenstein. In accordance with a commercialization agreement signed in 2013 between Samsung Bioepis and Biogen, Biogen will lead the commercialization and distribution of Flixabi® in the EU and EEA member states.
In a 54-week Phase III 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 broad 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 investigational biosimilar candidate referencing Enbrel® (etanercept)
- SB2 investigational biosimilar candidate referencing Remicade® (infliximab)
- SB5 investigational biosimilar candidate referencing Humira® (adalimumab)
- SB9 (MK-1293) investigational biosimilar candidate referencing Lantus® (insulin glargine)
- SB3 investigational biosimilar candidate referencing Herceptin® (trastuzumab)
SB8 investigational biosimilar candidate referencing Avastin®
Commercialization of Samsung Bioepis Biosimilars
Samsung Bioepis is solely responsible for the development and manufacture of all immunology and oncology biosimilar candidates in its pipeline, as well as global clinical trials and regulatory registration in all markets worldwide for these biosimilar candidates. Following approval, Samsung Bioepis biosimilar products are marketed and distributed by its commercialization partners, Merck and Biogen.
About Samsung Bioepis Co., Ltd.
Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world's leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of 13 biosimilar candidates that include six first-wave product candidates that cover the therapeutic areas of immunology, oncology and diabetes. Samsung Bioepis is a joint venture between Samsung BioLogics and Biogen. For more information, please visit: www.samsungbioepis.com.