Samsung Bioepis' Flixabi® Infliximab Biosimilar Recommended for Approval in the European Union
Samsung Bioepis Co., Ltd. today 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), 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-α biosimilar developed by Samsung Bioepis to receive a positive recommendation for approval in Europe.
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Christopher Hansung Ko, President & CEO of Samsung Bioepis (Photo: Business Wire)
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 (EU) 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)
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, with whom Samsung Bioepis
has commercialization agreements that cover the six “first wave”
biosimilar candidates.
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 superior 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.
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Contact information
Samsung Bioepis Co., Ltd.
MEDIA CONTACT:
Mingi Hyun,
+82-32-455-6128
mingi.hyun@samsung.com
INVESTOR
CONTACT:
Kwang Ryu, +82-32-455-6149
kwang1.ryu@samsung.com
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