INCHEON, Korea – December 4, 2015 – Samsung Bioepis Co., Ltd. today announced that Korea’s Ministry of Food and Drug Safety (MFDS) has approved RENFLEXIS® – a biosimilar version of Remicade® (infliximab), also known as SB2 – for the treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, pediatric ulcerative colitis, psoriatic arthritis and plaque psoriasis. This marks the second regulatory approval for Samsung Bioepis in Korea. The MFDS approved in September 2015 Samsung Bioepis’ BRENZYS®, a biosimilar version of Enbrel® (etanercept), also known as SB4.
“We look forward to the introduction of RENFLEXIS® in Korea, where patients suffering from autoimmune diseases will soon have access to an affordable, high-quality biologic treatment option,” said Christopher Hansung Ko, President & CEO of Samsung Bioepis. “With an extensive pipeline of biosimilars on the way, we will continue to leverage our strengths in product development and quality assurance to bring these life-enhancing medications to patients who need them most.”
Samsung Bioepis is solely responsible for the development of all immunology and oncology biosimilars in its pipeline, including RENFLEXIS®, as well as global clinical trials and regulatory registration in all markets worldwide for these biosimilars. As according to the commercialization agreement signed in 2013 with Merck, MSD Korea will be responsible for the marketing, sales and distribution of RENFLEXIS® in Korea.
In a 54-week Phase 3 clinical study, RENFLEXIS® showed comparable safety and equivalent efficacy to Remicade®, as evidenced in ACR20 response rate of 65.3% in the RENFLEXIS® arm versus 69.2% in the Remicade® arm. The RENFLEXIS® study randomized 584 patients with moderate to severe rheumatoid arthritis despite methotrexate therapy across 73 sites in 11 countries.
In addition to RENFLEXIS®, Samsung Bioepis has been developing two other anti-tumor necrosis factor-alpha (anti-TNF-α) investigational biosimilar candidates, the latest developments for which are as follows:
Samsung Bioepis was established in 2012 with a mission to develop affordable, high-quality biopharmaceutical products and to provide better patient access to these life-enhancing medications. The company aims to be the world’s leading biopharmaceutical company through innovations in product development and quality assurance.
Samsung Bioepis has commercial agreements with Biogen and Merck to commercialize and distribute biosimilar products in immunology, oncology and diabetes. The products and geographic responsibilities include:
Samsung Bioepis is a joint venture between Samsung Biologics and Biogen. For more information, please visit: www.samsungbioepis.com