The Ministry of Food and Drug Safety (MFDS)in South Korea has approved Renflexis (SB 2) infliximab biosimilar -Samsung Bioepis
Samsung Bioepis Co., Ltd. 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.
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.
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