Samsung Bioepis’ RENFLEXIS® Infliximab Biosimilar Receives Regulatory Approval in Korea

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.