Samsung Bioepis’ infliximab biosimilar receives approval in South Korea

Samsung Bioepis Co., Ltd. announced that Korea’s Ministry of Food and Drug Safety (MFDS) has approved Renflexis – a biosimilar version of Remicade (infliximab).

The product, also known as SB2 – is approved 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.