Samsung Bioepis has received approval from Korea’s Ministry of Food and Drug Safety (MFDS) for RENFLEXIS, a biosimilar version of J&J’s Remicade (infliximab), 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 company’s second regulatory approval in Korea; BRENZYS, a biosimilar version of Amgen’s Enbrel (etanercept), was approved in September 2015.

Samsung Bioepis is responsible for the development of all immunology and oncology biosimilars in its pipeline, including RENFLEXIS, as well as global clinical trials and regulatory registration. Under the commercialization agreement with Merck signed in 2013, MSD Korea will be responsible for marketing, sales and distribution of RENFLEXIS in Korea.

The Phase III study of 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.

“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 and chief executive officer 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.”