FDA approved Samsung Bioepis’s Renflexis® (SB2, infliximab-abda) on Friday, April 21, 2017. Renflexis® is the fifth biosimilar approved by the FDA and the second infliximab biosimilar to Janssen’s Remicade®. Infliximab is an Anti-Tumor Necrosis Factor (Anti-TNF) monoclonal antibody approved in the U.S. for treating rheumatoid arthritis, ulcerative colitis, Crohn’s disease, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. FDA previously approved Celltrion’s Inflectra® (infliximab-dyyb), the first biosimilar to Remicade®, on April 5, 2016, and that product was launched in the United States in November 2016 under a marketing agreement with Pfizer.
Samsung Bioepis announced that the FDA had accepted its biologics license application for SB2, its infliximab biosimilar, in May 2016. The company has publicly stated that when launched, marketing and distribution of Renflexis® will be handled by Merck in the United States. Renflexis® is Samsung Bioepis’s first biosimilar approved by the FDA, but the product was approved earlier in South Korea (in December 2015), Europe (in May 2016), and Australia (in November 2015).