Samsung Bioepis Wins Korean Approval for Remicade Biosimilar

Samsung Bioepis, a joint venture between Samsung Biologics and Biogen, has won approval from Korea’s Ministry of Food and Drug Safety for Renflexis, a biosimilar of Johnson & Johnson’s Remicade.

The biosimilar was approved for treatment of rheumatoid arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis, psoriatic arthritis and plaque psoriasis. The knockoff showed in a 54-week, 584-patient Phase 3 study comparable safety and equivalent efficacy to Remicade (infliximab), with an ACR20 response rate of 65.3 percent versus 69.2 percent in the Remicade arm.

Last month, the European Medicines Agency recommended approval of Samsung Bioepis’ autoimmune disease therapy Benepali, a biosimilar of Amgen’s blockbuster Enbrel (etanercept)‎.