FDA Approves Renflexis, Biosimilar to Remicade

The U.S. Food and Drug Administration has approved Renflexis (infliximababda, Samsung Bioepis), the second biosimilar to Remicade (infliximab, Janssen Biotech). Inflectra (infliximab-dyyb, Celltrion) was the first approved biosimilar. The tumor necrosis factor blocker is an intravenous infusion (100 mg) indicated for the same indications as Remicade: Crohn’s disease, ulcerative colitis, rheumatoid arthritis (in combination with methotrexate), ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The most common adverse reactions that occurred in fewer than 10 percent of patients in clinical trials were infections (e.g., upper respiration infection, sinusitis and pharyngitis), infusion-related reactions, headache and abdominal pain, which are similar to those seen with Remicade. In addition, Renflexis also comes with the same boxed warning as Remicade concerning the increased risk of serious infections.