Second Biosimilar to Remicade Approved

A second biosimilar to infliximab, marketed as Remicade by Johnson & Johnson, has received FDA approval. Infliximab-abda (Renflexis) was developed by Samsung Bioepis/Merck and has been approved for multiple indications: adult and pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

Renflexis is a tumor necrosis factor (TNF) blocker that is delivered as an intravenous infusion. It will be available in single-dose vials of 100 mg. The most common adverse reactions include infections, infusion-related reactions, headache, and abdominal pain. The drug should not be given during an active infection and the warning on the label notes that the incidence of malignancies was greater in patients treated with the TNF blocker compared with the control group.

The drug is contraindicated with anakinra and abatacept. Use of Renflexis with those 2 medications increases the risk of serious infection, according to the drug label. In addition, it has not been studied in children younger than age 6 who have Crohn’s disease or ulcerative colitis.

The biosimilar had been approved almost 2 years ago in South Korea.

Inflectra was the first biosimilar to Remicade that the FDA approved. It was approved April 2016 for multiple indications and it is also administered by intravenous infusion. Inflectra first became available in the United States in November 2016.