Another Remicade Biosimilar Granted FDA Approval

Today, the FDA approved intravenous Renflexis (infliximab-abda), a biosimilar to Remicade (infliximab). This is the second FDA-approved biosimilar for Remicade.

Renflexis is indicated to treat adult and pediatric Crohn’s disease, ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, and plaque psoriasis, according to the prescribing label.

The similarity between Renflexis and the reference product has been demonstrated for indications, dosing, and administration. While the inactive ingredients vary between the 2 drugs, there are no clinically meaningful differences in safety and efficacy.

Common side effects include upper respiratory infections, sinusitis, and pharyngitis, infusion-related reactions, headache, and abdominal pain, according to the FDA.

In April 2016, the FDA approved the first biosimilar of Remicade, Inflectra (infliximab-dyyb), for multiple indications across a range of autoimmune diseases. Inflectra was the second biosimilar to be approved in the United States and is also administered by intravenous infusion.

Remicade was the first anti-tumor necrosis factor-alpha treatment approved in the United States to be approved in gastroenterology, rheumatology, and dermatology, according to Janssen. The safety and efficacy of the drug has been well established in clinical trials over the past 22 years, with more than 2.6 million patients treated worldwide.