FDA Approved Inflectra Drug Set To Treat Most Autoimmune Diseases

On April 5, 2016, the Food and Drug Administration, or FDA approved its second biosimilar drug, Inflectra, close to a year after approving Zarxio in March 2015. Closely related to Remicade which was licensed in 1998, Inflectra is administered through intravenous infusion to treat most autoimmune diseases.   

How It Works

Inflectra belongs to a family of drugs known as tumor necrosis factor-alpha, or TNF-A inhibitors. It contains infliximab, an active substance in the form of a protein antibody designed to attach to chemical messengers responsible for causing inflammation. By blocking these messengers, the drug alleviates inflammation and other associated symptoms. drug-approval-processFDA approved use of Inflectra basing on evidence gathered from human and animal study results as well as technical research data which compared the drug with Remicade.


Inflectra is indicated for reducing symptoms in patients suffering from various diseases including:

– Rheumatoid arthritis, an immune-system disease that causes inflammation of joints. When combined with methotrexate, Inflectra cuts symptoms of arthritis including joint pain, tenderness and redness.

– Moderate and severe Crohn’s disease. The drug treats cases of Crohn’s disease that have less response to standard therapy in individuals who are six years and older. Patients who do not respond to the drug after prolonged use are unlikely to respond and considerations should be given to discontinue using it.

– Ulcerative colitis. Inflectra induces and maintains mucosal remission and healing for colitis, which is characterized by inflammation and ulcers in the lining of the gut.

– Psoriatic arthritis. The biosimilar drug inhibits progression of structural damage to the skin and joints, improving physical functioning in patients with psoriatic arthritis and severe plaque psoriasis.


Inflectra is available as a powder, which is made into a solution for infusion into the vein. It is administered as 3 mg per kilogram body weight for rheumatoid arthritis and 5 mg per kilogram for other autoimmune illnesses. The dosage can be increased if necessary, and how often the treatment is repeated depends on the patient’s response to the drug and the disease being treated.

Side Effects

Common side effects of the drug include flu, cold sores, headache, sinusitis, nausea and abdominal pain. Side effects such as colds and infections are more common in children than adults. Reactions to the drug may be noticed within two hours after administration. More serious side effects may include blood disorder, liver damage and problems with the nervous system.


The drug is not ideal for use in patients with a history of hypersensitivity to infliximab and any versions of Remicade. Individuals suffering from tuberculosis and other infections, as well as those with moderate or severe heart failure should not use the drug.