FDA Approves Inflectra, Biosimilar for All Indications

The FDA has approved Inflectra (infliximab-dyyb/Celltrion, Inc), the biosimilar for Remicade (infliximab) for the treatment of patients suffering from serious autoimmune diseases.

Administered by intravenous infusion, Inflectra is the first biosimilar to receive approval in the US for the treatment of rheumatic diseases.

Inflectra can be prescribed by a health care professional for the treatment of:

· Adult patients and pediatric patients (ages 6 and older) with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy

· Adult patients with moderately to severely active ulcerative colitis who have had an inadequate response to conventional therapy

· Patients with moderately to severely active rheumatoid arthritis in combination with methotrexate

· Patients with active ankylosing spondylitis (arthritis of the spine)

· Patients with active psoriatic arthritis

· Adult patients with chronic severe plaque psoriasis

The FDA’s approval followed an evidence review surrounding the clinical safety and efficacy supporting that Inflectra is biosimilar to Remicade.

Officials noted that Inflectra has been approved as biosimilar, not as an interchangeable product.

The most commonly expected side effects include respiratory infections, sore throat, headache, coughing, and stomach pain.

Additionally, some patients experience infusion reaction, the symptoms of which can include fever, chills, chest pain, low or high blood pressure, shortness of breath, rash, and itching.

According to Janet Woodcock, MD, director of FDA’s Center for Drug Evaluation and Research, “Biosimilars can provide access to important treatment options for patients who need them. Patients and the healthcare community can be confident that biosimilar products are high quality and meet the agency’s rigorous scientific standards.”