US Food and Drug Administration approves biosimilar drug for multiple conditions including rheumatoid arthritis

The Food and Drug Administration (FDA), in the US, has approved Celltrion’s Inflectra (infliximab-dyyb) – a biosimilar to infliximab – for multiple conditions, including rheumatoid arthritis and psoriatic arthritis. This is the second biosimilar approved by the FDA and is biosimilar to Janssen Biotech’s Remicade (infliximab), which was originally licensed in 1998.

In the US, Inflectra can be prescribed by healthcare professionals for the treatment of:

• adult patients and pediatric patients (ages six years 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.

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

In a statement released by the American College of Rheumatology, Dr Joan Von Feldt, the group’s president said, “The safe adoption of biosimilars into the [United States] US marketplace remains a top priority for the American College of Rheumatology (ACR). Biologics are a lifeline for patients living with rheumatic disease, helping many to avoid pain, long-term disability and life-threatening complications. Unfortunately, many of our patients struggle to afford these complex therapies due to their high cost.”

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