FDA Approves Remicade Biosimilar (Inflectra )


April 05, 2016

The US Food and Drug Administration (FDA) today approved a biosimilar version of infliximab (Remicade, Janssen Biotech) called infliximab-dyyb (Inflectra, Janssen Biotech) that treats gastrointestinal disorders, rheumatoid arthritis, and most other conditions indicated for its predecessor, the agency announced today.

Infliximab-dyyb is the second biosimilar product that the FDA has approved. The first is filgrastim-sndz (Zarxio, Sandoz/Novartis), greenlighted in March 2015.

The agency defines biosimilars as very much akin to biological drugs such as infliximab that are generally derived from a living organism. Biosimilars also must demonstrate that they are just as safe and effective as their reference product.

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

Infliximab-dyyb, a tumor necrosis factor (TNF) blocker, is an intravenous infusion indicated for:

  • Adults and children aged 6 years or older with moderately to severely active Crohn's disease who have not responded well 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.

  • Patients with active psoriatic arthritis.

  • Adults with chronic, severe plaque psoriasis.

The original infliximab is approved for all of these indications as well as pediatric ulcerative colitis.

The FDA approved infliximab-dyyb based on reviews of evidence that ranged from structural and functional characterization to human pharmacokinetic data.

The most common adverse events the agency expects to see with infliximab-dyyb include respiratory infections, headache, coughing, and stomach pain. Infusion reactions such as fever, chills, and shortness of breath can occur up to 2 hours after an infusion. These adverse events also apply to the original infliximab.

Likewise, infliximab-dyyb comes with the same boxed warning as its predecessor. The drug increases the risk for serious infections such as tuberculosis leading to hospitalization or death. Clinicians first should test patients for latent tuberculosis and, if found, treat it before administering infliximab-dyyb. Lymphomas and other malignancies have been reported in children and adolescents receiving infliximab products and other TNF blockers. There have been postmarketing cases of fatal hepatosplenic T-cell lymphoma in certain patients.

More information on today's decision is available on the FDA website.


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