New Biosimilar Inflectra Gets FDA Approval

The Food and Drug Administration (FDA) has approved Inflectra (infliximab-dyyb; Celltrion) for injection, a biosimilar to Remicade (infliximab; Janssen). This marks the second biosimilar product approved by the FDA and the first biosimilar monoclonal antibody (mAb) therapy.

Inflectra is approved for the treatment of:

Adult and pediatric patients (ages ≥6) 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;
Patients with active psoriatic arthritis;
Adult patients with chronic severe plaque psoriasis.

A biosimilar is a biological product that is approved based on a showing that it is highly similar to the existing biological product, known as the reference product. Minor differences in clinically inactive components may exist.

“Biosimilars can provide access to important treatment options for patients who need them,” said Janet Woodcock, M.D., 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.”

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