New Biosimilar Inflectra Gets FDA Approval

This is the first biosimilar monoclonal antibody (mAb) therapy to be approved by the FDA
This is the first biosimilar monoclonal antibody (mAb) therapy to be approved by the FDA

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.

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.” 

RELATED: Advisory Panel Recommends Approving Biosimilar of Remicade

The approval of Inflectra was based on evidence that included structural and functional characterization, animal study data, human pharmacokinetic and pharmacodynamics data, clinical immunogenicity data, and other clinical safety and effectiveness data that showed Inflectra was biosimilar to Remicade. Inflectra is not approved for use as an interchangeable product with Remicade.

Infliximab neutralizes the biological activity of TNFα by binding with high affinity to the soluble and transmembrane forms of TNFα and inhibit binding of TNFα with its receptors. Infliximab products do not neutralize TNFβ (lymphotoxin-α), a related cytokine that utilizes the same receptors as TNFα.

Inflectra is available as a 100mg strength 20mL vials in 10-count cartons. Pfizer has exclusive commercialization rights to Inflectra in the United States.

For more information call (800) 383-7504 or visit Celltrion.com or Pfizer.com.

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