The U.S. Food and Drug Administration (FDA) has approved Pfizer’s Ixifi (infliximab-qbtx), a biosimilar to Janssen Biotech’s Remicade, for all indications approved for the reference product, including ankylosing spondylitis.
Like Remicade, Ixifi is a chimeric human-murine monoclonal antibody against tumor necrosis factor (TNF). TNF is involved in autoimmune and immune-mediated disorders and is known to play a role in the inflammatory response. TNF blockers are pharmaceuticals that suppress the physiologic response to TNF and are used to treat several autoimmune and inflammatory conditions.
Ixifi is indicated for the treatment of the same disorders as Remicade, including ankylosing spondylitis (AS), plaque psoriasis, psoriatic arthritis, rheumatoid arthritis, and certain inflammatory bowel diseases (IBDs).
Ixifi’s approval follows the acceptance of a biologics license application (BLA) submitted to the FDA in April 2017 and is based on a strong body of evidence demonstrating the high degree of similarity to the reference product, according to a press release.
This evidence includes results from the Phase 3 REFLECTIONS B537-02 study (NCT02222493) in patients with moderate to severe rheumatoid arthritis. The trial evaluated the safety, effectiveness, and immunogenicity of Ixifi compared to Remicade in combination with methotrexate.
The primary goal of the trial — to achieve 20% or more improvement in measures of disease activity according to the American College of Rheumatology criteria at week 14 —was met. The findings were supported by additional data at week 30.
Sandoz acquired European rights to Ixifi in 2016 and is planning to develop, and eventually commercialize, the biosimilar therapy in 28 European Union member states, as well as in Iceland, Lichtenstein, and Norway.
Under the terms of the agreement, Pfizer retains commercialization and manufacturing rights over the drug in countries outside the European Economic Area.
So far, the FDA has approved two other biosimilars of infliximab, Renflexis (infliximab-abda, developed by Samsung Bioepis and Merck) and Inflecra (infliximab-dyyb, by Celltrion) for the same indications.
According to the FDA, approval of a biosimilar product is based on evidence showing that it is highly similar to an already approved biological reference product. Biosimilars must also demonstrate no clinically meaningful differences in safety and effectiveness from the reference product.