Pfizer has announced that the United States (US) Food and Drug Administration (FDA) has approved Ixifi (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody (mAb) against tumor necrosis factor, as a biosimilar to Remicade (infliximab) for all eligible indications of the reference product.

The FDA has approved Ixifi as a treatment for patients with rheumatoid arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.

FDA approval follows the acceptance of the Ixifi Biologics License Application in April 2017 and is based on the totality of evidence demonstrating a high degree of similarity to the reference product, including the REFLECTIONS B537-02 study in patients with moderate to severe active RA2. The phase 3, multi-national, randomized, double blind, two-arm, parallel group study evaluated the safety, efficacy, and immunogenicity of Ixifi versus Remicade administered intravenously in combination with methotrexate to treat patients with moderate to severely active RA who have had an inadequate response to methotrexate therapy. The study met its primary endpoint of ACR20 response (=20% improvement by American College of Rheumatology criteria) at Week 14, and was supported by data at week 30.

Pfizer has a portfolio of three marketed biosimilar medicines outside the US including Inflectra (infliximab), Retacrit (epoetin zeta), and Nivestim (filgrastim); and a biosimilars pipeline consisting of 13 distinct biosimilar molecules in various stages of development. As part of its global biosimilars strategy, Pfizer supplies Celltrion’s Inflectra (infliximab-dyyb) in the US and certain other markets across the globe.

Ixifi (infliximab-qbtx) is a chimeric human-murine mAb against tumor necrosis factor, approved as a biosimilar for all eligible indications of the reference product. Ixifi has been approved in the US for rheumatoid arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis.
 
In February 2016, Sandoz acquired the rights from Pfizer for the development, commercialization and manufacture of PF-06438179 in the 28 EU member states, as well as three of the four member states of the European Free Trade Association (EFTA) (Iceland, Liechtenstein and Norway) that form the European Economic Area (EEA).  Under the terms of the divestment, Pfizer retains commercialization and manufacturing rights to PF-06438179 in countries outside the EEA.