Pfizer Inc. announced that the United States (U.S.) 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 RA(2). 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 U.S. 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 U.S. and certain other markets across the globe.