New biosimilar listed for treatment of multiple conditions

Pfizer Inc.announced that the 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. The 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.

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.

Comment: Rights to PF-06438179 in Europe are licensed to Sandoz which filed a Marketing Authorisation Application (MAA) for the biosimilar in May 2017.