FDA Approves Pfizer Biosimilar to J&J’s Remicade

On Dec. 13, 2017, Pfizer announced that FDA approved Ixifi (infliximab-qbtx) as a biosmilar to Johson & Johnson’s (J&J) anti-inflammatory biologic, Remicade (infliximab), for all eligible indications of the reference product. Remicade is J&J’s top-selling drug, earning nearly $7 billion in 2016 sales.

Pfizer’s biosimilar, a chimeric human-murine monoclonal antibody against tumor necrosis factor, was approved by FDA for treating rheumatoid arthritis, Crohn's disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, and plaque psoriasis. The approval follows acceptance of the Ixifi biologics license application in April 2017.  

In February 2016, Sandoz acquired the rights from Pfizer for the development, commercialization, and manufacture of the biosimilar in the 28 European Union member states, as well as three of the four member states of the European Free Trade Association-Iceland, Liechtenstein, and Norway-that form the European Economic Area (EEA). Under this divestment, Pfizer retains commercialization and manufacturing rights to the biosimilar in countries outside the EEA.

Pfizer has a portfolio of three marketed biosimilar medicines outside the United States, including Inflectra (infliximab), Retacrit (epoetin zeta), and Nivestim (filgrastim). The company also has a biosimilars pipeline consisting of 13 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 world markets.

Source: Pfizer