US regulators approve Pfizer’s Remicade biosimilar

The US Food and Drug Administration has issued a green light for Pfizer’s biosimilar of Janssen’s mega blockbuster Remicade.

Ixifi (PF-06438179, infliximab-qbtx), a chimeric human-murine monoclonal antibody against tumor necrosis factor, has been cleared for all indications its reference product is approved for.

The decision allows physicians to prescribe the 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.

Approval was based on data from the REFLECTIONS B537-02 study in patients with moderate to severe active RA, which showed a "high degree of similarity" between Ixifi and Remicade, Pfizer said.

Pricing information is not yet available, but biosimilars are generally coming onto the market at up to 30 percent less than their reference products, which could further increase access to the treatment.

Earlier this year, US regulators also cleared Samsung Bioepis’ Remicade biosimilar Renflexis across all eligible indications.

In February 2016 Pfizer sold to Sandoz rights to PF-06438179 for the 28 EU member states, plus Iceland, Liechtenstein and Norway, but retains commercialisation and manufacturing rights to the drug in countries outside the European Economic Area.