On April 6, the U.S. Food and Drug Administration (FDA) approved Celltrion’s INFLECTRA™, a biosimilar version of Janssen Biotech, Inc.'s Remicade (infliximab).
INFLECTRA is the first biosimilar monoclonal antibody (mAb) medication to be approved for sale in the US. "Patients and the health care community can be confident that biosimilar products are high quality and meet the agency's rigorous scientific standards. Biosimilars can provide access to important treatment options for patients who need them," said Janet Woodcock, director of FDA's Center for Drug Evaluation and Research. INFLECTRA™ will be marketed by Pfizer in the US.
With the FDA approval of INFLECTRA™, South Korea's Celltrion has become the first biosimilar developer to have its biosimilar drug approved for sale in both the US and Europe, which take up 80 percent of the global antibody drug market.
Celltrion’s INFLECTRA™ is a cheaper version of Remicade, which is used in the treatment of rheumatoid arthritis. Remicade sales brought in approximately 9.9 billion dollars last year. The US rheumatoid arthritis drug market is worth 20 trillion won a year.
