Pfizer commends FDA committee for recommending infliximab for approval

Pfizer Inc. has commended the United States Food and Drug Administration (FDA) Arthritis Advisory Committee for its recommendation to approve the biosimilar infliximab (CT-P13) this week.

The investigational antibody won the approval by a vote of 21 to three. Pfizer holds the exclusive U.S. commercialization rights to infliximab, but the antibody was proposed to the U.S. FDA by Celltrion. It is the first biosimilar monoclonal antibody (mAb) therapy to have its licensure reviewed by the FDA. This is only the second time the FDA advisory committee has recommended an mAb for approval.

Infliximab is under consideration of the FDA for the treatment of rheumatoid arthritis, adult ulcerative colitis, plaque psoriasis, psoriatic arthritis, ankylosing spondylitis and adult and pediatric Crohn’s disease. All of these diseases, or indications, were included in the licensure. The recommendation for approval by the FDA’s advisory committee is a crucial step in creating a market for biosimilars in the United States.

Pfizer has identified this important step as an opportunity to provide patients with alternative treatments, through the use of biosimilars, that are of a higher quality and more affordable. Pfizer began working with Celltrion in 2009 to develop CT-P13, as well as other biosimilar products.