Large Molecule

FDA Oks Pfizer's Second Remicade Biosim

Dec 14, 2017

The U.S. FDA approved Pfizer’s second biosimilar to Johnson & Johnson’s blockbuster rheumatoid arthritis drug, Remicade.

The Agency 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.

Ixifi is the ninth biosimilar approved in the U.S. and joins two other biosimilars that have claimed market share from Remicade, including Pfizer/Celltrion’s Inflectra and Merck/Samsung Bioepsis' Renflexis.

According to reporting from RAPS, Pfizer, not wanting to compete against its own product, will not launch Ixifi in the United States. Pfizer's Inflectra, the second biosim approved by the U.S. FDA, was given the green light in April 2016.

Read the press release