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Pfizer's 2nd copy of J&J's Remicade wins FDA approval

The U.S. Food and Drug Administration approved Pfizer Inc.'s second biosimilar of Johnson & Johnson's rheumatoidarthritis drug Remicade.

The drug, named Ixifi, was approved to treat patients with rheumatoid arthritis, Crohn's disease, pediatric Crohn's disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis.

Ixifi's approval follows the acceptance of its biologics license application in April. The approval is based on data from a phase 3 trial where the drug showed a high degree of similarity to the reference product.

Pfizer's first copy of Remicade, Inflectra, was approved in 2016.