FDA Approves Ixifi® (infliximab-qbtx), Third Biosimilar of Remicade® in U.S.

Today, the FDA announced that it has approved Pfizer’s Ixifi® (infliximab-qbtx) as a biosimilar to Remicade®. Ixifi® is indicated for the treatment of most of the same conditions as its reference product: Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis (in adult patients), rheumatoid arthritis, ankylosing spondylitis and plaque psoriasis.  (Remicade® is additionally indicated for the treatment of pediatric ulcerative colitis.)

Ixifi® is the ninth biosimilar overall to obtain FDA approval under the abbreviated regulatory pathway of the BPCIA.  It is the third FDA-approved biosimilar of Remicade® to receive FDA approval, after Celltrion’s Inflectra® (infliximab-dyyb) in April 2016 and Samsung Bioepis’s Renflexis® (infliximab-abda) in April of this year.

Stay tuned to Big Molecule Watch for further developments.