On October 23, 2023, Celltrion announced FDA approval for ZYMFENTRA (infliximab-dyyb), a subcutaneous formulation for maintenance therapy for patients with moderately to severely active ulcerative colitis and Crohn’s disease.  Infliximab is a TNF blocking agent that was first approved by the FDA as an intravenous formulation for the treatment of Crohn’s disease in 1998.  Since its initial approval, intravenous infliximab has been approved for several additional indications including ulcerative colitis, psoriatic arthritis, and ankylosing spondylitis.  As stated by Celltrion, “ZYMFENTRA™ is the first and only FDA-approved subcutaneous (SC) formulation of infliximab approved for the maintenance treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s disease.”

The FDA approved Celltrion’s infliximab biosimilar, administered by intravenous infusion, in April 2016 under the trade name INFLECTRA (infliximab-dyyb).

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