FDA Approves Zymfentra (infliximab-dyyb) Subcutaneous Formulation for the Treatment of People with Inflammatory Bowel Disease
October 23, 2023 — Celltrion USA has announced that the U.S. Food and Drug Administration (FDA) has approved Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) and Crohn’s disease (CD) following treatment with an infliximab product administered intravenously. Zymfentra is the first FDA-approved subcutaneous formulation of infliximab.
Zymfentra is a subcutaneous version of Celltrion’s infliximab biosimilar. Zymfentra blocks the action of tumor necrosis factor-alpha (TNF-alpha), a protein that can be overproduced in response to certain diseases and causes the immune system to attack normal, healthy parts of the body. The infliximab biosimilar developed and manufactured by Celltrion was the world’s first monoclonal antibody biosimilar. It is indicated for the treatment of eight autoimmune diseases including Crohn’s disease (CD) and ulcerative colitis (UC). The U.S. Food and Drug Administration approved the biosimilar in April 2016 under the trade name INFLECTRA®.
Zymfentra is a prescription medicine indicated in adults for maintenance treatment of moderately to severely active Crohn’s disease or moderately to severely active ulcerative colitis following treatment with an infliximab product administered intravenously.
It is not known if Zymfentra is safe and effective for children under 18 years of age.
