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FDA Approves Biosimilar Infliximab-dyyb for Inflammatory Bowel Disease

Infliximab-dyyb (Zymfentra; Celltrion USA) is a subcutaneous version of Celltrion’s infliximab biosimilar for the maintenance treatment of adults with moderately to severely active ulcerative colitis and Crohn disease.

FDA Approves First Subcutaneous Infliximab for Maintenance Therapy in UC and Crohn Disease

The approval of infliximab-dyyb as a maintenance therapy following IV infliximab for patients with moderately to severely active ulcerative colitis and Crohn disease was announced on October 22, 2023.

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