Celltrion USA announces US FDA approval of Zymfentra (infliximab-dyyb), the first and only subcutaneous infliximab, for the treatment of people with inflammatory bowel disease

Celltrion

22 October 2023 - Zymfentra is the first and only FDA approved subcutaneous formulation of infliximab approved for the maintenance treatment of adult patients with moderately to severely active ulcerative colitis and Crohn’s disease.

Today, Celltrion USA announced that the US FDA has approved Zymfentra (infliximab-dyyb) for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn’s disease following treatment with an infliximab product administered intravenously.

Read Celltrion press release

Michael Wonder

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Michael Wonder

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Outcome , Medicine , US , Biosimilar