FDA Approves Celltrion’s Zymfentra for Autoimmune Diseases

SEOUL - South Korean pharmaceutical giant Celltrion Inc. announced that its new treatment for autoimmune diseases has received approval from the U.S. Food and Drug Administration (FDA).

According to a new release by Yonhap News Agency, the FDA approved Celltrion's Zymfentra, a subcutaneous injection formulation of infliximab Remsima. The drug is designated for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn's disease who have previously been treated with intravenously administered infliximab. Zymfentra is Celltrion's first newly developed drug to gain FDA approval and will be under patent protection until 2037 for its dosage form and route of administration until 2040.

The treatment has also received approval from drug safety authorities in 50 countries, including Canada and European nations, under the brand name Remsima SC. The company expects Zymfentra to bring in 600 billion won (US$443.7 million) in annual sales upon its U.S. market debut. Celltrion Healthcare Co., a sales affiliate, will lead the marketing and sales of the drug in the United States.

Thomas Nusbickel, the chief commercial officer at Celltrion USA, stated that the approval provides a new treatment option for patients with inflammatory bowel diseases, offering an alternative administration method.

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