SEOUL, Oct. 23 (Yonhap) — Celltrion Inc., a major South Korean pharmaceutical firm, announced on Monday that the U.S. Food and Drug Administration (FDA) has approved its new autoimmune disease treatment, Zymfentra. This is the company’s first newly developed drug to receive FDA approval and will be under patent protection until 2037 for its dosage form and route of administration until 2040.
Zymfentra is a subcutaneous injection formulation of infliximab Remsima, and is used for maintenance therapy in adults with moderately to severely active ulcerative colitis and Crohn’s disease following treatment with an infliximab administered intravenously. It has also been approved by drug safety authorities in 50 countries, including Canada and those in Europe, under the brand name Remsima SC.
Celltrion estimates that Zymfentra will generate 600 billion won (US$443.7 million) in annual sales upon its U.S. market debut. Its sales affiliate Celltrion Healthcare Co. will lead marketing and sales of the drug in the United States.
Thomas Nusbickel, chief commercial officer at Celltrion USA, commented, “The approval of Zymfentra provides an innovative and effective treatment option that offers patients with inflammatory bowel disease an alternative administration option providing control of how and where they receive their treatment.”
A photo of Zymfentra, Celltrion's new autoimmune disease treatment, provided by the company (PHOTO NOT FOR SALE) (Yonhap)
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