On 17 March 2024, Celltrion USA launched ZYMFENTRA™ (infliximab-dyyb), the first subcutaneous formulation of infliximab approved by the U.S. FDA in 2023. Zymfentra is approved for maintenance therapy in adults with active ulcerative colitis or Crohn’s disease following an induction treatment regimen with an intravenous infliximab product.
Celltrion emphasised that the sub-cutaneous administration method offers patients greater flexibility in managing their disease. According to Celltrion, ZYMFENTRA™ is patent protected until 2037 for the formulation and 2040 for the method of treatment.