Celltrion USA (3/17/24): ZYMFENTRA™(infliximab-dyyb), the first and only FDA-approved subcutaneous infliximab, now commercially available in the U.S.
Excerpts:
- “ZYMFENTRA is approved for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) or moderately to severely active Crohn’s disease (CD) following an induction treatment regimen with an infliximab product administered intravenously. The recommended dose of ZYMFENTRA for maintenance treatment is 120 mg every two weeks.”
- ” ZYMFENTRA is considered a new biologic with a first-approved subcutaneous administration form and thus will be under patent protection for its dosage form by 2037 and for its route of administration by 2040.”
FDA Label: Zymfentra Prescribing Information
My take: If the cost of the subcutaneous infliximab is competitive with the intravenous formulations, then this is going to result in a lot less infusions. Currently, this product does not have a pediatric indication. Projected cost per internet search: $6,181.08 for two shots over four weeks.
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