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Approval Alert: FDA Approves Celltrion’s Zymfentra® (infliximab-dyyb), Biosimilar to Janssen’s Remicade®, and the First Approved SC Infliximab

Oct 23, 2023

Celltrion announced that the FDA has approved its subcutaneous formulation of Zymfentra® (infliximab -dyyb), biosimilar to Janssen’s Remicade®, as maintenance treatment for ulcerative colitis (UC) and Crohn’s disease (CD) following treatment with an IV infliximab.  This is the first FDA approved subcutaneous formulation of infliximab.  Zymfentra® is marketed as Remsima SC® in Europe.

On 2 October 2023, Celltrion announced that the FDA approved Yuflyma®, biosimilar to AbbVie’s Humira® (adalimumab), in 20mg (pre-filled syringe) and 80mg (pre-filled autoinjector and pre-filled syringe) dosage forms.