Celltrion Gets FDA Nod For Subcutaneous Infliximab

Zymfentra, Marketed Globally As Remsima SC, Receives Approval In US

 
• By David Wallace
  
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Celltrion has received FDA approval for Zymfentra, its subcutaneous formulation of infliximab that is marketed in other global territories as Remsima SC.

Sign outside of FDA's headquarters in White Oak, MD
Celltrion has received FDA approval for its subcutaneous infliximab • Source: Alamy

Celltrion has received approval from the US Food and Drug Administration for its Zymfentra (infliximab-dyyb) subcutaneous infliximab product, marketed elsewhere in the world as Remsima SC. While based on an existing molecule, the product has not been registered through biosimilar pathways as the original Remicade brand does not have a subcutaneous formulation to be used as a reference product.

Billing the product as the “first and only subcutaneous infliximab, for the treatment of people with inflammatory bowel disease” –...

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