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APRIL 6, 2016

FDA Approves Inflectra, Biosimilar to Remicade

 
The FDA has approved the second U.S. biosimilar, Inflectra (infliximab-dyyb, Celltrion/Hospira/Pfizer), for all eligible indications of the reference product, Remicade (Janssen), but the new agent did not receive the designation for interchangeability.
 
Inflectra, the first biosimilar monoclonal antibody, is administered by IV infusion and is indicated for:
  • adults and children (aged 6 years and older) with moderate to severe Crohn’s disease who have had an