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Hospira, Korea’s Celltrion Get EU Nod For First Monoclonal Antibody Biosimilar

Executive Summary

EMA recommends approval for two brands of Celltrion’s infliximab, one to be marketed by Hospira, as Europe moves closer to its first MAb biosimilar. The positive decision is significant not only because the product will take on J&J/Merck’s bestselling Remicade in an era of budgetary pressures, but also because of its breadth. It is for all indications already approved in Europe for Remicade.

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