Hospira, Korea’s Celltrion Get EU Nod For First Monoclonal Antibody Biosimilar
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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If approved in Europe this year, as expected, Celltrion/Hospira’s biosimilar infliximab will provide a compelling test of whether and how quickly budgetary pressures can override physician caution. It will also set the stage for the $70 billion worth of copycat antibodies in development.
SEOUL - South Korea's Celltrion inked an agreement with U.S.-based Hospira to collaborate on manufacturing and marketing Celltrion's eight biogeneric products in global markets including the U.S. and Europe
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