Hospira, Korea’s Celltrion Get EU Nod For First Monoclonal Antibody Biosimilar
This article was originally published in PharmAsia News
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 product would take on J&J/Merck’s Remicade in an era of budgetary pressures, but also physician concerns about biosimilar safety.
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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.
Multiple IPF drugs are being rushed into Phase III based on early-stage signals of efficacy and safety presented at the ATS meeting. Scrip spoke with the University of Pittsburgh's Kevin Gibson about the candidates, trial design, combination therapy and limitations of current therapy.