Search Results: Biosimilar News

Federal Circuit Oral Arguments in NYC Today

This week, six Federal Circuit panels will hear oral argument on at various venues in New York City.  Two of today’s oral arguments are in biosimilar cases that we have been closely following on this blog. First, at 10:00 AM, a panel will hear oral argument at the U.S. Court…

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Ireland's Department of Health is Requesting Comments Regarding its National Biosimilars Medicines Policy

Ireland’s Department of Health (the “Department”) recently reported on its website that it is “developing a National Biosimilar Medicines Policy to promote the use of biosimilar medicines and to create a sustainable environment for biological medicines in Ireland.”  The Department is now asking the public for its views regarding the…

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Scott Gottlieb’s Stance on Biosimilars

On May 11, 2017, Scott Gottlieb was sworn in as the 23rd Commissioner of the U.S. Food & Drug Administration.   Before his confirmation, Gottlieb was vocal about his disapproval of the FDA’s “well-established” attitude: an excessive desire for certainty, which he says “is impeding the availability of safe, effective drugs…

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European Commission Report on Impact of Biosimilars Competition

The European Commission recently announced a report on the impact of biosimilar competition on price, volume and market share, based on full-year data from 2016. The report, prepared by QuintilesIMS, analyzed six established therapy areas with biosimilar competition—epoietin (EPO), G-CSF, hGH, anti-TNF, fertility/gonadotropin preparations, and recombinant human insulins—and identified four…

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