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Extrapolation main focus of first biosimilar advisory committee meeting

January 6, 2015 3:20 AM UTC

The two most important unresolved biosimilar policy issues for the U.S. biosimilars pathway -- nonproprietary naming and standards for assessing interchangeability -- are not on the agenda for a Wednesday advisory committee meeting on the first application submitted to FDA for a biosimilar candidate.

FDA will ask the Oncologic Drugs Advisory Committee to confirm the agency's conclusion that Zarxio ( EP2006) from the Sandoz unit of Novartis AG (NYSE:NVS; SIX:NOVN) is biosimilar to neutropenia drug Neupogen filgrastim from Amgen Inc. (NASDAQ:AMGN), and that it should be approved for all of Neupogen's indications. An FDA Zarzio. ...