Generic biologics was not a priority for Andrew von Eschenbach when he accepted the job as acting commissioner of FDA. But two events -- a federal court ruling requiring a decision on Sandoz' Omnitrope NDA and the European Union approval of the follow-on biologic -- mean FDA may be pressed to take action on a regulatory pathway. The Omnitrope ruling makes it more important than ever that FDA have a fully confirmed leader in place, but it will also make it harder to get one.
By Kate Rawson
Andrew von Eschenbach really didn’t want to deal with follow-on biologics when he accepted the job as acting commissioner of the Food & Drug Administration.
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Advanz Pharma would have had to show that the European Commission’s decision to revoke Ocaliva’s conditional marketing approval risked causing serious and irreparable harm, according to lawyers from Van Bael & Bellis.
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