BakerHostetler | USA | 16 Jun 2017
On June 13, 2017, the U.S. Supreme Court issued its opinion in Sandoz v. Amgen. In doing so, it answered two questions raised under the Biologics…
BakerHostetler | USA | 7 May 2015
Six years after legislation was adopted creating a new pathway for the approval of biological products that are biosimilar to existing FDA-approved…
BakerHostetler | USA | 15 Jan 2015
A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States…