BakerHostetler | USA | 18 May 2017
Welcome to this week's edition of the Health Law Update. In this Issue Capitol Hill Healthcare Update Senate Panel OKs FDA User Fees Legislation…
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 | 22 Apr 2015
On March 6, 2015, FDA released a statement announcing its issuance of the first biosimilar license to Zarxio. In the same month, CMS issued a number…
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…
BakerHostetler | USA | 25 Sep 2014
Last week, the Food and Drug Administration (FDA) announced that it has published a list of licensed biological products and interchangeable…