Polsinelli Podcasts - FDA Denies Amgen Citizen Petition in Biosimilar Dispute
It has been nearly 10 years since the U.S. Biosimilars Pathway (the Biologics Price Competition and Innovation Act) was enacted. The first biosimilar product in U.S. history was approved and launched in 2015. Ten biosimilars...more
AMGEN INC. v. HOSPIRA, INC. Before Moore, Bryson, and Chen. Appeal from the United States District Court for the District of Delaware. Summary: Biological engineering activity that would otherwise constitute patent...more
Here are our picks for the top-five most significant legal developments regarding biosimilars in 2017...more
In one of the first Biologics Price Competition and Innovation Act (BPCIA) litigations to reach trial, a jury on Friday awarded Amgen $70 million in damages for Pfizer’s infringement of one of Amgen’s expired patents...more
The U.S. Food and Drug Administration rejected Amgen Inc.’s request that biosimilars makers be forced to share their applications and manufacturing processes with competitors, exacerbating the company’s recent defeat in...more