In a closely-watched case between Amgen and Sandoz regarding the first biosimilar approved (Zarxio), the Federal Circuit interpreted key Biologics Price Competition and Innovation Act (BPCIA) provisions regarding Sandoz's...more
7/23/2015
/ Amgen ,
Biologics ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
Declaratory Judgments ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Hatch-Waxman ,
Healthcare ,
Pharmaceutical Industry ,
Prescription Drugs ,
Sandoz ,
Sandoz v Amgen
Earlier this month the Food and Drug Administration ("FDA") published three industry guidances for the Biologics Price Competition and Innovation Act of 2009 ("BPCIA")....more
Late last week, the U.S. Food and Drug Agency (FDA) dismissed a citizen petition filed by Amgen, Inc. asking the agency to require that biosimilar applicants provide the reference product sponsor with a copy of their...more