The Federal Circuit recently issued decisions in a pair of appeals that provide guidance about when international filers of abbreviated Biologics License Applications (aBLAs) are subject to jurisdiction in the United States....more
The first biosimilar is now available in the United States. Sandoz announced the availability of Zarxio™ (filgrastim-sndz) earlier today, after the Federal Circuit denied Amgen Inc.'s attempt to stall the launch. The launch...more
9/4/2015
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Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
Food and Drug Administration (FDA) ,
Hatch-Waxman ,
Injunctions ,
Patent Dance ,
Patent Litigation ,
Patents ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Sandoz
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