In Amgen v. Apotex, the Federal Circuit held that under the Biologics Price Competition and Innovation Act (“BPCIA”), “an applicant must provide a reference product sponsor with 180 days’ post-licensure notice before...more
7/22/2016
/ Abbreviated New Drug Application (ANDA) ,
Amgen ,
Apotex ,
Biosimilars ,
BPCIA ,
CAFC ,
Commercial Marketing ,
Exclusivity ,
FDA Approval ,
Federal Food Drug and Cosmetic Act (FFDCA) ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice Requirements ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Public Health Service Act ,
Rulemaking Process