Congress passed the Biologics Price Competition and Innovation Act (“BPCIA”) in 2009 in an effort to bring biosimilar drug products to market. The goal was for the BPCIA to mimic for biologic drugs the Hatch-Waxman statute...more
9/14/2015
/ aBLA ,
Biologics ,
Biosimilars ,
BPCIA ,
Disclosure Requirements ,
FDA Approval ,
Injunctive Relief ,
Notice Requirements ,
Patent Dance ,
Patent Infringement ,
Patent Litigation ,
Patents ,
Pharmaceutical Patents ,
Sandoz v Amgen