The cases show that—even given a recent US Supreme Court interpretation of the statute—uncertainty still exists about complying with the “patent dance" information exchange requirements under the Biologics Price Competition...more
Apotex—Biosimilars Must Provide 180-Day Marketing Notice after FDA Approval July 06, 2016 According to the Federal Circuit, post-licensure notice 180 days before commercial marketing is mandatory for biosimilars....more
7/6/2016
/ Amgen ,
Apotex ,
Appeals ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Notice Requirements ,
Patent Infringement ,
Patents ,
Pharmaceutical Patents ,
Preliminary Injunctions