On September 9, 2016, Apotex Inc. filed a petition for writ of certiorari in the U.S. Supreme Court seeking review of the Federal Circuit’s decision in Amgen Inc. v. Apotex Inc., Case No. 2016-1308. This case involves...more
On July 5, the Federal Circuit issued another important decision regarding the meaning of certain provisions of the Biologics Price Competition and Innovation Act (BPCIA). See Amgen Inc. v. Apotex Inc., Fed. Cir. Case No....more
7/6/2016
/ Amgen ,
Apotex ,
Biologics Price Competition and Innovation Act of 2009 ,
Biosimilars ,
BPCIA ,
Commercial Marketing ,
FDA Approval ,
Food and Drug Administration (FDA) ,
Generic Drugs ,
Notice Requirements ,
Pharmaceutical Industry ,
Sandoz ,
Sandoz v Amgen
On February 9, 2016, the FDA’s Arthritis Advisory Committee voted 21-3 to recommend that CT-P13, Celltrion’s proposed biosimilar of Janssen Biotech, Inc.’s Remicade® (infliximab) be approved for all indications — including,...more