BioCentury
ARTICLE | Company News

Amgen pushes for access to biosimilar information

September 19, 2016 7:00 AM UTC

In an appellate brief filed in federal court, Amgen Inc. (NASDAQ:AMGN) said a U.S. District Court's failure to force the Hospira Inc. unit of Pfizer Inc. (NYSE:PFE) to supply manufacturing information for a biosimilar "threatens to undermine the entire balance" of the Biologics Price Competition and Innovation Act (BPCIA).

Amgen filed the brief in the U.S. Court of Appeals for the Federal Circuit (CAFC), where it is challenging a lower court's ruling regarding Retacrit, Hospira's proposed biosimilar of Epogen epoetin alfa from Amgen and Procrit epoetin alfa from the Janssen Biotech unit of Johnson & Johnson (NYSE:JNJ). ...