Amgen, J&J, Pfizer hematology, biosimilars news
In an appellate brief filed in the U.S. Court of Appeals for the Federal Circuit (CAFC), Amgen said a lower court’s refusal to force Pfizer’s Hospira Inc. unit to supply manufacturing information for a biosimilar “threatens to undermine the entire balance” of the Biologics Price Competition and Innovation Act (BPCIA).
In the brief, Amgen argued that a prior CAFC ruling obligates biosimilar developers to provide reference drug sponsors with access to manufacturing information via the discovery process if a reference product sponsor files a lawsuit. Denying access, Amgen argued, would allow biosimilar sponsors to “unilaterally control” which patents may be challenged through selective disclosures. CAFC ruled last year that biosimilar developers are not required to provide BLAs and manufacturing information (see BioCentury, July 27, 2015). ...