Amgen, Apotex hematology, biosimilars news

A federal judge in the U.S. District Court for the Southern District of Florida ruled that two biosimilars from Apotex do not infringe a patent held by Amgen. Amgen sought a ruling that Apotex’s biosimilar versions of neutropenia drugs Neulasta pegfilgrastim and Neupogen filgrastim infringed Amgen’s U.S. Patent No. 8,952,138, which covers a process of protein refolding. In his opinion, the judge said Amgen “has not met its burden” to prove that Apotex’s refolding process infringes the ‘138 patent. Amgen declined to comment on whether it would appeal. ...