Apotex Inc. faces no current legal barriers to the launch of its biosimilars to Amgen Inc.'s Neulasta (pegfilgrastim) and Neupogen (filgrastim) now that the US Court of Appeals for the Federal Circuit has ruled they do not infringe Amgen's manufacturing process patent. But the fate of Apotex's applications at FDA remain uncertain three years after they were filed.
In a Nov. 13 decision, the Federal Circuit affirmed a district court ruling that Apotex's biosimilars do not infringe patent No
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