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Mylan's Next Up For A Shot At Neulasta Biosimilar After Coherus CRL

 
• By Jessica Merrill

FDA issued a complete response letter to Coherus' application for a biosimilar version of Amgen's Neulasta (pegfilgrastim), giving Amgen a reprieve, though Mylan has an application pending at the US agency.

FDA's complete response letter to Coherus BioSciences Inc.'s application for a biosimilar version of Amgen Inc.'s neutropenia blockbuster Neulasta (pegfilgrastim), announced June 12, likely delays the launch of a biosimilar rival to the brand until 2018 at the earliest.

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