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Fly News Breaks for August 12, 2015
AMGN
Aug 12, 2015 | 11:28 EDT
Cowen said Apotex's biosimilar application on Neulasta is pending at the FDA with a decision expected later this year. The firm said recent court documents indicate Amgen is asserting a newly issued manufacturing patent against Apotex. At a minimum, Cowen believes this patent could postpone the launch of a Neulasta biosimilar, providing additional time for Amgen to convert its second largest drug to the On Body device.
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