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FDA advisory panel recommends approval of biosimilar Zarxio


SILVER SPRING, Md. — Sandoz may be on track to receive the first biosimilar drug approval from the Food and Drug Administration for its Zarxio, which is highly similar to Amgen's Neupogen (filgrastim). An FDA advisory panel unanimously recommended the approval Wednesday by a vote of 14-0, according to reports. 


“GPhA is pleased that the FDA ODAC has voted unanimously to recommend that the FDA approve filgrastim, a Sandoz biosimilar under agency review, for each of the five indications in the application," stated Ralph Neas, president and CEO for the Generic Pharmaceutical Association. "This encouraging step forward means that it is very likely now only a question of when, rather than if, filgrastim will be available for patients in the United States. GPhA will continue to work with our regulatory partners at FDA to ensure the introduction of biosimilars in the United States."


Neupogen is indicated to reduce the risk of infection in patients with some tumors, who are receiving strong chemotherapy that may cause severe neutropenia with fever.


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