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FDA Approves 12th Biosimilar, 2nd for Filgrastim

Posted 23 July 2018 | By Zachary Brennan 

FDA Approves 12th Biosimilar, 2nd for Filgrastim

The US Food and Drug Administration (FDA) on Friday approved the 12th biosimilar, Pfizer’s Nivestym (filgrastim-aafi), which is a biosimilar to Amgen’s Neupogen (filgrastim), for all eligible indications of the reference product.

This is the second biosimilar to Neupogen (the first was the first biosimilar approved in the US in 2015, Sandoz's Zarxio (filgrastim-sndz)) and Pfizer said it expects Nivestym to be available in the U.S. at a significant discount to the current wholesale acquisition cost of Neupogen. In Europe, Hospira’s Nivestim (filgrastim) was approved in June 2010.

According to last week’s biosimilar action plan from FDA, as of 1 July 2018, 68 biosimilar programs were enrolled in FDA’s Biosimilar Product Development program, and the Center for Drug Evaluation and Research has meeting requests to discuss the development of biosimilars for 31 different reference products.

Categories: Regulatory News

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