Posted by Michael Wonder on 20 Jul 2018
U.S. FDA approves Pfizer's biosimilar Nivestym (filgrastim-aafi)
20 July 2018 - Nivestym, a biosimilar to Neupogen (filgrastim), is Pfizer's fourth biosimilar to be approved by the FDA.
Pfizer today announced that the U.S. FDA has approved Nivesytm (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible indications of the reference product.
The FDA approval was based on a review of a comprehensive data package and totality of evidence demonstrating a high degree of similarity of Nivesytm compared to its reference product.
