The Food and Drug Administration approved Nivestym (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for five eligible indications. The Food and Drug Administration (FDA) approved Nivestym ...

Pfizer has added another offering to its biosimilar portfolio, having won FDA approval of its version of Amgen’s oncology treatment Neupogen. The approval comes as the Pharma giant is giving added ...

NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM™ (filgrastim-aafi), a biosimilar to Neupogen 1 ...

FDA LOGO BLUE The approval was based on data demonstrating that the biosimilar product and the reference product are highly similar, and that there are no clinically meaningful differences between the ...

A second biosimilar to Amgen’s Neupogen, which treats neutropenia, has been approved in the United States. The FDA approved Pfizer’s filgrastim-aafi, which will be sold under the brand name Nivestym.

Already facing competition from Sandoz, Amgen’s Neupogen white blood cell stimulator faces another cut-price near-copy after the FDA approved Pfizer’s biosimilar, Nivestym. Nivestym has been approved ...

The US Food and Drug Administration (FDA) has approved filgrastim-aafil (Nivestym, Pfizer), a biosimilar filgrastim (Neupogen, Amgen), making it the second biosimilar for this agent in the United ...

Pfizer’s Neupogen biosimilar Nivestym has been approved by the US Food and Drug Administration and is expected to hit the market at a “significant discount” to its reference drug. Pfizer’s Neupogen ...

Pfizer Inc. today announced that the United States (U.S.) Food and Drug Administration (FDA) has approved NIVESTYM ™ (filgrastim-aafi), a biosimilar to Neupogen (filgrastim), for all eligible ...