biotechnology drug, by approving Novartis’ white blood cell-boosting Zarxio.
The drug contains the same active ingredient as Amgen Inc’s Neupogen, or filgrastim, which generated 2014 sales of $1.2 billion worldwide.
The Food and Drug Administration said it approved Zarxio for the same five conditions for which Neupogen is used – preventing infections in cancer patients undergoing various treatments.
The move had been expected after Zarxio, which is made by Novartis’ Sandoz generics unit, won unanimous backing from an FDA panel in January.
Biosimilars have been available in Europe since 2006. Health insurers have said biotech drugs with expired patents should also face lower-cost competition in the United States, leading to savings in the same way generic versions of conventional medicines have cut prescription costs.