Novartis Wins Approval for First U.S. Biosimilar Drug

The Aug. 12, 2005 file photo shows the logo of Swiss company Novartis in Basel, Switzerland. Swiss pharmaceutical giant Novartis AG announced a series of multibillion-dollar deals Tuesday, April 22, 2014 with other major pharmaceutical companies that it said would reduce sales but boost profitability, while affecting some 15,000 of its employees globally. (AP Photo/Keystone, Steffen Schmidt)
The Aug. 12, 2005 file photo shows the logo of Swiss company Novartis in Basel, Switzerland. Swiss pharmaceutical giant Novartis AG announced a series of multibillion-dollar deals Tuesday, April 22, 2014 with other major pharmaceutical companies that it said would reduce sales but boost profitability, while affecting some 15,000 of its employees globally. (AP Photo/Keystone, Steffen Schmidt)
The Aug. 12, 2005 file photo shows the logo of Swiss company Novartis in Basel, Switzerland. Swiss pharmaceutical giant Novartis AG announced a series of multibillion-dollar deals Tuesday, April 22, 2014 with other major pharmaceutical companies that it said would reduce sales but boost profitability, while affecting some 15,000 of its employees globally. (AP Photo/Keystone, Steffen Schmidt)

 

(Reuters) – U.S. regulators on Friday gave a green light to sales of the country’s first “biosimilar,” or copied version of a 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.

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