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The first drug of its kind was just approved, and it could signal a massive change for pharmaceuticals

Lauren F Friedman,Reuters   

The first drug of its kind was just approved, and it could signal a massive change for pharmaceuticals
Science1 min read

Swiss drugmaker Novartis' logo is seen behind scaffolding at the company's plant in the northern Swiss town of Stein January 27, 2015. REUTERS/Arnd Wiegmann

Thomson Reuters

Swiss drugmaker Novartis' logo is seen at the company's plant in the northern Swiss town of Stein

(Reuters) - U.S. regulators on Friday gave a green light to sales of the country's first copied version of a biotechnology drug, or "biosimilar," with approval of Novartis' white blood cell-boosting Zarxio.

The drug contains the same active ingredient as Neupogen, or filgrastim, which logged 2014 worldwide sales of $1.2 billion for manufacturer Amgen.

The Food and Drug Administration (FDA) said it approved Zarxio for treating the same five conditions for which Neupogen is used.

The move had been expected after Zarxio, which is made by Novartis' generics unit Sandoz, won unanimous backing from an FDA panel in January.

(Reporting by Ben Hirschler. Editing by Jane Merriman)

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