March 6, 2015 / 2:55 PM / 5 years ago

UPDATE 2-Novartis wins approval for first U.S. biosimilar drug

* Zarxio from Novartis generics unit Sandoz approved by FDA

* Copy of Amgen’s white cell-boosting medicine Neupogen

* Sandoz exec says Zarxio will be priced “competitively”

* Amgen seeking to block biosimilar’s launch (Adds Amgen comment)

By Deena Beasley and Ben Hirschler

March 6 (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.

The FDA, however, only received the authority to approve biosimilars with the passing of the Affordable Care Act, also known as Obamacare, in 2010.

Biological medicines, whose price tags can run into tens of thousands of dollars per patient per year, account for about 30 percent of U.S. drug spending.

Unlike chemical compounds, such as aspirin or statins, biotech drugs are made inside living cells, and tiny variations are inevitable, depending on the exact production process. As a result, a copycat version can only ever be similar to the original, rather than identical.

One technical uncertainty with a biosimilar is its official generic name, an important point for pharmacists filling prescriptions. The FDA said Zarxio would, for now, carry the hyphenated name “filgrastim-sndz” while the agency works on a comprehensive naming policy.

In a statement, Amgen said it believed Neupogen, with a wholesale price of $315 for the lowest packaged daily dose, “continues to have an important role to play in helping patients.”

Sandoz declined to specify Zarxio’s pricing ahead of the U.S. introduction. “The only thing we can say is it will be competitively priced,” Carol Lynch, global head of biopharmaceuticals and oncology injectables, told Reuters.

Amgen has sued to block Zarxio. Sandoz previously agreed to delay its U.S. launch until a court decision on Amgen’s request for a preliminary injunction, or until April 10, whichever comes first. A U.S. District Court hearing is scheduled for March 13. (Editing by Jane Merriman, Mark Potter and Lisa Von Ahn)

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