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4 September 2015Americas

Sandoz launches Zarxio biosimilar

Drug maker Sandoz has officially launched its Zarxio (filgrastim-sndz) biosimilar after a US appeals court declined to issue an injunction that would have prevented it from being sold.

Zarxio, a biosimilar of Amgen’s drug Neupogen (filgrastim), is used to help cancer patients by boosting their white blood cell count. It is the first biosimilar to be approved in the US.

In July this year, after a challenge from Amgen, the US Court of Appeals Court of Appeals for the Federal Circuit said Sandoz was free to launch Zarxio.

Amgen, which has appealed against the ruling, had attempted to secure a temporary injunction preventing the drug’s launch pending its appeal.

But on Wednesday, September 3, the federal circuit, which has not yet decided whether to hear Amgen’s appeal, denied the request.

In a statement after the ruling, Richard Francis, global head of Sandoz, said the company was now free to launch the biosimilar.

He said: “As the pioneer and global leader in biosimilars, Sandoz has maintained a commitment to bringing high-quality biosimilar medicines to patients and healthcare professionals around the world.

“With the launch of Zarxio, we look forward to increasing patient, prescriber and payer access to filgrastim in the US by offering a high-quality, more affordable version of this important oncology medicine,” he added.

The Food and Drug Administration approved Sandoz’s biosimilar application in March. The drug had already been launched in Europe in 2009.

Ralph Boccia, medical director at the Center for Cancer and Blood Disorders, welcomed the decision.

He said: “While biologics have had a significant impact on how diseases are treated, their cost and co-pays are difficult for many patients and the healthcare budget in general.

“Biosimilars can help to fill an unmet need by providing expanded options, greater affordability and increased patient access to life-saving therapies,” he added.

Zarxio was launched at a 15% discounted price compared to Amgen’s Neupogen.

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22 July 2015   The US Court of Appeals for the Federal Circuit has ruled that biosimilar applicants can opt out of the so-called patent dance, paving the way for Sandoz to sell a biosimilar version of an Amgen drug.
Americas
23 July 2015   The US Court of Appeals for the Federal Circuit’s decision in Amgen v Sandoz is what the biosimilar industry would have been hoping for but clarity is lacking in several areas, lawyers have told LSIPR.
Americas
19 October 2015   The US Court of Appeals for the Federal Circuit has declined to hear the Amgen v Sandoz ‘patent dance’ dispute en banc.

More on this story

Americas
22 July 2015   The US Court of Appeals for the Federal Circuit has ruled that biosimilar applicants can opt out of the so-called patent dance, paving the way for Sandoz to sell a biosimilar version of an Amgen drug.
Americas
23 July 2015   The US Court of Appeals for the Federal Circuit’s decision in Amgen v Sandoz is what the biosimilar industry would have been hoping for but clarity is lacking in several areas, lawyers have told LSIPR.
Americas
19 October 2015   The US Court of Appeals for the Federal Circuit has declined to hear the Amgen v Sandoz ‘patent dance’ dispute en banc.