June 3, 2015 / 8:50 PM / 4 years ago

Novartis tries to get U.S. ban lifted on sale of Neupogen copycat

WASHINGTON (Reuters) - Novartis AG unit Sandoz asked a U.S. appeals court on Wednesday to lift a preliminary injunction barring it from selling its biosimilar Zarxio, a cheaper version of a drug that fends off infections in cancer patients.

In October, Amgen Inc, maker of the $1.2 billion-a-year drug Neupogen, sued Sandoz in district court in San Francisco, saying Zarxio infringed the patent on Amgen’s drug. The court refused to grant a preliminary injunction barring the sale of Zarxio while the lawsuit continued, but in May the injunction was granted by the U.S. Court of Appeals for the Federal Circuit.

The hearing on Wednesday was to discuss if the Federal Circuit’s order would remain.

Zarxio is a biosimilar, which is essentially a close copy of a brand name biologic medicine. Since biosimilars are copies of biologic products, which are made of living cells, they are not considered exact duplicates. Insurers hope they will cost the public 40 percent to 50 percent less than the original brands.

Zarxio would become the first biosimilar sold in the United States.

Much of the discussion on Wednesday focused on whether Sandoz had made appropriate disclosures to Amgen that it planned to bring out a copy of Neupogen, as the law requires.

Sandoz lawyer Deanne Maynard of Morrison Foerster said the company had done so twice, once when it applied for approval for Zarxio from the Food and Drug Administration and again when it received that approval.

Judge Raymond Chen, sitting on a panel of three, appeared to discount the notice given at the time of the application.

“You don’t have any clue as to whether your application will be approved,” he said.

Arguing for Amgen, Nicholas Groombridge of Paul, Weiss, Rifkind, Wharton & Garrison said Sandoz had failed to follow regulations about how notice is to be given on the launch of a biosimilar.

“Sandoz didn’t follow the rules,” he said.

The case is Amgen Inc v Sandoz, U.S. Court of Appeals for the Federal Circuit, No. 2015-1499.

Editing by Ted Botha and Marguerita Choy

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