Judge Denies Amgen's Request to Block Novartis's Biosimilar of Neupogen

By Peter Loftus 

A federal judge denied Amgen Inc.'s request to block Novartis AG from selling a copy of an Amgen drug for chemotherapy patients in the U.S.

U.S. District Judge Richard Seeborg in San Francisco issued an order Thursday finding that Novartis's Sandoz division was "within its rights" not to disclose certain information to Amgen about Novartis's proposed copy of the biotechnology drug, Neupogen, according to a court document. Copies of biotechnology drugs are known as "biosimilars."

The judge denied Amgen's request for a preliminary injunction to block the Novartis product from the market, and dismissed Amgen's claims in a lawsuit that Novartis failed to follow U.S. regulatory rules in its attempt to sell the biosimilar by allegedly not disclosing information about its product to Amgen. Novartis denied the allegations.

Amgen's claims that Novartis is infringing upon a patent for Neupogen remain unresolved and could still go to trial.

The U.S. Food and Drug Administration this month approved Novartis's product, Zarxio, for U.S. sale. It was the FDA's first approval of a biosimilar under new regulatory criteria designed to facilitate the introduction of lower-cost copies of biotechnology drugs.

The drug industry is closely watching the litigation surrounding the Neupogen biosimilar because the outcome could signal whether a coming wave of biosimilar drugs will face speed bumps on their way to market.

A Novartis spokesman said the company welcomes the court decision and looks forward to selling Zarxio, but didn't say when it would do so. He said Novartis has agreed with Amgen to jointly request a speedy review of any appeal to a federal appellate court.

An Amgen spokeswoman said the company is disappointed in the decision and will seek review by the appeals court. She noted that Thursday's order didn't address Amgen's patent infringement action, "which remains for trial."

Write to Peter Loftus at [e-mail]

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