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 peter.loftus@wsj.com
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