By Peter Loftus
A U.S. appeals court has blocked Novartis AG from selling its
knockoff version of an Amgen Inc. cancer supportive-care drug in
the U.S. until the court resolves a legal fight between the
rivals.
The U.S. Court of Appeals for the Federal Circuit in Washington
on May 5 granted Amgen's request for an injunction blocking
Novartis' Zarxio from the U.S. market until the court resolves
Amgen's appeal of a lower-court ruling that gave the green light to
Zarxio's market entry.
The new order is expected to keep Zarxio off the U.S. market at
least until June 3, when oral arguments are scheduled, though
resolution of the case could take longer.
Zarxio is a close copy of Amgen's Neupogen, a drug given to ward
off infections in cancer patients receiving chemotherapy, and which
had $839 million in U.S. sales last year. The U.S. Food and Drug
Administration granted marketing approval to Zarxio in March,
making it the first so-called "biosimilar" to be approved using
new, abbreviated criteria for copies of biotechnology drugs.
But Novartis still hasn't started selling Zarxio in the U.S.
because it agreed to delays as part of ongoing litigation with
Amgen. Amgen filed a lawsuit in federal court in San Francisco last
year accusing Novartis of failing to disclose certain information
about its product to Amgen, which Amgen said was required under
U.S. regulations. Amgen also alleged Zarxio would infringe upon a
patent for Neupogen. Novartis denies the allegations.
In March, a federal judge in San Francisco denied Amgen's
request for an injunction blocking Zarxio and dismissed Amgen's
claims that Novartis didn't follow the rules about disclosing
product information. That order didn't resolve the patent dispute,
which is pending. Amgen appealed the lower-court ruling.
The drug industry and its lawyers are closely watching the
Neupogen biosimilar case because the outcome could shape the path
to market for a coming wave of biosimilar drugs that are expected
to cost less than the original brands.
A Novartis spokesman said the company looks forward to a prompt
resolution of the appeal, and to launching Zarxio "in the near
future."
An Amgen spokeswoman said the company was pleased with the
appellate court injunction.
Write to Peter Loftus at peter.loftus@wsj.com
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