Novartis to Begin Selling Copy of Amgen's Neupogen in U.S.--3rd Update
September 03 2015 - 01:11PM
Dow Jones News
By Neil MacLucas, Denise Roland and Peter Loftus
ZURICH-- Novartis AG said Thursday that it would begin selling
the first biosimilar drug in the U.S. at a 15% discount to the
original after an appeals court denied Amgen Inc.'s request to
block the Swiss drug maker's sale of its copycat version of
blockbuster remedy Neupogen.
Basel, Switzerland-based Novartis's move followed the decision
Wednesday by the U.S. Court of Appeals for the Federal Circuit that
cleared the way for the firm's Sandoz unit to start selling Zarxio,
a knockoff version of Neupogen that was approved by the U.S. Food
and Drug Administration in March. The drugs help to boost the
white-blood-cell count in chemotherapy patients and others with
compromised immune systems.
The drug industry and its lawyers have been 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.
Unlike generic drugs, which copy "classic" chemically-made
drugs, biosimilars mimic biotechnology drugs made through more
complex processes involving living cells. The results are a close,
but not exact, copy.
The U.S. market accounted for more than 70% of Amgen's $1.16
billion in global sales of Neupogen last year.
A Novartis spokesman said the company would sell Zarxio at a 15%
discount to Neupogen, based on list prices. For example, a
300-microgram syringe of Zarxio would list for $275.77, compared
with $324.30 for an equivalent dose of Neupogen. The pricing is on
the low end of the 15% to 30% discounts on biosimilars in Europe,
where they have been available for several years. But the Novartis
spokesman said he expected a "similar competitive dynamic to play
out in the U.S." as in Europe, where the discount for its
biosimilar Neupogen has increased to 20% to 30% as more
participants have entered the market.
More biosimilar versions of Neupogen are expected to hit the
U.S. market. Apotex Inc., a Canadian generic-drug manufacturer, has
applied for U.S. Food and Drug Administration approval to market
its version of Neupogen, a product jointly developed with Intas
Pharmaceuticals Ltd. of India. An Apotex spokesman said the
application is under review.
Zarxio was the first biosimilar approved by the FDA under
abbreviated criteria enabled by a provision of the 2010 Affordable
Care Act. However, the product's introduction has been delayed by a
legal dispute between Amgen and Novartis.
The dispute began when Thousand Oaks, Calif.-based Amgen filed a
lawsuit in federal court in San Francisco last year, accusing
Novartis of failing to disclose certain information about its
copycat product to Amgen, which the U.S. firm said was required
under the new criteria for FDA approval of biosimilars. Amgen also
alleged Zarxio would infringe upon a patent for Neupogen. Novartis
denies the allegations.
In Europe, which introduced its first biosimilar nearly a decade
ago, these copycats have eroded sales of the original drug more
gradually than "classic" generic drugs, which can cause sales of
the original to plummet within months. It took four years for
Novartis' biosimilar Neupogen to overtake sales of the original.
There are now eight competing biosimilars for Neupogen in Europe,
and together they account for nearly 80% of the market.
An Amgen spokeswoman said Thursday that the company would
continue to promote Neupogen and "compete effectively."
Write to Neil MacLucas at neil.maclucas@wsj.com
Subscribe to WSJ: http://online.wsj.com?mod=djnwires
(END) Dow Jones Newswires
September 03, 2015 12:56 ET (16:56 GMT)
Copyright (c) 2015 Dow Jones & Company, Inc.
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