Novartis to Begin Selling Copy of Amgen's Neupogen in U.S.
September 03 2015 - 5:24AM
Dow Jones News
By Neil MacLucas
ZURICH-- Novartis AG said Thursday it would begin selling the
first biosimilar drug in the U.S. 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.
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.
Novartis hasn't announced a price for Zarxio. In Europe, where
biosimilars have been available for several years, they typically
cost 15% to 30% less than the original brands.
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. Novartis launched biosimilar
Neupogen under the name Zarzio in 2009, and it took four years 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.
Denise Roland contributed to this article.
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 05:09 ET (09:09 GMT)
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