Hospira Learning Valuable Lessons In European Biosimilar Market
02 10월 2009 - 2:22AM
Dow Jones News
Hospira Inc. (HSP) expects the experience of entering the
biosimilar market in Europe to benefit its planned entry into the
U.S., regardless of whether legislation provides a path for generic
biotech drugs.
Hospira, spun off from Abbott Laboratories (ABT) in 2004, sells
injectable generic drugs and medical devices, and is developing
biosimilars that have $18 billion in current branded sales. Chief
Executive Christopher Begley doesn't expect biosimilars to become
key to its financial forecasts for at least five years, but he is
learning a few tricks about the future market from going
head-to-head with biotech marketing veterans Amgen (AMGN) and
Johnson & Johnson (JNJ).
"When you have a drug that is $1 billion or $2 billion and very
profitable, you don't go away easily," Begley said, noting that the
branded companies are using "every possible tactic out there to
prevent generic competition from entering the market and
establishing themselves."
A J&J spokesman declined to comment, while Amgen officials
didn't respond to questions. Biosimilars have hurt sales of branded
drugs, reportedly causing prices to drop 25%-30% on certain
biologics in Europe.
Biosimilars are as close to a generic version as possible for
complex biologic drugs, which are produced through biological
processes, but there is currently no regulatory pathway for their
approval in the U.S. That could change as their introduction is
expected to be part of coming healthcare reform.
Several biosimilars are sold in Europe, including
erythropoietin, or EPO, an anemia treatment sold as Epogen by Amgen
and used widely in cancer, kidney and HIV patients.
Amgen doesn't sell the drug in Europe because of a licensing
agreement with Johnson & Johnson, which sells a similar product
called Eprex. Amgen does sell Aranesp, a longer lasting version of
Epogen, and has admitted to cutting prices to defend market share
in response biosimilar competition in some countries.
Both drugs are costly. In the U.S., they are among Medicare's
top medication expenses.
Hospira launched a biosimilar of Epogen in Europe last year,
called Retacrit, and plans to launch a biosimilar of Amgen's
Neupogen, used in chemotherapy patients, in late 2010. Other
copycat versions of both products are already on the market.
Hospira plans to enter the U.S. market with a biosimilar of Epogen
in 2015.
Begley estimates that biosimilars only make up about 5% of the
total EPO market in Europe, but he said Hospira has a 30% market
share and is about two-thirds into its launch, already selling in
15 counties.
In the process, Hospira is learning about how the branded
companies present data related to the drugs to physicians,
including "how medical professionals are used and what those
medical professionals say or don't say."
Although Begley doesn't expect the U.S. market to be identical
to Europe, he expects many lessons to translate.
"It better prepares us for the U.S., when the hand-to-hand
combat takes place between the sales reps," he said.
Although Begley expects biosimilar legislation in the U.S. by
year-end, he is prepared to pursue other options to bring
biosimilars to the market. That could include filing a biologic
license application with the Food and Drug Administration - the
current process for introducing a new biologic therapy - and using
clinical trials to demonstrate the effectiveness and safety of the
drug.
It is unclear if such a tactic would succeed, but Teva
Pharmaceutical Industries Ltd. (TEVA) has said it may pursue a
similar strategy if timely biosimilar legislation doesn't pass.
-Thomas Gryta; Dow Jones Newswires; 212-416-2169;
thomas.gryta@dowjones.com