Hospira, Inc. (NYSE: HSP), the world's leading provider of
injectable drugs and infusion technologies, today announced an
important milestone, commemorating five years of providing
biosimilars to the European market and delivery of more than five
million doses of high-quality biosimilar medicines at a lower cost
to patients in Europe and Australia. Biosimilars are an important
industry topic at the BIO International Convention in Chicago this
week, with multiple sessions devoted to topics such as biosimilar
regulatory approval, manufacturing and market formation.
"Bringing biosimilars to the United States is the next major
step toward reducing costs for the U.S. healthcare system," said
Thomas Moore, president, U.S., Hospira. "As the first U.S. company
to market biosimilars globally, Hospira will build on our track
record of success to introduce biosimilars in the United States and
increase access for Americans to high-quality biologic medications
that treat severe and life-threatening diseases."
Global Experience and Data
Hospira's biosimilars in Europe and Australia entered the
markets after robust regulatory approval processes. These approvals
were supported by a rigorous scientific evaluation to demonstrate
the products' therapeutic equivalence to the reference products,
including an extensive clinical study program. Furthermore,
Hospira's biosimilars have been subject to extensive post-marketing
studies that continue to support their safety and effectiveness in
routine use.
Retacrit™, Hospira's first biosimilar, was launched in Europe in
early 2008. A total of more than 1,600 patients were studied to
support intravenous (I.V.) and subcutaneous administration of the
product. Retacrit is a recombinant human erythropoietin, or "EPO
biosimilar." It is used to treat symptomatic anemia associated with
chronic renal failure in adult and pediatric patients and anemia in
adult patients receiving chemotherapy for solid tumors, malignant
lymphoma or multiple myeloma. Hospira's second marketed biosimilar
product is Nivestim™, a biosimilar version of filgrastim (GCSF) –
used for a condition known as neutropenia in which the body makes
too few infection-fighting white blood cells. Nivestim entered the
European market in 2010 and the Australian market in 2011.
Increased Affordability and Patient Access
Since Hospira launched its biosimilars, prices have decreased
and patient access has increased.
In Europe and Australia, biosimilar treatments offer cost
savings to healthcare systems of approximately 25 percent to 30
percent.1 In the United States, newer biologic treatments can cost
$100,000 or more per patient, per year.2 A price decrease in the
United States similar to the one experienced in Europe would
benefit patients and payers alike.
A number of studies predict that successful adoption of
biosimilars in the United States could result in significant
savings for U.S. patients and the U.S. healthcare system driven by
increased competition. A 2013 study by accounting firm Grant
Thornton found that biosimilars hold the potential to save $20
billion annually in the United States.3
Market Penetration of Biosimilars and U.S. Market
Formation
With the continued safe and effective record of biosimilars in
European Union clinical practice, use in many markets is widespread
and growing rapidly. Throughout the European Union, biosimilar
versions of GCSF had gained almost 41 percent of the total daily
GCSF market by the end of 2012, up from 30 percent at the start of
the year.4 During the same period, EPO biosimilars had grown their
market share to 19 percent of the European short-acting EPO market,
up from 15 percent at the beginning of 2012.5
"Biosimilars have come to stay in Europe, and we're very pleased
with the progress we are seeing," Hospira's Moore said. "European
and Australian physicians trust in the safety, efficacy and quality
of biosimilars for their patients."
Hospira is currently conducting a Phase III U.S. clinical trial
program with its biosimilar version of EPO, which is being
evaluated as a biosimilar to erythropoietin alpha. Hospira's broad
biosimilars pipeline, including products it shares with South
Korean partner Celltrion, includes 11 products and is one of the
largest in the industry. In 2012, Hospira filed for European
approval of a biosimilar version of infliximab, a treatment for
auto-immune diseases, including rheumatoid arthritis, Crohn's
disease, ulcerative colitis and psoriasis. Hospira also has a
biosimilar version of an oncolytic, trastuzumab, in clinical
studies.
Hospira's extensive U.S. clinical development program, coupled
with its marketing track record in Europe, position the company
well in its efforts to bring biosimilar products to U.S.
patients.
About Hospira
Hospira, Inc. is the world's leading provider of injectable
drugs and infusion technologies. Through its broad, integrated
portfolio, Hospira is uniquely positioned to Advance Wellness™ by
improving patient and caregiver safety while reducing healthcare
costs. The company is headquartered in Lake Forest, Ill., and has
approximately 16,000 employees. Learn more at www.hospira.com.
Private Securities Litigation Reform Act of
1995 --
A Caution Concerning Forward-Looking
Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements regarding Hospira's biosimilars program.
Hospira cautions that these forward-looking statements are subject
to risks and uncertainties that may cause actual results to differ
materially from those indicated in the forward-looking statements.
Economic, competitive, governmental, regulatory, legal,
technological, manufacturing supply, quality and other factors that
may affect Hospira's operations and may cause actual results to be
materially different from expectations include the risks,
uncertainties and factors discussed under the headings "Risk
Factors" and "Management's Discussion and Analysis of Financial
Condition and Results of Operations" in Hospira's latest Annual
Report on Form 10-K and subsequent Forms 10-Q filed with the
Securities and Exchange Commission, which are incorporated by
reference. Hospira undertakes no obligation to release publicly any
revisions to forward-looking statements as the result of subsequent
events or developments.
1 Internal Hospira data
2 A. Pollack, "Biotech Firms, Billions at Risk, Lobby States To
Limit Generics," New York Times; Jan. 29, 2013
3 Generic Pharmaceutical Association press release, Feb. 1,
2013;
http://www.gphaonline.org/gpha-media/press/gpha-press-granthornton
4 IMS Midas: Dec. 2012
5 IMS Midas: Dec. 2012
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