Hospira Marks Five Years of Biosimilars Success at 2013 BIO International
-- Global experience, data and improved patient access indicate strong market
for future U.S. biosimilars --
2013 BIO International Convention
CHICAGO -- April 24, 2013
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
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.
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;
^4 IMS Midas: Dec. 2012
^5 IMS Midas: Dec. 2012
Dan Rosenberg, (224) 212-3366
Ruth Venning, (224) 212-2711
Karen King, (224) 212-2711
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