LAKE FOREST, Ill., Jan. 12, 2015 /PRNewswire/ -- Hospira,
Inc. (NYSE: HSP), the world's leading provider of injectable
drugs and infusion technologies, and a global leader in
biosimilars, today announced that it has submitted a Biologics
License Application (BLA) to the U.S. Food and Drug
Administration (FDA) for Retacrit™, a proposed biosimilar to
Amgen's EPOGEN® (epoetin alfa) and Janssen's PROCRIT
® (epoetin alfa).
The biosimilar application was submitted on Dec. 16, 2014, under the new 351(k) approval
pathway created by the Biologics Price Competition and Innovation
Act of 2009 (BPCIA).
"As one of the first companies to submit a biosimilar
application in the United States,
we are proud to be a leader who can help our country's healthcare
system decrease unsustainable costs by embracing a new frontier in
medicine," said Sumant Ramachandra, M.D., Ph.D., senior vice
president, chief scientific officer, Hospira. "Hospira is
proud to build upon our global experience of providing biosimilars
to patients across the world."
Biosimilars are biologic drugs that are highly similar to a
reference biopharmaceutical product and demonstrate no clinically
meaningful differences in terms of the safety, purity and potency
of the product. Biosimilars offer high-quality, lower-cost
alternatives to reference biologics.
About Hospira Biosimilars
Globally, Hospira has many
years of experience in the field of biologics and has one of the
largest biosimilar pipelines in the industry. Hospira is the only
U.S.-based company with biosimilars in the European market,
including Retacrit™ (epoetin zeta), which was launched in
Europe in early 2008, and
Nivestim™ (filgrastim), which entered the European market in 2010
and Australian market in 2011. In 2013, Hospira received European
Medicines Agency (EMA) approval for Inflectra™ (infliximab), the
first biosimilar monoclonal antibody approved in Europe.
For more information, please visit
www.hospira.com/biologics.
About Hospira
Hospira, Inc. is the world's leading
provider of injectable drugs and infusion technologies, and a
global leader in biosimilars. 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. Learn more at
www.hospira.com.
Private Securities Litigation Reform Act of
1995 --
A Caution Concerning Forward-Looking
Statements
This press release contains, or may contain, forward-looking
statements within the meaning of the Private Securities Litigation
Reform Act of 1995. 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. Factors that may affect Hospira's
operations, and may cause actual results to be materially different
from expectations also 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 U.S. Securities and Exchange
Commission, which are incorporated by reference. Hospira undertakes
no obligation to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except
as required by law.
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SOURCE Hospira, Inc.