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Hospira, Alliance for Health Reform Bring Food and Drug Administration, Industry Experts Together to Discuss the Future of Biosimilars in the United States
Date:5/20/2015

WASHINGTON, May 20, 2015 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP) joined forces with the Alliance for Health Reform and Amgen to bring the U.S. Food and Drug Administration (FDA) and industry leaders together today to discuss the future of biosimilars in the United States.

With the U.S. Congress focused intently on the discovery, development, and delivery pipeline for innovative drugs and devices -- and in the wake of the first-ever U.S. approval of a biosimilar medication -- key biosimilars policy and regulatory questions are being actively debated, with important implications for industry, patients and the health care system. 

Moderated by Ed Howard, executive vice president of the Alliance for Health Reform, expert panelists discussed the U.S. and global markets for reference biologics and biosimilars, outlined current policy and regulatory issues, and described implications for the future of the U.S. biosimilar industry.

Panelists included:

  • Sally Howard, J.D., deputy commissioner for policy, planning, and legislation, U.S. Food and Drug Administration; 
  • Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira;
  • Amanda Bartelme, director, Avalere; and
  • Geoff Eich, executive director, external affairs for Amgen Biosimilars.

"There is an unmet need that requires governments to develop strategies to help increase the understanding of biosimilars, to support successful market formation and to unlock value to help fund healthcare for their citizens," said Sumant Ramachandra, M.D., Ph.D., senior vice president and chief scientific officer, Hospira. "In order to advance a positive market formation and uptake of biosimilars in the United States, public stakeholder understanding and support of biosimilars needs to be a priority."

Hospira is currently marketing biosimilars in Australia, Canada and Europe, where the company has seen biosimilars decrease the costs of biologics by 20 to 30 percent. This has allowed these global healthcare systems to reduce their healthcare spending, while at the same time increasing patient access to these important biologic medicines.

About the Alliance for Health Reform

The Alliance for Health Reform is a nonpartisan, nonprofit health policy education organization that aims to help members of Congress, their staff members, reporters and other opinion leaders understand the roots of the nation's health care problems and the trade-offs posed by various proposals for change. The Alliance is committed to helping policy makers and others move toward an improved health care system that can deliver affordable, quality care for all.

For more than 20 years, the Alliance has pursued that goal by organizing nonpartisan, evidence-based briefings and other events for congressional staff members, media and other health policy opinion leaders. During that time, the Alliance has conducted more than 500 briefings on Capitol Hill and around the nation on timely and important topics, always in a bipartisan manner and with a range of policy or political views represented on its speaker panels.  Learn more at www.allhealth.org.  

About Hospira Biosimilars

Hospira is one of the first companies to submit regulatory applications for biosimilars to the Food and Drug Administration (FDA), with two applications already submitted, including one through its partnership with Celltrion, a South Korean company that specializes in monoclonal antibodies. Hospira is the only U.S.-based company with biosimilars approved in Europe, including Retacrit™ (epoetin zeta), which was launched in Europe in early 2008, and Nivestim™ (filgrastim), which entered the European market in 2010 and was approved in Australia in 2011. In 2013, Hospira received European Medicines Agency (EMA) approval for Inflectra™ (infliximab), the first biosimilar monoclonal antibody approved in Europe. Hospira's global biosimilar pipeline is one of the largest in the industry, comprised of a combination of biosimilars being developed in-house and biosimilars from Hospira's partners.

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
Learn more about how biosimilars will impact healthcare at www.hospira.com/biologics or http://www.biosimilarfacts.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 Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Forward-looking statements generally relate to future events or Hospira's future financial or operating performance. In some cases, you can identify forward-looking statements because they contain words such as "may," "will," "should," "expects," "plans," "anticipates," "could," "intends," "target," "projects," "contemplates," "believes," "estimates," "predicts," "potential" or "continue" or the negative of these words or other similar terms or expressions that concern Hospira's expectations, strategy, plans or intentions. Forward-looking statements in this press release include, but are not limited to Hospira's expectations regarding regulatory approvals, clinical trials and the actions of competitors. Hospira's expectations and beliefs regarding these matters may not materialize, and actual results in future periods are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, challenges inherent in creating and developing compounds and product candidates and economic, competitive, governmental, regulatory, legal, supply and other factors. Information on these and additional risks affecting Hospira's business and operating results are more fully discussed in the section entitled "Risk Factors" in its most recently filed annual report on Form 10-K and any subsequently filed quarterly report on Form 10-Q. The forward-looking statements in this press release are based on information available as of the date hereof, and Hospira disclaims any obligation to update any forward-looking statements, except as required by law.

 


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