Hospira Statement on FDA Approval of the First Biosimilar in the United States

Mar 06, 2015, 11:39 ET from Hospira, Inc.

LAKE FOREST, Ill., March 6, 2015 /PRNewswire/ -- Hospira, Inc. (NYSE: HSP), applauds Sandoz and the U.S. Food and Drug Administration (FDA) on today's FDA approval of the first biosimilar in the United States. This is a watershed moment for improving patient access to safe, effective and more affordable biologic medicines. As a leading global provider of biosimilars, Hospira has seen first-hand the positive impact of biosimilars in other countries, and we are a proud participant in these early stages of the development of a pathway for these medicines in the United States.

Hospira is the only U.S.-based company currently marketing biosimilars in the highly regulated markets of Europe and Australia, where we have seen biosimilars decrease the costs of biologics by 20 to 30 percent. This has allowed European healthcare systems to reduce their healthcare spending, while at the same time increasing patient access to these important biologic medicines.

"Biosimilars represent a transformational opportunity to improve patient access and provide much-needed financial relief to the U.S. healthcare system," said Sumant Ramachandra, M.D., Ph.D., senior vice president, Research & Development and Medical & Regulatory Affairs, and chief scientific officer, Hospira. "This approval is good news for the entire healthcare system and brings us one step closer to making these important medications available for the patients who need them.

"With two biosimilar applications currently under review by the U.S. FDA, Hospira is committed to bringing more affordable biologic medicines to patients in the United States. We look forward to continuing to partner with the FDA on the approval pathway for our biosimilars, so that more and more patients and healthcare providers have access to the benefits of biosimilars," continued Ramachandra.

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. For more information about biosimilars, please visit 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. 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.

 

SOURCE Hospira, Inc.



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