Hospira : Statement On FDA's Final Biosimilar Guidance Documents

LAKE FOREST, Ill., May 1, 2015 -- Hospira, Inc. (NYSE: HSP), is pleased that the U.S. Food and Drug Administration (FDA) has issued its final guidance documents on biosimilar products. This regulatory guidance represents an important milestone as we collectively work to improve patient access to safe, effective and more affordable biologic medicines.

According to the FDA, the guidance documents -- Scientific Considerations in Demonstrating Biosimilarity to a Reference Product; Quality Considerations in Demonstrating Biosimilarity of a Therapeutic Protein Product to a Reference Product; and Biosimilars: Questions and Answers Regarding Implementation of the Biologics Price Competition and Innovation Act of 2009-- are intended to provide clear direction on the scientific and regulatory considerations for sponsors initiating biosimilar development programs.

The FDA's final guidance reinforces the Agency's support of extrapolation across indications, which the Agency employed in the recent approval of the first U.S. biosimilar product in March. Specifically, the scientific guidance document states, "If the proposed product meets the statutory requirements for licensure as a biosimilar product under section 351(k) of the PHS Act based on, among other things, data derived from a clinical study or studies sufficient to demonstrate safety, purity, and potency in an appropriate condition of use, the applicant may seek licensure of the proposed product for one or more additional conditions of use for which the reference product is licensed."

In addition, in its final guidance, the FDA also confirmed that a biosimilar sponsor may use data from a non-U.S.-licensed comparator product to support its application for biosimilarity, stating that the sponsor may seek to use data derived from animal or clinical studies comparing a proposed product with a non-U.S.-licensed comparator product to address, in part, the requirements under section 351(k)(2)(A) of the PHS Act.

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 and chief scientific officer, Hospira. "The issuance of these final guidance documents is an important step in making these important medications available for the patients who need them.

"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 as we seek approval 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 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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Julie Ferguson
224-212-3040

Financial Community:
Karen King
224-212-2711

Ruth Venning
224-212-2774

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