Hospira statement on FDA approval of the first biosimilar in the United States

March 7, 2015 10:06 AM

Hospira, Inc., applauds Sandoz and the U.S. Food and Drug Administration (FDA) on 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.


Source: Hospira press release


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