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Amgen To Provide Testimony At FDA Stakeholder Hearing On Biosimilars
Date:5/11/2012

THOUSAND OAKS, Calif., May 11, 2012 /PRNewswire/ -- Amgen (NASDAQ: AMGN) announced today that Joseph P. Miletich, M.D., Ph.D., senior vice president of Research and Development at Amgen will testify at the United States (U.S.) Food and Drug Administration (FDA) stakeholder hearing on biosimilars. Miletich will urge members of the FDA panel charged with implementing a pathway for biosimilars to establish approval standards that advance patient safety and promote confidence in biosimilars marketed in the U.S.

In his opening remarks, Miletich will underscore the wealth of experience Amgen brings to the discussion on biosimilars approval pathway implementation. "As a leading provider of high quality biologic medicines, Amgen appreciates the challenges of developing and manufacturing innovative and biosimilar medicines."

"Put patients first and sound policy will follow," Miletich states.  "Amgen appreciates the FDA's efforts on the guidelines and encourages adoption of a thorough review and approval process. However, Amgen believes some changes and additional clarity are needed."

Noting the complexities of biological products and the potential differences in products created from different living cells, Miletich will emphasize that biotechnology is an evolving field.  "While much more is known today than 30 years ago, FDA's guidance documents should candidly acknowledge that there are some things we still do not scientifically know today," says Miletich.

Miletich will state that "patient safety must be a non-negotiable priority for FDA and manufacturers, and that focus on patient safety does not end with drug approval."  He will outline three key recommendations that the FDA should consider as it finalizes its guidances:  

  1. Adopt policies to facilitate attribution of adverse events and
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SOURCE Amgen
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