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Amgen to Provide Testimony at FDA Hearing on Biosimilars
Date:11/1/2010

THOUSAND OAKS, Calif., Nov. 1, 2010 /PRNewswire/ -- Amgen (Nasdaq: AMGN) Senior Vice President of Research and Development Joe Miletich, M.D., Ph.D., will urge members of a U.S. Food and Drug Administration (FDA) panel charged with implementing a pathway for biosimilars to establish approval standards that ensure patient safety and follow a science-based approach.

"Put patients first and sound policy will follow," Dr. Miletich said.  "Amgen believes biosimilars have a meaningful role to play in the health care system.  However, biosimilars—unlike generic drugs—are not identical to the innovative biological products."  Getting the biosimilar pathway 'right' could benefit the future of biopharmaceuticals, whereas "imprudent policy" could simultaneously put patients unacceptably at risk, undermine the policy goals and set back the promise of new biologic treatments for patients.Noting the complexities of biological products and the likely differences in products created from different living cells, Dr. Miletich will outline three key recommendations that the FDA should consider as it moves forward:

  1. Use well-designed clinical trials to establish biosimilarity;
  2. Ensure the product manufacturer and lot number is known for all administered biological; and
  3. Set scientific and practical criteria for interchangeability.

"The question before the agency is how we can minimize patient risk and uncertainty associated with the approval of biosimilars," Dr. Miletich said.  "The challenge with biosimilars is knowing which structural variations matter clinically and which do not.  Many differences probably do not matter, while some differences are important.  Other differences remain open questions.  Clinical evaluations and experience are necessary to address these questions."'/>"/>

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