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

e scope of harm from unexpected adverse events associated with use of any biological product.  These measures should include development and implementation of a pharmacovigilance system that provides accurate and comprehensive association and reporting of adverse events with the implicated product, as well as specific labeling to differentiate products that are biosimilar from those that are interchangeable to enable physicians to make informed treatment decisions.

In his concluding comments, Dr. Miletich urged the FDA to outline approval standards through a transparent and public process.  "Not all classes of biological products have the same level of complexity or risk, thus class-specific approval standards must be developed," Dr. Miletich stated.  "Case-by-case approaches generate uncertainty leading to delays and increased cost.  Class-by-class standards are consistent with good review practices.  A public process for approval standards creates confidence among patients and physicians."

On March 23, 2010, President Obama signed into law the Patient Protection and Affordable Care Act which contained a provision authorizing the FDA to create an abbreviated approval pathway for biological products shown to be biosimilar to with an already FDA-approved biological medicine.  Several countries around the globe have already implemented approval pathways for biosimilars.  The European Union and Japan are among those that have successfully devised a set of science-based criteria to permit biosimilars in their jurisdictions.  With the FDA's hearing on November 2-3, the United States is beginning the implementation process.

Dr. Miletich’s testimony was submitted in response to FDA’s

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