THOUSAND OAKS (dpa-AFX) - Amgen (AMGN) announced that Joseph Miletich, senior vice president of Research and Development at Amgen will testify at the United States Food and Drug Administration stakeholder hearing on biosimilars.
The company said 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.
'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.'
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 guidance: Adopt policies to facilitate attribution of adverse events and foster manufacturer accountability; Conduct a communications campaign about biologics and biosimilars; Foster supply chain stability.
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