Amgen To Provide Testimony At FDA Stakeholder Hearing On Biosimilars
In his opening remarks, Miletich will underscore the wealth of experience
"Put patients first and sound policy will follow," Miletich states. "
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,
Miletich will state that "patient safety must be a non-negotiable priority for
- Adopt policies to facilitate attribution of adverse events and foster manufacturer accountability
- Conduct a communications campaign about biologics and biosimilars
- Foster supply chain stability
On the first recommendation, Miletich will underscore the need for accurate tracking and tracing. "The challenge and importance of accurate tracking and tracing will increase significantly with the arrival of biosimilars in the U.S. marketplace," says Miletich. "We believe prompt identification and resolution of product problems will be facilitated by distinguishable established names. Unlike other identifiers, established names present a risk that two or more products could share the same name, which would affirmatively confound the attribution of adverse events."
Secondly, "The biosimilar approval pathway is a new initiative in the U.S. with many scientific and administrative challenges and nuances," Miletich says. "It will be essential for
For the third recommendation, Miletich will emphasize that
"Recent medicine shortages have been an opportunity for some manufacturers to suggest that
In response to the
Scientific Considerations Draft Guidance:
Quality Considerations Draft Guidance:
Q&A Draft Guidance:
Miletich's written testimony was submitted in response to
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