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

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 FDA to clearly communicate to all stakeholders what biosimilar products are and are not.   For example, there should be no perception, implied or otherwise, that an FDA-approved biosimilar is somehow less effective or less safe than the reference product. However, at this time, biosimilars are not appropriate for automatic substitution – that is, without the explicit consent of the prescribing physician - unless deemed interchangeable by FDA." 

    For the third recommendation, Miletich will emphasize that FDA policy should foster supply chain stability.     

    "Recent medicine shortages have been an opportunity for some manufacturers to suggest that FDA's standards are overly rigorous and a source of the drug shortage problem.  This is exactly wrong," Miletich says. "Complex products require high standards. It is by maintaining appropriately robust good manufacturing practices and facility inspection standards that FDA assures the public the reliable supply of high quality products
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