Amgen Requests Biosimilars Clinical Trial Clarification

Amgen, the world’s largest biotechnology company, have replied to the US FDA’s recent draft advice on biosimilars, noting that certain “changes and additional clarity are needed.”

In February, the US Food and Drug Administration (FDA) presented three initial draft guidance documents on the regulation of biosimilars.  In response to these documents, Amgen commented “we appreciate FDA’s commitment to working with stakeholders in a transparent guidance development process.”  The company then listed several recommendations for the draft guidance.

These proposed changes included “defining ambiguous terms” and recognising and confronting “current technical and scientific limitations related to regulatory advice or requirements.”  Amgen adds that any guidance from the FDA needs to “make clear that clinical studies will be necessary for the foreseeable future due to the complexity and diversity of human biology and the limits of scientific knowledge today.”

The company notes that “it is appropriate for the agency to acknowledge that analytical studies will increasingly facilitate reduction in the size and scope of clinical studies needed.”

Other suggested improvements call on the Food and Drug Administration agency to publish “class-specific guidance that discusses the approval standards and other key implementation issues for particular product classes” and to “require all biological products to have a distinguishable non-proprietary name in order to facilitate accurate attribution of adverse events.”

Amgen states the US FDA’s awareness “that determining interchangeability is scientifically difficult at this time is also important.”  They add that “patient safety does not stop at approval” and “distinguishable product names and post-approval activities, including on-going monitoring, are essential.”

Amgen is just one of approximately 40 interested parties who have submitted a response on the US FDA’s proposals prior to a stakeholder meeting on May 11th to be held at US agency’s head office in Maryland.


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