Make Interchangeability Decision After Biosimilar Approval, Amgen Urges FDA

A proposal for a two-tiered system that would require a biological product to be approved first as a biosimilar and then later become applicable for “interchangeable” status with a reference product using post-marketing data drew attention at an FDA public meeting on November 2-3 at the agency’s White Oak campus in Silver Spring, Maryland.

FDA held the public hearing to obtain input on specific issues and challenges associated with the implementation of the new biosimilars legislation.

The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) was introduced in Congress last fall and signed into law in March.  The Act establishes an abbreviated approval pathway for biological products that are demonstrated to be “highly similar” (biosimilar) to, or “interchangeable” with, an FDA-licensed biological product.

The agency will take the information it obtained from the public hearing into account in its implementation of the BPCI Act and in the development of related guidances and rulemaking.

The suggestion for the two-tiered approval system was made to the FDA panel during the public forum by Amgen Senior R&D VP Joseph Miletich.

“It is very difficult for me to think of an example where it would be prudent to approve interchangeability at the time of approval,” Miletich stated. “I think post-marketing experience and surveillance would definitely be required because of the complexity of interchangeability” and the unpredictability of how these molecules may act in the human body.

[More on Amgen’s input on interchangeability and biosimilarity at the FDA forum is provided for subscribers here.  Non-subscribers may purchase the three-page story for $55 by contacting Karen Bertani (  To subscribe to IPQ, click here.]