Amgen's Leah Christl makes the case to keep the interchangeability designation for biosimilars
Amgen and its portfolio of 11 biosimilars is standing behind interchangeability, saying the designation should not be rescinded and that the FDA needs to retain its regulatory flexibilities.
The position puts Amgen in opposition to bipartisan legislation that’s pushing to remove the interchangeability designation for biosimilars and to the industry-led Biosimilars Forum, whose executive director recently told Endpoints News they were backing the push to remove the designation. The interchangeability designation allows biosimilars to be swapped with their brand name reference products without the intervention of a prescriber.
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