AJMC November 5, 2024
The US could start catching up to Europe on biosimilars if the FDA removed the need for switching studies to be granted interchangeability.
The FDA’s draft guidance to remove the requirement for switching studies to gain the interchangeability designation could change payer perspectives and bring the US more in line with Europe, explained James D. Chambers, PhD, professor, Center for the Evaluation of Value and Risk in Health, Institute for Clinical Research and Health Policy Studies, Tufts Medical Center.
This transcript has been lightly edited for clarity.
Transcript
The FDA has published draft guidance to remove the requirement for switching studies for biosimilar interchangeability. What is the current challenge with conducting switching studies and how will getting rid of the...
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