1. Pink Sheet

Biosimilar Non-Medical Switching: Advocacy Groups, FDA Advisors Push For Action

 
• By Sue Sutter

FDA considering public statement reflecting its view that biosimilars not deemed interchangeable will not be substituted at pharmacy, but the extent such a statement would limit payer-driven practice remains in question.

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Patient advocacy groups and some of FDA's external advisors are urging the agency to come out with a public stance against non-medical switching of patients from innovative biologics to non-interchangeable biosimilars.

However, the extent of any agency statement – and its impact on payers and pharmacy benefit managers who have the...

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