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

15 Jul 2016

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.

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...