BIOSIMILAR DEVELOPMENT – Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices
Drug Development & Delivery
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In 2019, the US FDA issued its final guidance document that details the pathway for how biosimilar products may be deemed “interchangeable” and substituted for the reference biologic without the intervention of a clinical prescriber. Since then, a number of issues have arisen that may impede ideal patient outcomes. Specifically, whether “interchangeability” guidance might stifle innovation in drug delivery devices, and how this might affect patient experiences.
In this article, Darren Mansell plays out the situation and seeks to stimulate discussion and feedback from readers.