BIOSIMILAR DEVELOPMENT – Guidance on Biosimilar Interchangeability: The Debate Over Drug Delivery Devices

Drug Development & Delivery is a print publication and online content provider exclusively committed to advancing the applied science, technology, and related business practices of pharmaceutical and biological drug development. Through insightful scientific, business, and news content, Drug Development & Delivery provides pharmaceutical professionals with practical solutions to the opportunities and challenges in the ever-evolving drug development communities.

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.