Drug Development & Delivery is a print magazine and online platform fully dedicated to furthering the science, technology, and business strategies in pharmaceutical and biological drug development. By delivering insightful scientific, business, and news content, Drug Development & Delivery equips pharmaceutical professionals with practical solutions to the challenges and opportunities across the drug development landscape.
In 2019, the US FDA published its final guidance outlining the requirements for biosimilar products to be considered “interchangeable” and substituted for the reference biologic without direct input from a clinical prescriber. Since then, several concerns have surfaced that could impact optimal patient outcomes. In particular, there is debate on whether “interchangeability” guidelines might limit innovation in drug delivery devices, affecting patient experience.
In this article, Darren Mansell explores the issue and encourages readers to share feedback and engage in discussion.