GENERICS AND BIOSIMILARS INITIATIVE JOURNAL
Official Journal of the Generics and Biosimilars Initiative
Volume 13 / Year 2024 / Issue 1
Opinion
Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars
Author(s): Michael S Reilly, Esq
Page: 34-6Abstract: The US Food and Drug Administration (FDA) proposed eliminating the distinction between biosimilars and interchangeable biosimilars with the stated aim of aligning with European policy and enhance biosimilar uptake. However, this move is misguided as it would result in widespread generic-style automatic substitution at the pharmacy level; which is rare in Europe. Physician confidence […]