Preserve the US interchangeable standard that has helped drive physician and patient confidence in biosimilars

The US Food and Drug Administration (FDA) proposed eliminating the distinction between biosimilars and interchangeable biosimilars, aiming to align with European policy and enhance biosimilar uptake. However, this move is misguided, as biosimilars diff er from generics and require individualized treatment plans. Physician confidence in biosimilars remains high, and the interchangeable standard has effectively built trust. Additionally, biosimilar uptake is influenced by formulary design, not interchangeability. Targeting pharmacy benefit managers practices could better support biosimilar adoption.