Confusion Persists Over US Biosimilar Interchangeability

Urgent Need For Clarity Over Misperceptions Linked To Unique US Designation, Paper Insists

23 Jun 2022

The US biosimilars industry is being constrained by misunderstandings stemming from the country’s interchangeability designation, a new paper in BioDrugs has highlighted, citing an urgent need for clarity over the misperception that interchangeable biosimilars are superior to biosimilars without the designation.

Vials Question Marks Confusion — The US interchangeability designation has led to confusion over biosimilars • Source: Shutterstock

The interchangeability designation for biosimilars is a “legal distinction in the US, not a clinical one,” authors of a new paper have emphasized, claiming an urgent need for clarity over the term to avoid damaging misunderstandings.

In particular, the paper published in BioDrugs – written by Samsung Bioepis’s Joseph Park, Byoungin Jung, Hyung Ki Park,...