USA – Biosimilar labeling guidance suggests cutting interchangeability details from labels

In new draft guidance on biosimilar labeling, the US Food and Drug Administration (FDA) recommends removing details about interchangeability from the labels of these products, suggesting that the designation is confusing to prescribers and patients.

“[A] labeling statement noting that certain products within a 351(k) [Biologics License Application] have been approved as interchangeable, and explaining the interchangeability standard, is not likely to be useful to prescribers, who can prescribe both biosimilar and interchangeable biosimilar products in place of the reference product with equal confidence that they are as safe and effective as their reference products,” FDA said in the Federal Register announcement of the proposed changes.

The 20-page guidance document is the first update to Labeling for Biosimilar and Interchangeable Biosimilar Products” since 2018, the FDA noted. If finalized, the new draft guidance will replace the 2018 document…