USA – Stakeholders urge FDA to retain interchangeability statements on biosimilar labeling

Two major pharmaceutical industry groups opposed the US Food and Drug Administration’s (FDA) proposal to remove details about interchangeability from product labels in its biologics labeling guidance. They assert that eliminating these statements would create confusion and that these labels are a major source of information for health care providers and prescribers.

Groups also complained that FDA’s plan to refer health care providers and prescribers to the Purple Book Database of Licensed Biological Products to obtain information about a product’s interchangeable status is not a feasible option.

FDA’s draft guidance document, which was issued in September 2023, is the first update of its labeling rules since 2018 (RELATED: Biosimilar labeling guidance suggests cutting interchangeability details from labels, Regulatory Focus 18 September 2023)…