The US Food and Drug Administration (FDA) faces opposition from major pharmaceutical industry groups regarding its proposal to remove interchangeability details from product labels in the biologics labeling guidance. The proposed change, outlined in the FDA’s draft guidance document issued in September 2023, marks the first update to labeling rules since 2018. The FDA argues that interchangeability statements are not crucial for prescribers, who can confidently prescribe both biosimilar and interchangeable biosimilar products.
However, stakeholders, including the Biotechnology Innovation Organization (BIO) and the Pharmaceutical Research and Manufacturers of America (PhRMA), express concerns over potential confusion and the practicality of relying on the Purple Book Database of Licensed Biological Products for this information. Both groups emphasize that product labels are the primary source of information for healthcare professionals and argue that the Purple Book is not as widely recognized or routinely used.
BIO warns that discontinuing interchangeability statements may lead to unintended consequences, such as implying interchangeability when it doesn’t exist. PhRMA adds that eliminating the statement, which is already present on over 40 FDA-approved biosimilars, could sow confusion among stakeholders.
In contrast, biosimilar groups, the Biosimilars Council and the Biosimilars Forum, support the FDA’s proposal. They argue that the Purple Book is well-suited for conveying information on biosimilarity and interchangeability and that aligning with generic drug labels, which lack similar statements, makes sense.
The Alliance for Safe Biologic Medicines (ASBM), representing various stakeholders, urges the FDA to retain interchangeability statements based on survey results showing high importance ratings from physicians and pharmacists. The ASBM argues that these statements are valued by prescribing healthcare professionals.
With 22 comments received on the guidance, the FDA faces a divided response from stakeholders. While some support the proposed elimination, major industry groups stress the importance of retaining interchangeability statements on biosimilar labels for clarity and effective communication with healthcare providers. The fate of the proposal awaits further consideration and decision by the FDA.