Biosimilars Council submits comments to FDA for promotional labeling, advertising considerations

On behalf of its members, the Biosimilars Council has submitted comments to the Food and Drug Administration on draft guidance that discusses considerations for presenting data and information about reference or biosimilar products in promotional communications.

“The Biosimilars Council applauds the FDA’s continued commitment to combatting misinformation about biosimilars, and we strongly support the revised Draft Guidance,” said David Gaugh, interim president and CEO for AAM. “Misinformation has been a significant impediment to use of safe and effective lower priced biosimilars, and the revised guidance will help ensure that sponsors engage in truthful and non-misleading communications regarding biosimilars, including interchangeable biosimilars and their reference products.”

The Council’s comments also call for a clear statement from the FDA, affirming the quality, efficacy and safety of both interchangeable biosimilars and biosimilar medicines.

[Read more: Prioritizing Lower-Priced Biosimilar Medications]

Gaugh continued, “The guidance would benefit from an affirmative statement from the FDA that interchangeability does not represent a higher standard or convey increased quality, safety, or efficacy than biosimilarity, and that a healthcare provider can be just as confident in prescribing a biosimilar as an interchangeable, regardless of whether the patient is new to treatment or is currently being treated with the reference product.”

Full Comments to FDA can be found here.