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

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WASHINGTON — Today, on behalf of its members, the Biosimilars Council submitted comments to the FDA on draft guidance that discusses considerations for presenting data and information about reference products or biosimilar products in promotional communications.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the FDA’s continued commitment to combatting misinformation about biosimilars, and we strongly support the revised Draft Guidance,” said David Gaugh, Interim President & CEO for AAM.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 Biosimilars Council, a division of the Association for Accessible Medicines, represents the manufacturers of biosimilar medicines, which are FDA-approved safe and effective, lower cost versions of brand biologics. The Council works to increase patient access to lifesaving, affordable generic and biosimilar medicines. Biosimilars are the key to reducing prescription drug costs and increasing access to care, generating more than $23 billion in savings since 2015.

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.

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.”


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