Drugs

Praise for Biological Labeling Draft Guidance

Two stakeholders are praising a revised FDA draft guidance on promotional labeling and advertising considerations for prescription biological reference products, biosimilar products, and interchangeable biosimilar products. The Biosimilars Council, a division of the Association for Accessible Medicines, says it applauds FDA’s continued commitment to combatting misinformation about biosimilars. “Misinformation has been a significant impediment to use of safe and effective lower-priced biosimilars,” the comment letter says, “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 says the draft makes clear that there are no clinically meaningful differences between a biosimilar product and its reference product in terms of safety, purity, and potency and clearly conveys that it would be false or misleading to suggest that biosimilars are less safe and effective than interchangeables or than their reference products.

It says the draft would benefit from an affirmative statement from FDA that interchangeability does not represent a higher standard or convey increased quality, safety, or efficacy than biosimilars, 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.

The Biosimilars Forum uses similar language to make the same points as the council.

Both stakeholders give line-by-line specific recommendations.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome