The Biosimilars Forum Filed Comment on FDA’s Notice Detailing the Impact of Disclosure Statements in Biosimilar Promotional Materials

Washington D.C. — The Biosimilars Forum recently filed a comment on the FDA’s notice, “Examination of Secondary Claim Disclosure and Biosimilar Disclosures in Prescription Drug Promotional Materials,” announcing that the agency will be researching the impact of disclosure statements in biosimilar promotional materials, adding general informational statements about biosimilars, and naming a reference product. 

At present, biosimilar usage is relatively limited in the U.S. market for several reasons. A contributing factor for this slow adoption has been the instances of disparagement and misinformation about biosimilars sowing confusion among many healthcare professionals and patients.

The Forum’s comments to the FDA’s notice are intended to help enhance the quality, utility, and clarity of the information collected in the FDA’s study—including what topics are covered, the tone of disclosure statements, avoiding vague or overly complex messages, and establishing a sunset provision for disclosure statements. 

When biosimilar use is limited in healthcare systems, patients lose access to safe and effective lower-cost treatment options and the healthcare system loses billions in potential savings,” said Juliana Reed, President of the Biosimilars Forum. “To help patients and health care providers understand the basic principles of biosimilars, we urge the FDA to prioritize education about how biosimilars are as safe and effective as their reference product, the FDA’s rigorous biosimilar approval process and high-quality standards, and how patients have been benefiting from use of biosimilars for many years. We appreciate the FDA’s work on this study, and look forward to working with them as they evaluate its findings.

More information about disparagement and misinformation of biosimilars can be found in the BioDrugs article titled “The Importance of Countering Biosimilar Disparagement and Misinformation,” published by the Biosimilars Forum’s Education Committee Co-Chairs, Hillel Cohen and Dottie McCabe.

To read the Biosimilars Forum’s full comment submitted to the FDA, click here. For more information about biosimilars and the Biosimilars Forum, please visit biosimilarsforum.org or supportbiosimilars.com.

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