Food & Drug Administration Takes Strong Enforcement Action Against Biosimilar Misinformation

FDA’s Action Sends a Strong Signal to Companies Engaging in Unfair Practices to Protect Market Share at Patients’ Expense

The Biosimilars Forum applauds the Food & Drug Administration’s (FDA) enforcement action this week against a company for misleading communications about biosimilars.

Misinformation about the safety and efficacy of biosimilars emanating from market-leading brand-name drug companies is rampant. The Biosimilars Forum has consistently engaged with the FDA and Federal Trade Commission (FTC) on this issue since day one, including calling on both agencies to take aggressive enforcement actions.

“Spreading false claims and misinformation harms patients and is a barrier to access to safe, effective and lower-cost biosimilars,” said Meaghan R. Smith, Executive Director of the Biosimilars Forum. “But sadly, this is part of a cynical strategy by some companies to protect market share at the expense of patients and taxpayers. We hope the FDA’s action sends a strong signal that deters similar unfair practices in the future.”

The FDA’s enforcement action comes on the heels of President Biden’s Executive Order directing the Department of Health and Human Services “to increase support for generic and biosimilar drugs, which provide low-cost options for patients.” President Biden’s order directs HHS and the FTC to work together to address “any efforts to impede generic drug and biosimilar competition, including but not limited to false, misleading, or otherwise deceptive statements about generic drug and biosimilar products and their safety or effectiveness.”

“At a time when consumers need lower cost medicines, the Biosimilars Forum will continue to serve as a voice for patients and advocate for commonsense policy solutions in Washington that give more patients access to lifesaving, lower-cost biosimilar drugs,” added Smith.

For more information on the Biosimilars Forum, visit