The Importance of Dispelling Misinformation About Biosimilar Therapies

The promise of biosimilars is real. Biosimilars — which treat serious diseases, including cancers, rheumatoid arthritis, psoriasis, inflammatory bowel disease, and Crohn’s Disease — are FDA-approved, equally safe, and have no clinically meaningful differences between their reference biologics. Yet biologic manufacturers have continued to sow doubt about the safety and efficacy of biosimilars. By creating confusion throughout the industry and hampering the biosimilars market, these tactics are only harming patients who are ultimately losing out on billions of dollars in potential cost-savings.

Today, the FDA and FTC are holding a public workshop exploring how best to increase patient access to biosimilars and help ensure that the biologics market is robust and competitive. As part of this interagency collaboration, the FDA and FTC are explicitly discussing the importance of “[discouraging] false or misleading communications about biosimilars, and [deterring] anticompetitive behaviors in the biologic product marketplace.”

The Biosimilars Forum’s Hillel Cohen, co-chair of the Forum’s Education Committee, is participating in the panel, where he explains how biosimilar use is still limited in many health care systems because they are not well understood by many health care professionals and patients. This mistrust is exacerbated by negatively biased information or intentional misinformation disseminated by biologics manufacturers and other parties.

Different types of misinformation pushed by biologic manufacturers include:

• Statements about biosimilar science or policy that are factually incorrect.
• Misleading information, where the information is correct but is provided out-of-context.
• Incomplete information, where only partial or a limited set of facts are provided.
• Creation of a false narrative, especially in scientific and medical literature, that provides a set of references to support incorrect conclusions.
• Negative framing of factual statements to create a negative perception.

This misinformation only hurts physicians’ ability to prescribe the treatments their patients need, and will result in billions in lost savings for patients and the U.S. health care system.

Clear and unbiased scientific messaging will help biosimilars become widely accepted by patients and their doctors as valid treatments. Fortunately, the FDA and the Federal Trade Commission have acknowledged that biosimilar disparagement and misinformation exists and are taking steps to counter these efforts and to support the nascent biosimilar industry.

The Biosimilars Forum welcomes these developments and looks forward to continuing to work with the health care community to instill confidence in these life-saving, lower-cost therapies.

Learn more about the promise of biosimilars and the many benefits to patients and health care providers with the new suite of educational materials and resources from the FDA: https://www.fda.gov/biosimilars