FDA Draft Study on Biosimilar Disclosures Draws Fire

In a quest to ensure that product labeling disclosures about biosimilars are not unduly influencing the opinions of health care providers (HCPs) and consumers toward biosimilars, the FDA aims to conduct a study that will examine HCP and consumer responses to different types of label wording.

In public comments submitted about the draft outlines for the study, various pharmaceutical companies and groups have offered their suggestions for improving the value of these studies and upgrading standard biosimilar disclosures so that unwarranted perceptions do not form in the minds of HCPs and consumers.

“In the context of prescription drug promotion, there is initial evidence that—when noticed—disclosures may effectively convey important information; however, what role disclosures may play in educating or correcting misunderstanding warrants further investigation,” the FDA stated in describing the purpose of the study.

Combatting Biosimilar Misinformation

Promotional claims about biosimilars have been a focus for the FDA and Federal Trade Commission this year, as they endeavored to respond to industry concerns that the public’s perception of biosimilars has been warped by multiple factors, including unintentionally and deliberately misleading promotions, from regulatory language to competitors’ claims about biosimilars.

The FDA plans to examine how label claims about nonprimary investigative goals, or secondary end points, in clinical studies will affect perceptions among HCPs and consumers. Participants enrolled in the study will view different versions of a website showing information about a fictitious product and answer questions based on their perceptions of that information.

The second part of the study will evaluate how disclosing that a drug product is a biosimilar affects HCP and consumer perceptions. Participants will also be asked to respond to various informational statements about biosimilars.

Study participants will also be asked for their reactions to multiple versions of language describing biosimilars and their relative safety and efficacy to reference products.

“This approach allows us to examine the effect of disclosing biosimilar status, examines the additive effect of including 1, 2, or 3 additional basic statements of information about biosimilars, and measures the effect of naming the reference product,” the FDA wrote.

In public comments about the study proposal, the Biosimilars Forum, representing biosimilars developers, said it was concerned about how language used to describe biosimilars may be “couched in cautionary or negative terms,” which hold the potential to be off-putting to HCPs and consumers.

It asked for a stronger emphasis in the study on garnering patient perceptions of biosimilar disclosures. “In the 6 years since the Forum was founded, we have found that while knowledge and perceptions of HCPs have increased…knowledge levels of patients are still low,” the group wrote.

Similarly, the drug company Bayer commented that the language of the study as it would be presented to participants sounded clinical and should be rewritten for consumer participants so that it was “patient friendly.”

The Hematology/Oncology Pharmacy Association asked that the study also evaluate the value of adding information about use of biosimilars for all indicated uses, or extrapolations, of the reference product. “Several studies have indicated that understanding, or lack of understanding of biosimilars in extrapolated indications, impacts a health care professional’s use of a biosimilar,” the group said.

A further critique of the study came from the Pharmaceutical Research and Manufacturers of America, which contended the study will not provide useful information because such information is already available to the FDA from other sources, the proposed study as designed is "flawed" because secondary end points are more important to a product’s indicated uses than the study design seems to suggest, and the study unfairly uses a genuine product, Humira (adalimumab) as a case example while using an anonymous or fictitious biosimilar.

That last point also drew an objection from AbbVie, which owns the Humira brand. The “FDA should refrain from using the name of a reference product currently on the market in the questionnaire and instead use a fictitious name for a reference product, as it does for the biosimilar,” the company said.

Importance of Consumer Perception

The importance of getting label language right for biosimilars is illustrated by the problem with consumers' understanding of alternative health products, the FDA noted. "Research on consumer attitudes [has] found some people believe that FDA evaluates certain dietary supplement claims despite the presence and consumer awareness of language required by the Dietary Supplement Health and Education Act, which clearly states that FDA has not evaluated those claims."