Consumers and Providers Face Biosimilar Knowledge Hurdles

Despite the growing presence of biosimilar prescription drugs in the US health care market, a recent analysis revealed significant knowledge gaps and uncertainties among both consumers and health care professionals (HCPs).1 This widespread lack of understanding could hinder the full potential of biosimilars, which are poised to expand access to life-saving medications and potentially lower health care costs across the nation. The findings underscored an urgent need for clearer, more comprehensive educational initiatives to foster better understanding and adoption of these crucial therapeutic options.

The abbreviated approval pathway for biosimilars is rigorous, allowing for more affordable treatment options and increased patient access to crucial medications for conditions like chronic skin diseases, arthritis, and cancer. However, prior research had consistently shown a lack of familiarity and understanding of biosimilars among both patients and prescribers. Misconceptions around their efficacy, safety, and interchangeability had created hesitancy in their adoption.

With the FDA having issued draft guidance in 2020 on promotional labeling and advertising for biosimilars, particularly concerning disclosure statements, the present study aimed to experimentally test how different forms of disclosure impacted understanding and perceptions.2 The goal was to identify effective communication strategies that could inform and educate both groups in a neutral manner, dispelling misconceptions without unduly influencing perceptions.1

The study employed an experimental design involving 379 consumers and 368 HCPs (primary care providers with prescribing authority) recruited via an online panel. Participants were randomized into one of seven biosimilar disclosure conditions or a control group.

Each condition presented a mock advertisement for "Kesterin," a fictitious biosimilar for rheumatoid arthritis. Disclosures varied by: identifying the product as a biosimilar; the comprehensiveness of the definition provided (ranging from basic to expanded details on safety, efficacy, source, dosage, and administration); and whether a specific reference product ("Mytrozen") was named. Consumer disclosures used lay language, while HCP disclosures used medical terminology. Researchers assessed the impact of these disclosures on participants' comprehension, perceptions of benefit and risk, attitudes, intentions (to use or prescribe), and preferences.

Key Findings and Their Implications

The study's results highlighted significant knowledge gaps. Overall, comprehension of biosimilar information was suboptimal, even when participants were provided with a definition. Only 48.5% to 62.0% of consumers and 68.4% to 88.4% of HCPs accurately understood core characteristics, such as comparable safety and efficacy.

Specifically, comprehension was lowest for the statement, "Kesterin has the same safety and efficacy as the original biologic," for both groups. Perceptions of benefit, comparative efficacy, and safety remained largely neutral across all groups, including the control, suggesting that existing perceptions were deeply ingrained and not easily shifted by brief disclosures.

Crucially, the content of the biosimilar definition generally did not significantly influence outcomes for consumers. However, for HCPs, expanded definitions led to more positive attitudes toward the biosimilar drug and stronger intentions to prescribe. For instance, HCPs exposed to the most comprehensive definition reported more positive attitudes (mean, 4.23) compared to those who only saw the "Kesterin is a biosimilar" statement (mean, 3.83; P = .014) or the control group (mean, 3.80; P = .009). Similarly, their intentions to prescribe were significantly higher with expanded definitions (mean = 3.76) compared to the control (mean, 3.21; P = .009) or the biosimilar-only condition (mean, 3.00; P < .001).

Both consumers and HCPs expressed a preference for these more detailed definitions. HCPs also specifically preferred seeing the named reference product, although this did not directly impact other study outcomes, possibly due to the fictitious nature of the named reference product. Notably, HCPs largely agreed that biosimilars could be used "interchangeably" with their reference product, which signaled a potential misunderstanding of the specific regulatory designation of "interchangeability."

These findings had significant implications for the biosimilar industry and the US health care system. The persistent knowledge gaps and neutral perceptions among both consumers and HCPs indicated that the full potential of biosimilars, including their cost-saving benefits and increased access to treatment, might not be fully realized.

"Our findings clearly signaled that there were knowledge gaps and uncertainty regarding biosimilar products among consumers and HCPs," the study authors concluded. "Further education was warranted around these products, and communications for both groups required careful testing to ensure that the information was understood and did not result in a negative perception of the product."

Researchers suggested that future educational efforts should focus on providing comprehensive and easily digestible information, particularly for HCPs, given their stated preference for expanded definitions and their increased prescribing intentions when presented with more detail. For the biosimilar industry, this means refining direct-to-consumer and professional-facing promotional materials to incorporate clearer, more informative disclosures that addressed core misconceptions about biosimilar equivalence, safety, and efficacy.

For the broader health care system, effective education was mentioned by the authors as paramount to fostering trust and increasing the adoption of these important therapeutic options, which will ultimately contribute to better patient outcomes and more sustainable health care spending.

References

1. Johnson M, Thompson JE, Tilley AA, O’Donoghue AC, Aikin KJ. Perceptions and preferences for defining biosimilar products in prescription drug promotion. J Am Board Fam Med. 2025;38(1):94-106. doi:10.3122/jabfm.2024.240151R1

2. FDA. Promotional labeling and advertising considerations for prescription biological reference and biosimilar products questions and answers: Guidance for industry. 2020. Accessed July 1, 2025. https://www.fda.gov/media/134862/download