Abstract
BACKGROUND: Prescription biosimilars are highly similar to and have no clinically meaningful differences from existing FDA-approved reference products. Despite increased availability in the marketplace, consumers and clinician lack awareness of these products. Our study experimentally tested understanding of and preference for brief descriptions of biosimilars in the form of disclosure statements in a fictitious prescription drug advertisement. METHODS: Consumers (n = 379) and HCPs (n = 368) viewed a mock advertisement and responded to an online survey. Study participants were randomized to 1 of 7 biosimilar disclosure definitions or a control. Disclosure conditions varied with regard to 1) identifying the product as a biosimilar; 2) information provided in the definition; and 3) naming the reference product. We tested the effects of disclosure conditions on comprehension, perceptions, attitudes, intentions, and preferences. RESULTS: Overall, comprehension of information in the biosimilar disclosure was less than optimal (48.5%-62.0% and 68.4%-88.4% for consumers and HCPs, respectively), even when provided with a definition. Perceptions of benefit, comparative efficacy, and safety were neutral. Content of the biosimilar definition generally did not influence outcomes, except that HCPs reported more positive attitudes toward the biosimilar and stronger intentions to prescribe when provided with expanded definitions. Both groups preferred the expanded definitions, and HCPs preferred seeing a named reference product. HCPs generally agreed with a statement that biosimilars could be used "interchangeably" with the reference product. CONCLUSIONS: Our findings signal some knowledge gaps and uncertainty regarding biosimilars among consumers and HCPs. Further education is warranted around these products, and communications for both groups require careful testing to ensure that the information is understood and does not result in a negative perception of the product.