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Federal Register / Vol. 86, No. 174 / Monday, September 13, 2021 / Notices
The stimuli in both phases use language appropriate to each sample and, where possible, use plain language in the consumer versions for greater clarity.
We crafted the statements about biosimilars using terminology from FDAs Biosimilar Basics Patient Materials https www.fda.gov/drugs/
biosimilars/patient-materials. However, when examining perceptions around complex concepts, such as biosimilars, plain language substitutes for certain terms are not always available.
Comment 4 One comment suggested we measure diabetes and obesity comorbidities of the Phase 1 consumer sample. One comment suggested we restrict the Phase 2 sample to consumers who have rheumatoid arthritis RA, half of whom are being treated with a biologic for that condition, and one comment suggested we only sample rheumatologists.
Response 4 In Phase 1 we are measuring participants self-reported diagnosis of type 2 diabetes, knowledge about the disease and treatments for type 2 diabetes and weight loss, and prior experience with type 2 diabetes and weight loss treatment. These will be used as covariates in the analyses, where appropriate.
With respect to the suggestion to limit the sample to diagnosed consumers and rheumatologists in Phase 2, there are several factors to consider. Diagnosed sample participants are likely to be more motivated to read the ad because it is relevant to their medical condition.
On the other hand, participants in that sample are also more likely to be familiar with treatments for their condition and bring with them prior knowledge that may influence their responses. As in Phase 1, we will assess treatment familiarity and diagnosis amongst our general population sample and control for those variables. While we understand that the Phase 2 topic may be relevant for specialists, and we do often include specialists in our research, we chose not to limit our HCP
sample. Recruiting from a wider HCP
sample is more reflective of the reality of the healthcare environment where patients interact with HCPs across multiple specialties and expertise.
Further, specialists make up a small proportion of HCPs, which makes them harder to recruit. In 2020, for example, the proportion of specialists representing each specialty area ranged from 3 percent endocrinologists to 17
percent emergency medicine specialists Ref. 7. These data demonstrate that the pool of potentially eligible specialists is limited.
Comment 5 One comment suggested we focus the study on patients rather
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than HCPs, as the knowledge levels of patients is low, or perhaps conduct separate but parallel studies of both HCPs and patients.
Response 5 The study will be conducted among two separate populations, consumers from the general population and HCPs. As shown in table 1, the study design incorporates parallel arms for consumers and HCPs.
Comment 6 One comment suggested FDA ensure a sufficient sample size to conduct rigorous statistical analysis.
Response 6 We conducted a power analyses to determine the sample size per study arm and will have a sufficient sample to rigorously test our research questions.
Comment 7 Two comments suggested studying comparative claims in a separate study to reduce participant burden and confusion.
Response 7 Our proposed design examines the impact of adding comparative and quantitative information to the disclosure of interest see table 1. Each participant will see only one claim. Because these variables are fully crossed in the design, we will be able to examine the impact of comparative information and quantitative information separately.
Comment 8 One comment asked FDA to explain the added value and appropriateness of including disclosures in biosimilar product promotional materials. The comment cautioned that disclosures must not be couched in cautionary or negative terms or include statements that are ambiguous or of minimal relevance to patients.
Response 8 Currently, FDA neither requires nor prohibits biosimilar-related disclosures in biosimilar product promotion, and this research does not presuppose or reflect any established FDA position on their value. FDA is using this research to gather information to assess how certain biosimilar product disclosures, if they are used in promotion, could impact perceptions.
Our study seeks to test several variations of biosimilar statements. We specifically examined potential negative reactions during in-depth cognitive interviews. Participants in our interviews expressed that the language was neutrally worded, and participants did not perceive the statements to be negative or cautionary.
Comment 9 One comment questioned whether there was a control group in the Phase 2 questionnaire and suggested a control group that will not identify the product as a biosimilar be included.
Response 9 The Phase 2 study includes a control condition where the
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promotional material does not identify the product as biosimilar.
Comment 10 One comment noted that the prescribing information for a biosimilar does not include a named reference product and questioned why FDA is mandating inclusion of a named reference product in biosimilar promotional materials.
Response 10 Sponsors may choose to disseminate promotion in which a comparator product is named. These comparative promotions exist in the marketplace. One purpose of Phase 2 is to examine the difference between a disclosure statement that includes a named comparator and one that refers to a comparator generally. The fact that FDA is conducting research that includes specific disclosures does not create a requirement that sponsors use any of those disclosures or any other requirement.
Comment 11 Two comments suggested concepts that should be conveyed in the biosimilar disclosures.
One comment stressed the importance of the tone of the disclosure statement about biosimilars. The following key messages were proposed for inclusion in the study:
1. Patients can expect that biosimilars will provide the same safety and effectiveness as the reference product.
2. FDA has a rigorous review and approval process, applying the same high-quality standards to both biosimilars and reference products.
3. Patients have been benefitting from the use of biosimilars for many years.
The second comment suggested the study should also include an examination of the impact of adding additional information about the list of extrapolated indications, and the rationale for extrapolation of indications to a biosimilar product to assess impact on HCP perceptions.
Response 11 This study seeks to test several variations on potential biosimilar statements but does not attempt to test all possible statements.
We decline to expand this study to test additional content like that suggested by the comments, but other content may be considered in future research. With regard to the comment about tone, for the disclosure variations that we will test, we examined potential negative reactions during in-depth cognitive interviews. Participants in our interviews expressed that the language was neutrally worded, and participants did not perceive the statements to be negative or cautionary. An examination of how HCPs perceive a biosimilar based on extrapolated indications is beyond the scope of this research. It may be considered in future research.

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