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Research ArticleOriginal Research

Perceptions and Preferences for Defining Biosimilar Products in Prescription Drug Promotion

Mihaela Johnson, Jessica E. Thompson, Avery A. Tilley, Amie C. O’Donoghue and Kathryn J. Aikin
The Journal of the American Board of Family Medicine April 2025, jabfm.2024.240151R1; DOI: https://doi.org/10.3122/jabfm.2024.240151R1
Mihaela Johnson
From the RTI International, Research Triangle Park, NC (MJ, JET, AAT); U.S. Food and Drug Administration, Office of Prescription Drug Promotion, Silver Spring, MD (KJA, ACO).
PhD
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Jessica E. Thompson
From the RTI International, Research Triangle Park, NC (MJ, JET, AAT); U.S. Food and Drug Administration, Office of Prescription Drug Promotion, Silver Spring, MD (KJA, ACO).
PhD
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Avery A. Tilley
From the RTI International, Research Triangle Park, NC (MJ, JET, AAT); U.S. Food and Drug Administration, Office of Prescription Drug Promotion, Silver Spring, MD (KJA, ACO).
MS
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Amie C. O’Donoghue
From the RTI International, Research Triangle Park, NC (MJ, JET, AAT); U.S. Food and Drug Administration, Office of Prescription Drug Promotion, Silver Spring, MD (KJA, ACO).
PhD
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Kathryn J. Aikin
From the RTI International, Research Triangle Park, NC (MJ, JET, AAT); U.S. Food and Drug Administration, Office of Prescription Drug Promotion, Silver Spring, MD (KJA, ACO).
PhD
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Article Figures & Data

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    Figure 1.

    Example consumer (top) and health care providers (HCPs) (bottom) biosimilar advertisement disclosure.

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    Figure 2.

    Recruitment flow diagram. Abbreviation: HCP, Health care provider.

Tables

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    Table 1.

    Participant Characteristics

    Consumers
    (n = 379)
    HCPs
    (n = 368)
    Female202 (53.3%)119 (32.3%)
    Age - Mean (SD)53.4 (17.1)50.9 (12.6)
    Race/ethnicity
     White (non-Hispanic)261 (68.9%)210 (57.1%)
     Black (non-Hispanic)35 (9.2%)9 (2.4%)
     Asian (non-Hispanic)15 (4.0%)86 (23.4%)
     American Indian (non-Hispanic)2 (0.5%)2 (0.5%)
     Native Hawaiian (non-Hispanic)2 (0.5%)1 (0.3%)
     Multiracial (non-Hispanic)8 (2.1%)5 (1.4%)
     Other (non-Hispanic)6 (1.6%)6 (1.6%)
     Hispanic38 (10.0%)21 (5.7%)
     Refused/Missing12 (3.2%)28 (7.6%)
    Education
     High school or less54 (14.3%)
     Some college110 (29.0%)
     Associates degree87 (23.0%)
     Bachelor’s degree or higher128 (33.8%)
    Familiarity with Biosimilars
     Aware55 (14.5%)267 (72.6%)
    Training and practice
     Medical Doctor/Physician327 (88.9%)
     Physician assistant16 (4.3%)
     Nurse practitioner25 (6.8%)
     Average prescriptions weekly- Mean (SD)129.9 (142.5)
     Average years in medical practice -Mean (SD)18.9 (11.1)
    Consumer experience with condition
     Ever diagnosed with rheumatoid arthritis36 (9.5%)
     Ever taken prescription for rheumatoid arthritis29 (7.6%)
    • Abbreviations: HCPs, Health care providers; SD, Standard deviation.

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    Table 2.

    Comprehension of Information by Biosimilar Disclosure Characteristic

    Biosimilar Disclosure Characteristic
    Kesterin is a Biosimilar + EffectiveKesterin is a Biosimilar + Effective + Same SourcesKesterin is a Biosimilar + Effective + Same Sources + Dosage and AdministrationNames the Reference Drug Mytrozen in DefinitionDoes Not Name Reference Drug in Definition
    Consumers (n = 379)
     Correctly understood Kesterin has the same safety and efficacy as original50 (48.5%)44 (48.4%)55 (57.3%)81 (54.0%)68 (48.6%)
     Correctly understood Kesterin is made from the same types of sources as originalN/A56 (61.5%)53 (55.2%)62 (62.0%)47 (54.0%)
     Correctly understood Kesterin has the same strength and dosage as originalN/AN/AN/A27 (51.9%)22 (50.0%)
    HCPs (n = 360)
     Correctly understood Kesterin has the same safety and efficacy as original65 (74.7%)65 (68.4%)70 (72.2%)99 (74.4%)101 (69.2%)
     Correctly understood Kesterin is made from the same types of sources as originalN/A84 (88.4%)77 (79.4%)78 (83.9%)83 (83.8%)
     Correctly understood Kesterin has the same strength and dosage as originalN/AN/AN/A34 (75.6%)43 (82.7%)
    • Abbreviation: HCPs, Health care providers.

    • Note: All P-values across for described comparisons were nonsignificant at the Bonferroni adjusted values. Control condition did not receive comprehension questions.

    • N/A – comprehension item not assessed for given condition.

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    Table 3.

    Consumer Perceptions, Attitudes, and Intentions by Biosimilar Disclosure Characteristics

    Control
    (no definition)
    Kesterin is a BiosimilarKesterin is a Biosimilar + EffectiveKesterin is a Biosimilar + Effective + Same SourcesKesterin is a Biosimilar + Effective + Same Sources + Dosage and AdministrationNames the Reference Drug Mytrozen in DefinitionDoes Not Name Reference Drug in Definition
    Perceived benefit/efficacy
     Benefit likelihood3.93 (1.39)3.84 (1.40)4.04 (1.22)4.13 (1.34)4.38 (1.16)4.05 (1.23)4.32 (1.24)
     Benefit magnitude3.87 (1.29)3.84 (1.35)4.04 (1.23)4.14 (1.30)4.25 (1.11)3.98 (1.17)4.31 (1.23)
     Benefit compared to MytrozenN/AN/A3.53 (1.44)4.12 (1.50)3.86 (1.59)3.81 (1.52)N/A
     Benefit compared to other drugs3.67 (1.17)3.89 (1.22)3.69 (1.15)3.77 (1.42)3.96 (1.22)3.66 (1.22)3.96 (1.30)
    Perceived risk/safety
     Side effect likelihood3.87 (1.31)3.93 (1.19)3.74 (1.25)3.93 (1.31)3.97 (1.12)3.89 (1.17)3.86 (1.29)
     Side effect severity3.35 (1.11)3.37 (1.02)3.53 (0.94)3.47 (1.00)3.60 (1.06)3.5 (1.09)3.57 (0.91)
     Safety compared to MytrozenN/AN/A3.53 (1.46)4.12 (1.45)3.82 (1.69)3.80 (1.54)N/A
     Safety compared to other drugs3.67 (1.28)4.00 (1.28)3.84 (1.18)3.79 (1.47)3.98 (1.26)3.71 (1.2)4.05 (1.38)
    Attitudes toward the biosimilar drug4.27 (1.31)4.39 (1.18)4.33 (1.20)4.37 (1.24)4.69 (1.16)4.38 (1.18)4.55 (1.24)
    Intention to take biosimilar drug4.07 (1.53)3.98 (1.45)3.90 (1.43)3.93 (1.47)4.32 (1.34)3.93 (1.42)4.18 (1.42)
    • Note: All planned comparisons were statistically nonsignificant at the Bonferonni adjusted levels. Items measured on a 1-6 Likert sale where larger values reflect stronger perceptions or agreement.

    • N/A – comprehension item not assessed for given condition.

    • View popup
    Table 4.

    HCP Perceptions, Attitudes and Intentions by Biosimilar Disclosure Characteristics

    ControlKesterin is a BiosimilarKesterin is a Biosimilar + EffectiveKesterin is a Biosimilar + Effective + Same SourcesKesterin is a Biosimilar + Effective + Same Sources + Dosage and AdministrationNames the Reference Drug Mytrozen in DefinitionDoes Not Name Reference Drug in Definition
    Perceived benefit/efficacy
     Benefit likelihood3.56 (1.16)3.59 (0.91)3.84 (0.97)3.94 (1.01)3.82 (1.19)3.86 (1.18)3.87 (0.95)
     Benefit magnitude3.49 (1.16)3.54 (0.96)3.77 (0.97)3.89 (1.04)3.77 (1.09)3.71 (1.09)3.91 (0.98)
     Benefit compared to MytrozenN/AN/A2.66 (1.24)2.94 (1.45)2.83 (1.23)N/A2.81 (1.3)
     Benefit compared to other drugs3.42 (1.14)3.54 (0.89)3.16 (1.12)3.28 (1.28)3.30 (1.32)3.27 (1.31)3.23 (1.18)
    Perceived risk/safety
     Side effect likelihood3.37 (0.8)3.63 (0.77)3.54 (0.94)3.61 (0.98)3.72 (1.12)3.58 (1.15)3.67 (0.89)
     Side effect severity3.35 (1.11)3.37 (1.02)3.53 (0.94)3.47 (1.00)3.60 (1.06)3.50 (1.09)3.57 (0.91)
     Safety compared to MytrozenN/AN/A2.78 (1.26)2.89 (1.43)2.88 (1.28)N/A2.86 (1.32)
     Safety compared to other drugs3.53 (1.00)3.63 (1.02)3.10 (1.12)3.31 (1.25)3.33 (1.30)3.28 (1.28)3.23 (1.18)
      Attitudes toward the biosimilar drug3.80 (0.93)3.83 (0.97)4.21 (1.02)4.37 (1.03)4.12 (1.07)4.18 (1.43)4.41 (1.3)
      Intention to prescribe biosimilar drug3.21 (1.36)3 (1.23)3.57 (1.30)3.84 (1.11)3.84 (1.37)4.27 (1.07)4.20 (1.02)
      Perception that Kesterin and original biologic can be used “interchangeably”N/AN/A4.18 (1.40)4.37 (1.37)4.34 (1.35)4.62 (1.16)4.90 (1.24)
    • Abbreviation: HCP, Health care providers.

    • Note: All planned comparisons were statistically nonsignificant at the Bonferonni adjusted levels. Items measured on a 1-6 Likert sale where larger values reflect stronger perceptions or agreement.

    • View popup
    Table 5.

    Consumer Preferences for Biosimilar Disclosures

    % Preference among Those Assigned to Disclosure Condition% Preference among Those Not Assigned to Disclosure Condition
    KESTERIN is a biosimilar.8.7%8.8%
    KESTERIN is a biosimilar. This biosimilar is a safe and effective medication and provides the same treatment benefits as an FDA-approved original biologic30.7%26.3%
    KESTERIN is a biosimilar. This biosimilar is a safe and effective medication and provides the same treatment benefits as MYTROZEN, an FDA-approved original biologic40.6%39.5%
    KESTERIN is a biosimilar. This biosimilar is a safe and effective medication and provides the same treatment benefits as an FDA-approved original biologic. Biosimilars are made from the same types of sources as the FDA-approved original biologic48.6%47.2%
    KESTERIN is a biosimilar. This biosimilar is a safe and effective medication and provides the same treatment benefits as MYTROZEN, an FDA-approved original biologic. This biosimilar is made from the same types of sources as MYTROZEN.50.0%51.6%
    KESTERIN is a biosimilar. This biosimilar is a safe and effective medication and provides the same treatment benefits as an FDA-approved original biologic. Biosimilars are made from the same types of sources as the FDA-approved original biologic. KESTERIN is given the same way and has the same strength and dosage as the FDA-approved original biologic.69.9%69.0%
    KESTERIN is a biosimilar. This biosimilar is a safe and effective medication and provides the same treatment benefits as MYTROZEN, an FDA-approved original biologic. This biosimilar is made from the same types of sources as MYTROZEN. KESTERIN is given the same way and has the same strength and dosage as MYTROZEN.64.8%66.6%
    • Abbreviation: FDA, Food and drug administration.

    • View popup
    Table 6.

    HCP Preferences for Biosimilar Disclosures

    % Preference among Those Assigned to Disclosure Condition% Preference among Those Not Assigned to Disclosure Condition
    KESTERIN is a biosimilar.12.3%8.5%
    KESTERIN is a biosimilar. This biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing reference product.35.0%32.6%
    KESTERIN is a biosimilar. This biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from MYTROZEN, an existing FDA-approved reference product.46.1%51.7%
    KESTERIN is a biosimilar. This biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. Biosimilars are made from the same types of sources as the FDA-approved reference product.39.9%41.7%
    KESTERIN is a biosimilar. This biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from MYTROZEN, an existing FDA-approved reference product. This biosimilar is made from the same types of sources as MYTROZEN.48.6%58.0%
    KESTERIN is a biosimilar. This biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from an existing FDA-approved reference product. Biosimilars are made from the same types of sources as the FDA-approved reference product. KESTERIN has the same route of administration, dosage form, and strength as an existing FDA-approved reference product54.8%62.8%
    KESTERIN is a biosimilar. This biosimilar is a biological product that is highly similar to and has no clinically meaningful differences from MYTROZEN, an existing FDA-approved reference product. This biosimilar is made from the same types of sources as MYTROZEN. KESTERIN has the same route of administration, dosage form, and strength as MYTROZEN.73.2%72.8%
    • Abbreviation: HCP, Health care providers.

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Perceptions and Preferences for Defining Biosimilar Products in Prescription Drug Promotion
Mihaela Johnson, Jessica E. Thompson, Avery A. Tilley, Amie C. O’Donoghue, Kathryn J. Aikin
The Journal of the American Board of Family Medicine Apr 2025, jabfm.2024.240151R1; DOI: 10.3122/jabfm.2024.240151R1

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Perceptions and Preferences for Defining Biosimilar Products in Prescription Drug Promotion
Mihaela Johnson, Jessica E. Thompson, Avery A. Tilley, Amie C. O’Donoghue, Kathryn J. Aikin
The Journal of the American Board of Family Medicine Apr 2025, jabfm.2024.240151R1; DOI: 10.3122/jabfm.2024.240151R1
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