Abstract
BACKGROUND:
The US Food and Drug Administration (FDA) considers an interchangeable biosimilar to produce the same clinical result as the reference product in any given patient. Interchangeability standards indicate that the biosimilar can be automatically substituted by pharmacists for the reference product without the intervention of the prescribing health care provider, where state law permits. More research is needed to describe pharmacists’ and physicians’ perceptions and experience with biosimilars in real-world settings for immunological disorders.
OBJECTIVE:
To assess US providers’ perceptions and decision-making around the prescribing and dispensing of biosimilars, including those with an interchangeability designation.
METHODS:
US outpatient pharmacists and physicians who prescribe biologics for dermatological, gastroenterological, rheumatological, or other immunological disorders responded to a cross-sectional electronic survey. Respondents reported data on professional characteristics, pharmacy characteristics, familiarity with regulatory guidelines, workflow relevant to treatment substitutions, and perceived barriers to navigating the interchangeability designation and dispensing interchangeable biosimilars. Data were aggregated and summarized descriptively.
RESULTS:
One hundred fifty physicians and 99 pharmacists (total n = 249) from diverse practice settings responded to the survey. Continuing education units related to biosimilars were obtained by 65.7% of pharmacists and 50.7% of physicians. A higher percentage of pharmacists (35.4%) than physicians (20.0%) reported themselves as “extremely familiar” with pharmacy retention of communication records. A greater proportion of pharmacists (47.5%) than physicians (31.3%) were “extremely likely” to recommend a biosimilar product to new start patients (ie, never treated with a reference biologic and/or biosimilar). Among all providers, the barriers to biosimilars most often perceived to be “extremely significant” were payer coverage/formulary placement (51.0%) and cost to the patient (41.0%). The strategies that were reported as the highest likelihood of improving the uptake of interchangeable biosimilars (reported as either “likely” or “extremely likely”) were as follows: conducting studies and developing educational programs that assess outcomes of biosimilars and biosimilars with an interchangeability designation in clinical practice (82.3%), FDA guidance on biosimilars with an interchangeability designation for treatment-naive patients (81.9%), FDA guidance on biosimilars with an interchangeability designation for switching patients (81.6%), and educational programs on billing and reimbursement (79.1%).
CONCLUSIONS:
Pharmacists reported higher rates of familiarity and training with biosimilars and recommendation of biosimilars to patients than physicians. A diverse sample of physicians and pharmacists expressed perceived barriers and strategies to improve biosimilars uptake, including educational programs and FDA guidance. Further research is needed to determine if providers’ perceptions of biosimilars are associated with biosimilars uptake.
Plain language summary
This study used surveys of a variety pharmacists and doctors to understand their opinions about biosimilars. Biosimilars produce the same result as other medications, often at a lower cost. Pharmacists had a greater understanding of biosimilars and recommended them to patients more often than doctors. Doctors and pharmacists reported health insurance and costs were barriers to using biosimilars. Pharmacists and doctors suggested that lowering the costs and teaching providers about biosimilars might increase biosimilar uptake.
Implications for managed care pharmacy
These findings provide important context to the limitations of biosimilar use, how perceived barriers may influence real-world biosimilar use, and possible strategies to improve biosimilar uptake from the perspectives of pharmacists and physicians.
The US Food and Drug Administration (FDA) defines an interchangeable biosimilar as a biosimilar that produces the same clinical result as the reference product in any given patient. Depending on individual state laws, interchangeability standards include that a biosimilar can be automatically substituted at the pharmacist level without the intervention of the prescribing health care provider. 1 – 3 To achieve interchangeable status, a biosimilar must meet the standards of biosimilarity and additional requirements for interchangeability. 1 , 3 Manufacturers may conduct studies to assess if switching between a biosimilar and the reference product increases safety risk or reduces efficacy compared with the reference product. 1 , 3
Biosimilars are designed to reduce the costs of biologics, which are commonly used for the treatment of immunological disorders. 2 , 4 Immunological disorder treatment represents up to 37% of all drug spending. 2 , 4 Biosimilars were attributed to savings up to $12.4 billion in 2023. 2 , 4 , 5 Rising health care costs highlight the growing importance biosimilars may play in the health care system and the need for continued education and research to address existing barriers to their adoption.
The Biologics Price Competition and Innovation Act of 2009 amends the Public Health Service Act to create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product. 3 , 6 The Biologics Price Competition and Innovation Act was introduced to improve patient access to biologics; however, confusion about interchangeability designation for biosimilars is one of the most referenced knowledge gaps among providers. 7 , 8 Provider education on biosimilars and biosimilars’ interchangeability designation are key components of promoting biosimilars uptake, as recognized by the FDA in its Biosimilars Action Plan. 9
Although biosimilars uptake in the United States is dependent on several factors, prescribing health care providers and pharmacists who guide treatment decisions are key to that uptake. 9 Data from Europe and the United States demonstrate that increased provider confidence with biosimilars increases adoption of biosimilars. 9 However, there is little research describing pharmacists’ and physicians’ perceptions and experience with biosimilars in real-world settings (eg, clinical settings without experimental manipulation) as opposed to structured research settings (eg, clinical trials).
Despite increased acceptance of biosimilar therapies by physicians and pharmacists, challenges persist with biosimilars uptake. A lack of understanding around interchangeability designations may have downstream effects impacting the optimal management of rheumatological and immunological disorders. 10 Physicians and pharmacists may still approach the use of biosimilars with caution because of concerns about switching, interchangeability, pharmacist-led substitution, and the extent of any cost savings. 11 Physicians appear positive toward biosimilars; however, this appears to have limited translation into real-world practice. 2 , 9 , 10 , 12 Physician biosimilar prescribing is limited, in particular among patients previously using biologics. 2 , 9 , 10 , 12 Limited biosimilar use may be due to the documented skepticism among health care providers including both physicians and pharmacists. 13
In 2022, a Cardinal Health report showed that 10% of rheumatological providers were not comfortable with prescribing biosimilars. 10 Thirty-eight percent of providers were concerned about the efficacy of biosimilars, and 66% stated they are unlikely to switch their patients from the reference product to biosimilars. 10 The report showed a correlation between biosimilar adoption and increases in payer coverage. 10
In 2023, Stevenson et al reported on a pharmacist biosimilar survey showing several knowledge gaps including that only 20% of pharmacists displayed an understanding of interchangeability as defined by the FDA. 14 Giavatto et al in 2024 used a cross-sectional survey to examine 31 autoimmune providers’ and 44 health system specialty pharmacists’ knowledge and perceptions of biosimilars in the United States. 12 The authors found that 16.0% of medical doctors and 13.4% of pharmacists said they felt “very prepared” to talk with patients about biosimilar choices. Approximately 13% of medical doctors would give a biosimilar to patients already using a biologic medication, and 18.1% of pharmacists would suggest a biosimilar for patients who are already doing well on a biologic treatment. 12
As the US health care market continues to evolve, providers will be faced with increasingly complex scenarios including choices around biosimilars. Providers are tasked with managing the clinical, operational, and financial considerations of having multiple biosimilars available for the same originator biologic, some of which are anticipated to have an interchangeability designation.
Despite these studies, knowledge gaps remain about providers’ and pharmacists’ biosimilars proficiency and perceptions. Findings from this cross-sectional survey of physicians and pharmacists regarding biosimilars may inform and potentially accelerate development of solutions to address biosimilar and interchangeability barriers within the United States.
This study assessed US providers’ perceptions and decision-making around prescribing and dispensing biosimilars, including those with an interchangeability designation. To assess providers’ perceptions and decision-making, there were primary, secondary, and exploratory objectives.
The primary objective was to describe real-world, provider-reported familiarity with US federal regulatory guidelines for biosimilars, state laws regarding biosimilar interchangeability, and provider-reported perceptions barriers to prescribing or dispensing biosimilars for immunological disorders. The secondary objective was to characterize provider perceptions on potential solutions that reduce the barriers to biosimilar adoption. The exploratory objective was to compare provider familiarity with regulatory guidelines and state laws regarding biosimilars, provider perceptions on barriers to prescribing/dispensing biosimilars, and strategies to facilitate biosimilar adoption by physicians and pharmacists.
Methods
DESIGN
This study was a cross-sectional electronic survey of provider-reported data collected from US outpatient physicians and pharmacists. Purposive sampling was used to recruit rheumatologists, gastroenterologists, dermatologists, and pharmacists from Cardinal Health’s Specialty Provider Extended Networks. Respondents reported data on professional characteristics, pharmacy characteristics, familiarity with regulatory guidelines, workflow relevant to treatment substitutions, and perceived barriers to navigating the interchangeability designation and dispensing interchangeable biosimilars. Data were aggregated and summarized descriptively.
QUESTIONNAIRE DEVELOPMENT
The questionnaire was created in 2022 by research scientists and clinical experts to measure provider perceptions and decision-making around biosimilars. The questionnaire also examined the clinical relevance, readability, and understanding of guidelines around biosimilars. The study team developed the questionnaire considering published literature on provider perceptions regarding biosimilars. 10 , 13 – 16
The study team programmed and tested the survey including component functionality and internal systems testing. The study team performed extensive unit testing and internal systems testing to ensure functionality across web-based user environments, performed testing looping logic to ensure proper alignment of data-related fields, and completed automated and manual programmatic checks to reduce the possibility of collecting erroneous data. Results of the testing were reviewed internally by the study team, after which the survey was further refined as agreed on by the study team. All questionnaires are included in the Supplementary Materials (179.4KB, pdf) (available in online article).
DATA ELEMENTS
The data elements gathered in this study included practice characteristics, provider characteristics, and general knowledge about biosimilars. The practice characteristics included specialty, practice size, setting, urbanicity, state, years in practice, prescription volume, patient volume, and biologic volume. The provider characteristics included specialty, practice size, setting, urbanicity, state, years in practice, prescription volume, patient volume, biologic volume, rheumatology/gastroenterology/dermatology patient volume, biosimilar knowledge, biosimilar with an interchangeable designation knowledge, familiarity with biosimilar interchangeability state laws, and substitution laws. General physician and pharmacists’ knowledge included areas where the biosimilars training was received (eg, biosimilars products and interchangeability designation), familiarity with the FDA’s purple book website on lists of licensed biological products with reference product exclusivity or interchangeability evaluations and how to navigate it, availability of biosimilar products on pharmacy shelves, biosimilars workflow (eg, how workflow for carrying/dispensing biosimilars with an interchangeability designation differs from workflow for carrying/dispensing small molecule generics, among those workflows for carrying dispensing biosimilars with an interchangeability designation), workflow responsibilities, and workflow cost impact (eg, plans for pharmacy to develop a workflow for carrying/dispensing biosimilars with an interchangeability designation in the future).
ELIGIBILITY CRITERIA
Eligible physicians were aged at least 18 years, were licensed to practice medicine in the United States, specialized in rheumatology, gastroenterology, or dermatology, and had prescribed biologics to treat rheumatological or other immunological disorders within the last year. Eligible pharmacists were aged at least 18 years, were registered as a pharmacist in the United States, and actively worked in an outpatient pharmacy that manages and dispenses biologics for rheumatological or other immunological disorders. There were no exclusion criteria for pharmacists and physicians.
DATA COLLECTION
Data collection occurred between August 18, 2023, and October 2, 2023. Rheumatologists, gastroenterologists, dermatologists, and pharmacists from Cardinal Health’s Specialty Provider Extended Network were recruited via e-mail to participate in a voluntary electronic survey.
DATA QUALITY CONTROL
All data were verified using real-time logic checks and clinical, scientific, and programmatic review and validation processes conducted by the appropriately qualified study team members at the close of data collection. Additionally, data analysts and scientists reviewed the results for individual and aggregate validity (eg, statistical outliers, survey completion in an unexpectedly short time). No resampling to replace any excluded surveys was conducted.
STATISTICAL ANALYSIS
Data were described using frequency counts and proportions for dichotomous and categorical variables and measures of centrality (eg, mean, median) and spread (eg, minimum, maximum, SD, IQR, as appropriate) for continuous variables. Data were summarized descriptively into subgroups: all respondents, all physicians, and all pharmacists. Data from physicians were further reported in subgroups based on primary practice setting including solo practice, privately owned community, community practice owned by an academic center or affiliated teaching hospital, and other. Data from pharmacists were further reported in subgroups based on the pharmacy setting of the responding pharmacist including pharmacy benefit manager (PBM)/health insurance, retail outpatient pharmacy, health system/integrated delivery network (IDN), independent, and other. Statistical comparisons between subgroups were not performed. All data processing and analysis was performed in SAS v9.4 software (SAS Institute Inc.).
Results
One hundred fifty physicians and 100 pharmacists responded to the survey. One pharmacist’s data were removed after quality control checking because of the pharmacist being retired. The final analytic sample size was 150 physicians and 99 pharmacists (total 249).
PHYSICIAN CHARACTERISTICS
The 150 physicians who completed surveys were a median age of 50.0 years and reported a median of 17.5 years in practice. Their medical specialties included rheumatology (36.0%), dermatology (35.3%), and gastroenterology (28.7%). Sixty percent of practices were suburban, 33.3% were urban, and 6.7% were rural (Table 1). Physicians’ practice settings were split between large, privately owned, community practice (>10 physicians) (28.0%), small, privately owned, community practice (2-5 physicians) (19.3%), medium-sized, privately owned, community practice (6-10 physicians) (18.0%), affiliated teaching hospital (14.0%), and solo practitioners (14.0%). The most frequently occurring states where physicians were located were New York (10.7%), Illinois (9.3%), California (8.0%), Pennsylvania (6.0%), New Jersey (5.3%), and Ohio (5.3%) with representation across 34 states. The most common disorders that physicians had prescribed biologics for were immunological (91.3%) and rheumatological disorders (53.3%) (not in a table).
TABLE 1.
Physician Characteristics
| All physicians | Solo practitioner | Privately owned community | Community practice owned by an academic center or affiliated teaching hospital | Other a | |
|---|---|---|---|---|---|
| (N = 150) | (n = 21) | (n = 98) | (n = 29) | (n = 2) | |
| Age of physician, years | |||||
| Mean (SD) | 50.6 (11.1) | 56.1 (8.6) | 49.4 (11.2) | 51.3 (11.6) | 38.0 (1.4) |
| Median (P25-P75) | 50.0 (41.0-59.0) | 57.0 (50.0-62.0) | 49.0 (40.0-59.0) | 49.0 (41.0-59.0) | 38.0 (37.0-39.0) |
| Min, max | 32.0, 91.0 | 34.0, 68.0 | 32.0, 91.0 | 35.0, 73.0 | 37.0, 39.0 |
| Years in practice | |||||
| Mean (SD) | 18.0 (1.0) | 23.6 (7.4) | 16.8 (9.6) | 18.7 (10.7) | 6.0 (4.2) |
| Median (P25-P75) | 17.5 (9.0-27.0) | 24.0 (21.0-29.0) | 16.0 (8.0-24.0) | 18.0 (10.0-30.0) | 6.0 (3.0-9.0) |
| Min, max | 1.0, 40.0 | 7.0, 34.0 | 1.0, 40.0 | 4.0, 35.0 | 3.0, 9.0 |
| Physicians with board-certified medical specialties, n (%) | |||||
| Dermatology | 53 (35.3) | 10 (47.6) | 38 (38.8) | 5 (17.2) | 0 (0.0) |
| Gastroenterology | 43 (28.7) | 3 (14.3) | 30 (30.6) | 9 (31.0) | 1 (50.0) |
| Rheumatology | 54 (36.0) | 8 (38.1) | 30 (30.6) | 15 (51.7) | 1 (50.0) |
| Urbanicity of practice, n (%) | |||||
| Urban | 50 (33.3) | 3 (14.3) | 33 (33.7) | 14 (48.3) | 0 (0.0) |
| Suburban | 90 (60.0) | 15 (71.4) | 60 (61.2) | 13 (44.8) | 2 (100.0) |
| Rural | 10 (6.7) | 3 (14.3) | 5 (5.1) | 2 (6.9) | 0 (0.0) |
| Physicians who obtained CEUs related to biosimilars, n (%) | |||||
| Yes | 76 (50.7) | 8 (38.1) | 53 (54.1) | 14 (48.3) | 1 (50.0) |
Other physician practice settings include health system–owned community practice or practice owned by a community hospital.
CEU = continuing education unit; P25-P75 = IQR 25th and 75th percentiles.
Continuing education units (CEUs) related to biosimilars were obtained by 50.7% of physicians (Table 1). Among physicians, the most common sources of CEUs were online (21.1%), American Academy of Dermatology (17.1%), UpToDate (9.2%), American College of Gastroenterology (7.9%), American College of Rheumatology (6.6%), and Digestive Disease Week (3.9%) (not in a table).
PHARMACIST CHARACTERISTICS
There were 99 pharmacists who completed surveys with a median age of 41.0 years and a median of 13.0 years as a licensed provider. Most pharmacists graduated from their training program from 2010 to 2019 (46.5%), and their pharmacy’s estimated total prescription volume per day was less than or equal to 500 for 58.6% of pharmacists. One hundred percent of PBM/health insurance, 85.7% of independent, 75.0% of other, 73.3% of retail outpatient, and 38.8% of health system/(IDN) pharmacists had an estimated prescription volume of less than or equal to 500 prescriptions per day. Of all pharmacists, 65.7% had obtained CEUs related to biosimilars (Table 2). The most common sources of CEUs were professional associations (18.5%), online (16.9%), Pharmacist’s Letter (13.8%), Pharmacy Times (13.8%), Free CE (7.7%), and PowerPak (7.7%). Pharmacists’ practice settings were split between health system/IDN (49.5%), other (20.2%), retail outpatient pharmacy (15.2%), independent (14.1%) and PBM/health insurance (1.0%). The 5 most frequently occurring states where pharmacists were located were Florida (14.1%), New Jersey (9.1%), California (8.1%), New York (8.1%), and Ohio (5.1%), with representation across 31 states. Twenty and two-tenths percent of pharmacies had a specialty accreditation including the 30.6% of health system/IDN and 20.0% of retail outpatient pharmacists (not in a table).
TABLE 2.
Pharmacist Characteristics
| All pharmacists | PBM/health insurance | Retail outpatient pharmacy | Health system/ IDN | Independent | Other a | |
|---|---|---|---|---|---|---|
| (N = 99) | (n = 1) | (n = 15) | (n = 49) | (n = 14) | (n = 20) | |
| Age of pharmacist, years | ||||||
| Mean (SD) | 43.0 (9.8) | 43.0 (NC) | 43.9 (10.8) | 41.9 (9.2) | 38.6 (6.6) | 48.2 (10.6) |
| Median (P25-P75) | 41.0 (35.0-51.0) | 43.0 (43.0-43.0) | 39.0 (34.0-52.0) | 37.0 (35.0-50.0) | 39.0 (34.0-43.0) | 48.0 (41.0-53.0) |
| Min, max | 28.0, 69.0 | 43.0, 43.0 | 32.0, 69.0 | 30.0, 64.0 | 28.0, 50.0 | 30.0, 68.0 |
| Years as licensed provider | ||||||
| Mean (SD) | 16.9 (10.1) | 17.0 (NC) | 18.7 (12.0) | 16.0 (9.8) | 12.6 (6.1) | 20.9 (10.9) |
| Median (P25-P75) | 13.0 (9.0-23.0) | 17.0 (17.0-17.0) | 15.0 (9.0-29.0) | 12.0 (8.0-23.0) | 13.0 (8.0-15.0) | 20.5 (11.5-25.5) |
| Min, max | 3.0, 46.0 | 17.0, 17.0 | 6.0, 46.0 | 6.0, 41.0 | 3.0, 26.0 | 4.0, 45.0 |
| Year of graduation from training program, n (%) | ||||||
| 1970-1979 | 3 (3.0) | 0 (0.0) | 1 (6.7) | 1 (2.0) | 0 (0.0) | 1 (5.0) |
| 1980-1989 | 4 (4.0) | 0 (0.0) | 1 (6.7) | 1 (2.0) | 0 (0.0) | 2 (10.0) |
| 1990-1999 | 17 (17.2) | 0 (0.0) | 2 (13.3) | 10 (20.4) | 1 (7.1) | 4 (20.0) |
| 2000-2009 | 29 (29.3) | 1 (100.0) | 5 (33.3) | 9 (18.4) | 6 (42.9) | 8 (40.0) |
| 2010-2019 | 46 (46.5) | 0 (0.0) | 6 (40.0) | 28 (57.1) | 7 (50.0) | 5 (25.0) |
| Pharmacy’s estimated total prescription volume per day, n (%) b | ||||||
| ≤500 prescriptions per day | 58 (58.6) | 1 (100.0) | 11 (73.3) | 19 (38.8) | 12 (85.7) | 15 (75.1) |
| >500 prescriptions per day | 41 (41.4) | 0 (0.0) | 4 (26.7) | 30 (61.2) | 2 (14.3) | 5 (25.0) |
| Pharmacists who obtained CEUs related to biosimilars, n (%) | ||||||
| Yes | 65 (65.7) | 0 (0.0) | 8 (53.3) | 36 (73.5) | 7 (50.0) | 14 (70.0) |
Other pharmacy settings include closed door, federally qualified health center, hospital, infusion center, long-term acute care hospital, mail order, remote, VA health care system, and government.
Prescription volume was assessed by asking the pharmacists “What is your pharmacy’s estimated total prescription volume per day?”
CEU = continuing education unit; IDN = integrated delivery network; NC = not calculated; P25-P75 = IQR 25th and 75th percentiles; PBM = pharmacy benefit manager.
PROVIDER PERCEPTIONS OF BIOSIMILAR ADOPTION BARRIERS AND STRATEGIES TO IMPROVE UPTAKE
All providers reported they were most often “likely” to recommend a biosimilar product to new start patients (ie, never treated with a reference biologic and/or biosimilar) (42.6%) and switch patients (42.2%). Pharmacists reported they were “extremely likely” to recommend a biosimilar for new start patients 47.5% of the time compared with physicians at 31.3% of the time. A greater proportion of pharmacists (47.5%) than physicians (38.7%) were “likely” to recommend a biosimilar product to switch patients. Among all providers, 37.8% were “extremely likely” to recommend a biosimilar for new start patients, whereas 18.9% were “extremely likely” to recommend a biosimilar for switch patients (Table 3). Of the physician subgroups, among those in privately owned community practices and community practices owned by an academic center or affiliated teaching hospital, the most common ranking for recommending biosimilars to new start patients and switch patients was “likely,” 48.0%, 40.8% and 44.8%, 48.3%, for each subgroup, respectively. Health system/IDN pharmacists reported they were “likely” to recommend biosimilars to new start patients 40.8% of the time and for switch patients 53.1% of the time (not in a table).
TABLE 3.
Perceived Likelihood of Recommending Biosimilars and Barriers to Biosimilars Uptake
| All providers | All physicians | All pharmacists | |
|---|---|---|---|
| (N = 249) | (N = 150) | (N = 99) | |
| Likelihood of recommending a biosimilar product to following patient types, n (%) | |||
| New start patients | |||
| Extremely unlikely | 5 (2.0) | 5 (3.3) | 0 (0.0) |
| Unlikely | 15 (6.0) | 11 (7.3) | 4 (4.0) |
| Neither likely nor unlikely | 29 (11.6) | 19 (12.7) | 10 (10.1) |
| Likely | 106 (42.6) | 68 (45.3) | 38 (38.4) |
| Extremely likely | 94 (37.8) | 47 (31.3) | 47 (47.5) |
| Switch patients | |||
| Extremely unlikely | 7 (2.8) | 6 (4.0) | 1 (1.0) |
| Unlikely | 41 (16.5) | 29 (19.3) | 12 (12.1) |
| Neither likely nor unlikely | 49 (19.7) | 31 (20.7) | 18 (18.2) |
| Likely | 105 (42.2) | 58 (38.7) | 47 (47.5) |
| Extremely likely | 47 (18.9) | 26 (17.3) | 21 (21.2) |
| Significance of barriers to biosimilars, n (%) | |||
| Cost to patient (ie, affordability) | |||
| Not at all significant | 18 (7.2) | 9 (6.0) | 9 (9.1) |
| Slightly significant | 21 (8.4) | 11 (7.3) | 10 (10.1) |
| Somewhat significant | 48 (19.3) | 34 (22.7) | 14 (14.1) |
| Moderately significant | 60 (24.1) | 41 (27.3) | 19 (19.2) |
| Extremely significant | 102 (41.0) | 55 (36.7) | 47 (47.5) |
| Payer coverage/formulary placement | |||
| Not at all significant | 7 (2.8) | 3 (2.0) | 4 (4.0) |
| Slightly significant | 13 (5.2) | 7 (4.7) | 6 (6.1) |
| Somewhat significant | 37 (14.9) | 24 (16.0) | 13 (13.1) |
| Moderately significant | 65 (26.1) | 41 (27.3) | 24 (24.2) |
| Extremely significant | 127 (51.0) | 75 (50.0) | 52 (52.5) |
| Provider education/knowledge surrounding biosimilar safety and efficacy | |||
| Not at all significant | 12 (4.8) | 8 (5.3) | 4 (4.0) |
| Slightly significant | 26 (10.4) | 12 (8.0) | 14 (14.1) |
| Somewhat significant | 87 (34.9) | 50 (33.3) | 37 (37.4) |
| Moderately significant | 77 (30.9) | 51 (34.0) | 26 (26.3) |
| Extremely significant | 47 (18.9) | 29 (19.3) | 18 (18.2) |
| Provider education/knowledge surrounding biosimilar use among new start vs switch patients | |||
| Not at all significant | 13 (5.2) | 7 (4.7) | 6 (6.1) |
| Slightly significant | 32 (12.9) | 18 (12.0) | 14 (14.1) |
| Somewhat significant | 85 (34.1) | 55 (36.7) | 30 (30.3) |
| Moderately significant | 74 (29.7) | 41 (27.3) | 33 (33.3) |
| Extremely significant | 45 (18.1) | 29 (19.3) | 16 (16.2) |
| Administrative barriers (eg, legal support, workflow processes/disruptions) | |||
| Not at all significant | 13 (5.2) | 4 (2.7) | 9 (9.1) |
| Slightly significant | 24 (9.6) | 12 (8.0) | 12 (12.1) |
| Somewhat significant | 56 (22.5) | 36 (24.0) | 20 (20.2) |
| Moderately significant | 94 (37.8) | 60 (40.0) | 34 (34.3) |
| Extremely significant | 62 (24.9) | 38 (25.3) | 24 (24.2) |
| Patient choice (ie, negative patient perception of biosimilar safety and efficacy) | |||
| Not at all significant | 20 (8.0) | 10 (6.7) | 10 (10.1) |
| Slightly significant | 32 (12.9) | 15 (10.0) | 17 (17.2) |
| Somewhat significant | 72 (28.9) | 43 (28.7) | 29 (29.3) |
| Moderately significant | 80 (32.1) | 49 (32.7) | 31 (31.3) |
| Extremely significant | 45 (18.1) | 33 (22.0) | 12 (12.1) |
| Manufacturer supply reliability | |||
| Not at all significant | 13 (5.2) | 8 (5.3) | 5 (5.1) |
| Slightly significant | 39 (15.7) | 23 (15.3) | 16 (16.2) |
| Somewhat significant | 63 (25.3) | 39 (26.0) | 24 (24.2) |
| Moderately significant | 66 (26.5) | 40 (26.7) | 26 (26.3) |
| Extremely significant | 68 (27.3) | 40 (26.7) | 28 (28.3) |
| Competitiveness of biosimilar pricing | |||
| Not at all significant | 7 (2.8) | 4 (2.7) | 3 (3.0) |
| Slightly significant | 23 (9.2) | 11 (7.3) | 12 (12.1) |
| Somewhat significant | 56 (22.5) | 36 (24.0) | 20 (20.2) |
| Moderately significant | 81 (32.5) | 50 (33.3) | 31 (31.3) |
| Extremely significant | 82 (32.9) | 49 (32.7) | 33 (33.3) |
| Provider knowledge surrounding biosimilar billing and reimbursement | |||
| Not at all significant | 19 (7.6) | 8 (5.3) | 11 (11.1) |
| Slightly significant | 31 (12.5) | 19 (12.7) | 12 (12.1) |
| Somewhat significant | 64 (25.7) | 39 (26.0) | 25 (25.3) |
| Moderately significant | 80 (32.1) | 51 (34.0) | 29 (29.3) |
| Extremely significant | 55 (22.1) | 33 (22.0) | 22 (22.2) |
| Total economic impact (eg, workflow cost, contract reimbursement/formulary restrictions) | |||
| Not at all significant | 12 (4.8) | 7 (4.7) | 5 (5.1) |
| Slightly significant | 26 (10.4) | 12 (8.0) | 14 (14.1) |
| Somewhat significant | 68 (27.3) | 48 (32.0) | 20 (20.2) |
| Moderately significant | 74 (29.7) | 45 (30.0) | 29 (29.3) |
| Extremely significant | 69 (27.7) | 38 (25.3) | 31 (31.3) |
| Product attributes (eg, concentration [50 vs 100 mg], presence of citrate in formulation, presence of latex in delivery device, needle gauge, ease of use [eg, auto injector]) | |||
| Not at all significant | 15 (6.0) | 6 (4.0) | 9 (9.1) |
| Slightly significant | 37 (14.9) | 20 (13.3) | 17 (17.2) |
| Somewhat significant | 75 (30.1) | 41 (27.3) | 34 (34.3) |
| Moderately significant | 77 (30.9) | 48 (32.0) | 29 (29.3) |
| Extremely significant | 45 (18.1) | 35 (23.3) | 10 (10.1) |
BARRIERS TO BIOSIMILARS UPTAKE
The barriers to biosimilars uptake most frequently reported as “extremely significant” among all providers were payer coverage/formulary placement (51.0%) and cost to patient (41.0%). Pharmacists reported costs to the patient as “extremely significant” 47.5% of the time compared with physicians at 36.7% of the time (Table 3).
FAMILIARITY AND COMFORT LEVEL WITH BIOSIMILARS
All providers reported their familiarity with the FDA’s definition of a biosimilar most often as “moderately” (40.2%). All providers reported their familiarity with FDA’s definition of a biosimilar as “somewhat familiar” to “extremely familiar” 92.8% of the time. All providers reported their familiarity with the FDA’s definition of a biosimilar with an interchangeable designation most often as “moderately” 38.6% of the time. Physicians most often reported their familiarity as “moderately” (42.7%), and pharmacists most often reported their familiarity as “moderately familiar” (32.3%) with the FDA’s definition of a biosimilar with an interchangeable designation. All providers’ familiarity with the laws surrounding automatic substitution for biosimilars with an interchangeability designation was most often reported as “moderately” (28.5%).
Respondents were also assessed for their comfort level with biosimilars. Among all providers, 38.6% were “extremely comfortable” with biosimilars, 32.1% were “extremely comfortable” with biosimilars with an interchangeability designation, and 66.3% were “extremely comfortable” with small molecule generics. The comfort level with biosimilars was similar between physicians and pharmacists for most biosimilars except there were more physicians who reported their comfort as “extremely comfortable” (34.0%) compared with pharmacists (29.3%) for biosimilars with an interchangeability designation. Providers reported their comfort level with biosimilars as “somewhat comfortable” to “extremely comfortable” 88.8% of the time (Table 4). Physicians who were in a community practice owned by an academic center or affiliated teaching hospital reported their comfort with biosimilars with an interchangeability designation as “extremely comfortable” the most out of the physician subgroups at 41.4%. Independent pharmacists reported their comfort as “extremely comfortable” the least frequently at 7.1% (not in a table).
TABLE 4.
Providers’ Familiarity With Biosimilar Regulatory Guidelines and State Laws Regarding Biosimilars With an Interchangeability Designation
| All providers | All physicians | All pharmacists | |
|---|---|---|---|
| (N = 249) | (N = 150) | (N = 99) | |
| Familiarity with FDA’s definition of a biosimilar, n (%) | |||
| Not at all familiar | 2 (0.8) | 0 (0.0) | 2 (2.0) |
| Slightly familiar | 16 (6.4) | 6 (4.0) | 10 (10.1) |
| Somewhat familiar | 42 (16.9) | 23 (15.3) | 19 (19.2) |
| Moderately familiar | 100 (40.2) | 60 (40.0) | 40 (40.4) |
| Extremely familiar | 89 (35.7) | 61 (40.7) | 28 (28.3) |
| Familiarity with FDA’s definition of a biosimilar with an interchangeable designation, n (%) | |||
| Not at all familiar | 8 (3.2) | 3 (2.0) | 5 (5.1) |
| Slightly familiar | 32 (12.9) | 13 (8.7) | 19 (19.2) |
| Somewhat familiar | 45 (18.1) | 21 (14.0) | 24 (24.2) |
| Moderately familiar | 96 (38.6) | 64 (42.7) | 32 (32.3) |
| Extremely familiar | 68 (27.3) | 49 (32.7) | 19 (19.2) |
| Familiarity with the laws surrounding automatic substitution for biosimilars with an interchangeability designation in state of provider, n (%) | |||
| Not at all familiar | 27 (10.8) | 18 (12.0) | 9 (9.1) |
| Slightly familiar | 30 (12.0) | 18 (12.0) | 12 (12.1) |
| Somewhat familiar | 69 (27.7) | 41 (27.3) | 28 (28.3) |
| Moderately familiar | 71 (28.5) | 43 (28.7) | 28 (28.3) |
| Extremely familiar | 52 (20.9) | 30 (20.0) | 22 (22.2) |
| Comfort level with biosimilars, n (%) | |||
| Biosimilars | |||
| Not at all comfortable | 4 (1.6) | 3 (2.0) | 1 (1.0) |
| Slightly comfortable | 24 (9.6) | 14 (9.3) | 10 (10.1) |
| Somewhat comfortable | 41 (16.5) | 22 (14.7) | 19 (19.2) |
| Moderately comfortable | 84 (33.7) | 50 (33.3) | 34 (34.3) |
| Extremely comfortable | 96 (38.6) | 61 (40.7) | 35 (35.4) |
| Biosimilars with an interchangeability designation | |||
| Not at all comfortable | 8 (3.2) | 3 (2.0) | 5 (5.1) |
| Slightly comfortable | 26 (10.4) | 15 (10.0) | 11 (11.1) |
| Somewhat comfortable | 63 (25.3) | 34 (22.7) | 29 (29.3) |
| Moderately comfortable | 72 (28.9) | 47 (31.3) | 25 (25.3) |
| Extremely comfortable | 80 (32.1) | 51 (34.0) | 29 (29.3) |
FDA = US Food and Drug Administration.
STRATEGIES FOR IMPROVING BIOSIMILARS UPTAKE
The strategies that were reported as the highest likelihood of improving uptake of interchangeable biosimilars (reported as either “likely” or “extremely likely”) were as follows: conducting studies and developing educational programs that assess the outcomes of biosimilars and biosimilars with an interchangeability designation in clinical practice (82.3%), FDA guidance on biosimilars with an interchangeability designation for the treatment of naive patients (81.9%), FDA guidance on biosimilars with an interchangeability designation for switching patients (81.6%), and educational programs on billing and reimbursement (79.1%). A higher percentage of physicians (56.0%) than pharmacists (38.4%) reported FDA guidance on biosimilars with an interchangeability designation for treatment-naive patients as “likely” to improve the uptake of biosimilars (Table 5).
TABLE 5.
Perceived Strategies for Improving Biosimilars Uptake
| All providers | All physicians | All pharmacists | |
|---|---|---|---|
| (N = 249) | (N = 150) | (N = 99) | |
| Likelihood of strategies to improve interchangeable biosimilars, n (%) | |||
| Conducting studies and developing educational programs that assess outcomes of biosimilars and biosimilars with an interchangeability designation in clinical practice | |||
| Extremely unlikely | 5 (2.0) | 1 (0.7) | 4 (4.0) |
| Unlikely | 9 (3.6) | 3 (2.0) | 6 (6.1) |
| Neither likely nor unlikely | 30 (12.0) | 15 (10.0) | 15 (15.2) |
| Likely | 122 (49.0) | 77 (51.3) | 45 (45.5) |
| Extremely likely | 83 (33.3) | 54 (36.0) | 29 (29.3) |
| Educational programs on billing and reimbursement for biosimilars | |||
| Extremely unlikely | 3 (1.2) | 2 (1.3) | 1 (1.0) |
| Unlikely | 5 (2.0) | 4 (2.7) | 1 (1.0) |
| Neither likely nor unlikely | 44 (17.7) | 26 (17.3) | 18 (18.2) |
| Likely | 125 (50.2) | 71 (47.3) | 54 (54.5) |
| Extremely likely | 72 (28.9) | 47 (31.3) | 25 (25.3) |
| FDA guidance on biosimilars with an interchangeability designation for treatment-naive patients | |||
| Extremely unlikely | 1 (0.4) | 0 (0.0) | 1 (1.0) |
| Unlikely | 2 (0.8) | 1 (0.7) | 1 (1.0) |
| Neither likely nor unlikely | 42 (16.9) | 25 (16.7) | 17 (17.2) |
| Likely | 122 (49.0) | 84 (56.0) | 38 (38.4) |
| Extremely likely | 82 (32.9) | 40 (26.7) | 42 (42.4) |
| FDA guidance on biosimilars with an interchangeability designation for switching patients | |||
| Extremely unlikely | 2 (0.8) | 1 (0.7) | 1 (1.0) |
| Unlikely | 7 (2.8) | 5 (3.3) | 2 (2.0) |
| Neither likely nor unlikely | 37 (14.9) | 22 (14.7) | 15 (15.2) |
| Likely | 103 (41.4) | 69 (46.0) | 34 (34.3) |
| Extremely likely | 100 (40.2) | 53 (35.3) | 47 (47.5) |
| Reducing patient cost sharing | |||
| Extremely unlikely | 4 (1.6) | 0 (0.0) | 4 (4.0) |
| Unlikely | 6 (2.4) | 5 (3.3) | 1 (1.0) |
| Neither likely nor unlikely | 43 (17.3) | 23 (15.3) | 20 (20.2) |
| Likely | 100 (40.2) | 62 (41.3) | 38 (38.4) |
| Extremely likely | 96 (38.6) | 60 (40.0) | 36 (36.4) |
| Incentivizing providers by adjusting fee schedules | |||
| Extremely unlikely | 11 (4.4) | 5 (3.3) | 6 (6.1) |
| Unlikely | 25 (10.0) | 14 (9.3) | 11 (11.1) |
| Neither likely nor unlikely | 69 (27.7) | 38 (25.3) | 31 (31.3) |
| Likely | 87 (34.9) | 56 (37.3) | 31 (31.3) |
| Extremely likely | 57 (22.9) | 37 (24.7) | 20 (20.2) |
| Innovative contracting based on performance/outcomes | |||
| Extremely unlikely | 9 (3.6) | 4 (2.7) | 5 (5.1) |
| Unlikely | 25 (10.0) | 13 (8.7) | 12 (12.1) |
| Neither likely nor unlikely | 69 (27.7) | 35 (23.3) | 34 (34.3) |
| Likely | 113 (45.4) | 76 (50.7) | 37 (37.4) |
| Extremely likely | 33 (13.3) | 22 (14.7) | 11 (11.1) |
| Establishing patient support/adherence programs | |||
| Extremely unlikely | 3 (1.2) | 2 (1.3) | 1 (1.0) |
| Unlikely | 10 (4.0) | 5 (3.3) | 5 (5.1) |
| Neither likely nor unlikely | 70 (28.1) | 45 (30.0) | 25 (25.3) |
| Likely | 112 (45.0) | 67 (44.7) | 45 (45.5) |
| Extremely likely | 54 (21.7) | 31 (20.7) | 23 (23.2) |
| Streamlining administrative processes for biosimilar billing and reimbursement (eg, point-of-sale workflow solutions, supply chain) | |||
| Extremely unlikely | 4 (1.6) | 2 (1.3) | 2 (2.0) |
| Unlikely | 8 (3.2) | 4 (2.7) | 4 (4.0) |
| Neither likely nor unlikely | 50 (20.1) | 26 (17.3) | 24 (24.2) |
| Likely | 116 (46.6) | 74 (49.3) | 42 (42.4) |
| Extremely likely | 71 (28.5) | 44 (29.3) | 27 (27.3) |
FDA = US Food and Drug Administration.
Discussion
This study included 150 physicians and 99 pharmacists representing diverse practice settings, ages, years in practice, specialties, and regions of the United States. Respondent physicians’ and pharmacists’ ages and sex at birth were similar to other studies, although this study included a wider variety of providers across practice settings, graduation years, years as licensed providers, and regions of the United States. 12 , 14 The median years as a licensed provider for pharmacists (13.0 years) was similar to other studies. 12 , 14 Past research surveyed pharmacists with approximately two-thirds having more than 10 years in practice 12 and 50.0% being in practice for 1 to 5 years. 14 The current study also reports pharmacists’ experience with CEUs, which has rarely been reported in past research. 12 , 14 The particular characteristics of the physicians and pharmacists included in this survey may have influenced their responses. Therefore, it would be beneficial to conduct similar surveys with different populations of providers to validate and generalize our findings.
This is one of the first studies reporting CEUs related to biosimilars for immunological disorders. The majority of physicians and pharmacists received CEUs related to biosimilars; however, a greater proportion of pharmacists received CEUs related to biosimilars than physicians (65.7% vs 50.7%). A study by Briggs et al found oncology physicians, pharmacists, nurses, and administrators reported earning CEUs for biosimilars at a rate of approximately 85%, 15 which is higher than the 50.7% of physicians who had received CEUs observed in this study. CEUs related to biosimilars were obtained by 65.7% of pharmacists in this study, similar to past literature, which reports rates between 22% and 74%. 16 The rates of biosimilar CEUs found in this study and past research suggests there is opportunity for both physicians and pharmacists to become more knowledgeable about biosimilars by pursuing dedicated trainings.
Perceived barriers to adopting interchangeable biosimilars, strategies to improve uptake, familiarity, and comfort levels with biosimilars were similar overall between physicians and pharmacists, with some differences between the provider types.
Pharmacists reported higher rates of familiarity and training with biosimilars and recommendation of biosimilars than physicians, consistent with past research. 12 All providers reported their familiarity with the FDA’s definition of a biosimilar as “somewhat familiar” to “extremely familiar” 92.8% of the time and their comfort level with biosimilars as “somewhat comfortable” to “extremely comfortable” 88.8% of the time. Past research found less reported comfort with biosimilars, with 58.0% of providers rating their comfort as moderately and very comfortable 12 and 51% moderately and very comfortable with using biosimilars. 14
Despite reported familiarity with the FDA’s definition and comfort levels, this study suggests that physicians may be more reluctant to recommend biosimilar products to new start and switch patients than pharmacists. Physicians were “extremely likely” to recommend a biosimilar for new start patients 31.3% of the time compared with 47.5% for pharmacists. For switch patients, physicians were “likely” to recommend a biosimilar product 38.7% of the time compared with 47.5% for pharmacists. These findings are similar to those described in the study by Giavatto et al, which found that a higher percentage of pharmacists would suggest a biosimilar for patients (18.1%) compared with medical doctors (13.3%), 12 although both rates are lower than those found in the current study. A Cardinal Health report on biosimilars showed a similar rate of physicians (38%) reporting they were likely to switch to a biosimilar from a biologic. 10 The higher rate of pharmacists’ likelihood of recommending biosimilars compared with physicians suggests efforts to increase biosimilars uptake may need to target both pharmacists and physicians with a greater focus on physicians.
Familiarity with biosimilar regulatory guidelines and state laws regarding biosimilars with an interchangeability designation was similar between physicians and pharmacists.
Although familiarity was similar, there were a few notable differences between physicians and pharmacists. A higher percentage of pharmacists (35.4%) than physicians (20.0%) reported themselves as “extremely familiar” with their pharmacy’s record retention of communication records to prescriber/patient. A higher percentage of physicians (42.7%) than pharmacists (32.3%) were “moderately familiar” with the FDA’s definition of a biosimilar with an interchangeable designation. These rates are similar to past research, which reported less than half of prescribers (48.0%) and pharmacists (42.0%) understood regulations of interchangeability and substitution. 12 , 14
The perceived significance of barriers to biosimilars were similar between physicians and pharmacists. Among all providers, the barriers most often perceived to be “extremely significant” were payer coverage/formulary placement (51.0%) and cost to patient (ie, affordability) (41.0%). Reducing patient cost sharing and improved accessibility and visibility of FDA guidance on biosimilars with an interchangeability designation emerged as strategies perceived to be beneficial in improving uptake of biosimilars for pharmacists and physicians. These perceived barriers may influence biosimilar use in clinical settings. This study also explored strategies to improve interchangeable biosimilars uptake, which may be targeted to overcome the perceived barriers.
The likelihood of the queried strategies to improve interchangeable biosimilars uptake was overall perceived similarly between physicians and pharmacists. Across all providers, the strategies that were reported as the highest likelihood of improving interchangeable biosimilars were educational programs and FDA guidance. This is consistent with past research, which suggests education of providers is crucial to increase adoption of biosimilars. 9 , 17 These findings provide important context to the limitations of biosimilar use and possible strategies to improve biosimilar uptake. Future research may explore if the perceptions of physicians and pharmacists regarding biosimilars’ uptake including familiarity and barriers to biosimilars translates to real-world biosimilars use in clinical settings.
LIMITATIONS
This study employed purposive sampling, which targeted providers based on prespecified selection criteria, and as such may not be representative of providers who prescribe and pharmacists who dispense biosimilars. This study did not examine if physicians’ and pharmacists’ reported familiarity with and likelihood to recommend biosimilars influences clinical practice. There were no statistical comparisons performed between provider types or subgroups. Finally, as with any self-report data, responses may have been impacted by self-presentation and social desirability biases.
Conclusions
Results from this study contribute important data on physicians’ and pharmacists’ general knowledge, perceptions of biosimilars, and their opinions on strategies that can improve biosimilar uptake. The results were largely similar across physicians and pharmacists except for several notable differences. These differences included that pharmacists reported higher rates of recommending a biosimilar and receiving CEUs related to biosimilars. The results of this study suggest that education on biosimilars may be beneficial to potentially increase biosimilar use by physicians and pharmacists. The barriers to biosimilars uptake including payer coverage/formulary placement and cost to patients may be overcome by implementing reduced patient cost sharing and FDA guidance on biosimilars with an interchangeability designation. The findings of this study may be used to direct the development of systems to improve interchangeable biosimilar adoption as more biosimilars are approved, including the 69 approved as of April 2025. 18 Further research is needed to determine if providers’ perceptions of biosimilars are associated with actual biosimilars uptake.
ACKNOWLEDGMENTS
The authors would like to acknowledge Karthika Jothivel of Cardinal Health for project management contributions and Bindu Kalesan of Cardinal Health for providing medical writing support.
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