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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

Articles

Explore the latest advancements in rheumatology biosimilars, including FDA approvals, patient switching trends, and real-world efficacy insights.

Biosimilars Rheumatology Roundup: June 2025

About 13% of patients who switch from Humira to an adalimumab biosimilar switch back to the originator, according to research from Truveta. However, the presented data may not tell the full story.

Adalimumab Double Take: The Unexpected Return to Reference Humira

Cameron Santoro is an associate editor for The Center for Biosimilars

Videos

Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, explain that widespread biosimilar adoption requires addressing patient and provider education gaps through pharmacists and rectifying perverse financial incentives within health care contract structures. 

Expert Insights on Overcoming Patient Education Gaps, Biosimilar Financial Hurdles

Here are the top 5 biosimilar articles for the week of June 23, 2025.

The Top 5 Biosimilar Articles for the Week of June 23

The Center for Biosimilars connects professionals with insights on biosimilars, health economics, regulatory outcomes, and emerging treatment paradigms.

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Kashyap Patel, MD, is the managing partner at Carolina Blood and Cancer Care and has been with them since its inception in 2004. Dr Patel received his medical degree from Thomas Jefferson University Hospital, has authored several research articles regarding melanoma, and is board certified in hematology, oncology, and internal medicine.

Kashyap Patel, MD, CEO of Carolina Blood and Cancer Care, a member of the Community Oncology Alliance, and member of The Center for Biosimilars® Advisory Board, glances back at the development of the biosimilar industry and the last 5 years of progress.

The Role of Biosimilars: Advancing Access, Financial Health, and System Sustainability

 on whether comparative efficacy trials add much of value to the evidence for biosimilar approval in the United States.

The requirements for FDA approval of biosimilars are appropriate.

There is no longer any need for comparative clinical efficacy trials.

The requirements for demonstration of biosimilarity need to be increased.

Check out the results from our last poll:

There are diverging opinions on whether comparative efficacy trials add much of value to the evidence for biosimilar approval in the United States.

Polls

Biosimilars Poll: What is Your Opinion on Clinical Efficacy Trials?

Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health.

Josh Canavan, PharmD, head of pharmacy at RazorMetrics, and Chris O'Dell, senior vice president of market solutions at Turquoise Health, discussed key misconceptions about pharmacy benefit manager (PBM) impact on biosimilar adoption and evolving industry dynamics in an interview with The Center for Biosimilars

Canavan outlined major trends impacting PBMs, including a significant move towards transparency, driven by new legislation and demands from health plans and members for clear savings and passed-on benefits. He also emphasized a growing focus on value-based care, shifting PBMs from a sole focus on the bottom line to prioritizing patient outcomes, quality of care, and preventative measures.


O'Dell highlighted a major misconception regarding cheaper biosimilars that are believed to automatically translate to lower reimbursement and overall costs. He explained that hospitals and pharmacies often receive similar reimbursement for biosimilars as for brand-name drugs, leading to "spread pricing" where PBMs acquire drugs for less but charge employers/insurers similarly, thus not passing on the full savings.


This transcript was lightly edited for clarity; narration and captions were generated by AI.

The intricate world of pharmacy benefit managers, or PBMs, play a pivotal role in the health care ecosystem, influencing everything from drug pricing to patient access. Despite their widespread impact, a clear understanding of their functions and effects remains elusive for many.

What are the most significant misconceptions or information gaps regarding PBM impact on biosimilar adoption, and how do you foresee these dynamics evolving alongside the major trends impacting PBMs in the coming year?

I think the first one that will be the biggest trend is around transparency. We've already seen a lot of transparency, PBMs start to develop, and with the PBM Transparency Act, which passes on certain medication savings, it prohibits unfair practices, and can now be enforced by the FTC [Federal Trade Commission], PBMs are definitely trending more towards transparent practices. The health plans want to see what the actual savings are from the PBM, and then members want to know that the PBM is working for them. They also want to see those savings get passed on as well.


The second trend is around value-based care. Right now, there's a focus on quality of care, and there's a growing focus on the total outcomes for the patient, more than simply the bottom line. It also focuses on provider performance, best practices, evidence-based medicine, and there's also a focus on patient experience. With value-based care, you have care coordinators that work with patients, there's a focus on preventative medicine, and then it also tries to remove barriers around transportation. Then, it looks a lot at patient goals, and so PBMs are really starting to look at value-based care more, instead of just the bottom line.


Then, the next trend I think we'll see is around reducing prescription cost. Right now, there's a big focus on specialty GLP-1s [glucagon-like peptide-1], those are expensive medications. PBMs are trying to control them with prior authorizations and step therapy. I think we'll start to see more around lower-cost alternatives and decreasing poor outcomes, specifically around polypharmacy.


The biggest misconception around biosimilar adoption is that just because a drug is cheaper or produced for cheaper or costs less, that it means it's reimbursed less. There are many examples where the biosimilar might be acquired for significantly less, but whether it be payment from the insurance to the hospital or payment to the pharmacy, the reimbursement is not much less than what it would be for the brand-name drug.


This whole promise that these would drive down cost is a little bit of a misconception so far, because hospitals are often getting paid the same amount. On the PBM side, this is called spread pricing, which is when, effectively, the amount that they're paying to the pharmacy is a lot less than what they're acquiring it for. In essence, it costs the same to the employer or the insurer. I think that's probably the biggest misconception, that these will be cheaper, they'll drive down costs, and we just haven't seen that yet.

Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, explain the misconception that cheaper biosimilars automatically lead to lower costs due to pharmacy benefit manager (PBM) spread pricing, while also highlighting major PBM trends toward increased transparency, value-based care, and efforts to reduce prescription costs.

Biosimilar Misconceptions, PBM Transparency, and Value-Based Care: Insights From Canavan & O'Dell

In response to the need for more real-world evidence on adalimumab biosimilars, new findings from a large cross-sectional survey across France, Germany, Italy, Spain, and the UK offer compelling insights into the practical benefits of ABP 501 (Amgevita/Amjevita), a leading adalimumab biosimilar.

The treatment of debilitating immune-mediated inflammatory diseases (IMIDs) like rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and psoriasis (PsO) has seen a dramatic shift with the introduction of adalimumab biosimilars.

, involving 1296 patients who either started on ABP 501 or switched from the reference product (Humira), directly tackled critical questions about its real-world effectiveness, patient satisfaction, and impact on daily life.

The data emphatically demonstrated that ABP 501 delivered positive treatment outcomes, earning high satisfaction marks from both patients and their treating physicians, regardless of prior exposure to the reference product. Physicians reported overwhelming satisfaction with disease control provided by ABP 501. Among patients who initiated ABP 501 as their first advanced therapy, physician satisfaction rates exceeded 89% across all disease cohorts, even reaching more than 95% in AS, PsA, and PsO.

For those initiating ABP 501, a significant majority of patients across all IMIDs were assessed by their physicians as having mild disease at the time of consultation—ranging from 63.2% in AS to an impressive 83.0% in PsO after a median of 10.4 to 12.3 months on the biosimilar. Pain levels also showed remarkable improvement, with a large proportion of patients experiencing mild or no pain.

Patients echoed their physicians' positive assessments. A substantial majority of ABP 501 initiators, more than 86% across all indications, reported high satisfaction with their treatment regimen. Importantly, their health-related quality of life (HRQOL) measures consistently indicated minimal disease impact on their daily lives. Low scores for work productivity and activity impairment further emphasized the biosimilar's positive effect on patients' ability to participate in daily activities and work.

The study also shed light on the experiences of patients who transitioned from the reference product to ABP 501. The drivers for these switches were often pragmatic, with physicians citing formulary-driven switches, financial considerations, and insurance restrictions as primary reasons. Crucially, these non-clinical motivations did not translate into compromised patient care or satisfaction. Both physicians and patients maintained high satisfaction levels with ABP 501 after the switch, exceeding 93% for physicians and at least 94.7% for patients across indications. Moreover, patient-reported HRQOL remained strong following the switch, demonstrating a seamless transition without any discernible negative impact on patient well-being or treatment efficacy. This finding is particularly significant for managed care organizations, as it helps to alleviate concerns about potential "nocebo effects" sometimes associated with biosimilar transitions.

This robust real-world evidence provides compelling arguments for managed care organizations to fully embrace adalimumab biosimilars like ABP 501. Driven by financial and administrative advantages, these biosimilars offer a significant opportunity to reduce health care expenditures for IMID management, leading to more efficient resource allocation and benefiting a broader patient population.

The high satisfaction among both physicians and patients, coupled with positive clinical outcomes, should bolster confidence in prescribing biosimilars, especially for extrapolated indications. The sustained high HRQOL and satisfaction reported by patients after switching underscore that biosimilars maintain positive patient experiences and promote adherence.

Another real-world analysis focusing on nonmedical switching from the adalimumab originator to adalimumab biosimilars revealed that patient-reported outcomes were maintained post-switch, showing the continued safety and efficacy for patients with chronic inflammatory conditions.

The authors of the present study concluded, “Our findings add to the growing body of real-world experience with biosimilar use which help address barriers to utilization due to lack of awareness and concerns about inadequate efficacy from both patients and physicians, especially for indications approved on the principle of extrapolation and for patients who switch from the reference product.”

1. Jin R, Haughton JM, Goddard EJ, et al. Real-world experience with an adalimumab biosimilar (ABP 501) in patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis in Europe: results from the Adelphi Disease Specific Programme. 

. 2025;12(3):469-492. doi:10.1007/s40744-025-00755-9

2. Jeremias S. Study on nonmedical switching for adalimumab biosimilars warns about nocebo effect. The Center for Biosimilars

. April 27, 2023. Accessed June 2, 2025. 

https://www.centerforbiosimilars.com/view/study-on-nonmedical-switching-for-adalimumab-biosimilars-warns-about-nocebo-effect

New research highlights the efficacy and high patient satisfaction of adalimumab biosimilars in treating inflammatory diseases.

Clinical

Business & Practice

European Data Confirm Real-World Benefits of Adalimumab Biosimilars

(Otulfi; Fresenius Kabi) had no clinically relevant effect on efficacy, safety, or immunogenicity and demonstrated therapeutic equivalence to reference ustekinumab in patients with moderate to severe plaque psoriasis, supporting its therapeutic equivalence and potential for broader application in other indications, according to a study published in 

Even though biological therapies showed improvements in psoriasis management and other inflammatory conditions, high costs continue to limit access. Over the past decade, adalimumab, infliximab, and etanercept biosimilars have been adopted which have helped increase the number of patients who benefit from treatment.

Previous researchers found that patients with psoriasis who received either adalimumab, etanercept, or ustekinumab underwent dose escalations more frequently with ustekinumab compared with the other 2 treatments.

 They also discontinued treatment after dose escalation occurred more often with adalimumab and etanercept than with ustekinumab.

Currently, US regulatory bodies require evidence that the molecule is like the reference product in terms of structure, function, pharmacokinetics, clinical efficacy, and safety for biosimilar approval.

 Researchers have proposed dropping these blanket requirements, deeming them redundant, and modeling regulatory agencies after the United Kingdom and European Union.

Researchers conducted a multicenter randomized, double blind, parallel group phase 3 study across 27 sites in Estonia, Georgia, Poland, and Ukraine.

 About 40% of the patient population was women with an average age of 42 years, with a 24.4 mean Psoriasis Area and Severity Index (PASI) score. Of the patients, 19.4% reported prior systemic biological treatment for psoriasis, and only 9.2% of these reported an inadequate response or intolerance.

Researchers randomized a total of 392 patients to either FYB202 (n = 197) or reference ustekinumab (n = 195). Some patients did not respond (FYB202, 4; reference ustekinumab, 5), and a few patients in the reference ustekinumab group did not undergo rerandomization due to adverse events (AEs) leading to study discontinuation (n = 2) or nonattendance at week 28 (n = 1).

In the FYB202 group, 189 patients continued treatment to week 52, and researchers rerandomized 186 in the reference group (FYB202, 89; reference ustekinumab, 97). Following rerandomization, 372 patients completed the study until week 52. There were 187 patients who remained on FYB202, 97 patients who remained on reference ustekinumab, and 88 patients who switched from reference ustekinumab to FYB202.

Patients treated with FYB202 showed an estimated mean percent improvement in PASI score of 79.5% (95% CI, 74.6%-84.4%) for the primary end point from baseline to week 12, while patients treated with reference ustekinumab achieved 76.2% (95% CI, 71.5%-81%). All secondary efficacy end points were also similar between treatment groups.

Percentages of patients who reached PASI 75 (FYB202, 97.9%; reference ustekinumab, 96.4%) and PASI 90 (FYB202, 81.7%; reference ustekinumab, 78.2%) at week 28 were similar. Switching from reference ustekinumab to FYB202 had no impact on therapeutic efficacy. A total of 97.7% patients in the switch group maintained their PASI 75 response at week 52.

No differences emerged between the groups that maintained their initial treatment for the entire 52 weeks. A PASI 75 response at week 52 was maintained by 96.2% of patients in the FYB202 group and 94.6% of patients in the reference ustekinumab group.

Both treatments patients tolerated well, and researchers found the safety profiles comparable between groups. Patients reported at least 1 AE during the first 28 weeks in 39.6% of the FYB202 group and 41% of the reference group. Before rerandomization, patients most frequently reported injection site pain (FYB202, 11.2%; reference ustekinumab 7.7%), nasopharyngitis (FYB202, 4.6%; reference ustekinumab, 2.6%), and COVID-19 (FYB202, 3.6%; reference ustekinumab, 2.6%).

AEs caused 1% of patients treated with FYB202 and 1.5% of patients treated with reference ustekinumab to withdraw from the study. After rerandomization, 3 patients in the FYB202 group, 1 patient in the reference ustekinumab group, and 1 patient in the reference ustekinumab to FYB202 switch group reported serious AEs. Only 1 patient in the reference ustekinumab to FYB202 switch group discontinued because of an AE (congenital anomaly).

At baseline, 5.1% of patients in the FYB202 group and none in the reference ustekinumab group had confirmed positive adenosine deaminase (ADA) tests. ADA prevalence from week 4 to week 52 was lower for FYB202 compared with reference ustekinumab. Researchers observed the maximum proportion of patients with ADAs at week 28 in both groups.

After rerandomization, ADA and neutralizing antibody positivity declined in all 3 groups. No patients who were ADA negative at week 28 became ADA positive following the switch from reference ustekinumab to FYB202, indicating that the switch from reference ustekinumab to FYB202 did not impact immunogenicity. Mean percent improvement in PASI score from baseline to week 12 was slightly lower in ADA positive patients compared with ADA negative patients, and both treatment groups showed a similar reduction.

Researchers observed higher geometric mean C

 levels for patients treated with FYB202 compared with patients treated with reference ustekinumab, especially at early time points, which may be due to the differences in ADA incidences at the early time points as well some differences in the protein content. The serum C

 levels of ustekinumab showed a high interpatient variability particularly at weeks 4 and 12. Researchers observed smaller interpatient variability during steady state at weeks 16, 28, 40, and 52. They also observed similar and stable C

 levels from week 16 to week 52 in all 3 rerandomized groups from week 28 to week 52.

The study was not powered for statistical comparisons of equivalence after switching from reference ustekinumab to FYB202. Researchers included only a single switch, but clinical practice may involve multiple treatment switches. Additionally, regulatory authorities required the trial to detect differences between treatments for biosimilar approval, not to prove 

 efficacy. Researchers selected a narrower patient population than clinical practice might expect to ensure comparison sensitivity. Finally, the study lacked racial diversity as all patients were White, but extrapolation allows inferring similar treatment effects for other populations.

“Using a totality of evidence approach, proof of therapeutic equivalence in this sensitive psoriasis population allows for extrapolation to other indications, with similar clinical performance of FYB202 and reference ustekinumab assumed across all approved indications,” study authors concluded.

1. Papp K, Balser S, Nopora K, et al. A randomised, double-blind trial to compare the efficacy, safety, and immunogenicity of the biosimilar ustekinumab FYB202 with reference ustekinumab in patients with moderate-to-severe plaque psoriasis. 

. 2025;42:2135-2149. doi:10.1007/s12325-025-03138-2

2. Santoro C. Differences in psoriasis treatment: ustekinumab dose escalation vs adalimumab, etanercept discontinuation. The Center for Biosimilars

https://www.centerforbiosimilars.com/view/differences-in-psoriasis-treatment-ustekinumab-dose-escalation-vs-adalimumab-etanercept-discontinuation

3. Niazi SK. BioRationality: a new bill to transform the future of biosimilars. The Center for Biosimilars. May 5, 2025. Accessed June 9, 2025. 

https://www.centerforbiosimilars.com/view/biorationality-a-new-bill-to-transform-the-future-of-biosimilars

Switching from reference ustekinumab to biosimilar FYB202 maintained comparable efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis.

Biosimilar FYB202 Shows Therapeutic Equivalence to Ustekinumab for Plaque Psoriasis

A health policy in British Columbia that required biosimilar prescriptions showed no increase in hospital visits or complications, according to real-world evidence that etanercept biosimilars for inflammatory arthritis are as effective as their originator biologics without increasing hospital utilization.

 was conducted to address the gap between clinical trial data and real-world outcomes for biosimilars, particularly among patients newly initiating treatment for inflammatory arthritis. While randomized controlled trials have established the efficacy and safety of etanercept biosimilars under ideal conditions, there remains limited evidence on how these therapies perform in routine clinical practice.

In 2017, British Columbia introduced a policy requiring that new prescriptions for certain biologic drugs be filled with biosimilars to qualify for coverage under the public drug plan.

 The program was rolled out in several phases and has since been replicated to some extent in nearly every other Canadian province due to the success seen in BC.

 This mandate, which has already accumulated $732 million in savings in the first 5 years for the province,

 created a “natural experiment” for the researchers, who used it to evaluate health care utilization as an indicator of biosimilar safety and effectiveness in real-world settings.

“Lack of confidence in biosimilars' effectiveness, safety and interchangeability has been identified as one of the top barriers impairing the adoption of biosimilar therapies…Our findings on no unintended consequences of policy change at the health system level inform decisions in biosimilar policy development and implementation in other jurisdictions,” wrote the researchers.

The authors of the retrospective cohort study assessed the impact of British Columbia’s policy by applying a regression discontinuity design to real-world administrative health data from 2014 to 2023. Researchers identified adult patients diagnosed with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who were newly prescribed etanercept. Patients were grouped based on whether they started treatment just before or just after the policy took effect, allowing for a natural comparison.

Outcomes such as hospitalizations, emergency department visits, and physician encounters were tracked for three years. Both intention-to-treat and instrumental variable analyses were conducted to evaluate health care utilization, accounting for both policy exposure and actual biosimilar uptake.

Researchers analyzed outcomes among 1626 incident users in the pre-policy period (2014-2017) and 1378 in the post-policy period (2017-2020). Demographics were similar across groups (mean age at diagnosis, 52.5 years; 63.7% female). Biosimilar initiation rose from just 0.06% pre-policy to 78.3% post-policy. Despite this sharp uptake, no significant changes in healthcare utilization were observed.

For all-cause hospitalizations (ACH), intention-to-treat (ITT) analysis yielded unadjusted and adjusted rate ratios at the policy cut-off of 0.97 (95% CI, 0.55-1.69) and 0.84 (95% CI, 0.49-1.44), respectively. Complier average causal effect (CACE) analysis showed similarly neutral effects with ratios of 0.97 (95% CI, 0.53-1.75) and 1.01 (95% CI, 0.53-1.92). Infection-related hospitalizations (IRH) were rare, and both ITT and CACE analyses showed wide confidence intervals with no statistically significant impact: the adjusted CACE ratio was 0.89 (95% CI, 0.03-23.35).

No meaningful differences were observed for emergency room visits (ERV) or hospital length of stay (LOS). For example, adjusted ITT rate ratios for LOS and ERV were 0.94 (95% CI, 0.41-2.15) and 0.91 (95% CI, 0.44-1.88), respectively. Sensitivity analyses using alternative statistical methods and bandwidths confirmed the robustness of findings. Analysis of adalimumab initiators, which were unaffected by biosimilar policy, showed no concurrent changes in health care use, supporting the specificity of the results.

“The equivalent real-world effectiveness and safety of etanercept biosimilars shown in this study will increase healthcare providers' and patients' confidence in prescribing and taking this important medication,” the authors expressed.

1. Zhou VY, Lacaille D, Zheng Y, et al. The impact of biosimilar use on healthcare utilization among new users of etanercept for inflammatory arthritis: a population-based regression discontinuity analysis.

. Published online April 11, 2025. doi:10.1016/j.lana.2025.101058

2. Davio K. British Columbia becomes the first Canadian province to mandate a switch to biosimilars. The Center for Biosimilars

. May 28, 2019. Accessed June 17, 2024. 

https://www.centerforbiosimilars.com/view/british-columbia-becomes-the-first-canadian-province-to-mandate-a-switch-to-biosimilars

3. Hagen T. British Columbia moves into third phase of mandatory switching. The Center for Biosimilars. August 25, 2020. Accessed May 27, 2025. 

https://www.centerforbiosimilars.com/view/british-columbia-moves-into-third-phase-of-mandatory-switching

4. Jeremias S. Manitoba adopts biosimilar switching policy. The Center for Biosimilars. August 7, 2024. Accessed May 27, 2025. 

https://www.centerforbiosimilars.com/view/manitoba-adopts-biosimilar-switching-policy

5. Jeremias S. British Columbia’s biosimilar switching program saves $732 million in 5 years. The Center for Biosimilars. June 18, 2024. May 27, 2025. 

https://www.centerforbiosimilars.com/view/british-columbia-s-biosimilar-switching-program-saves-732-million-in-5-years

Despite a dramatic shift toward biosimilar use following British Columbia’s policy, researchers found no rise in hospital visits or complications, underscoring the real-world reliability of etanercept biosimilars in managing inflammatory arthritis.

British Columbia’s Biosimilar Policy Shows No Impact on Hospital Visits

Patients with moderate-to-severe inflammatory bowel disease (IBD) “at high risk of disease progression and bowel damage, or those who do not respond to conventional therapies within a reasonable time," should receive anti-tumor necrosis factor (TNF)-α therapy as early as possible to prevent disease progression, but the high cost of anti-TNF therapy is a major barrier to timely treatment, according to a 

 by an expert panel of gastroenterologists.

The panel discussed strategies to increase biosimilar use in IBD with the goal of improving patient access to early initiation of anti-TNF therapy.

IBD, including Crohn disease (CD) and ulcerative colitis (UC), are chronic immune-mediated inflammatory diseases of the gastrointestinal system. TNF inhibitors, such as infliximab and adalimumab, are effective for treating moderate to severe IBD, but biologics are associated with high costs. The authors noted that the economic burden of IBD is driven mainly by the cost of anti-TNF biologics, which negatively affects patient access to treatment and, therefore, outcomes.

As of 2024, 17 biosimilars were approved for treating IBD in the US and European Union, and 15 in Canada, and biosimilars had been used in IBD for more than 10 years. However, the panel wrote, the use of biosimilars in clinical practice remains “suboptimal.”

Early Treatment With Anti-TNF Biologics Could Delay Disease Progression

Research suggests that initiation of anti-TNF therapy earlier in the disease course could improve outcomes and delay disease progression, especially in CD. With evidence for a “top-down” approach to IBD treatment accumulating, the authors said, treatment guidelines are shifting, but standard treatment for IBD in many regions still follows a “step-up” approach, in which non-biologic therapies, such as aminosalicylates, corticosteroids, or immunomodulators, must be failed before biologics can be initiated.

According to the panel, the major barrier to anti-TNF use overall is cost, and biosimilars could address the cost barrier. Research has confirmed the effectiveness and safety of biosimilars, and the authors noted that many professional societies, including the American Gastroenterological Association (AGA) and the European Crohn’s and Colitis Organisation (ECCO), support the use of biosimilars in IBD, including switching patients from an originator to a biosimilar. Furthermore, surveys suggest that physician confidence in biosimilars is growing.

However, they said a disconnect exists between guidance and clinical practice. They continued by discussing barriers that may be limiting the use of anti-TNF biosimilars in IBD, and potential solutions.

Barrier 1: Complex Reimbursement/Insurance Policies

According to the expert panel, this barrier is “particularly true” in the US, with many insurance companies requiring prior authorization which may delay treatment and charging high co-pays for biologics as “specialty drugs” which increases out-of-pocket spending. They cited a study that reported over 90% of US-based insurance companies required failure of at least 1 conventional therapy before permitting biologic treatment. Additionally, several countries with single-payer systems require failure of one or even 2 non-biologic treatments before biologic treatment becomes reimbursable.

Exacerbating the issue in the US, there are financial incentives for pharmacy benefit managers to place higher-cost reference biologics on formularies, which favors those reference products over biosimilars and leaves many healthcare professionals unable to choose a biosimilar for their patients.

The panel recommended the removal of payer requirements for the patient to fail on conventional therapies before initiating biologics to allow for earlier initiation of anti-TNF therapy and bring the ‘top-down’ treatment guidance into clinical practice. They added that the improved outcomes from earlier initiation of biologics could “potentially support a reduction in the cumulative costs of sustained disease.”

Barrier 2: Concerns of Health Care Professionals

Although attitudes of health care professionals are trending toward acceptance of biosimilars, “some resistance” persists,” the authors wrote, citing a US study from 2020 that found 73% of physicians surveyed refrained from prescribing biosimilars. The panel explained that physician skepticism and lack of confidence in biosimilars may stem from the differences in the development and approval pathways between originators and biosimilars, and a lack of understanding of extrapolation to additional indications or biosimilar switching data. Importantly, patients are likely to lack confidence in biosimilars if their physician does.

As a solution to address this barrier, the expert panel proposed continued education on the robustness of the biosimilar development process and safety of switching between originator and biosimilar products, as well as encouraging peer-to-peer education for physicians to share their experiences with biosimilars. They also recommended conducting more randomized controlled trials and real-world studies to address physician concerns, development of tailored educational materials on biosimilars that address specific needs and concerns of subpopulations of health care professionals, and integrating biosimilar education into medical and pharmacy school curricula.

A patient’s concerns around biosimilars could lead to reluctance to begin treatment, as well as poorer outcomes due to the nocebo effect. The panel cited research showing that people with IBD frequently share negative experiences around biologics on social media, including concerns about safety and side effects. A lack of understanding of biosimilars can lead to a lack of confidence. The panel cited surveys finding large proportions of patients had not heard of biosimilars, and many of those who had were not confident in their effectiveness and safety, or viewed them as of lesser quality than reference biologics.

That anti-TNF biologics are delivered via intravenous or subcutaneous injection is another source of hesitation for some patients, due to fear of needles or previous injection site reactions or pain.

The panel recommended leveraging the educational materials of nonprofits and IBD patient support groups, such as the European Federation of Crohn’s and Ulcerative Colitis Associations (EFCCA), and discussed essential aspects of communication with patients, such as providing understandable, consistent, and up-to-date information, communicating transparently and positively to reduce the likelihood of a nocebo effect, and tailoring the materials to individual patient needs. They recommended physicians, nurses, and pharmacists adopt these strategies to ensure that information is accurate and explain how biosimilars can support the patient’s treatment goals.

Although there are structural barriers to the use of anti-TNF biosimilars, the expert panel emphasized that healthcare professionals can take action now to increase confidence in anti-TNF biosimilars in IBD, supporting the “top-down” approach to IBD treatment, “ultimately improving long-term disease management and patient outcomes, as well as paving the way for the future biosimilar landscape in IBD.”

Fiorino G, Ananthakrishnan A, Cohen RD, Cross RK, Deepak P, Farraye FA, Halfvarson J, Steinhart AH. Accelerating earlier access to anti-TNF-α agents with biosimilar medicines in the management of inflammatory bowel disease. 

. 2025;14(5):1561. doi:10.3390/jcm14051561

There's a need for early anti-tumor necrosis factor (TNF) therapy in inflammatory bowel disease (IBD), with new data showing that biosimilars can address cost barriers and enhance patient access and outcomes.

Kashyap Patel, MD

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