Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

Switching from reference infliximab to biosimilars (infliximab-abda and infliximab-dyyb) for rheumatic diseases may lead to treatment delays and a higher risk of disease flares, particularly when the switch is mandated by insurance. | Image Credit: nick - stock.adobe.com

Infliximab biosimilars (infliximab-abda and infliximab-dyyb) may delay treatment after patients switch from the reference product, suggesting a possible risk factor for flaring/loss of disease control, according to a study published in the 

Clinicians often treat rheumatic diseases like ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and uveitis, with the anti-tumor necrosis factor agent, infliximab. Over the past few years, the FDA approved 4 infliximab biosimilars. The FDA approved the first biosimilar, infliximab-dyyb, in April 2016, and they approved infliximab-abda in May 2017.

 A few months later, the FDA approved infliximab-qbtx in December 2017, and it approved infliximab-axxq in December 2019.

Under the Biologics Price Competition and Innovation Act, a biosimilar product becomes interchangeable when it meets additional requirements that may produce the same clinical result as the reference product in any given patient, and pharmacists may substitute it for the reference product without prescriber input.

 Currently, researchers have not gathered any interchangeable related data for infliximab.

Researchers conducted a retrospective analysis of data to evaluate the level of disease control after nonmedical switches from reference infliximab to biosimilars in patients with rheumatic disease. A total of 48 patients met the inclusion criteria, the majority were White women on reference infliximab products with a mean age of 59 years and a psoriatic arthritis diagnosis.

Several patients who remained on reference infliximab used a concomitant disease-modifying antirheumatic drug (DMARD), with methotrexate (55.2%) being the most common. Patients who switched to the biosimilar product also included some who used a concomitant DMARD, with methotrexate (63.2%) being the most common.

Primary insurance coverage varied between the 2 groups; commercial and Medicare coverage split almost evenly for patients in the infliximab reference group. Commercial and Medicaid serve as the primary coverages for the biosimilar group.

Researchers observed 60.4% of patients on the reference infliximab and 39.6% who switched to the biosimilar; 42.1% flared after switching to the biosimilar. All patients taking the biosimilar used infliximab-dyyb, and insurance mandated 89.5% to switch. Almost half of all patients (42.1%) experienced flares/loss of disease control after switching products. Most of the patients who experienced flares no longer use the biosimilar product (75%).

Two patients who flared after switching to a biosimilar (25%) experienced a delay in treatment because they attempted to receive prior authorization for reference infliximab. There were 75% of patients who reported the flare/loss of disease control within the first 4 months following the switch.

Overall, pharmacists play an important role in the multidisciplinary team approach to manage chronic inflammatory diseases. Pharmacists play an important role in the substitution of biosimilars and patient education surrounding their use.

 The role of pharmacists in this space will only continue to grow as more biosimilars gain FDA-approved interchangeability status. Researchers need future studies that directly compare the rate of flares/loss of disease control in rheumatology patients who remain on the reference product with patients who switch to a biosimilar.

The study design limited the results because of the small sample size and a single health network that included a primarily White population. Researchers expressed that they should label the study a pilot because it needs more data to draw meaningful conclusions. Ultimately, this may have indicated more flares than clinicians found relevant. Lastly, the health network’s formulary does not include every available infliximab biosimilar, which limits the findings of the study only to infliximab-abda and infliximab-dyyb.

“Pharmacists should follow patients who switch to biosimilar closely during the transition period, to provide education on biosimilars and to monitor for signs of flares/loss of disease control,” study authors concluded.

1. Jankowska M, Dessureault K, MacDougall J, Sowers M, Merchand M, Kennedy AG. Impact of nonmedical switches from reference infliximab to biosimilars on disease control within a rheumatology practice. 

. Published online December 21, 2024. doi:10.1177/87551225241308475

2. Biosimilar approvals. The Center for Biosimilars

. January 7, 2025. Accessed June 4, 2025. 

https://www.centerforbiosimilars.com/biosimilar-approvals

3. Halpern L. As biosimilar substitutions become more common, education and patient counseling are paramount. 

https://www.pharmacytimes.com/view/as-biosimilar-substitutions-become-more-common-education-and-patient-counseling-are-paramount

Articles

Switching from reference infliximab to biosimilars (infliximab-abda and infliximab-dyyb) for rheumatic diseases may lead to treatment delays and a higher risk of disease flares, particularly when the switch is mandated by insurance.

Infliximab Biosimilar Switch Due to Flare Risk: Monitoring Patients Is Crucial for Pharmacists

Here are the top 5 biosimilar articles for the week of May 26, 2025.

 for age-related macular degeneration, enhancing vision preservation with its effective vascular endothelial growth factor inhibition.

 could provide European patients with paroxysmal nocturnal hemoglobinuria and atypical hemolytic uremic syndrome better access to care for a better price, similar to successes seen in other biosimilar markets, according to a review.

 were more frequent with ustekinumab in patients with psoriasis compared with adalimumab and etanercept, highlighting varied outcomes for dose optimization in psoriasis management.

: Despite the clear promise of cost savings and expanded access, the path to integrating generics and biosimilars across the 

Middle East and North Africa (MENA) region

 is tangled in a web of distrust, inconsistent policies, and deep-rooted cultural preferences for branded drugs.

India's recently revised 2025 biosimilar guidelines

 represent a significant and rational step towards global regulatory alignment by deemphasizing animal and human efficacy testing in favor of scientifically robust, risk-based, and ethically sound frameworks.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of May 26

Elena Wolff-Holz, MD.

Elena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, supports automatic substitution of biosimilars at the pharmacy, citing that Europe often grants this immediately with marketing authorization. She highlights interchangeability in the US specifically refers to automatic substitution, and 

Wolff-Holz emphasizes the importance of patient education at the pharmacy, especially if a biosimilar involves a different administration device compared with the originator drug. She explains how pharmacists would be responsible for explaining these differences and stakeholders would highlight any distinctions and provide necessary educational materials.

This transcript was lightly edited for clarity; captions were auto-generated.

How do you feel about automatic substitution of biosimilars at the pharmacy level, and what safeguards do you believe are necessary?

I think automatic substitution at the pharmacy level is an option, it’s possible, it should be possible. I think this whole discussion on interchangeability that are granted in Europe immediately with the granting of the marketing authorization, and then at a national level, the automatic substitution can also be decided. Several countries, I think most recently, France, has accepted that, but other countries, also in Europe and in the United States, have a slightly different definition of interchangeability, in the United States compared with Europe. In the US, interchangeability really speaks to automatic substitution and if you can solidly justify that, and it is justified for Yesintek, so we've been granted the interchangeability status, then I think it's absolutely possible to do it. It's a clear, clear option.


I think what may have to happen is patient education also at the pharmacy level. If there were different devices, different ways that the drug would be applied, for example, also by the patient himself or herself, then it is important that the pharmacist takes on also the responsibility of educating the patient that there are maybe slightly different features in the apparatus, but it's not the drug, it's how you apply the drug. I think this is absolutely possible. I think we as a company, if there were differences to the originator, would then need to highlight this and bring out the materials, or make sure the pharmacist is aware of that. This could be an aspect, but so far, I don't think it is a problem.

What are the biggest misconceptions the general public has about biosimilars, and how can your research help to correct those misconceptions?

I think there could be an unfounded fear that something that is cheaper is less good, and that's why I don't like the word 

, because it's about affordability. These are more affordable; these are not cheaper products, but more affordable products. They are highest quality, they have to go through a very rigid regulatory process, and at the end of the day, they have been applied to human subjects. 

Our research has proven that. We've done all the analytics. We've done more than 100 orthogonal assays to look that really all the characteristics are the same. We've done a PK [pharmacokinetic] trial, where the dose curves are absolutely superimposable. Plus, we also did the phase 3 efficacy trials. Not only have we confirmed the analytical data with the PK trial, but also, all of those data with a phase 3 trial. There's absolutely no need to be fearful.


The other aspect is, I think, in the clever clinical trial design that we have, we've integrated the switch for those patients. Half the patients that were originally on Stelara, at week 16, they were rerandomized in a 1:1 split. Either they stayed on the Stelara or they then took the BMAb-1200 and we carefully monitored whether there would be a change in the effect or in safety or immunogenicity. We saw that there was no difference. Preswitch and post switch was not impacted, and all these are very solid data that really should ascertain and give the confidence to the patient, to the physician, and ultimately the payer, that these are high quality drugs.

Elena Wolff-Holz, MD, discussed the rationale and safety surrounding the automatic substitution of biosimilars at the pharmacy level, as well as common misconceptions about these medications.

Automatic Biosimilar Substitution and Patient Education Advocated by Elena Wolff-Holz, MD

Here are the top 5 biosimilar articles for the week of May 19, 2025.

 as a pathway to a more equitable global health care system by reducing costs and expanding treatment access.

 for inflammatory skin diseases has placed significant pressure on its health system—but a new report suggests biosimilars could offer financial relief, provided uptake barriers are addressed through policy reform and education.

Trump administration’s latest executive order

 touts sweeping drug price cuts through international benchmarking, the broader pharmaceutical pricing crisis in the US reveals a far more complex web of development costs, profit incentives, and absent price controls—raising the question of whether any single policy, including potential drug tariffs, can truly untangle it.

The Top 5 Biosimilar Articles for the Week of May 19

Dose escalations were more frequent with ustekinumab in patients with psoriasis compared with adalimumab and etanercept, highlighting varied outcomes for dose optimization in psoriasis management. | Image Credit: Daniel Beckemeier - stock.adobe.com

Patients with psoriasis treated with either adalimumab, etanercept, or ustekinumab underwent dose escalations more frequently with ustekinumab compared with the other 2 treatments and discontinued treatment after dose escalation occurred more often with adalimumab and etanercept than with ustekinumab, according to a study published in the 

Treatment options for psoriasis, a chronic inflammatory skin disease, have increased significantly with the most recent approvals, with IL [interleukin]-17 and IL-23 inhibitors as the most effective. For the past decade, IL-17 and IL-23 inhibitors have improved in efficacy and safety, providing an unprecedented change in treatment management.

 As psoriasis treatment continues to evolve, researchers identify new potential therapeutic targets to create a future treatment.

New and currently available treatments have helped improve the understanding of immunology and reduce costs, leading to precision medicine becoming more viable.

 Tailored dosing includes one aspect of precision medicine where clinicians achieve dose escalation either by increasing the amount of drug administered or reducing the interval between administrations. In a previous study, researchers determined above-label dosing of biologics for psoriasis treatment was linked with substantial additional pharmacy costs but few significant safety concerns.

Researchers conducted a retrospective study on prospectively collected registry data with the objective of exploring the frequency and outcomes of dose escalation among patients treated with adalimumab, etanercept, and ustekinumab.

 A total of 554 patients received 946 treatment episodes of adalimumab, etanercept, or ustekinumab from 2009 to 2021. Patients treated with ustekinumab had numerically higher peak Psoriasis Area and Severity Index (PASI), peak Dermatology Life Quality Index, prevalence of psoriatic arthritis, and prevalence of nail lesions compared with patients treated with adalimumab and etanercept.

Out of the 946 treatment episodes, 17% had at least 1 instance of the above-labeled dosing. Researchers estimated the cumulative incidence of dose escalation at 4.1 per 100 treatment years. During the follow-up period, ustekinumab had HRs for dose escalation of 2.27 (95% CI, 1.55-3.35) and 2.46 (95% CI, 1.69-3.60), compared with etanercept and adalimumab, respectively, in unadjusted models. In the adjusted models, ustekinumab had HRs for dose escalation of 1.93 (95% CI, 1.25-2.98) and 2.20 (95% CI, 1.42-3.41), compared with etanercept and adalimumab, respectively.

About 50% of patients treated with adalimumab and etanercept discontinued treatment within 1 year of dose escalation, while patients treated with ustekinumab remained on treatment for more than 5 years after dose escalation. Researchers estimated the HRs for treatment discontinuation after dose escalation with adalimumab and etanercept compared with ustekinumab at about 2.41 (95% CI, 1.32-4.38) and 5.08 (95% CI, 3.06-8.46), respectively, in the unadjusted models. After dose escalation, the HRs for treatment discontinuation with adalimumab and etanercept compared with ustekinumab were 3.10 (95% CI, 1.56-6.18) and 7.15 (95% CI, 3.96-12.94), respectively.

The median PASI score was higher after compared with before dose escalation for etanercept (

 = .036), and researchers found no statistically significant difference between after and before dose escalation PASI scores for adalimumab (

 = .300). The proportion of patients on treatment with above-standard dosing at given time points was comparatively low for adalimumab and etanercept. The proportion of patients on the above-labeled dosing for ustekinumab increased from each time interval evaluated to the next.

The study faces limitations due to the data collection methods that took place over a long period of time and treatment practices that may have changed throughout the timeframe of the study. It is important to consider that between 2009 and 2015, ustekinumab was the most recently approved biologic for psoriasis treatment and therefore potentially the last-line agent for many patients. Researchers may have residual confounding because the study was not randomized, and readers should interpret estimated differences in frequency of dose escalation with caution. The overall generalizability and transportability of the findings may be limited, particularly as the flat pricing of the 2 ustekinumab dosing options and the lack of formulary restrictions in Sweden may reduce the transportability of the results to settings where pricing and formulary rules are different.

“Furthermore, data on the safety of treatments that are used for more prolonged periods at above standard dosing would be important to consider,” study authors concluded.

1. Svedbom A, Wennerström C, Hjelm F, Tjärnlund A, Ståhle M. Frequency and outcomes of treatment dose escalation with biologics in moderate-to-severe psoriasis: a Swedish register study. 

. 2024;35(1):2398170. doi:10.1080/09546634.2024.2398170

2. Batta S, Khan R, Zaayman M, Limmer A, Kivelevitch D, Menter A. IL-17 and -23 inhibitors for the treatment of psoriasis.  

. Published online April 12, 2023. doi:10.33590/emjallergyimmunol/10301362

3. Bagel J, Glick B, Wu JJ, et al. Dose escalation and associated costs in biologic treatment of psoriasis based on real-world data. 

. 2021;24(1):782-791. doi:10.1080/13696998.2021.1937187

Dose escalations were more frequent with ustekinumab in patients with psoriasis compared with adalimumab and etanercept, highlighting varied outcomes for dose optimization in psoriasis management.

Differences in Psoriasis Treatment: Ustekinumab Dose Escalation vs Adalimumab, Etanercept Discontinuation

Here are the top 5 biosimilar articles for the week of May 12, 2025.

: Patients with rheumatoid arthritis (RA) who switched from 

Enbrel (reference etanercept) to a biosimilar

 maintained remission, even after their dose was reduced, with no signs of worsening based on clinical scores, ultrasound scans, or lab tests, according to a new study.

: Shreehas P. Tambe, MD, highlighted the significant potential for 

biosimilars to expand into other disease areas

 like diabetes, offering crucial cost-saving solutions amid a rising global burden of noncommunicable diseases.

: Incentivizing physicians with modest financial bonuses may seem like a small step, but in Japan’s outpatient oncology setting, it helped push 

 toward broader adoption, demonstrating how even limited reimbursement reforms can reshape prescribing behavior under the right conditions.

: Alvotech/Teva and Biocon Biologics advanced 

 with FDA interchangeability for ustekinumab biosimilars, Selarsdi and Yesafili, plus broad 2025 formulary coverage for Biocon’s Yesintek.

: Sarfaraz K. Niazi, PhD, discusses US Senator Rand Paul's Expedited Access to Biosimilars Act, which 

aims to streamline the biosimilar approval process

 by eliminating redundant clinical study requirements, potentially lowering drug prices and improving access to life-saving treatments.

The Top 5 Biosimilar Articles for the Week of May 12

Ivo Abraham, PhD, highlights follow-on biologics as a pathway to a more equitable global health care system by reducing costs and expanding treatment access. | Image Credit: hamkin - stock.adobe.com

Follow-on biologics, including biosimilars, biobetters, and bioparallels, hold significant promise for creating a more equitable and accessible global health care landscape by driving down costs and enabling budget-neutral expansion of treatment options, according to Ivo Abraham, PhD, director, center for health outcomes and pharmacoeconomic research at The University of Arizona Cancer Center.


Abraham delivered a keynote session at the 

 held from April 23-24 in San Diego, California, about biosimilars promoting value, access, and equity.

 He introduced the concept of biobetters, defining them as novel molecules designed to improve the properties of existing ones. Additionally, bioparallels are novel follow-on biologics that do not reference another biologic and compete on price through a different regulatory route in the US.


“Whether it's a biosimilar, biobetter, or bioparallel, this yields cost efficiencies. Importantly, this enables budget-neutral expanded access,” Abraham stated.

Follow-on biologics also improve patient equity and expand access on a global scale, in addition to lowering treatment costs, yielding cost-efficiencies, and enabling budget-neutral expanded access. The advancement of follow-on biologics can be demonstrated with comparative values, such as budget impact and affordability analysis, as well as shadow modeling of value approaches. Demonstrating the comparative values of follow-on biologics through cost-effectiveness studies and alternative metrics like quality-adjusted life years remains significant.


Building evidence based on real-world clinical practice patterns and outcomes can also help advance the use of follow-on biologics. Abraham emphasized the importance of due diligence, clinical review, and validation methods. He suggested modeling risk and risk exposure to anticipate, manage, and mitigate risk. This can be done by modeling the risk of interchangeability with the reference product, the risk with consequences of administration failure, price evolution and erosion, along with supply chain disturbances.


“The modeling of interchangeability can be modeled statistically, and those results will most likely be much more informative, much more robust than having a switching trial with a few 100 patients, especially in terms of safety data,” Abraham stated.


Exclusivity contracts and private labeling impact provider adoption, and clinical guidelines influence treatment decisions. Supply chain disturbances, like natural disasters and import/export constraints, were identified as potential risks that alternative production and distribution strategies could mitigate.


Potential remains in bringing follow-on biologics as biological therapies to lower- and middle-income countries, emphasizing the need for realistic and collaborative approaches. Price adjustments can help make follow-on biologics more accessible in global markets, and public-private sector collaboration holds potential.


“This is where international organizations, international foundations, may come in and be helpful. We need to facilitate public-private sector collaboration, design innovative and sustainable pricing and financing models, and enable provider innovation awareness and trust campaigns,” Abraham concluded.


Abraham I. Biosimilars: promoting value, access, and equity. Presented at: Festival of Biologics USA; April 23-24, 2025; San Diego, CA.

Ivo Abraham, PhD, highlights follow-on biologics as a pathway to a more equitable global health care system by reducing costs and expanding treatment access. 

Follow-On Biologics Poised to Expand Global Health Care Access and Lower Costs

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

 on the future of ustekinumab biosimilars for treating Crohn disease (CD) 

, including a lack of data in CD and opportunities to improve access to treatment.

: Christopher T. Robertson, JD, PhD, reviewed 

 of providing access to drugs before FDA approval, highlighting the crucial role of clinical trials and ethical safeguards at the 2025 Festival of Biologics USA.

 demands bold collaboration, early global partnerships, and a fresh approach to development strategies to overcome uncertainty and drive future success.

: A wave of biosimilar approvals, aggressive pricing strategies, and a regulatory sea change are setting the stage for unprecedented momentum in the 

, with 2025 already proving to be a landmark year in reshaping cost, access, and innovation across therapeutic areas.

The Top 5 Biosimilar Articles for the Week of May 5

Shreehas P. Tambe, MD, highlighted the significant potential for biosimilars to expand into other disease areas like diabetes, offering crucial cost-saving solutions amid a rising global burden of noncommunicable diseases. | Image Credit: oatawa - stock.adobe.com

Biosimilars are gaining acceptance, and with oncology drugs exceeding 80% adoption, biosimilars in the US are saving the health care system $13 billion to $15 billion annually, according to Shreehas P. Tambe, MD, managing director and CEO at Biocon Biologics.


 held from April 23-24 in San Diego, California, about biosimilars in health care systems as they face a transformative shift in evolving regulatory, market, and policy landscapes to drive changes in access, affordability, and innovation.

The global disease burden for noncommunicable diseases is expected to increase significantly. For example, oncology incidence is expected to increase to 30 million patients by 2040 and diabetes is expected to affect 1 in 8 adults by 2045.

Projections indicate the overall share of biologics across all pharmaceutical spend will be about 40% by 2026. Additionally, the global biosimilars market is predicted to grow about 3 times more by 2028, reaching $54 billion.


Noncommunicable diseases like oncology, diabetes, and immunology are major contributors to the evolving global disease burden, with biologics representing 12 of the 15 top-selling drugs in 2023, and 45 blockbuster drugs losing exclusivity, presenting a $270 billion opportunity.


Biosimilar adoption in the US has varied widely based on the medication, but the market has shown strong overall adoption among several molecules. Market adoption between 2019 to 2024 grew over 50% for 5 of 8 biosimilars measured. The highest adoption rates were among adalimumab, bevacizumab, rituximab, trastuzumab intravenous, and tocilizumab. Bevacizumab volume increased 34% since biosimilar entry in the US market.

“The oncology drugs have already exceeded that 80% threshold. If you see most of the other products, even those which have been launched in the last 3 to 4 years, have all trended in excess of 50%,” Tambe added.

As diabetes prevalence rises in the US, an urgent need for more affordable solutions could increase the role of biosimilars. The US ranks third globally in adult diabetes prevalence, with another 9.6 million predicted to be undiagnosed. Diabetes accounts for one of the highest health care expenditures among adults, estimated at $404.5 billion in costs.


These challenges intertwine with the unique market archetypes in the US. Physicians administer drugs in the medical benefit (Part B) space, allowing payers to control coverage, but account economics also influence purchase decisions. Additionally, average sales price–based reimbursement affects profit and drives market depreciation.


On the pharmacy benefit side (Part D), vertically integrated payers and specialty pharmacies make decisions, often with incentives. Although health care providers write prescriptions, interchangeable biosimilars empower pharmacies. Immunology biosimilars are beginning to show progress, but insulin adoption remains slow.


The growing US biologics market is expected to have a 26% compound annual growth rate from 2021 to 2025. Over the next couple of years, savings are expected to exceed $180 billion.


 is projecting to show that between now and 2030, we will already start seeing far higher benefits than what we've seen. So when I say that the next 5 years are far more exciting than the 5 years that we've seen, it's not just exciting for those developing products, but it's also exciting for the health care system,” Tambe said.

To successfully bring these biosimilars to market, Tambe emphasized the need for:

“Biosimilars present a massive opportunity to bring health savings that the health care system is looking for. The signs of savings are already in place. We are looking forward to a far more exciting time than what we've seen so far,” Tambe concluded.

1. Tambe SP. Biosimilars in healthcare. Presented at: Festival of Biologics USA; April 23-24, 2025; San Diego, CA.

2. Lutzmayer S. Pharma’s frozen assets: cold chain medicines. IQVIA white paper. Accessed May 5, 2025. 

https://www.iqvia.com/-/media/iqvia/pdfs/library/white-papers/iqvia-pharmas-frozen-assets_final.pdf

Shreehas P. Tambe, MD, highlighted the significant potential for biosimilars to expand into other disease areas like diabetes, offering crucial cost-saving solutions amid a rising global burden of noncommunicable diseases.

Oncology Biosimilars Cut Costs; Diabetes and Other Diseases Could Follow

The Top 5 Biosimilar Articles for the Week of April 28

: Sophia Humphreys, PharmD, MHA, BCBBS, emphasized that 

legislative support and formulary changes

 are crucial for overcoming unique challenges in specialty pharmacies and driving the growth of biosimilar adoption, which has significant cost saving potential in the next decade.

: Dracey Poore, MS, director of biosimilars and emerging therapies at Cardinal Health, highlighted that biosimilars saved $36 billion over the last decade by 

improving patient access and the supply chain

, but continued education and a robust pipeline are crucial for future growth.

 in the fight against inflammatory bowel disease (IBD), offering a cost-effective alternative to biologics with similar efficacy and safety, while innovative drug delivery systems promise to further enhance treatment outcomes and accessibility for millions worldwide.

: Sandoz's antitrust suit against Amgen, the 

 for Celltrion’s adalimumab biosimilar, and the inclusion of an ustekinumab biosimilar in Costco’s prescription program highlight growing momentum to expand biosimilar access and affordability for patients with chronic inflammatory diseases.

: Sarfaraz K. Niazi, PhD, shares his latest 

, calling on the agency to waive clinical efficacy testing in response to the European Medicines Agency's (EMA) efforts towards the same goal.

Here are the top 5 biosimilar articles for the week of April 28, 2025.