Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

Here are the top 5 biosimilar articles for the week of June 9, 2025.

: Leading biosimilar companies Sandoz, STADA Arzneimittel, and Samsung Bioepis 

, driven by strong denosumab biosimilars and expanding portfolios.

lower development costs and streamlined regulations

 to enhance patient access to affordable biosimilars.

 launch in the US, enhancing access to affordable treatments for osteoporosis and cancer-related skeletal events.

 accelerate the entry of generics and biosimilars, saving the health care system $422.9 billion and enhancing drug accessibility.

 matches Prolia in efficacy, offering a cost-effective treatment option for postmenopausal osteoporosis.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of June 9

Switching from reference ustekinumab to biosimilar FYB202 maintained comparable efficacy, safety, and immunogenicity in patients with moderate to severe plaque psoriasis. | Image Credit: SNAB - stock.adobe.com

(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

Articles

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

Here are the top 5 biosimilar articles for the week of June 2, 2025.

 for new biosimilars like Starjemza and Hadlima enhance treatment options, addressing urgent needs for affordability and policy reform.

: Denosumab biosimilars Wyost and Jubbonti launch in the US, enhancing access to affordable treatments for 

osteoporosis and cancer-related skeletal events

FDA designates 2 biosimilars as interchangeable

, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.

, enhancing treatment options for rheumatic and gastrointestinal conditions.

The Top 5 Biosimilar Articles for the Week of June 2

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

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.

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. 