Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

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.

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.

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.

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

To read all of these articles and more, visit 

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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

Articles

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

Elena Wolff-Holz, MD

Elena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, discussed the approval of 

, for psoriasis treatment, a biosimilar referencing Stelara (ustekinumab). She highlighted the comparable efficacy and safety with reference Stelara, including positive switching data.


Wolff-Holz believes biosimilars will increase patient access through reduced costs and suggests that reference product manufacturers should focus on innovative drug development. She noted that Yesintek has shown to be less immunogenic than the reference product, potentially offering an additional benefit to patients.

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

With the recent launch of three ustekinumab biosimilars in the US market, how do you see BMAb-1200 fitting into this rapidly evolving landscape?

I think the real comparison is really the biosimilars vs the reference medicine product, Stelara. Coming back to what biosimilars are, these are absolutely high quality products, highly regulated products, and the primary analysis really are at the quality level.


Comparative analytical studies are required, many more than you would have for new drug application and you have to look for physical chemical analysis, for biological functional comparability on very, very solid ground and then you go on with the PK study or with another trial. Actually, the onus, really, of the proof is in this initial quality comparison that really, truly, this is the same biologic drug, and this rigidity with which you have to prove the amino acid sequence is the same, the higher order structures are the same, the glycosylation pattern must be within very strict comparability model. All of this must be done by all biosimilar contestants, and you can only get approved if you have these if you have proven that this comparability exists.

One biosimilar vs another, I think here the features would be how the drug is given, so whether you have it in a PFS or other devices, things like that. Otherwise, it's really the same, and it's rather the question, do you still need the reference medicinal product on the market? That's really the question. I mean, they've been around for 10 years or even more, through patent prolongation. I really think their job should be to think of new drugs, innovative drugs. That is their primary capability, that should be their challenge.


I think they should leave the biosimilars alone. Once they're on the market, I think, from my point of view, the reference medicinal product is superfluous.

What are your thoughts on the impact that these biosimilars will have on patient access and the overall cost of psoriasis treatment?

I think BMAb-1200 or Yesintek on the market is just a wonderful addition to ustekinumab antibodies. I think the good news is it is less immunogenic than the reference medicine product. That is something that you observe, typically, not so much because of the product as such, that is the substance, the actual drug substance, but rather the fluid, the excipients that constitute the other part that makes up the medicinal product. This is something I would say that is quite, quite beneficial.


I think obviously the biggest advantage is reduced price, affordability is a big thing. Bringing down the costs considerably, and by doing that, increases the access patient access, it’s something that we've seen with many biosimilars.


 has nicely studied this, that this does happen, and it's really important, because ultimately, it improves health care. This would serve both sides and free up the space for more expensive, innovative drugs, but on the other hand, you would have then less expensive biosimilar products. This is something where I would think, Yesintek is a fantastic candidate.

Elena Wolff-Holz, MD, discussed the approval and benefits of the ustekinumab biosimilar, Yesintek, emphasizing its comparable efficacy and safety to Stelara, and potential for increased patient access due to lower costs, and a possible lower immunogenicity profile.

Yesintek Biosimilar Shows Comparable Efficacy, Lower Immunogenicity Than Stelara, Says Elena Wolff-Holz, MD

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.

Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape 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. | Image Credit: wladimir1804 - stock.adobe.com

Despite a high approval rate for expanded access requests, the history of preapproval drug access underscores the critical importance of rigorous clinical trials and ethical considerations, advocating for a "proof-before-profit" approach to drug availability, according to Christopher T. Robertson, JD, PhD, professor at Boston University school of law.


Robertson spoke at the 2025 Festival of Biologics USA about the law and ethics of providing access to drugs before FDA approval, highlighting the FDA’s multistep process of proving drug safety and efficacy.


In the 1960s and 1970s, marketers presented laetrile to address the widespread cancer crisis, but the FDA rejected its approval, leading 27 states to attempt to legalize it. In 1979, 

a case argued before the Supreme Court, saw patients with terminal cancer and their spouses argue against government interference in the sale of laetrile.

Ultimately, the active ingredient in laetrile, cyanide, cannot cure cancer. Robertson explained that critics have called the drug "the slickest, most sophisticated and certainly the most remunerative cancer quack promotion in medical history."

The FDA then decided to formalize and issue regulations, thus creating the expanded access program (EAP). This program enables patients with serious or life-threatening conditions to access investigational drugs or medical devices outside of clinical trials.

Robertson further highlighted that although many believe the FDA's purpose is to protect people from unsafe drugs, the Supreme Court decision and modern thinking about the FDA implicitly reveal its true purpose: to produce knowledge and largely solve the collective action problem of determining drug safety and effectiveness.


Additionally, the FDA responded to the AIDS crisis by making more drugs available through compassionate use. For example, in 2008, 

 introduced constitutional questions about patients with terminal illnesses and their rights to override the FDA. In the end, the court ruled that states have regulated drugs since the 1700s and the federal government has done so since the 1840s, and it was unwilling to change this.

“One reason it's worth lingering on now, though, is the Supreme Court we have today is not a real big fan of unenumerated rights unless it speaks to a different political priority, so you may well see a case like this come back in another way,” Robertson stated.


In 2016, the 21st Century Cures Act declared that companies must have a policy on expanded access. However, challenges hinder access to drugs before approval, and companies often refuse to provide the medications. Robinson explored the potential benefits of providing preapproval access, such as gaining perspective from key opinion leaders and producing real-world data.


The Right to Try Act of 2017 allows patients with terminal illnesses to access drugs that have cleared phase 1 investigations but have not received FDA approval. This act prohibits the FDA from using data on these patients' outcomes and does not require their review, potentially immunizing physician and company negligence.

Physicians can request access from manufacturers during or after phases 1, 2, or 3 of clinical trials for patients to gain access through the EAP. The federal Right to Try Act grants patients access through physicians who can request access from manufacturers after phase 1 is completed and during or after phase 2 or 3 of clinical trials.


Robinson explained that if a company provides a product with a limited supply, the question arises: who receives it? Who should be prioritized? Who will gain the most benefit?


“Ultimately, the basic principles are proof before profit, prioritizing clinical trials to get the evidence so you can actually help more people in the end, and make sure there's reasonable risks, and informed consent,” Robinson concluded.

Robertson CT. Law and ethics of providing access to drugs before FDA approval. Presented at: Festival of Biologics USA; April 23-24, 2025; San Diego, CA.

Christopher T. Robertson, JD, PhD, reviewed the history and ethical landscape 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. 

FDA's Expanded Access: From Laetrile to Right to Try, Ethical Debates Over Early Drug Access

Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas. | Image Credit: WrightStudio - stock.adobe.com

Streamlining regulatory processes, addressing patent abuse, and evolving reimbursement models to ensure sustainability can help overcome barriers and expand biosimilars into new therapeutic areas, according to Sonia T. Oskouei, PharmD, vice president of biosimilars and specialty at Sandoz.


Oskouei spoke at the 2025 Festival of Biologics USA from April 23-24 in San Diego, California, on how to bridge the biosimilar void through solutions that create a more sustainable market. In 2015, the first biosimilar, Zarxio (filgrastim-sndz), launched; it has generated $1.6 billion in savings for the US health care system between 2016 and Q1 2022.


Like many other speakers, Oskouei emphasized the 118 biologics that will lose patent protection between 2025 and 2034, representing a $234 billion market opportunity, but currently only 12 of those medicines have biosimilars in development.


“To look at it more in a positive light, the biosimilar void is not permanent. It's a pivotal moment to be claimed. We do have tools, expertise, and, naturally, more experience than ever with these products, not just in the US, but globally. We should be able to use those more and more to shape policy makers and stakeholders to build a biosimilars market that is sustainable and offers patients access to these critical treatments,” Oskouei explained.


The regulatory process for developing biosimilars has not evolved at the same pace as technological advancements, creating a gap between potential and reality. Significant barriers in the biosimilar landscape, from patent abuse and supply chain disruptions to misaligned stakeholders, regulatory complexity, a lack of health care provider awareness, and dynamic environments, all contribute to this issue.

For example, the long, complex, and expensive process of biosimilar development prevents the ultimate availability of medicines. Oskouei proposed a tailored regulatory framework for biosimilar development that maintains high scientific standards to streamline the approval process and improve overall patient access.

The average sales price model for reimbursement is also not sustainable, and evolving this model is necessary to ensure long-term sustainability and investment in biosimilars, she said. Additionally, the Medicare Part B reimbursement system and misaligned incentives create significant barriers. Evolving reimbursement models for medical benefit biosimilars can transform this barrier into an opportunity by encouraging a competitive and sustainable biosimilar market.


“These are barriers and we should not consider them roadblocks. There's a key difference. These are not insurmountable, and there's distinct things that we could do to take action and make sure that we make progress again. We're in a very pivotal time in this space where we need to be more bold than ever, in my opinion, to ensure that we have the continued investment to bring biosimilars to market,” Oskouei stated.


Patent thickets and anticompetitive tactics by originator companies delay biosimilar entry, prioritizing profits over patients, Oskouei said, which remains another challenge of patent abuse. Policy makers can implement legislative or regulatory solutions to stop delay tactics that ultimately limit access to affordable treatments.

According to Oskouei, tariffs directly threaten the affordability and accessibility of biosimilars, necessitating bold advocacy and policy engagement. The health care ecosystem's barriers, not biosimilars themselves, prevent the rollout of high-quality, lower-cost treatment options.


Safeguarding the biosimilar industry amid a dynamic environment is essential to unlock its full potential for patients. Collaboration, especially through partnerships with US policy makers and advocacy for positive change, will further progress in this industry.


“It's not really just a policy issue, I actually think it comes down to a moral issue. Every dollar wasted that could have been saved is preventing advancement in health care delivery from care research or the next generation of innovative treatment options. We are in an exciting time with biosimilars,” Oskouei concluded.

Oskouei ST. Bridging the biosimilar void: solutions for a sustainable market. Presented at: Festival of Biologics USA; April 23-24, 2025; San Diego, CA.

Sonia T. Oskouei, PharmD, emphasized strategies to streamline regulations and evolve to overcome barriers and expand the availability of cost-effective biosimilar treatments across more therapeutic areas. 