Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

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.

To read all of these articles and more, visit 

Videos

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.

Articles

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. 

Addressing Patent Abuse, Reimbursement Models Key to Sustainable Biosimilar Market

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. | Image Credit: Pornarun - stock.adobe.com

Legislative support and formulary changes, among other actions from industry stakeholders, are crucial to overcome unique challenges and drive further growth in biosimilar adoption within specialty pharmacies, given the significant opportunities presented by expiring biologic patents, according to Sophia Humphreys, PharmD, MHA, BCBBS, executive director of pharmacy at Providence.


Humphreys spoke at the 2025 Festival of Biologics USA from April 23-24 in San Diego, California, about how to navigate the unique challenges for biosimilar adoption in specialty pharmacies. She began by recognizing 118 biologics will lose exclusivity in the next 10 years, presenting opportunities for biosimilars.


“If you catch them all, the total US—just US—sale opportunity is $234 billion that's up for grabs [in the] next 10 years,” Humphreys stated.


She touched on the successes of biosimilars in the US, from their initial launch in 2015 to the approval of 69 biosimilars. Humphreys noted that the FDA approved 28 biosimilars in 2024 and another 6 by the end of Q1 2025.

Biosimilar developers face barriers like the high costs and time that research and development (R&D), FDA approvals, and manufacturing require. Immunology and oncology account for the highly concentrated R&D costs. Additionally, reducing R&D costs can make more life-saving products accessible to patients.

“That would help us to expand to more therapeutic classes, to even have any company considering entering into orphan drugs entering into those less popular, less exciting classes like oncology,” she said.

Humphreys detailed the void in biosimilar R&D due to:

The high cost to develop biosimilars ($100-$250 million)

The time commitment of approximately 6 years

Lack of biosimilar entry for orphan drugs

A lack of interest in biosimilar R&D relative to medicine total sales


Various factors complicate the biosimilar market, including barriers posed by payers and pharmacy benefit managers, specialty pharmacies, interchangeability designations, FDA policy updates, and average sales price-based payments. Additionally, the Inflation Reduction Act (IRA) presents both pros and cons regarding biosimilar R&D, integrated delivery network costs, and the new requirement for identical delivery systems, all of which create market barriers.


Regulatory burdens, the IRA under the Trump administration, newer or better-tolerated agents, potential originator formulation improvements, and the expansion to more therapeutic drug classes contribute to the uncertain future of the biosimilar market.


Pharmacy benefit considerations include promoting more patient/provider education, reimbursing at dispensing, enabling interchangeability and pharmacy-level switching, implementing payer mandates, specialty pharmacy vertical integration, and the use of private labels that may further discourage competition.


“Expanding therapeutic classes—this is really key for our success in the future. We can stay all in our comfort zone, which I understand why we stay in oncology, immunology: [there is] big money [and a] large patient population. However, if we don't develop into other therapeutic classes, we are—as the industry, as a branch of the health care industry—going to face a lot more burdens and a lot less competition, and less competition means higher prices,” Humphreys concluded.


Humphreys S. Navigating the unique challenges for biosimilar adoption in specialty pharmacies. Presented at: Festival of Biologics USA; April 23-24, 2025; San Diego, CA.

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.

Unlocking Biosimilar Potential in Specialty Pharmacies With Legislative Support, Formulary Changes

Dracey Poore, MS, director of biosimilars and emerging therapies at Cardinal Health, highlighted 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. | Image Credit: phimprapha - stock.adobe.com

Over the past 10 years, the biologics market has demonstrated significant savings of $36 billion, along with increased patient access and a stronger supply chain, according to Dracey Poore, MS, director of biosimilars and emerging therapies at Cardinal Health and a member of The Center for Biosimilars® Advisory Board.

Speaking at the 2025 Festival of Biologics USA, taking place April 23-24 in San Diego, California, Poore highlighted a 

 report reviewing the past decade's biosimilar milestones.


The biosimilars market has increased patient access, particularly for costly treatments, and established a stronger overall supply chain. Furthermore, biosimilars foster a competitive landscape that curbs price escalation, and regulatory maturation alongside stakeholder education and acceptance have shifted approval processes while increasing trust in biosimilars.


“I remember when we first launched the biosimilars, I was in the industry then as well, and we were just trying to teach about how they got to market, the approval process. We don't have to talk about that so much anymore. Now we're talking about sustainability. We're talking about viability. We've evolved. We've matured,” Poore explained.


Education has moved the industry, but continued efforts are necessary for growth as more biosimilars enter new therapeutic areas. Poore referred to research focused on the retina, a biosimilar market with fast uptake, where ranibizumab biosimilars have reached 55% uptake. Poore emphasized that the future of retina biosimilars is promising, with the aflibercept market estimated to have $6.3 billion in wholesale acquisition cost sales in 2024.


“Dr [Jon] Adelberg, one of the retina specialists I spent a lot of time with, said that in his practice, only 1 in every 100 patients knows what a biosimilar is. If you think that the education piece is over, it's not,” Poore said.


In oncology, practices have found ways to make biosimilars more profitable, thus improving adoption despite economic barriers like reimbursement policies and pricing dynamics and noneconomic barriers such as provider/patient awareness, inventory management, and benefit investigation processes.

Poore emphasized that tight revenue cycle management, strong collaboration with a pharmacy team, payer analysis, and on-time ordering are some avenues for success. She also addressed sustainability concerns, noting adalimumab biosimilars have a 28% market share, falling short of the predicted 46% by the end of 2025, despite the demonstrated cost savings potential of biosimilars.


Poore explained how the oncology biosimilars market aligns with the value-based care model to improve patient outcomes and reduce costs, and practices with strong payer relationships can successfully leverage them to secure biosimilar coverage.


Looking ahead, Poore highlighted key priorities:

Education to improve provider and patient confidence and trust

Clarifying interchangeability designation to increase market adoption

Market viability to align stakeholder incentives with policy support

Pipeline expansion, as only 10% of the 118 biologics expected to lose patent protection in the next decade have biosimilars in development

Poore expressed concerns about whether the current drug pipeline is sufficient to provide market savings for funding future innovations, align stakeholder incentives, and ensure market viability and profitability.

“I do believe the foundation has been built, and I think we've done a great job the last decade of building the foundation. Obviously, we have not unleashed the full impact of this market, but we have the next 10 years to do that,” Poore concluded.

Poore D. A decade of biosimilars. Presented at: Festival of Biologics USA; April 23-24, 2025; San Diego, CA.

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. 

Decade of Biosimilars Yields $36 Billion in Savings and Strengthens Supply Chain

The Top 5 Biosimilar Articles for the Week of April 14

: Early market entry, manufacturing efficiency, and market share are critical to biosimilar development success, while technical complexity and competition heavily impact returns, according to a study presenting a risk-adjusted 

, pharmaceutical companies accelerated biosimilar expansion through strategic acquisitions and partnerships in hopes of boosting patient access to lower-cost treatments in immunology and oncology.

: Teva and Samsung Bioepis have launched Epysqli, a cost-saving Soliris biosimilar, offering a 30% discount and new hope for patients with rare, life-threatening 

: Lawmakers and expert witnesses emphasized the potential of biosimilars to lower health care costs by overcoming barriers like pharmacy benefit manager practices, limited awareness, and regulatory delays to improve access and competition in chronic disease management 

: Biocon Biologics expands its oncology biosimilar roster after gaining 

 (bevacizumab-nwgd), the sixth biosimilar referencing Avastin (bevacizumab).

Here are the top 5 biosimilar articles for the week of April 14, 2025.

Trastuzumab biosimilars saw significant market uptake in Japan after reimbursement incentives were implemented, but bevacizumab biosimilars did not experience a similar response. | Image Credit: Shevon - stock.adobe.com

Reimbursement incentives significantly increased the market uptake of trastuzumab biosimilars for cancer treatment but failed to produce a similar effect for bevacizumab biosimilars, suggesting policy makers design reimbursement strategies tailored to each biosimilar to optimize effectiveness, according to a time series analysis published in 

Novel cancer drug costs are continuously rising, and health care systems are looking to rely on the entry of biosimilars to lead them to significant cost reductions. Patients receiving cancer treatment in Japan have an estimated annual economic burden of about $12.6 million (¥1296 million), including $11 million (¥1128 million) for targeted therapy, $1.3 million (¥130 million) for nontargeted therapy, and $0.4 million (¥38 million) for anticancer therapy–related costs.

The Japanese government is focusing more on reimbursement incentive policies to promote biosimilar adoption within the health care system.

 The biosimilar adoption incentive policy will offer medical institutions a premium of approximately $10 (¥1500) per prescription for up to 3 months.

Researchers aimed to determine the effectiveness of this policy intervention for oncology drugs, specifically trastuzumab and bevacizumab, in outpatient settings using an interrupted time series analysis. They utilized health insurance claims data from January 1, 2005, to March 31, 2023, for Tokyo, Japan.

Trastuzumab insurance claims (22,440) for treating breast or gastric cancer and bevacizumab claims (14,022) for treating colorectal or lung cancer were utliized for this analysis. There were 11,622 claims in the preintervention period for trastuzumab (April 2021-March 2022) and 10,818 in the postintervention period (April 2022-March 2023). Bevacizumab had 6973 claims prior to intervention and 7049 afterward.

For trastuzumab, 97% of the claims were from female patients in both periods while for bevacizumab, 42% of claims were for female patients before the policy change and 43% afterward. There were also more trastuzumab claims for treating breast cancer (96%) than gastric cancer (4%). Bevacizumab was used at the treatment for 86% to 87% of the claims for colorectal cancer and 13% to 14% of the claims for lung cancer in both observed periods.

The time series analysis demonstrated a significant preintervention monthly increase in biosimilar use of 0.65% (95% CI, 0.48%-0.83%). The postintervention slope change of 0.33% (95% CI, 0.07%-0.58%) and the overall postintervention slope of 0.98% per month (95% CI, 0.8%-1.16%) also were significant, showing a continued increase in biosimilar uptake.

Bevacizumab had a significant increase in biosimilar usage before the policy intervention, with a slope of 1.56% per month (95% CI, 1.44%-1.69%). The level change postintervention was 0.16% (95% CI, –1.52% to 1.83%). The slope change postintervention was –0.18% (95% CI, –0.41% to 0.06%), which was not significant. The postintervention slope remained positive and significant at 1.38% per month (95% CI, 1.17%-1.60%).

The prices for the originator and biosimilar versions of trastuzumab, as of April 2022, were $231 (¥34,670) and $127 (¥19,118) for 150 mg, respectively. Bevacizumab’s originator and biosimilar were priced at $811 (¥121,608) and $363 (¥54,403) for 400 mg, respectively.

The results may not be fully representative of the overall Japanese population, and the medications may not have been analyzed long enough to capture the effects of the policy over the long term. Also, the outcomes are tied to specific characteristics of Japanese health care and reimbursement systems that might not be directly applicable to the differing health care infrastructures, regulatory environments, and approaches to biosimilar promotion of other countries. The study also is limited by the external validity of our conclusions, especially since each country has a unique policy landscape that could influence the effectiveness of similar interventions.

“It is crucial for policy makers to design reimbursement strategies that are specifically tailored to the characteristics of each biosimilar to optimize their effectiveness,” study authors concluded.

1. Mamiya H, Fukasawa T, Kawakami K. Effects of reimbursement add-on policies on trastuzumab and bevacizumab biosimilar adoption in Japanese oncology setting. 

2025;46:101090. doi:10.1016/j.vhri.2025.101090

2. Yusuke Kajimoto, Honda K, Nozawa K, Mukai M, Teng L, Igarashi A. Use of anticancer therapies and economic burden near the end of life in Japan: results from claims database. 

. 2022;8:e2200227. doi:10.1200/go.22.00227

Trastuzumab biosimilars saw significant market uptake in Japan after reimbursement incentives were implemented, but bevacizumab biosimilars did not experience a similar response.

Trastuzumab Biosimilar Adoption Increased in Japan Due to Reimbursement

Elena Wolff-Holz, MD

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

 as a biosimilar to reference ustekinumab (Stelara) to treat psoriasis.


Wolff-Holz emphasized the comparable efficacy and safety results observed, including pre- and postswitch data, while acknowledging challenges in patient recruitment and navigating diverse global regulatory requirements.

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

What specific clinical end points or patient-reported outcomes did you find most compelling in support of the study comparing BMAb-1200 with reference ustekinumab?

Well, maybe just a few introductory statements, so BMAb-1200 is now an approved drug. It just got recently approved and is called Yesintek [ustekinumab-kfce] here in the United States and will also be launched in Europe and Japan in the next few weeks.


The clinical basis, the clinical study, the phase 3 trial that was conducted in support of the marketing authorization application, was a clinical trial that lasted 52 weeks. It was a double-blind randomized trial in 384 patients, and they were rerandomized; those patients that received the originator drug Stelara were rerandomized at week 16 to either continue on the Stelara or get the BMAb-1200, and then all patients were followed in a blind fashion until week 52.


In terms of end points, the primary end point, and I think that was the most compelling, was at week 12. That's important because it's sort of in the steep part of the dose-response curve, and you can really, if there was a difference, you would detect it at that time point. Actually there was, in terms of change of the PASI [Psoriasis Area and Severity Index] score from baseline, there was absolutely no difference.


The FDA and also EMA, they have certain requirements on how they define confidence intervals. The 2 drugs must be within this confidence interval, and [for] FDA plus/minus 10% is allowed. We had a difference of 0.68%, so that's very compelling primary end point results. Above and beyond, we've also looked at week 4, 8, 16, and 20-week data, and that was also highly similar. We looked at preswitch and postswitch data, and again, the switching would not have any impact with regard to the PASI score or safety or immunogenicity.


These are all very important findings, and I would think, in summary, those are the most important ones, but there's also the PsA [psoriatic arthritis], actually, and they were also comparable. All of this gives a very comprehensive story.

What were the most significant challenges encountered during the study, and how were they addressed? What lessons were learned that could benefit future biosimilar development?

This was a global study at 41 centers, 5 countries, and 384 patients, so recruiting these patients on time. We had a global development that would satisfy all the legislations, including PMDA [Pharmaceuticals and Medical Devices Agency], that is Japan's regulatory body. At that time, we were asked to have at least 15% Japanese patients, and that was a challenge to include. Luckily, the Japanese regulators now have changed this demand. It's no longer required. It also introduced heterogeneity. That's something we would change, and we would be allowed to change.

Otherwise, I think anything that enhances inspection readiness would be of advantage. I think we've implemented checkpoints already in the trial, but this is something also in terms of monitoring continuity from the CRO [contract research organization] site to the sites. I think that's something I would take more care even to have this continuity so one particular CRA [clinical research associate] or CRM [clinical research management] [is] really being available for the entire study and beyond to carry through, also the inspections.

Elena Wolff-Holz, MD, global head of clinical development at Biocon Biologics, discussed the approval of BMAb-1200, a biosimilar to reference ustekinumab for psoriasis, highlighting comparable efficacy and safety data while noting challenges in global patient recruitment and regulatory navigation.

The Global Biosimilar Development and Approval of Yesintek With Elena Wolff-Holz, MD

Here are the top 5 biosimilar articles for the week of April 7, 2025.

 Mvasi and Zirabev provided cost savings for metastatic colorectal cancer (mCRC) treatment without compromising effectiveness.

: High adherence rates, comparable clinical effectiveness, and cost savings have marked the early adoption of adalimumab biosimilars in the US, particularly in formulary-driven transitions, as shown in 2 retrospective studies presented at the 

Academy of Managed Care Pharmacy annual meeting (AMCP 2025)

, the market continues to evolve with expanded treatment options, cost savings, and a flurry of new competitors—yet regulatory challenges, market dynamics, and patient accessibility remain key hurdles to unlocking its full potential.

 Ongavia exhibited significantly less improvement in visual acuity and retinal thickness compared with aflibercept (Eylea) in treating neovascular age-related macular degeneration (nAMD), highlighting a potential trade-off between economic savings and clinical efficacy.

—fueled by its biosimilar portfolio and global expansion—highlights the booming profitability of biosimilars despite financial hurdles.

The Top 5 Biosimilar Articles for the Week of April 7

Here are the top 5 biosimilar articles for the week of March 31, 2025.

 demonstrated comparable efficacy, safety, and immunogenicity to reference drug Tysabri in patients with relapsing-remitting multiple sclerosis (RRMS), supporting its potential as a cost-effective treatment option.

 products does not affect drug effectiveness or treatment duration in patients who have psoriasis, according to a Danish study.

 lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.

denosumab biosimilars, Conexxence/Bomyntra

 (denosumab-bnht), expanding treatment options for osteoporosis, bone metastases, and other bone-related conditions, amidst a flurry of similar approvals and legal settlements.