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WHEN CHOICE ARRIVES: Competition & Consequences

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BIOSIMILAR APPROVALS

Kennedy Ferruggia is an Assistant Editor for Pharmacy Times

Articles

Adalimumab biosimilars differ from adalimumab in approved indications, concentration and dosage, and formulation.

Pharmacists Play a Crucial Role in Adalimumab Biosimilars for Patient Care

The approvals for Celltrion's denosumab-bmwo (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases.

FDA Approves Third Pair of Denosumab Biosimilars

A prospective cohort study found that switching back from the biosimilar SB2 to the reference infliximab did not affect clinical disease activity or safety in inflammatory bowel disease (IBD). 

No IBD Activity Changes Following Switch From Biosimilar to Originator Infliximab 

February brought policy updates and several biosimilar approvals, including the first FDA approval for an insulin aspart biosimilar.

Biosimilars Regulatory Roundup: February 2025

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Innovative statistical methods, such as simultaneous CIs and multiplicity-adjusted TOST (MATOST) were explored by researchers to address challenges posed by differing FDA and European Medicines Agency (EMA) regulatory requirements for biosimilar approvals, according to a review published in 

These differences have prompted research into innovative statistical methods for more efficient and accurate biosimilar assessments. When a biosimilar has both US and EU reference products, sponsors must conduct 3 bridging studies comparing the biosimilar product with the US-licensed reference product, the biosimilar product to the EU-approved reference product, and the US-licensed reference product to the EU-approved one.

Despite Europe's greater biosimilar adoption, regulatory disparities and complex US approval processes hinder development, underscoring the need for global harmonization.

The FDA and EMA also differ on foreign-approved comparators; the EMA permits them (with caveats), while the FDA requires 3-way comparisons.

Researchers criticize the conventional 3-way comparison for neglecting variability, underutilizing data, and creating multiple testing issues. This study investigated 2 alternatives, simultaneous confidence intervals and MATOST.

Regulatory Framework for Biosimilar Approval

Both agencies have slightly different definitions for biosimilars. The FDA defines biosimilars as biological products highly similar to the reference product, with no clinically meaningful differences between safety, purity, and potency compared with the reference product. However, the EMA defines biosimilars as biological medicinal products containing the same active substance as the reference product and similar in quality characteristics, biological activity, safety, and efficacy.

The FDA's stepwise approach assesses analytical similarity, investigating the structural and functional characteristics of the biosimilar product based on critical quality attributes at various stages of the manufacturing process. The stepwise approach includes a pharmacokinetics (PK) and pharmacodynamics (PD) similarity assessment, demonstrating PK and PD through human clinical pharmacology studies after passing animal toxicity studies, and a clinical similarity assessment, gathering information on immunogenicity, clinical efficacy, and safety.

Additionally, the main purpose of the 3-way comparison is to ensure the drug substance or product meets product specifications, to demonstrate biosimilarity between the test product and the US-licensed product, and to establish a bridge justifying the use of clinical data generated using the EU-approved reference product as the comparator. Strict requirements on biosimilar products are necessary to ensure the efficacy and safety of biosimilars on the market.

The drug sponsor should provide 3-way bridging evidence when using a non–US-licensed product in a regulatory submission for a biosimilar product. This evidence justifies the use of comparative data from the non–US-licensed product in assessing biosimilarity and bridging to the US-licensed reference product.

Disadvantages, such as underutilizing data collected from the entire study, can impair conventional pairwise comparisons, potentially biasing and misleading results. Since pairwise comparisons do not use the same reference product in each comparison, and each comparison may use a different equivalence acceptance criterion margin, the precision of each equivalence test varies. Multiple comparisons will inflate the type 1 error rate unless some significance-level adjustment approaches are considered. Overall, these pairwise comparisons cannot distinguish the relationship among the biosimilar product, the US-licensed reference, and the EU-approved reference.

Without loss of generality, the US-licensed reference product and the EU-approved reference product are considered as the 2 reference products, with the US-licensed reference as the primary reference.

Comparative Analysis of Statistical Approaches

The simultaneous CI method in a parallel study design used fiducial probabilities to perform pairwise equivalence tests. The simulation study used 4 methods for pairwise comparison and included 3 simultaneous CI methods with different assumptions and 1 conventional approach. The results found all approaches can maintain desired power when the sample size per arm is larger than 20. The simultaneous CI method under equal variability has the best performance among all the methods and can achieve similar statistical power to the conventional approach. The study found that the simultaneous CI method works well in parallel study design.

Among simulation results, the Holm and Bonferroni method were very conservative, and TOST was more likely to fail to reject the null hypothesis to control type 1 error inflation. In a crossover design with multiple formulations, especially within the Williams design, the MATOST method is not favorable since it may lead to an unrealistically large sample size, though it can control the type 1 error rate.

Addressing Challenges in Equivalence Testing

The FDA requires sponsors submitting biosimilar products for regulatory approval to conduct a 3-way pairwise comparison when both US-licensed and EU-approved reference products exist. Determining equivalence margins in the equivalence tests is crucial. Using sample estimation in the hypothesis setting is unnecessary because it does not consider the variability of the estimation.

Generalizing the CI method will allow researchers to determine equivalence margins by sampling standard deviations and considering the variability of the estimation. Researchers need to propose another method for controlling type 1 error inflation specifically for crossover designs to reduce the large sample size required for conducting a biosimilar study.

“For future research, it is possible to consider further utilization of fiducial inference under crossover designs and generalize the simultaneous CI method...,” the authors concluded. “Generalizing the simultaneous CI method can help researchers in determining equivalence margins by sampling standard deviations and taking the variability of estimation into consideration.”

Pong A, Chow S, Chow SC. Comparison of innovative and conventional methods in biosimilar bridging studies with multiple references. 

. 2024;18:377-387. doi:10.2147/btt.s470182

Jeremias S. Improving biosimilar access through global regulatory convergence. The Center for Biosimilars

. January 15, 2025. Accessed February 24, 2025. 

https://www.centerforbiosimilars.com/view/improving-biosimilar-access-through-global-regulatory-convergence

The FDA and European Medicines Agency (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.

Business & Practice

Clinical

Biosimilar Approvals Streamlined With Advanced Statistics Amidst Differing Regulatory Requirements

After Wezlana (ustekinumab-auub) became the first ustekinumab biosimilar to enter the market in January 2025,

 3 others joined the fray, expanding access to lower-cost versions of blockbuster Stelara (ustekinumab).

Samsung Bioepis/Sandoz, Biocon Biologics, and Teva/Alvotech launched their respective ustekinumab products: Pyzchiva (ustekinumab-ttwe), Yesintek (ustekinumab-kfce), and Selarsdi (ustekinumab-aekn).

Amgen's launch of Wezlana was part of an exclusive agreement with Nuvalia, Optum Rx’s biosimilar procurement business comparable to CVS Health's Cordavis and Cigna/Express Scripts' Quallent.

 Although Wezlana was the first ustekinumab biosimilar to receive FDA approval and first to launch, the Nuvaila deal partially limits access to patients, creating an opportunity for other FDA-approved biosimilars to fill the gap.

Overall, there are 7 ustekinumab. biosimilars approved by the FDA, all of which are slated to launch throughout 2025. In addition to the 4 on the market, there are Otulfi (ustekinumab-aauz), Imuldosa (ustekinumab-srlf), and Steqeyma (ustekinumab-stba).

 All 7 are approved for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

Ustekinumab biosimilars were originally expected in 2023; however, patent lawsuits brought about by Janssen and its parent company Johnson & Johnson (J&J) resulted in every biosimilar company looking to bring a Stelara biosimilar competitor to market being forced to delay their launches until the first half of 2025, with Amgen winning the first launch spot.

Additionally, these products are looking to compete in a market where the reference drug generated $10.4 billion in sales in 2024, according to J&J’s most recent financial statement.

Over 58.5 million American adults have been diagnosed with a rheumatic disease, with some estimates predicting psoriatic arthritis affects between 6% and 41% of patients with psoriasis.

 Additionally, inflammatory bowel disease, which includes Crohn disease and ulcerative colitis, is estimated to impact between 2.4 million and 3.1 million Americans, according to the CDC.

“The burden of Crohn’s disease and ulcerative colitis on patients’ daily lives is substantial. This is a meaningful advancement for eligible chronic disease patients, who now have more treatment options available,” Laura Wingate, chief education, support, and advocacy officer of the Crohn’s and Colitis Foundation, commented.

Biocon Biologics said that Yesintek will have commercial payer coverage at launch, as well as a patient assistance product that includes verification and co-pay support, among other services. The program is similar to the one offered for the reference product, and eligible patients could pay as little as $0 for the biosimilar.

Pyzchiva and Selarsdi were developed as part of exclusive commercialization agreements between a smaller international company and a larger American corporation. In the case of Pyzchiva, Samsung Bioepis oversaw development, registration, intellectual property, manufacturing, and supply, while Sandoz manages commercialization.

 Similarly, Selarsdi was developed by Alvotech and is commercialized by Teva.

Of the 3 newly launched products, only Pyzchiva provisionally determined Pyzchiva to be interchangeable, but it can’t officially have the dedication until Wezlana’s 1-year exclusivity for being the first interchangeable ustekinumab biosimilar has lapsed.

 Once it has the full designation, pharmacists will be able  substitute the reference drug with the Pyzchiva without waiting for provider approval, allowing patients to have easier access to their medications, particularly in the event of a drug shortage or supply chain issue.

1. Jeremias S. Welcome Wezlana: the first Stelara biosimilar to launch in the US. The Center for Biosimilars

. January 31, 2025. Accessed February 24, 2025. 

https://www.centerforbiosimilars.com/view/welcome-wezlana-the-first-stelara-biosimilar-to-launch-in-the-us

2. Samsung Bioepis announces US launch of Pyzchiva (ustekinumab-ttwe), biosimilar to Stelara. Press release. Samsung Bioepis. February 24, 2025. Accessed February 24, 2025. 

https://www.businesswire.com/news/home/20250223623917/en/Samsung-Bioepis-Announces-US-Launch-of-PYZCHIVA%C2%AE-ustekinumab-ttwe-Biosimilar-to-Stelara

3. Biocon Biologics launches Yesintek (ustekinumab-kfce) biosimilar to Stelara in the United States. Press release. Biocon Biologics. February 24, 2025. Accessed February 24, 2025. 

https://www.bioconbiologics.com/biocon-biologics-launches-yesintek-ustekinumab-kfce-biosimilar-to-stelara-in-the-united-states/

4. Teva and Alvotech announce Selarsdi (ustekinumab-aekn) injection now available in the U.S. Press release. Teva Pharmaceuticals. February 21, 2025. Accessed February 24, 2025. 

https://www.tevapharm.com/news-and-media/latest-news/teva-and-alvotech-announce-selarsdi-ustekinumab-aekn-injection-now-available-in-the-u.s

5. Biosimilar approvals. The Center for Biosimilars. Updated February 24, 2025. Accessed February 24, 2025. 

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

6. Jeremias S. Amgen’s Stelara biosimilar delayed until 2025 after settling with J&J. The Center for Biosimilars. May 29, 2023. Accessed February 24, 2025. 

https://www.centerforbiosimilars.com/view/amgen-s-stelara-biosimilar-delayed-until-2025-after-settling-with-j-j

7. Johnson & Johnson reports Q4 and full-year 2024 results. J&J. January 22, 2025. Accessed February 24, 2025. 

https://www.investor.jnj.com/news/news-details/2025/Johnson--Johnson-Reports-Q4-and-Full-Year-2024-Results/default.aspx#:~:text=2024%20Fourth%2DQuarter%20reported%20sales,quarter%20and%20full%20year%202024

8. American College of Rheumatology Releases 2022 Rheumatic Disease Report Card. Press release. American College of Rheumatology. September 15, 2022. Accessed February 24, 2025. 

https://rheumatology.org/press-releases/american-college-of-rheumatology-releases-2022-rheumatic-disease-report-card

9. Ogdie A, Weiss P. The epidemiology psoriatic arthritis. 

. 2015;41(4):545-568. doi:10.1016/j.rdc.2015.07.001

10. IBD facts and stats. CDC. Accessed February 24, 2025. 

https://www.cdc.gov/inflammatory-bowel-disease/php/facts-stats/index.html

11. Jeremias S. FDA approves Samsung Bioepis’ Pyzchiva, a biosimilar to Stelara. The Center for Biosimilars. July 1, 2024. Accessed February 24, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-samsung-bioepis-pyzchiva-a-biosimilar-to-stelara

Three ustekinumab biosimilars enter the US market, expanding access to more affordable options referencing Stelara (ustekinumab), one of the most profitable drugs in the world.

3 Ustekinumab Biosimilars Launch on US Market

This episode of Not So Different explores the possible implications of the Federal Trade Commission's (FTC) second interim report on pharmacy benefit managers (PBMs), which shed light on key issues with current PBM practices and their impact on drug prices. The report highlighted several troubling strategies, such as many cases where the big 3 PBMs were reimbursing their own affiliated pharmacies at higher rates than independent pharmacies. The report's latest findings raise important questions about the future of drug pricing transparency and regulation and challenge the notion of whether PBMs are delivering on their intended promise to benefit the health care system.

To help unpack these findings and their implications, The Center for Biosimilars

 was joined by Joe Wisniewski, an expert in PBM legislation, price transparency, and health care policy. Joe serves as assistant vice president of partnerships and government affairs at Turquoise Health and brings a wealth of insight into how PBMs are navigating the current landscape, especially with the rise of new biosimilars and shifting regulatory pressures.

This episode also explores how a second Trump administration could influence PBM practices, particularly in relation to biosimilars, and what that means for drug pricing efforts moving forward.

To learn more about the FTC's most recent report on PBMs, 

To learn more about the FTC's first report on PBMs, 

To learn more about health care actions taken by the second Trump Administration during it's first month, 

To learn more about the views of Mehmet Oz, MD (more commonly known as Dr. Oz) on price transparency ahead of his congressional confirmation hearings as President Trump's nominee for HHS Secretary, 

On this episode of Not So Different, we explore the Federal Trade Commission’s (FTC) second interim report on pharmacy benefit managers (PBMs) with Joe Wisniewski from Turquoise Health, discussing key issues like preferential reimbursement, drug pricing transparency, biosimilars, shifting regulations, and how a second Trump administration could reshape PBM practices.

Will the FTC Be More PBM-Friendly Under a Second Trump Administration?

Enhancing Biosimilar Adoption in Value-Based Oncology Care

Travis Brewer, vice president of payer and public health strategy at Texas Oncology, highlighted biosimilars' role in making cancer care more affordable and accessible, especially for underserved populations. He stressed the need to balance cost-effectiveness with efficacy and called for greater payer trust in oncologists' biosimilar selections. Brewer also advocated for expanding "gold carding" to reduce prior authorization hurdles, promoting smoother biosimilar adoption in value-based care models.

This transcript has been edited for clarity; captions were auto-generated.

In a value-based oncology care model, what role do biosimilars play in ensuring equitable access to cancer treatments, especially for underserved patient populations?

Well, to the extent that you have, , biosimilars available, that that may be more cost effective, yet equally efficacious, relative to a particular treatment regimen, I think that goes a long way. Going back to the original cost-containment idea, so the more affordable you can make cancer care, the more accessible it is to to to broader populations.

That said, it's not always the best idea to just pick the cheapest if the cheapest isn't the best. You have to balance that with the efficacy of the treatment.

Can value-based oncology care models incentivize more rapid biosimilar uptake, and if so, what mechanisms should be in place to ensure their successful implementation?

That's really where the payers come in. We, as a practice, do a very good job of monitoring what's available on the market, what is the most efficacious, and then balance that with what is the most cost-effective. Unfortunately, at times we'll find that what we think the correct answer is, is not what the payer prefers, and the payer prefers brand B, C, or D.

And then it becomes a little difficult from a practice management perspective to keep on hand every "flavor" of biosimilar that's out there. I've told payers before we are not Baskin-Robbins. We don't carry all the flavors. That can lend itself to some conflicts with the payer.

So, I think the payers opening themselves up to trusting the community oncology providers a little more relative to the selection of biosimilars would go a long way in this space.

How do current reimbursement policies and payer models impact the integration of biosimilars into value-based oncology care, and what changes are necessary to promote their wider adoption?

I think opening up some of the prior authorization guidelines, more gold carding for trusted physician groups. I push for a gold card every chance I get, and I have absolutely no issue with with a payer coming back on the back end and saying, "Okay, well, let me take a look at 10- year files and see if it's not the fox guarding the hen house here."

We really are doing the right things for the right reasons. So, I think there's an opportunity to partner more with the payers on that front and get the payers to back off. And the best way to get them to back off is to show that we are consistently providing the highest-value care in the most cost-effective manner.

Travis Brewer, vice president of payer and public health strategy at Texas Oncology, discusses the role of biosimilars in making cancer care more affordable and accessible, as well as the need for greater payer trust in oncologists’ treatment decisions.

Biosimilars are increasingly recognized for their potential to reduce healthcare costs and expand patient access to life-saving treatments. However, several economic and policy-related factors influence their adoption and overall impact on the health care system. To explore these critical dimensions, 

) spoke with James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies.

Chambers leads the Tufts Medical Center Specialty Drug Evidence and Coverage Database and the Medicare National Coverage Decisions Database, making him a key expert in analyzing drug policy, reimbursement trends, and health care economics. He's also partnering with Organon to share his insights as a health economist around the complex landscape of biosimilars. In this discussion, Chambers shares insights on the economic factors shaping biosimilar adoption, the barriers preventing wider uptake, and how these therapies can contribute to cost savings and improved patient access.

"What generics were to the US health care system in the 20th century is what biosimilars have the potential to become in the 21st century: a paradigm shift that may deliver more competition, increase treatment options, and may help lower costs to the health care system." — James D. Chambers, PhD, MPharm, MSc

: What role do value-based pricing models play in facilitating the integration of biosimilars into health care systems, and how can these models be optimized to better reflect the broader economic benefits?

Value-based pricing models align product pricing with the clinical and economic value offered by biosimilars. The potential value of biosimilars in today's health care landscape is significant, as adoption may help reduce the affordability burden to the health care system. Additionally, biosimilars have similar safety and efficacy compared with the reference products and help promote affordability and support health care system sustainability. This is especially critical given the fact that a significant number of patients who need biologic treatments suffer from a chronic disease requiring lifelong management that, historically, may have come with high out-of-pocket costs, even after insurance, and could place additional strain on the health care system. Value-based pricing models can help encourage the adoption of biosimilars by mitigating the financial uncertainties linked to biologic therapies.

: What steps can health care systems take to maximize the cost-saving potential of biosimilars while ensuring they are accessible to all patients?

While biosimilars may help reduce costs to the health care system and potentially increase access to medicines, there is no single solution; it’s a multifactorial issue that requires alignment of key stakeholders, such as physicians, payers, and pharmacy benefit managers (PBMs) alike, to usher in necessary adoption, but it’s only through aligned and collaborative efforts that we can unlock the potential value that biosimilars can create.

This also means an increase in provider education to address misconceptions about biosimilars, and the implementation of patient awareness campaigns to alleviate concerns about switching from originator products. For health care payers, it is crucial to designate biosimilars as preferred treatments in formularies and streamline prior authorization processes to facilitate their access.

: Given your expertise in health economics, what do you foresee as the biggest challenges and opportunities for biosimilars in the next 5 to 10 years?

What generics were to the US health care system in the 20th century is what biosimilars have the potential to become in the 21st century: a paradigm shift that may deliver more competition, increase treatment options, and may help lower costs to the health care system. There are points of evidence that support that the US is seeing benefits to the health care system and to patients and the growing adoption of value-based pricing models, including outcomes-based reimbursement models, can drive biosimilar use.

For example, in a recent 2024 study my team conducted using biosimilar products in rheumatology and oncology, trends were uncovered in payer coverage, market share, and pricing that reveal that biosimilar availability has yielded cost savings despite the adoption of different coverage strategies by originator product manufacturers.

Another opportunity is the generation of robust real-world evidence, which is has the potential to demonstrate biosimilar cost-effectiveness and the impact on health care budgets.

But we still have work to do. We need to tackle some of the observed barriers— from rebate tactics and the lack of physician biosimilar familiarity, as these factors directly influence the adoption of biosimilars.

Additionally, there is growing concern that the Inflation Reduction Act (IRA), which introduces Medicare price negotiations for certain drugs, may unintentionally limit originator biologic prices. This could cap potential earnings for biosimilar manufacturers, thereby weakening the financial incentives necessary for continued biosimilar development.

Another challenge lies in the lack of clear interchangeability guidelines in some jurisdictions. This ambiguity complicates biosimilar substitution at the pharmacy level, hindering widespread adoption and undermining their cost-saving potential.

: What is the role of biosimilars in addressing healthcare disparities, particularly in resource-constrained settings, and how can health care systems ensure equitable access while maintaining cost-efficiency?

Biosimilars have the potential to lower costs and improve access, enabling health care systems to reduce disparities in care delivery and advance equity. While biologics may only account for 2% of all prescriptions, they represent about $120 billion or 37% of net drug spending since 2014. We know biosimilars increase competition and can undercut reference product prices, thereby potentially reducing spending on treatment and increasing access, but in order for biosimilars to support health care disparities, there has to be support across all facets of the health care system—physicians, payers, and PBMs are just a few—to unlock their potential.

Health care systems can help ensure equitable access to biosimilars by centralizing procurement to enhance affordability, establishing clear interchangeability guidelines for quicker adoption, and conducting targeted education campaigns to build trust and acceptance.

: In light of evolving regulatory frameworks and changing global market dynamics, how can we future-proof biosimilars against potential policy shifts that may affect their pricing and accessibility?

There are always shifts on the horizon, no matter the market dynamics, and because addressing barriers to adoption is a multifactorial issue, the first step is always vigilance to understand which part of the health care system may be affected and if there is an expected spillover. From there, we have to work together to understand how these policy shifts may impact biosimilars and protect them from getting lost in red tape. We know that without competition from biosimilars, reference product prices were predicted to continue to increase as they historically have, further limiting patient access to treatments, so future-proofing biosimilars is critical to ensuring the health care system—and in some cases patients—continue to reap the benefits.

As noted earlier, the concern that the IRA could weaken financial incentives for biosimilar development highlights a potential unintended consequence of evolving regulatory frameworks.

: What challenges do you anticipate in the pricing and reimbursement landscape for ustekinumab biosimilars in the US, particularly in terms of insurer acceptance and patient access, given the history of similar biologics entering the market?

With entry into the US market, we can expect biosimilars to continue to face many of the same barriers and hurdles as those that have come before—particularly in terms of insurer acceptance. There are vast variations in how biosimilars are covered, compared to reference products, by commercial health plans.

For example, in 2019 my team conducted a study that found that US health plans covered biosimilars as “preferred” in only 14% of decisions. In 2023, another study we conducted found that among all biosimilar coverage decisions, 19.4% were covered more restrictively than their reference products. So, insurer acceptance has remained a large barrier to cross—in large part due to things like rebate walls, manufacturer negotiation power and the order in which a biosimilar enters the market. These challenges can create downstream impacts on patients, whose ability to benefit from biosimilars may depend on their health plan, potential cost savings, and their physician's knowledge and willingness to prescribe biosimilars.

That said, biosimilars of today are in a better place than they were in terms of physician/patient education and general understanding, and we have data to support that they make an impact on the health care system, and in some instances, patients. We are seeing estimated savings in the billions: from 2021 to 2025, biosimilars are estimated to save $38.4 billion to the health care system, if adopted. We are also seeing more sustained medication use thanks to biosimilars: the use of biosimilars has increased patient access, supporting more than 344 million incremental days of therapy. Biosimilars are helping to make it possible for patients to access and maintain consistent treatment—trends we anticipate will strengthen over time.

Biosimilars have the potential to reduce health care costs and expand patient access, but economic and policy barriers affect adoption, explored James D. Chambers, PhD, MPharm, MSc, associate professor at the Tufts Medical Center Institute for Clinical Research and Health Policy Studies, in an interview.

The Banking of Biosimilars: Insights From a Leading Health Economist

 Wyost/Jubbonti (denosumab-bddz; GP2411), the first biosimilar to reference Xgeva/Prolia (denosumab) in the US.

 The drugs will be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.

The FDA accepted Sandoz’ biologics license application for Wyost/Jubbonti in 

. This approval is also notable in that there are currently no denosumab biosimilars approved in the European Union. The news comes after the same products were approved in Canada 

Similar to the reference products, the biosimilars have the same drug compound (denosumab-bddz) but were approved with 2 brand names that will be used for different indications:

Wyost vs Jubbonti

Jubbonti is interchangeable with Prolia, and Wyost is interchangeable with Xgeva.

Wyost and Jubbonti were also approved with interchangeability designations, allowing them to be substituted for their respective reference product at the pharmacy level without needing to wait for a provider to give permission. It is the ninth biosimilar to receive this label.

"Sandoz has achieved the first FDA approval for biosimilars to denosumab, a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events, which are disease states that can profoundly reduce quality of life for patients. I am proud that Sandoz continues to pioneer access to these life-changing medicines for the patients who need them most," commented Keren Haruvi, President Sandoz North America, in a statement.

According to Sandoz, over 10 million adults over age 50 in the US have osteoporosis, of whom most (> 80%) are women. It is predicted that 1 in 2 women and 1 in 4 men will experience an osteoporosis-related fracture in their lifetime, which could result in decreased quality of life, disability, and death.

The approval of Wyost/Jubbonti was based on a comprehensive data package containing 

 results that were presented at the American Society of Clinical Oncology annual meeting 2023 and the American Society for Bone and Mineral Research annual meeting 2023, respectively.

Denosumab products are human monoclonal antibodies that bind to the RANKL protein, preventing activation of the RANK receptor on the surface of osteoclasts and preventing osteoclastic bone resorption.

Sandoz’ Wyost/Jubbonti (denosumab-bddz) references Prolia and Xgeva and can be used to treat osteoporosis and hypercalcemia as well as prevent skeletal-related events associated with bone metastases from solid tumors.

Kennedy Ferruggia

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