Skylar Jeremias is the Managing Editor for The Center for Biosimilars and The American Journal of Managed Care (AJMC).

Skylar Jeremias

In the first quarter of 2025, leading biosimilar developers Sandoz, STADA, and Samsung Bioepis each reported strong financial results fueled by robust biosimilar performance. The collective momentum underscores the accelerating commercial success and profitability of biosimilars globally, particularly in immunology and oncology, positioning these companies for continuous growth through expanded portfolios and new product launches.

Leading biosimilar companies Sandoz, STADA Arzneimittel, and Samsung Bioepis report impressive Q1 2025 growth, driven by strong denosumab biosimilars and expanding portfolios. | Image credit: alexkich - stock.adobe.com

Sandoz reported Q1 2025 net sales of $2.48 billion, with a 5% gain on a comparable growth basis.

 Biosimilars were a major growth engine, generating $671 million in sales, a jump of 11% (14% compound annual growth rate). These products now make up 27% of total revenue, up from 25% the year prior.

Key biosimilar performers included Hyrimoz (adalimumab) and Pyzchiva (ustekinumab) in Europe, and Omnitrope (somatropin) in international markets. Despite the Cimerli (ranibizumab) withdrawal affecting North America figures, adjusted biosimilar sales in that region still rose. The company expects more momentum in the second half of 2025, with anticipated launches of Tyruko (natalizumab) and Afqlir (aflibercept). Additionally, Wyost/Jubbonti (denosumab biosimilars) launched in the US last week, spelling potential success for the rest of the year.

Generics remained stable, representing 73% of total sales. European sales grew 7%, while international markets declined slightly due to the China business divestment. North America posted modest gains, helped by the launch of paclitaxel.

Sandoz confirmed its full-year forecast of mid single-digit net sales growth and a core earnings before interest, taxes, depreciation, and amortization (EBITDA) margin of around 21%. Recent US tariffs on Chinese and Canadian imports have been factored into projections, and the company emphasized confidence in managing these trade headwinds while continuing to expand access to affordable medicines.

STADA kicked off 2025 with solid results, reporting a 4% increase in revenue and a 5% rise in adjusted constant-currency EBITDA—marking a new quarterly record.

 Despite external challenges, the company continued to grow faster than the market, holding its position among the top players in Europe’s Consumer Healthcare and Generics sectors.

The standout performer this quarter was STADA’s Specialty segment, which saw a 22% jump in revenue. Much of this growth came from biosimilars, especially its ustekinumab, along with Oyavas (bevacizumab) and Hukyndra (adalimumab). These products helped drive momentum and showed the strength of STADA’s long-standing experience in the biosimilars space. The company also pointed to a promising pipeline, with biosimilars like denosumab, golimumab, and aflibercept under regulatory review.

Consumer Healthcare remained steady overall, with nonseasonal products seeing modest growth. Generics grew outside of Germany thanks to recent product launches, although total growth was modest due to strong results in the same quarter last year.

Overall, STADA’s first quarter reflected steady progress, with biosimilars playing a central role in its success and setting the stage for a strong year ahead.

Samsung Bioepis’ Climbing Profits for Q1 2025

Samsung Bioepis posted record-breaking profits in Q1 2025, with operating profit soaring by 236% and net profit climbing 154% year over year, according to a report from Korea Biomedical Review.

 The company, a biosimilar-focused subsidiary of Samsung Biologics, reported ₩400.6 billion (US$280.3 million) in revenue for the quarter—a 43% increase from Q1 2024. This surge was largely fueled by strong biosimilar sales in Europe and successful product launches in the US.

Key contributors included established biosimilars like SB4 (an etanercept biosimilar referencing Enbrel) and SB17 (a ustekinumab biosimilar referencing Stelara) in Europe, along with the US rollout of SB17 (Pyzchiva; pegfilgrastim) through Sandoz and SB12 (Epysqli, referencing Soliris [golimumab]) with Teva Pharmaceuticals. Regulatory momentum also continued, as SB16—a denosumab biosimilar to Prolia and Xgeva—secured approvals in the US and Europe.

 Samsung Bioepis has now commercialized all its biosimilars with completed clinical trials and holds 11 global regulatory approvals across therapeutic areas. The company currently markets 8 biosimilars in Europe, 6 in the US, and 9 in the Republic of Korea, solidifying its growing footprint in the global biosimilar landscape.

1. Sandoz reports Q1 2025 net sales in line with company expectations; full-year guidance confirmed. Press release. Sandoz; April 30, 2025. Accessed June 3, 2025. 

https://www.sandoz.com/sandoz-reports-q1-2025-net-sales-line-company-expectations-full-year-guidance-confirmed/

2. Jeremias S. Wyost and Jubbonti launch as first denosumab biosimilars in the US. The Center for Biosimilars

https://www.centerforbiosimilars.com/view/wyost-and-jubbonti-launch-as-first-denosumab-biosimilars-in-the-us

3. STADA Q1 2025 presentation June 2025 (PDF). STADA Arzneimittel. June 3, 2025. Accessed June 3, 2025. 

https://www.stada.com/media/10554/20250603_stada_q1_2025_presentation.pdf

4. Lee H-s, Samsung Bioepis operating profit surges 236% in Q1, backed by Europe sales, US biosimilar launches. Korea Biomedical Review. April 24, 2025. Accessed June 3, 2025. 

https://www.koreabiomed.com/news/articleView.html?idxno=27378

5. Jeremias S. FDA, EMA approve second pair of denosumab biosimilars. The Center for Biosimilars. February 17, 2025. Accessed June 3, 2025. 

https://www.centerforbiosimilars.com/view/fda-ema-approve-second-pair-of-denosumab-biosimilars

Articles

Leading biosimilar companies Sandoz, STADA Arzneimittel, and Samsung Bioepis report impressive Q1 2025 growth, driven by strong denosumab biosimilars and expanding portfolios.

Sandoz, STADA, and Samsung Bioepis Report Strong Earnings From Biosimilars

The latest IQVIA Institute for Human Data Science report highlighted a crucial challenge for the biosimilar industry: bridging the knowledge gaps among health care professionals (HCPs) to unlock the full potential of these cost-efficient alternatives.

 This came as the industry continued its robust trajectory, driving significant cost savings and expanding patient access to critical biologic therapies. While the industry keeps growing fast, helping more patients access important biologic therapies and saving billions in health care costs (with Europe on track to save €56 billion by July 2024),

 there's still a noticeable gap in awareness.

Osteoporosis is a chronic condition chracterized by weakened bones that affects 1 in 2 women and 1 in 5 men aged 50 years and older. | Image credit: eddows - stock.adobe.com

“In 2023, IQVIA Institute published a report highlighting the importance of physician perspectives on biosimilars for their optimal utilization. This viewpoint continues to remain relevant, particularly as biosimilars enter new disease areas, including ones that involve complex interactions with a broad set of healthcare professionals. In such cases, different physician groups within a disease area may have varied experience with biosimilars. Ensuring that all groups are comfortable with and have knowledge about biosimilars is crucial to continue to gain the benefits from these biosimilars,” wrote Murray Aitken, executive director of the IQVIA Institute for Human Data Science, in the report’s introduction.

One area that illustrates this awareness gap is osteoporosis, a chronic condition that affects 1 in 2 women and 1 in 5 men 50 years and older.

 Biosimilars have already shown that they can save money and help more people get the treatment they need, with a 2024 report showing that they have contributed to 6.9 billion more patient treatment days across the European Union since their introduction.

 With many more biosimilars expected to launch across different conditions in the next 6 years, there’s a real opportunity to expand their impact. But as the new IQVIA report pointed out, that hinges on making health care providers more familiar—and comfortable—with using them.

Managing osteoporosis involves a range of providers, from general practitioners to specialists like rheumatologists and endocrinologists, making coordination and shared knowledge essential. In a survey of 266 European health care professionals, 73% agreed that biosimilars offer similar safety, efficacy, and cost benefits. Still, there was a clear disconnect: general practitioners (GPs) and traumatologists were much less likely to be involved in prescribing biosimilars, and only 5% of GPs showed strong awareness of what’s currently available, let alone what’s in the pipeline. It’s a sharp reminder that without broader HCP engagement, even the best biosimilar can fall short of its potential.

For the biosimilar industry, these findings could represent a call to action. While the potential for substantial savings is estimated at over €998 million in osteoporosis care alone between 2025 and 2030, the success of biosimilars in this space could hinge on overcoming these awareness deficits. The report emphasized that a lack of experience among certain HCPs, particularly those in primary care who often served as the initial point of contact for osteoporosis patients, directly impeded optimal biosimilar uptake.

The path forward, as outlined by the IQVIA Institute, involved a multipronged strategy. This included proactive sharing of best practices across health care systems, timely updates to clinical guidelines that explicitly incorporated biosimilar usage, and dedicated HCP education initiatives. Furthermore, supportive policy frameworks that incentivized biosimilar prescribing and streamlined their integration into formularies were essential.

As new biosimilars continued to gain regulatory approval and enter the market, the industry's success increasingly depended on its ability to cultivate a well-informed and confident prescriber base. The insights from this osteoporosis-focused report served as a powerful reminder that while the science and economics of biosimilars were compelling, the human element—specifically, HCP awareness and comfort—remained the critical differentiator for realizing their full market potential.

The authors concluded that “biosimilar sustainability continues to be a crucial part of ensuring optimal patient care in a healthcare system. Biosimilar markets need to ensure that appropriate incentives exist for all stakeholders to participate, thereby allowing the healthcare system to reap the benefits of biosimilar entry.”

1. Unlocking biosimilar potential: learnings from an osteoporosis case study of complex patient pathways. IQVIA Institute for Human Data Science. May 29, 2025. Accessed June 7, 2025. 

https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/unlocking-biosimilar-potential-2025

2. The impact of biosimilar competition in Europe 2024. IQVIA. January 24, 2025. Accessed June 7, 2025. 

https://www.iqvia.com/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2024

3. Non-pharmacological management of osteoporosis: a consensus of the Belgian Bone Club. 

 2011;22(11):2769-2788. doi:10.1007/s00198-011-1545-x

The biosimilar industry faces awareness challenges among health care professionals (HCPs), which must be addressed to increase cost savings and patient access to treatments.

Boosting Biosimilar Use in Osteoporosis: Why HCP Education Matters

"Escaping the Void: All Things Biosimilars With Craig & G" with cohosts Craig Burton, executive director of the Biosimilars Council, and Giuseppe (G) Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), offers a compelling look into the evolving landscape of biosimilars, highlighting their significant impact on health care while also addressing the hurdles hindering their full potential. Their discussions, centered on the challenges and opportunities within this crucial sector, provide a roadmap for a more sustainable and accessible future for biologic medicines.

Craig Burton and Giuseppe Randazzo ep 1 preview video

Craig and G preview ep 1

5. Reforming Market Dynamics and Incentives

The existing market dynamics, particularly the current rebate structures, often inadvertently hinder biosimilar adoption. Burton highlighted this paradox, noting that, "Incentives reward [pharmacy benefit managers]...when they use and drive use of higher-priced medicines." This creates a disincentive for the adoption of lower-cost biosimilars, even when they offer comparable efficacy and safety. To truly unlock the potential of biosimilars, a fundamental reform of these rebate structures is necessary. Shifting incentives to reward the use of cost-effective biosimilars would encourage their broader adoption, ultimately benefiting patients and the health care system as a whole.

4. The Critical Need for Global Alignment

The fragmented nature of global regulatory standards presents another significant hurdle for biosimilar manufacturers. Randazzo's sentiment, "Testing it once just makes more sense," encapsulates the ideal scenario. Currently, manufacturers often face the burden of conducting multiple, redundant tests to meet the varying requirements of different regulatory bodies worldwide. This duplication of effort inflates development costs and extends timelines. Achieving greater alignment in regulatory standards and the acceptance of global comparators would be a game-changer. It would allow manufacturers to streamline their development processes, reduce unnecessary expenditures, and bring biosimilars to patients in diverse markets more quickly and efficiently.

3. The Imperative of Regulatory Streamlining

To foster a more efficient and productive biosimilar market, regulatory streamlining is essential. Randazzo articulated this need succinctly: "The idea is, how do we make the process more efficient?" A key area for reform involves removing outdated and redundant regulatory requirements. Specifically, the discussion pointed to the potential for cutting unnecessary clinical trials. While rigorous testing is crucial to ensure safety and efficacy, some existing requirements may be overly burdensome and not aligned with the unique nature of biosimilar development, which relies on demonstrating similarity to an approved reference product. By optimizing the regulatory pathway, development costs can be significantly reduced, making biosimilar production more attractive and accelerating their entry into the market.

2. Looming Challenges in Market Sustainability

Despite the clear benefits, the long-term sustainability of the biosimilar market faces significant challenges. A staggering 90% of biologic drugs losing patent exclusivity over the next 10 years have no biosimilar competition in the pipeline. This stark reality underscores a critical vulnerability. The absence of robust biosimilar pipelines for upcoming patent expirations poses a serious threat to the continued availability of affordable biologic treatments. Without new biosimilars entering the market to compete with off-patent biologics, the envisioned savings and expanded patient access could stagnate or even reverse. This highlights an urgent need for strategies to stimulate research and development in the biosimilar sector, ensuring a continuous supply of these vital medicines.

One of the most immediate and tangible benefits of biosimilars lies in their ability to drive down health care expenditures. Since the passing of the Biologics Price Competition and Innovation Act in 2010, the FDA has approved over 70 biosimilar medicines. This legislative framework has paved the way for a new era of competition in the biologics market. The results are already impressive, with US savings from biosimilars reaching a substantial $36 billion. These savings are not merely figures on a balance sheet; they translate directly into more affordable treatment options for patients, expanding access to life-changing therapies that might otherwise be out of reach due to exorbitant costs. The ripple effect of these savings extends throughout the health care system, freeing up resources that can be reinvested in research, development, and patient care initiatives.

Craig and Giuseppe’s insightful discussions in "Escaping the All Things Biosimilars" provide a comprehensive overview of the current state of biosimilars. By focusing on regulatory reform, global harmonization, and the realignment of market incentives, the series offers actionable insights and potential solutions to ensure that biosimilars continue to offer more affordable treatment options and positively influence health care for years to come.

https://www.centerforbiosimilars.com/view/escaping-the-void-all-things-biosimilars-with-craig-g

5 Key Takeaways From the "Escaping the Void" Video Podcast

Accelerated entry of generic and biosimilar drugs into the US market, often facilitated by settlement agreements, has resulted in an estimated $422.9 billion in health care system savings, according to a recent comprehensive analysis.

 The research, conducted by the IQVIA Institute for Human Data Science on behalf of the Association for Accessible Medicines (AAM), examined the impact of these agreements on drug availability and cost containment.

Patent settlements accelerate the entry of generics and biosimilars, saving the health care system $422.9 billion and enhancing drug accessibility. | Image credit: digicomphoto - stock.adobe.com

“The ability for generic and biosimilar manufacturers to procompetitively settle with brand-name drug manufacturers creates significant savings and efficiencies and brings lower-cost medicines to patients years earlier,” said John Murphy III, president and CEO of AAM, in a statement.

 “Efforts to severely limit patent settlements will hurt patients, cost billions of dollars, and exacerbate industry sustainability concerns in the generic medicines marketplace.”

The study focused on molecules with first generic or biosimilar launches between 2014 and the third quarter of 2024.

 Researchers utilized the IQVIA SMART U.S. Launch and Regulatory Insights module to identify molecules and their initial launch dates. Litigation and settlement details were gathered from various sources, including the Ark Patent Intelligence Database, US Securities and Exchange Commission filings, company announcements, and court decisions. To determine the "would-have-been" generic entry date without a settlement, patent expiration information was cross-referenced using the Orange Book database, Purple Book database, FDA approval letters, and the Ark Patent Intelligence database.

Of the 288 molecules assessed, 84 had settlements that resulted in early or timely generic and biosimilar entry after 2013. The findings indicated a significant acceleration of market entry, with launches occurring an average 64 months (approximately 5 years) before the original patent expiry for molecules with settlements. Specifically, 29% of the studied molecules saw generic or biosimilar entry between 1 and 5 years prior to patent expiration, and an impressive 30% experienced entry 5 to 10 years ahead of schedule.

One example highlighted in the report was teriflunomide, a multiple sclerosis drug. A settlement reached in 2017 with multiple generic abbreviated new drug application filers led to the launch of generics a remarkable 11 years before its anticipated patent expiry. This early entry alone translated into substantial savings, with the health care system saving an estimated $1.1 billion in 2023.

Across all molecules studied, generics and biosimilars that entered the market early due to settlements accrued an average of $5.0 billion in savings per molecule. Interestingly, the analysis did not find a strong correlation between the magnitude of health care savings and how early generic or biosimilar entry occurred.

Although the study underscored the immense benefits of settlements, it also shed light on instances of delayed generic or biosimilar entry despite such agreements. Four molecules with settlements experienced launch delays, primarily attributed to protracted FDA approval timelines or supply shortages for complex products. For instance, drugs like Welchol (colesevelam), Integrilin (eptifibatide), Aggrastat (tirofiban), and Istodax (romidepsin) saw settlements accelerate potential generic entry, but regulatory hurdles or supply chain issues ultimately slowed their market introduction. This emphasizes that although patent disputes may be resolved, other factors can still impede the swift availability of affordable medicines.

The report's findings carry significant implications for the future of the biosimilar and generic industries. The consistent pattern of earlier market entry through settlement agreements suggests that these strategies will continue to be crucial in fostering competition and increasing drug accessibility. The substantial health care savings realized underscore the economic advantages of promoting such agreements. However, the report also highlighted the need for streamlined regulatory processes and proactive measures to address potential supply chain issues, particularly for complex generic and biosimilar products.

Moving forward, the AAM predicted that the industry, in collaboration with regulators, will likely focus on optimizing the interplay between legal settlements and efficient approval pathways to maximize the benefits of earlier generic and biosimilar market penetration, thereby enhancing affordability and access to essential medicines.

1. Assessment of the impact of settlements: analysis results. AAM. June 3, 2025. Accessed June 3, 2025. 

https://accessiblemeds.org/wp-content/uploads/2025/06/202506-AAM-Impact-of-Patent-Settlements-IQVIA-Study.pdf

2. Generic and biosimilar patent settlements save $423 billion. Press release. AAM; June 3, 2025. Accessed June 3, 2025.

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

Billions in Health Care Savings Realized Through Early Generic, Biosimilar Settlements

For countless women navigating postmenopausal osteoporosis (PMO), effective treatment often comes with a hefty price tag.

 New research shows that denosumab biosimilar SB16 is equivalent to the reference product, Prolia (denosumab), up to 12 months, which carries substantial implications for expanding access to effective PMO treatment, particularly for those facing financial barriers to originator denosumab therapy.

The robust clinical evidence demonstrating the biosimilarity of SB16 to denosumab is a critical step toward increasing treatment accessibility for patients with postmenopausal osteoprosis. Image credit: Pixel-Shot - stock.adobe.com

PMO is a highly prevalent chronic bone disease affecting approximately 20% of women 50 years and older in the US, characterized by decreased bone mass and an increased risk of fragility fractures. Denosumab, a human monoclonal antibody, works by inhibiting osteoclast activity, leading to increased bone density. However, as an originator biologic, its cost can be prohibitive for many patients. Biosimilars, which are highly similar to already approved biologics in terms of quality, efficacy, and safety, offer a crucial alternative, often at a lower cost.

In February 2025, the FDA approved SB16 as denosumab-dssb, which will be marketed as Ospomyv and Xbryk depending on the indication.

 Denosumab-dssb is also approved in the European Union as Obodence or Xbryk. However, they are unable to enter the market until Samsung Bioepis settles its patent infringement case with reference manufacturer Amgen.

The present multinational, double-blind, randomized phase 3 study, conducted across 40 sites in 5 countries (Czech Republic, Denmark, Lithuania, Poland, and Republic of Korea) enrolled 457 postmenopausal women aged 55 to 80 years with a bone mineral density (BMD) T-score of the lumbar spine or total hip between –2.5 and –4.0. These participants were treatment-naive to biologic medicines for osteoporosis. The study's primary objective was to evaluate the biosimilarity of SB16 to denosumab in terms of efficacy, safety, pharmacokinetics (PK), pharmacodynamics (PD), and immunogenicity.

A key finding of the study was the equivalence of SB16 to denosumab in the primary efficacy end point: the percent change from baseline in lumbar spine BMD at month 12. In the full analysis set, the least-squares mean percent change from baseline in lumbar spine BMD was 5.63% for the SB16 group and 5.30% for the denosumab group, with a treatment difference of 0.33% (90% CI, –0.25% to 0.91%). This fell well within the predefined equivalence margin of –1.45% to 1.45%, demonstrating statistically significant equivalence. Similar results were observed in the per-protocol set.

Beyond the primary end point, secondary efficacy measures consistently supported the equivalence. For instance, mean percent changes from baseline in total hip BMD at month 12 were 3.50% for SB16 and 3.25% for denosumab. Femoral neck BMD also showed comparable increases, with 2.79% for SB16 and 2.30% for denosumab at month 12.

The PD profiles, assessed through bone turnover markers such as serum CTX and P1NP, were also remarkably similar between the 2 groups, indicating comparable effects on bone resorption and formation. At month 12, the median percent change from baseline in serum CTX concentrations was 69.0% for SB16 and 69.6% for denosumab. PK analyses further confirmed comparable drug concentrations between SB16 and denosumab throughout the study period.

In terms of safety, SB16 exhibited a profile consistent with that of denosumab. Overall, 70.7% of patients in the SB16 group experienced at least 1 treatment-emergent adverse event compared with 71.0% in the reference denosumab group. The incidence of serious AEs (SAEs) was comparable (3.6% for SB16 vs 3.5% for denosumab). The most frequently reported AE of special interest was hypocalcemia, occurring in 9.8% of the SB16 group and 11.7% of the reference denosumab group, with most cases being mild and asymptomatic.

Importantly, no cases of osteonecrosis of the jaw or atypical femoral fractures were reported in either group during the main study period. Immunogenicity was low and comparable, with fewer than 1% of patients in both groups testing positive for antidrug antibodies.

This robust clinical evidence demonstrating the biosimilarity of SB16 to denosumab is a critical step toward increasing treatment accessibility for patients with PMO. The high cost of originator denosumab has historically posed a significant barrier to consistent therapy, potentially leading to suboptimal bone health management and increased fracture risk.

“Because this study was initiated and designed to assess equivalence of a biosimilar to its reference product, a larger sample size to determine long-term fracture risk was not considered, which could be a potential limitation of this study,” the authors wrote.

1. Paying for Prolia. Amgen. Updated January 8, 2025. Accessed June 2, 2025. 

2. Langdahl B, Chung Y-S, Plebanski R, et al. Proposed denosumab biosimilar SB16 vs reference denosumab in postmenopausal osteoporosis: phase 3 results up to month 12. J 

. 2025;110(6):e1951-e1958. doi:10.1210/clinem/dgae611

3. Jeremias S. FDA, EMA approve second pair of denosumab biosimilars. The Center for Biosimilars

. February 17, 2025. Accessed June 2, 2025. 

4. Wong HK, Menon AB. Biosimilar cases to watch: Prolia/Xgeva and denosumab competitors. The Center for Biosimilars. March 11, 2025. Accessed June 2, 2025. 

https://www.centerforbiosimilars.com/view/biosimilar-cases-to-watch-prolia-xgeva-and-denosumab-competitors

New research confirms denosumab biosimilar SB16 matches Prolia in efficacy, offering a cost-effective treatment option for postmenopausal osteoporosis.

FDA-Approved SB16 Biosimilar Demonstrates Equivalence to Prolia

The US pharmaceutical market has witnessed the launch of the first denosumab biosimilars, Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), marking a significant development for patients and health care systems.

 These products are now available for use across all indications of their reference medicines, Xgeva (denosumab) and Prolia (denosumab), respectively.

These biosimilars were originally approved in March 2024 and were also approved with interchangeability, meaning that they can be substituted in place of their respective reference agents (Wyost to Xgeva; Jubbonti to Prolia) at the pharmacy level without waiting for a physician to approve the switch.

Denosumab is a critical therapeutic agent used to manage conditions such as osteoporosis and cancer-related skeletal events. Osteoporosis, a condition characterized by weakened bones, affects more than 10 million US adults 50 years or older, with many more at risk.

 Bone metastases, where cancer cells spread to the bone, impact approximately 330,000 individuals in the US, often leading to painful skeletal-related events and fractures.

Keren Haruvi, president of Sandoz’ North America division, commented on the significance of this launch. "Denosumab is a vital medicine for conditions such as osteoporosis and cancer-related skeletal events. Providing an additional high-quality, cost-effective treatment option helps improve access and affordability for US patients," he stated.

The availability of these biosimilars is anticipated to introduce increased competition within the denosumab market, which could contribute to greater affordability for patients and health care payers. Both Wyost and Jubbonti are designed to have the same dosage form, route of administration, dosing regimen, and presentation as their reference medicines. Additionally, these new biosimilars will launch with an established Q code, which is expected to facilitate reimbursement processes.

Organizations focused on patient advocacy have welcomed the development. Claire Gill, CEO of the Bone Health and Osteoporosis Foundation, noted the potential positive impact. "Bone loss and cancer-related skeletal complications can have a profound impact on patients’ lives, but access to effective treatments has often been impacted by cost. With the introduction of new biosimilar options, patients now have access to more treatments they need and deserve," Gill said.

Support resources for patients prescribed Wyost and Jubbonti, including reimbursement and financial assistance programs, are also being provided. The entry of these interchangeable denosumab biosimilars into the US market signifies the potential for wider availability of more affordable treatment options for patients requiring denosumab therapy.

1. Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients. Sandoz. June 2, 2025. Accessed June 2, 2025. 

https://www.sandoz.com/sandoz-launches-first-and-only-interchangeable-denosumab-biosimilars-us-providing-new-affordable/

2. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars

https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar

3. Osteoporosis: from the FDA Office of Women's Health. FDA. Updated May 13, 2024. Accessed June 2, 2025. 

https://www.fda.gov/consumers/womens-health-topics/osteoporosis

4. Bone metastasis. Moffitt Cancer Center. Accessed June 2, 2025. 

https://www.moffitt.org/cancers/bone-metastasis/

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

Wyost and Jubbonti Launch as First Denosumab Biosimilars in the US

The FDA’s recent approvals and interchangeability designations for multiple biosimilars mark significant strides in expanding affordable treatment options for complex diseases, even as US drug pricing and global regulatory challenges underscore the urgent need for policy reform and greater biosimilar adoption.

New Regulatory Designations for Biosimilars in the US

The FDA has approved Starjemza (ustekinumab-hmny) as a biosimilar to Stelara for treating various rheumatic and gastrointestinal conditions.

 It is the eighth ustekinumab biosimilar approved in the US, developed under a partnership between Hikma Pharmaceuticals and Bio-Thera Solutions. The approval was supported by phase 1 and phase 3 studies showing comparable efficacy, safety, and immunogenicity to Stelara. Since February 2025, 6 ustekinumab biosimilars have launched in the US market, with Imuldosa still in the pipeline.

Additionally, 3 biosimilars have received interchangeability designations from the FDA.

One of these is Cimerli (ranibizumab-eqrn), an interchangeable biosimilar to Lucentis (ranibizumab) that was approved in August 2022.

 Cimerli is used to treat several retinal disorders, including neovascular age-related macular degeneration, diabetic macular edema, and diabetic retinopathy. It matches the reference product in formulation, dosage, safety, efficacy, and immunogenicity, and must be administered via intravitreal injection by a qualified ophthalmic provider.

The other 2 biosimilars are Otulfi (ustekinumab-aauz) and Hadlima (adalimumab-bwwd).

 Otulfi, developed by Fresenius Kabi and Formycon AG, references Stelara and is approved for conditions such as Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis in both adults and children 6 years and older. It’s the first US launch from the Fresenius-Formycon collaboration and is available in injection and infusion forms. Its interchangeable status was granted based on data showing equivalent safety and efficacy to Stelara, including for patients who switch between products.

Meanwhile, Hadlima, a biosimilar to Humira, also received the interchangeability designation for both its high- and low-concentration formulations. Clinical trial data in patients with plaque psoriasis supported the designation, demonstrating comparable outcomes when switching between Hadlima and Humira. This expanded label could enhance access and affordability across multiple inflammatory conditions.

How International Regulatory Policies Could Be Improved

US drug pricing policies continue to face scrutiny amid high costs and limited regulation.

 Unlike many other countries with nationalized health systems and strict price controls, the US allows pharmaceutical companies to set and change prices freely. President Trump’s latest executive order seeks to implement “most-favored nation” pricing, aiming to align US drug prices with those in other countries. However, similar efforts in the past have faced legal setbacks, and even recent negotiated prices under the Inflation Reduction Act remain significantly higher than international benchmarks.

Development costs, pressure for shareholder returns, and limited price control contribute to high US drug prices. Further complicating the issue are pharmacy benefit manager (PBM) practices that often prioritize higher-cost originators over lower-cost generics and biosimilars. Despite bipartisan interest in reform, structural challenges—including PBM influence, lack of value-based pricing, and potential new pharmaceutical tariffs—continue to hinder meaningful change.

Biosimilar policies in the Middle East and North Africa (MENA) region face distinct challenges compared with the US.

 Despite the cost-saving potential of biosimilars and generics, adoption across MENA countries remains limited due to regulatory inconsistencies, knowledge gaps among health care providers, and cultural biases favoring branded drugs. A recent systematic review found that while pharmacists often support substitution, many physicians remain skeptical, particularly regarding biosimilars. Without harmonized regulations or targeted educational initiatives, uptake in the region continues to lag behind the more structured and policy-driven frameworks seen in the US and European Union.

In a recent opinion piece, Sarfaraz K. Niazi, PhD, highlights India’s 2025 draft guidelines on similar biologics from the Central Drugs Standard Control Organisation as a significant move toward harmonization with global regulatory standards.

 The guidelines align with those of the European Medicines Agency, the FDA, and the United Kingdom’s Medicines and Healthcare products Regulatory Agency. Key advancements include reduced reliance on animal and confirmatory efficacy testing, a greater focus on in vitro evidence, and risk-based immunogenicity assessments. While progressive, Niazi emphasized the need for more clarity on statistical methods, pharmacodynamic biomarker validation, and extrapolation criteria to enhance consistency and global alignment.

Expert Insights on Biosimilar Regulations in a New Format

In the first in a new vodcast series, Craig Burton, executive director of the Biosimilars Council, and Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), co-host a deep dive into the evolving biosimilar landscape. Presented by The Center for Biosimilars

 in partnership with AAM and the Biosimilars Council, this series explores the critical challenge of the "biosimilar void" — where 90% of biologics losing patent protection over the next decade currently have no biosimilar competition in development. Since 2010, biosimilars have generated $36 billion in savings for the US health care system, significantly enhancing patient access to affordable therapies. The vodcast underscores the urgent need for policy reforms and collaboration to break down barriers and sustain biosimilar growth for the benefit of patients and the broader health care system.

1. Jeremias S. FDA approves Starjemza as new Stelara biosimilar. The Center for Biosimilars. May 27, 2025. Accessed May 29, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-starjemza-as-new-stelara-biosimilar

2. Garcia M, Arakelians S. Cimerli offers a new, interchangeable biosimilar for ocular conditions. The Center for Biosimilars. May 15, 2025. Accessed May 29, 2025. 

https://www.centerforbiosimilars.com/view/cimerli-offers-a-new-interchangeable-biosimilar-for-ocular-conditions

3. Jeremias S. Eye on Pharma: interchangeability labels and expanded biosimilar partnerships. The Center for Biosimilars. May 29, 2025. Accessed May 29, 2025. 

https://www.centerforbiosimilars.com/view/eye-on-pharma-interchangeability-labels-and-expanded-biosimilar-partnerships

4. Jeremias S. The Trump administration’s drug price actions and why US prices are already sky-high. The Center for Biosimilars. May 17, 2025. Accessed May 29, 2025. 

https://www.centerforbiosimilars.com/view/the-trump-administration-s-drug-price-actions-and-why-us-prices-are-already-sky-high

5. Jeremias S. What stands in the way of biosimilar use across MENA countries? The Center for Biosimilars. May 21, 2025. Accessed May 29, 2025. 

https://www.centerforbiosimilars.com/view/what-stands-in-the-way-of-biosimilar-use-across-mena-countries-

6. Niazi SK. BioRationality: The revised Indian biosimilar guidelines finally bring rationality. The Center for Biosimilars. May 19, 2025. Accessed May 29, 2025. 

https://www.centerforbiosimilars.com/view/biorationality-the-revised-indian-biosimilar-guidelines-finally-bring-rationality

7. Jeremias S, Burton C, Randazzo G. Escaping the void: all things biosimilars with Craig & G. The Center for Biosimilars. May 4, 2025. Accessed May 29, 2025. 

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

Biosimilars Regulatory Roundup: May 2025

As the FDA granted interchangeable status to 2 biosimilars, Alvotech and Advanz Pharma have expanded their European biosimilar partnership to include new candidates targeting high-value biologics.

Two Biosimilars Are Deemed Interchangeable

Otulfi (ustekinumab-aauz) was 1 of 2 biosimilars recently granted interchangeable status by the FDA, meaning pharmacists can substitute it for Stelara (ustekinumab) without needing prescriber approval, depending on state laws.

Developed by Fresenius Kabi and Formycon AG, Otulfi is used to treat conditions like Crohn disease, ulcerative colitis, plaque psoriasis, and psoriatic arthritis in adults and kids 6 years and older. It’s the first product from the Fresenius-Formycon partnership to launch in the US, and it’s available in both injection and infusion forms. 

The FDA’s decision was based on data showing Otulfi is just as safe and effective as Stelara, even for patients who switch between the 2 products. The approval reflects newer FDA guidance that allows biosimilars to be designated interchangeable based on existing approval data, without requiring separate switching studies.

The other biosimilar to gain this label recently was Hadlima (adalimumab-bwwd), which references Humira (adalimumab).

 The new designation concerns both the high- and low-concentration versions of the biosimilar. 

The decision was backed by data from a clinical trial in patients with plaque psoriasis, showing that those who switched between Hadlima and Humira had comparable results in terms of drug levels, safety, and effectiveness. Originally approved in 2019, Hadlima has been available in both concentrations since 2023. Its broader interchangeability could help improve access to treatment and potentially reduce out-of-pocket costs, especially given data showing patients may pay significantly more for Humira. 

Like Otulfi, Hadlima treats several inflammatory conditions like rheumatoid arthritis, Crohn disease, ulcerative colitis, and psoriasis.

Alvotech and Advanz Pharma Expand Partnership

Alvotech and Advanz Pharma expanded their biosimilar partnership in late May 2025 to include 3 new biosimilar candidates. Under the deal, Alvotech took on development and supply responsibilities, while Advanz Pharma was set to handle registration and commercialization across Europe. Two of the new biosimilars target Ilaris (canakinumab) for various inflammatory diseases and Kesimpta (ofatumumab) for relapsing multiple sclerosis. The third product remains undisclosed. The agreement included up to $180 million in development and commercial milestone payments, along with revenue sharing.

This expansion built on their existing collaboration, which already covered biosimilars to high-profile biologics like Xolair (omalizumab), Simponi (golimumab), Entyvio (vendolizumab), Eylea (aflibercept), Dupixent (dupilumab), Taltz (ixekizumab), and Tremfya (guselkumab). Their commercial reach spans all European Union/European Economic Area countries, the UK, and Switzerland—with some rights also extending to Canada, Australia, and New Zealand.

Executives from both companies emphasized the partnership’s role in increasing access to specialty and rare-disease treatments across Europe. Together, the products covered by the partnership represent a market worth at least $13.8 billion.

1. FDA grants interchangeable designation to Fresenius Kabi’s biosimilar Otulfi (ustekinumab-aauz). Press release. Fresenius Kabi; May 19, 2025. Accessed May 29, 2025. 

https://www.businesswire.com/news/home/20250519113313/en/FDA-Grants-Interchangeable-Designation-to-Fresenius-Kabis-biosimilar-Otulfi-ustekinumab-aauz

2. US Food and Drug Administration (FDA) grants interchangeability designation to Samsung Bioepis and Organon Hadlima (adalimumab-bwwd) injection. Press release. Organon; May 27, 2025. Accessed May 29, 2025. 

https://www.businesswire.com/news/home/20250527970852/en/US-Food-and-Drug-Administration-FDA-Grants-Interchangeability-Designation-to-Samsung-Bioepis-and-Organon-HADLIMA-adalimumab-bwwd-Injection

3. Alvotech and Advanz Pharma extend strategic partnership to commercialize three additional biosimilars in Europe. Press release. Alvotech; May 28, 2025. Accessed May 29, 2025. 

https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-advanz-pharma-extend-strategic-partnership-0

The FDA designates 2 biosimilars as interchangeable, enhancing access to treatments for inflammatory diseases and multiple sclerosis, while 2 other companies expand their biosimilar partnership to include more products.

Eye on Pharma: Interchangeability Labels and Expanded Biosimilar Partnerships 

A health policy in British Columbia that required biosimilar prescriptions showed no increase in hospital visits or complications, according to real-world evidence that etanercept biosimilars for inflammatory arthritis are as effective as their originator biologics without increasing hospital utilization.

 was conducted to address the gap between clinical trial data and real-world outcomes for biosimilars, particularly among patients newly initiating treatment for inflammatory arthritis. While randomized controlled trials have established the efficacy and safety of etanercept biosimilars under ideal conditions, there remains limited evidence on how these therapies perform in routine clinical practice.

British Columbia was the first Canadian province to adopt a biosimilar switching policy. | Image credit: 93600361 - stock.adobe.com

In 2017, British Columbia introduced a policy requiring that new prescriptions for certain biologic drugs be filled with biosimilars to qualify for coverage under the public drug plan.

 The program was rolled out in several phases and has since been replicated to some extent in nearly every other Canadian province due to the success seen in BC.

 This mandate, which has already accumulated $732 million in savings in the first 5 years for the province,

 created a “natural experiment” for the researchers, who used it to evaluate health care utilization as an indicator of biosimilar safety and effectiveness in real-world settings.

“Lack of confidence in biosimilars' effectiveness, safety and interchangeability has been identified as one of the top barriers impairing the adoption of biosimilar therapies…Our findings on no unintended consequences of policy change at the health system level inform decisions in biosimilar policy development and implementation in other jurisdictions,” wrote the researchers.

The authors of the retrospective cohort study assessed the impact of British Columbia’s policy by applying a regression discontinuity design to real-world administrative health data from 2014 to 2023. Researchers identified adult patients diagnosed with rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis who were newly prescribed etanercept. Patients were grouped based on whether they started treatment just before or just after the policy took effect, allowing for a natural comparison.

Outcomes such as hospitalizations, emergency department visits, and physician encounters were tracked for three years. Both intention-to-treat and instrumental variable analyses were conducted to evaluate health care utilization, accounting for both policy exposure and actual biosimilar uptake.

Researchers analyzed outcomes among 1626 incident users in the pre-policy period (2014-2017) and 1378 in the post-policy period (2017-2020). Demographics were similar across groups (mean age at diagnosis, 52.5 years; 63.7% female). Biosimilar initiation rose from just 0.06% pre-policy to 78.3% post-policy. Despite this sharp uptake, no significant changes in healthcare utilization were observed.

For all-cause hospitalizations (ACH), intention-to-treat (ITT) analysis yielded unadjusted and adjusted rate ratios at the policy cut-off of 0.97 (95% CI, 0.55-1.69) and 0.84 (95% CI, 0.49-1.44), respectively. Complier average causal effect (CACE) analysis showed similarly neutral effects with ratios of 0.97 (95% CI, 0.53-1.75) and 1.01 (95% CI, 0.53-1.92). Infection-related hospitalizations (IRH) were rare, and both ITT and CACE analyses showed wide confidence intervals with no statistically significant impact: the adjusted CACE ratio was 0.89 (95% CI, 0.03-23.35).

No meaningful differences were observed for emergency room visits (ERV) or hospital length of stay (LOS). For example, adjusted ITT rate ratios for LOS and ERV were 0.94 (95% CI, 0.41-2.15) and 0.91 (95% CI, 0.44-1.88), respectively. Sensitivity analyses using alternative statistical methods and bandwidths confirmed the robustness of findings. Analysis of adalimumab initiators, which were unaffected by biosimilar policy, showed no concurrent changes in health care use, supporting the specificity of the results.

“The equivalent real-world effectiveness and safety of etanercept biosimilars shown in this study will increase healthcare providers' and patients' confidence in prescribing and taking this important medication,” the authors expressed.

1. Zhou VY, Lacaille D, Zheng Y, et al. The impact of biosimilar use on healthcare utilization among new users of etanercept for inflammatory arthritis: a population-based regression discontinuity analysis.

. Published online April 11, 2025. doi:10.1016/j.lana.2025.101058

Despite a dramatic shift toward biosimilar use following British Columbia’s policy, researchers found no rise in hospital visits or complications, underscoring the real-world reliability of etanercept biosimilars in managing inflammatory arthritis.