Maggie L. Shaw

CT-P39, an omalizumab biosimilar, and reference omalizumab demonstrated comparable efficacy, pharmacokinetics, pharmacodynamics, safety, and immunogenicity, as well as quality of life impact, in patients with chronic spontaneous urticaria, as confirmed by a 16-week follow-up of a phase 3 trial.

Omlyclo is approved in the European Union, Canada, and the US. | Image credit: NATALYA - stock.adobe.com

CT-P39, also known as Omlyclo, was approved by the European Medicines Agency in May 2025 as the first omalizumab biosimilar.

 The biosimilar was also approved by Health Canada in December 2024 and the FDA in March 2025.

The present international, multicenter, double-blind, randomized, active-controlled, parallel-group study, 

, sought to confirm that Omlyclo can perform with the same safety and efficacy as the original product.

 Access to omalizumab, an effective biologic for chronic spontaneous urticaria, can be limited by its high cost, prompting the development of biosimilars like CT-P39 to improve affordability and access. According to Novartis’ financial records, global sales for reference omalizumab (Xolair) in 2024 amounted to $4.4 billion, making it the seventh highest-grossing immunology product in the world.

The study involved 619 patients with chronic spontaneous urticaria across two 12-week treatment periods and a 16-week follow-up, in which patients received subcutaneous injections of either CT-P39 or reference omalizumab at 150-mg or 300-mg doses, with rerandomization or dose escalation in the second period. Throughout the study, efficacy, quality of life, pharmacokinetics, pharmacodynamics, safety, and immunogenicity were assessed using patient-reported outcomes, clinical monitoring, and blood analyses, with results summarized descriptively through week 40.

Of the 619 patients randomized, 554 (89.5%) entered the 16-week follow-up phase, and 518 (83.7%) completed the full study through week 40, with completion rates ranging from 80.6% to 88.7% across all treatment groups. Discontinuation rates and reasons were similar between groups, with the most common reason during follow-up being categorized as “other.”

Efficacy outcomes such as weekly itch severity scores, urticaria activity scores, and hives severity scores improved significantly during the 24-week treatment periods, which gradually declined during follow-up but remained better than baseline values, with no clinically meaningful differences between CT-P39 and reference omalizumab groups. At week 40, the number of antihistamine tablets used as rescue therapy remained lower than baseline in all groups, and fewer than 10% of patients in any group required an additional nonsedating H1-antihistamine as background therapy. Improvements in quality-of-life measures, including Dermatology Life Quality Index and Chronic Urticaria QoL Questionnaire, followed a similar pattern—peaking during treatment and partially declining by week 40, yet not returning to baseline levels.

Pharmacokinetic data showed a dose-related increase in omalizumab serum trough concentrations during treatment, followed by a gradual decrease after treatment cessation, with end-of-study mean concentrations ranging from 2.74 µg/mL (initial reference product 300-mg maintenance group) to 4.11 µg/mL (reference omalizumab 150-mg group). Pharmacodynamic results demonstrated a 2- to 3-fold increase in total immunoglobulin E (IgE) during treatment, with levels gradually decreasing during follow-up, while free IgE, which decreased during treatment, began to return to baseline after week 24 in all groups.

Safety profiles were consistent across groups during the follow-up period, with similar proportions of patients experiencing at least 1 treatment-emergent adverse event (TEAE). The most frequently reported TEAEs (≥ 2%) were COVID-19, headache, nasopharyngitis, tonsillitis, and upper respiratory tract infection. Serious TEAEs occurred in up to 3.1% of patients in any group and were considered unrelated to the study drug. No deaths, anaphylactic reactions, serum sickness, or parasitic infections were linked to the study treatment. One patient died by suicide, previously reported and determined unrelated to the drug. Injection-site reactions, the most common related TEAE, occurred only during the treatment period.

Immunogenicity analysis showed that the majority of patients tested negative for antidrug antibodies at week 40. Antidrug antibody positivity rates were 6.9% in the CT-P39 300-mg group, 1.5% in the reference omalizumab 300-mg group, 3.1% in the switched group (ref-OMA to CT-P39), 0% in the reference omalizumab maintenance group, 6.5% in the CT-P39 150-mg group, and 1.9% in the reference omalizumab 150-mg group.

The authors stated, “The overall safety profile of CT-P39 continues to be consistent with the known safety profile of omalizumab, with no new or unexpected concerns during the whole study period and no new safety findings, including after switching to CT-P39 from [reference omalizumab].”

1. Grattan C, Dytyatkovska Y, Springer M, et al. Efficacy and safety of CT-P39, an omalizumab biosimilar, in chronic spontaneous urticaria: 16-week follow-up study. 

. June 2, 2025. Accessed June 24, 2025. doi:10.1002/clt2.70069

2. Celltrion receives European Commission approval of Omlyclo (CT-P39), the first and only omalizumab biosimilar approved in Europe. Press release; Celltrion. May 24, 2025. Accessed June 23, 2025. 

https://celltrion.com/en-us/company/media-center/press-release/3246

3. Jeremias S. Health Canada approves first omalizumab biosimilar. The Center for Biosimilars®. December 16, 2024. Accessed March 7, 2025. 

https://www.centerforbiosimilars.com/view/health-canada-approves-first-omalizumab-biosimilar

4. Jeremias S. FDA approves first omalizumab biosimilar. The Center for Biosimilars. March 7, 2025. Accessed June 24, 2025. 

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

5. Novartis annual report 2024. Novartis. January 30, 2025. Accessed June 23, 2025. 

https://www.novartis.com/sites/novartiscom/files/novartis-annual-report-2024.pdf

6. Rashid A, Shashikumar S, Xie V, Kovacevic V. Top 10 best-selling immunology drugs by recent sales data. Xtalks. January 2, 2025. Accessed June 23, 2025. 

https://xtalks.com/top-10-best-selling-immunology-drugs-by-recent-sales-data-4025/

Articles

CT-P39, an omalizumab biosimilar, shows comparable efficacy and safety to the original in treating chronic spontaneous urticaria, enhancing patient access.

Omalizumab Biosimilar Matches Reference Product in Chronic Spontaneous Urticaria

Overcoming barriers to insulin access and adherence—particularly with biosimilar insulins—requires robust real-world evidence (RWE) and purpose-built data systems to improve diabetes outcomes and inform health policy, according to a review.

As of June 2025, there are 3 insulin biosimilars approved in the US: 2 insulin glargine (Semglee and Rezvoglar) and 1 insulin aspart (Merilog). | Image credit: Antto-AI - stock.adobe.com

, was conducted to address persistent challenges in realizing the full benefits of insulin therapy and to emphasize the importance of RWE in evaluating the safety, efficacy, and cost-effectiveness of biosimilar insulins. By highlighting current usage patterns, identifying critical data gaps, and proposing the development of purpose-built diabetes registers supported by trained clinical teams, the authors aim to strengthen real-world data infrastructure that can guide more equitable, timely, and effective diabetes care and policy.

As of June 2025, there are 3 insulin biosimilars approved in the US: 2 insulin glargine (Semglee and Rezvoglar)

According to the review, well-designed diabetes registers are essential for generating reliable RWE to guide clinical decisions, improve care quality, and inform health policies, especially in the use of cost-effective treatments like biosimilar insulins.

 Unlike unstructured electronic health records (EHRs), purpose-built registers ensure consistent data collection, enabling the assessment of treatment effectiveness, safety, adherence, and health care costs. When linked with EHRs and claims data, registers can track disease progression, identify care gaps, and evaluate interventions at both patient and population levels. With regulatory bodies increasingly recognizing RWE as critical for approval and policy decisions, robust diabetes registers are key to advancing data-driven, personalized diabetes care.

Recent RWE highlights key trends in insulin use, particularly among people with type 2 diabetes (T2D). Over the past 2 decades, there has been a clear shift from insulin monotherapy to combination therapy with oral glucose-lowering drugs across multiple regions, including Japan, the US, and Italy. Although insulin use as a first-line treatment has remained stable, its use as a second-line therapy is rising. Patterns vary regionally: Japan and the US show declines or stable use, while Hong Kong and Denmark report modest increases. There’s also been a notable global shift from human insulin to long-acting and fast-acting insulin analogues, especially in high-income countries. Basal-bolus regimens are increasingly common in people with T2D, while basal-only regimens are the most common treatment option for people with T2D. Concentrated insulin formulations are also gaining traction, especially in insulin-resistant populations.

Biosimilar insulin use is rising, especially in the US and Canada, where policy mandates have driven uptake. In contrast, adoption remains modest in Europe and many parts of Asia, reflecting variability in regulation, physician preference, and market access. Despite their cost benefits, biosimilars are still underused globally. These shifts underscore the need for better data from low- and middle-income countries, where most people with diabetes live, to understand global insulin use patterns and improve equitable access.

Insulin biosimilars match originators in efficacy and safety, including in insulin pumps, but real-world use remains low due to limited awareness and uptake. Despite being up to 64% cheaper, underutilization—seen even in countries like England and Spain—has prevented full cost savings. Therapeutic inertia, fear, stigma, and system-level barriers contribute to delays in insulin initiation and poor adherence, especially in lower-income regions. Nurse-led care and tech-based support improve outcomes, but provider education and trust in biosimilars remain essential. Compatibility with smart pens and novel delivery systems is still limited, hindering broader adoption.

Insulin needs vary across diabetes subtypes. People with type 1 diabetes require lifelong insulin due to absolute insulin deficiency, and incidence is rising globally, especially in low- and middle-income countries where access remains limited. Slowly progressing autoimmune diabetes (often misclassified as T2D) also leads to insulin dependence. Type 3c diabetes, linked to pancreatic disease, typically involves insulin deficiency and complex glucose regulation. Monogenic diabetes may require insulin, depending on the mutation, while around one-third of people with T2D will eventually need insulin due to progressive beta cell loss. Insulin use in T2D varies by age, duration, and region, with young-onset and older adults particularly affected.

Despite insulin’s century-old discovery, full benefits remain unrealized due to access, cost, and care quality barriers. The authors said that optimizing insulin use will require comprehensive phenotyping, timely initiation, and individualized management supported by education, monitoring tools, and emerging biosimilar options that may improve affordability and access.

The authors concluded, “Scientific evaluation with regulatory approval is critical in ensuring the quality of these technologies; it is here where diabetes registers implemented by a trained doctor–nurse team with system support can become an invaluable tool to assess the impacts of these technologies on clinical outcomes, quality of life and health care costs to inform practice and policies.”

1. Yang A, Yu J, Cheung JTK, Chan JCN, Chow E. Real world evidence of insulin and biosimilar insulin therapy—opportunities to improve adherence, outcomes and cost-effectiveness. 

. Published online April 15, 2025. doi:10.1111/dom.16386.

2. Hagen T. FDA approves Semglee insulin glargine as first interchangeable biosimilar. The Center for Biosimilars

. July 28, 2021. Accessed June 17, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-semglee-insulin-glargine-as-first-interchangeable-biosimilar

3. Rezvoglar broadens insulin glargine biosimilar options. The Center for Biosimilars. December 30, 2021. Accessed June 17, 2025. 

https://www.centerforbiosimilars.com/view/rezvoglar-broadens-insulin-glargine-biosimilar-options

4. Jeremias S. FDA approves first insulin aspart biosimilar. The Center for Biosimilars. February 17, 2025. Accessed June 17, 2025. 

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

Explore how real-world evidence and biosimilars enhance insulin access and adherence, improving diabetes care and outcomes for patients who have type 2 diabetes.

Strengthening Diabetes Care With Purpose-Built Data Infrastructure

The FDA’s decision to grant an interchangeable biosimilar designation to adalimumab-fkjp, marketed as Hulio, will be driven by compelling evidence from a pivotal clinical study that demonstrated the product’s equivalence to the reference biologic, the data from which were 

The authors conducted the study to fulfill FDA requirements for adalimumab-fkjp (Hulio) to be deemed interchangeable with Humira. | Image credit: Prostock-studio - stock.adobe.com

Interchangeability designations allow pharmacists to substitute a qualifying biosimilar for reference adalimumab (Humira) without prescriber intervention, allowing for easier and quicker access to biologic medicines that are a lower price and covered by the patient’s payer plan.

“The results of this study support the interchangeability status recently granted by FDA for adalimumab-fkjp in order to be used interchangeably with reference adalimumab for chronic plaque psoriasis and other indications,” the authors surmised.

Hulio launched on the US market in 2023, along with 9 other adalimumab biosimilars.

 Together, with the launch of (Selarsdi) in 2024,

 the adalimumab market has greatly expanded, with several options having interchangeability designations.

 With the exception of insulin biosimilars and biosimilars administered intravitreally, all biosimilars in the US must have data from switching studies to be declared interchangeable.

The randomized, double-blind, parallel-group trial enrolled 386 patients with moderate to severe plaque psoriasis.

 All participants initially received reference adalimumab. Those who achieved a 50% improvement in the Psoriasis Area and Severity Index (PASI-50 response) were then randomized to either continue treatment with the originator drug or undergo 3 switches between reference adalimumab and the biosimilar Hulio. The study aimed to determine whether repeated switching impacted pharmacokinetics (PK), efficacy, safety, or immunogenicity.

The study’s primary end point was to evaluate steady-state PK between the switch and nonswitch groups. Results showed that the 90% CIs for key PK parameters—area under the concentration-time curve at 104.76% and maximum observed concentration at 104.23%—were well within the FDA's accepted bioequivalence range of 80% to 125%. The minimum observed concentration also fell within this range at 107.85%.

“Our data clearly indicated that exposure to both products remained similar, regardless of switching,” noted one of the study authors, emphasizing the reliability of Hulio’s PK profile even in switching scenarios.

Efficacy and Safety Remain Consistent Despite Switching

Efficacy outcomes remained comparable across treatment arms. At week 28, the percentage of patients achieving “clear” or “almost clear” skin on the static Physician’s Global Assessment was 84.3% in the continuous reference adalimumab group and 84.15% in the switching group. Similarly, PASI response levels—PASI-50, PASI-75, PASI-90, and PASI-100—were highly consistent between the 2 arms.

Safety findings further reinforced the case for interchangeability. Treatment-emergent adverse events (TEAEs) were reported by 34.2% of patients in the nonswitch arm and 29.8% in the switch arm. Serious TEAEs were rare and occurred at nearly identical rates: 1.6% in the nonswitch group and 1.7% in the switch group. Discontinuations due to TEAEs were low in both groups (1.0% and 0.6%, respectively).

The study also monitored immunogenicity, assessing the development of antidrug antibodies. These results were consistent across both arms, indicating that multiple switches between biosimilar and reference product did not heighten immune system reactions.

Implications for Managed Care and Biosimilar Adoption

The study’s design—utilizing a homogeneous population treated with monotherapy—ensured clear, interpretable data. By meeting stringent FDA criteria, the study confirmed that switching between Hulio and reference adalimumab does not compromise patient safety or treatment effectiveness.

“Achieving interchangeable status is a crucial step for increasing patient access to biosimilars,” a study author commented. Pharmacist-level substitution can reduce prescribing barriers, improve affordability, and ease integration into managed care formularies.

Hulio’s new designation represents a significant advancement in the broader adoption of biosimilars in the US. The findings highlight the scientific rigor required to demonstrate interchangeability while also supporting cost savings, competitive markets, and expanded treatment access for patients relying on high-cost biologic therapies.

1. Deodhar S, Longanathan S, Reddy RKS, et al. Multiple switches between adalimumab-fkjp and reference adalimumab in moderate-to-severe chronic plaque psoriasis: a multicenter, double-blind, parallel-group, randomized clinical trial for interchangeability. 

 Published online June 10, 2025. doi:10.1007/s12325-025-03240-5

2. Jeremias S. Happy birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars

. January 31, 2024. Accessed June 16, 2025. 

https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition

3. Jeremias S. Eye on pharma: Simlandi US launch; ranibizumab partnership; expanded access for adalimumab biosimilars. The Center for Biosimilars. May 27, 2024. Accessed June 16, 2025. 

https://www.centerforbiosimilars.com/view/eye-on-pharma-simlandi-us-launch-ranibizumab-partnership-expanded-access-for-adalimumab-biosimilars

The new data were collected to fulfill the FDA's requirements to designate adalimumab-fkjp (Hulio) as interchangeable with Humira, enhancing access to affordable biologics for chronic plaque psoriasis treatment.

New Data Support Hulio as an Interchangeable Adalimumab Option

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

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

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

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 

The FDA has approved Starjemza (ustekinumab-hmny) as a biosimilar to Stelara (ustekinumab) for the treatment of several rheumatic and gastrointestinal conditions.

The FDA has approved 8 ustekinumab biosimilars in total. | Image Credit: wladimir1804 - stock.adobe.com

Starjemza, developed as part of a license and commercialization agreement between Hikma Pharmaceuticals and Bio-Thera Solutions, is the eighth ustekinumab biosimilar to receive the green light from the FDA, following the approval of Steqeyma (ustekinumab-stba), which was approved in September 2024.

"Tapping into the robust ongoing growth of the U.S. biosimilar market is a priority for Hikma. We are eager to use our excellent U.S. commercial capabilities to launch this important product and provide it to the many patients who will benefit from using it," wrote Bill Larkins, PhD, president of Hikma Injectables, in a statement.

Since February 2025, 6 ustekinumab biosimilars have launched on the US market: Wezlana (ustekinumab-auub), Selarsdi (ustekinumab-aekn), Pyzchiva (ustekinumab-ttwe), Otulfi (ustekinumab-aauz), Yesintek (ustekinumab-kfce), and Steqeyma.

 Some of them have launched exclusively through private label distributors, such as Wezlana, which is only available to plans that use Nuvaila.

 Imuldosa (ustekinumab-srlf) is the only other ustekinumab biosimilar in the launch pipeline.

The approval was based on data from 2 key clinical studies. A phase 1 randomized, double-blind, single-dose, 3-arm study (NCT04371185) compared the pharmacokinetics, safety, and immunogenicity of Starjemza with both US- and EU-sourced Stelara in healthy volunteers.

 Additionally, a phase 3 multicenter, randomized, double-blind study evaluated Starjemza against Stelara in patients with moderate to severe plaque psoriasis.

 These studies demonstrated that Starjemza has comparable efficacy, safety, and immunogenicity to the reference product, supporting its approval as a biosimilar.

1. Bio-Thera Solutions and Hikma Pharmaceuticals announce FDA approval of Starjemza (ustekinumab-hmny) Injection, a biosimilar referencing Stelara (ustekinumab) Injection. Press release. Bio-Thera Solutions; May 27, 2025. Accessed May 27, 2025. 

https://www.prnewswire.com/news-releases/bio-thera-solutions-and-hikma-pharmaceuticals-announce-fda-approval-of-starjemza-ustekinumab-hmny-injection-a-biosimilar-referencing-stelara-ustekinumab-injection-302465378.html

2. Jeremias S. FDA approves Steqeyma: the seventh Stelara biosimilar. The Center for Biosimilars

. December 18, 2024. Accessed May 27, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-steqeyma-the-seventh-stelara-biosimilar

3. Jeremias S. Welcome Wezlana: the first Stelara biosimilar to launch in the US. The Center for Biosimilars. January 31, 2025. Accessed May 27, 2025. 

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

4. Jeremias S. 3 ustekinumab biosimilars launch on US market. The Center for Biosimilars. February 24, 2025. Accessed March 12, 2025. 

https://www.centerforbiosimilars.com/view/3-ustekinumab-biosimilars-launch-on-us-market

5. Jeremias S. More ustekinumab biosimilars join US market share fight. The Center for Biosimilars. March 13, 2025. Accessed May 27, 2025. 

https://www.centerforbiosimilars.com/view/more-ustekinumab-biosimilars-join-us-market-share-fight

6. Wu M, Li X, Yang D, et al. Comparison of pharmacokinetic similarity, immunogenicity, and safety of ustekinumab and BAT2206 in healthy Chinese male subjects in a double-blind, randomized, single-dose, parallel-group phase I trial. 

. 2022;37(1):89-98. doi:10.1007/s40259-022-00563-5

7. Man X, Zaharieva K, Pulka G, et al. A randomized phase III study to compare efficacy and safety of BAT2206 (proposed ustekinumab biosimilar) with reference ustekinumab in patients with moderate to severe plaque psoriasis. 

. 2025;92(4):724-731. doi:10.1016/j.jaad.2024.10.104

Starjemza gains FDA approval as the eighth ustekinumab biosimilar, enhancing treatment options for rheumatic and gastrointestinal conditions.

FDA Approves Starjemza as New Stelara Biosimilar

Andre Harvin, PharmD, executive director of pharmacy and oncology services at Cone Health, explains how oncologists can work with other stakeholders to expand access to biosimilars and how patients can work with providers and biosimilar manufacturers to address financial challenges.