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

Skylar Jeremias

Pediatric patients with inflammatory bowel disease (IBD) treated with adalimumab biosimilars had “high durability and remission rates” at a lower cost of treatment, according to a 

 in 2 European centers. The authors said their findings confirm the cost-effectiveness of adalimumab biosimilars in pediatric IBD.

The authors said their findings confirm the cost-effectiveness of adalimumab biosimilars in pediatric IBD. | Image credit: zinkevych - stock.adobe.com

According to the authors, although real-world studies have reported similar safety and effectiveness of adalimumab biosimilars to the reference product in 

, there is very little data from pediatric populations. Their study assessed the long-term durability of adalimumab biosimilars in pediatric IBD centers in Scotland and Sicily over up to 72 months, as well as effectiveness, safety and cost savings.

Adalimumab, a monoclonal antibody targeting tumor necrosis factor (TNF)-α, is used to treat IBD in both adults and children. Following the expiration of the originator’s (Humira) patent in 2018, biosimilars have become available in Europe, including ABP 501 (Amgevita), GP2017 (Hyrimoz), and SB5 (Hadlima).

A total of 130 patients,115 (88%) with Crohn disease (CD), 7 (5%) with ulcerative colitis (UC), and 8 (6%) with IBD unclassified (IBDU) were included. The mean age was 12.3 years, and patients used biosimilars ABP 501 (85%), GP2017 (14%), and SB5 (1%). About one-third (32%) of patients switched from the originator to 1 of the biosimilars, 80% of whom were in clinical remission at the time.

The probabilities of durability at 6, 12, 24, 26, and 54 months were 93%, 86%, 75%, 62%, and 57%. After a median follow-up of 26 months (IQR, 12-50; maximum, 72 months), 87 (67%) patients remained on adalimumab biosimilar treatment.

One-third of patients (33%) discontinued therapy, due to primary non-response (14%), secondary loss of response (37%), adverse events (AEs; 33%), IBD-related surgery (14%), and severe needle phobia (2%).

When analyzing potential factors associated with treatment failure, the investigators found patients who had previously been exposed to the adalimumab reference product had a lower risk of biosimilar treatment failure (HR, 0.51; 95% CI, 0.26-0.99; 

 = .047). Other factors, such as IBD subtype, perianal disease, or previous exposure to infliximab were not associated with treatment failure.

Clinical remission rate improved over time, from 39% at baseline, to 71% at 6 months and 72% at 12 months. The investigators also observed improvements in luminal remission, C-reactive protein (CRP) levels, and fecal calprotectin levels over time.

Based on therapeutic drug monitoring (TDM) data, patients who experienced treatment failure had lower drug concentrations at 6 months (10.7 μg/ml; IQR 7.6-12.0) than those who continued treatment (12.0 μg/ml; IQR, 10.4-15.9). Trough levels of at least 11.6 μg/ml at 6 months were associated with greater durability of adalimumab biosimilar therapy.

AEs occurred in 46 (36%) patients, which were mainly psoriasis (13%) and injection site reactions (13%), and 1 case of lymphoma. Of the 14 who discontinued due to AEs, 6 switched to the originator because of injection site reactions or difficulty with delivery. Of patients who experienced injection site pain, most (94%) were receiving ABP 501, and the rest were receiving GP2017.

The cost savings from using an adalimumab biosimilar in place of the reference product were estimated at 5,030 Euro per patient per year. According to the authors, this is the first real-world study assessing the long-term durability of adalimumab biosimilars in pediatric IBD. “Durability can be considered a general marker of treatment success, as it reflects overall effectiveness, AEs, and patient acceptance,” they wrote. They said the treatment persistence rate they observed is comparable to 

, with a larger sample size and extended follow-up period, adding that the treatment persistence results were also similar to those found in adult patients with IBD.

Ancona S, Armstrong K, Longo C, Rabone R, Merrick V, Henderson P, Gandullia P, Wilson DC, Arrigo S, Russell RK. Adalimumab biosimilars demonstrate long-term durability and cost-effectiveness in paediatric inflammatory bowel disease: a real-world two-centre European cohort study. Biologics. 2025;19:265-279. doi:10.2147/BTT.S511248

Articles

A real-world study reveals that pediatric patients with IBD achieve high remission rates and cost savings using adalimumab biosimilars over time.

Long-Term Durability and Cost-Effectiveness of Adalimumab Biosimilars in Pediatric IBD

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

Celltrion announced the FDA had approved a new formulation of Steqeyma (ustekinumab-stba), a biosimilar to Stelara (ustekinumab). The approval, for a 45 mg/0.5 mL solution in a single-dose vial for subcutaneous injection, significantly broadened dosing flexibility for pediatric patients aged 6 to 17 years who weigh less than 60 kg and live with plaque psoriasis (PsO) or psoriatic arthritis (PsA). 

"Managing inflammatory diseases in pediatric patients can be particularly complex due to varying body weights and specific developmental needs," stated Hetal Patel, PharmD, MBA, vice president of medical affairs at Celltrion USA. | Image credit: WESTOCK - stock.adobe.com

The company stated that the strategic expansion ensures that Steqeyma now aligns with all existing dosage forms and strengths of its reference product, providing enhanced options for health care providers and individuals managing these chronic inflammatory conditions.

The FDA's decision marked a pivotal moment for pediatric dermatology and rheumatology, offering a precise dosing solution for a vulnerable patient population. Prior to this latest approval, in December 2024, the FDA had already granted approval for Steqeyma in 45 mg/0.5 mL and 90 mg/mL solutions in single-dose prefilled syringes for subcutaneous injection and a 130 mg/26 mL solution in a single-dose vial for intravenous infusion.

These initial approvals covered adult and pediatric patients aged 6 years and older with PsO and PsA, as well as adult patients with Crohn disease and ulcerative colitis. The addition of the new 45 mg/0.5 mL single-dose vial specifically addresses the nuanced requirements for precise weight-based dosing in smaller pediatric patients.

"Managing inflammatory diseases in pediatric patients can be particularly complex due to varying body weights and specific developmental needs," stated Hetal Patel, PharmD, MBA, vice president of medical affairs at Celltrion USA.

 "This new dosage form and strength of Steqeyma allows us to better meet the specific needs of young patients, giving physicians a valuable treatment option with flexibility, supported by a well-established safety and efficacy profile." This sentiment underscored the commitment to patient-centered care, a priority for managed care organizations focused on optimizing health outcomes and treatment adherence.

Thomas Nusbickel, chief commercial officer at Celltrion USA, emphasized the broader impact of the approval. "We are proud to offer a new presentation of Steqeyma that aligns with the indications of the reference product. This approval reinforces our commitment to broadening access for all patient populations, including children aged 6 years and older living with chronic inflammatory conditions."

The FDA’s approval of Steqeyma was built upon a comprehensive body of evidence, including the results from a phase 3 study conducted in adults with moderate to severe PsO. This study demonstrated that Steqeyma and the reference product exhibited high similarity, confirming no clinically meaningful differences in terms of safety and efficacy among adult individuals.

A key development for formulary decision-makers was the FDA’s decision to grant Steqeyma full interchangeability with Stelara across all its indications.

 Interchangeability status allows for direct pharmacy-level substitution, further simplifying access and potentially reducing health care costs.

The expanded approval of Steqeyma for pediatric patients represents a significant advancement in the treatment landscape for individuals living with PsO and PsA. By providing a full complement of dosage forms and strengths, Celltrion aims to enhance treatment continuity and improve access to a crucial therapeutic option, aligning with the core objectives of managed care to deliver high-quality, cost-effective care.

1. Celltrion announces U.S. FDA approval of additional presentation of Steqeyma (ustekinumab-stba), expanding dosing options for pediatric patients. Press release. Celltrion; June 15, 2025. Accessed June 17, 2025. 

https://www.prnewswire.com/news-releases/celltrion-announces-us-fda-approval-of-additional-presentation-of-steqeyma-ustekinumab-stba-expanding-dosing-options-for-pediatric-patients-302481004.html

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

. December 18, 2024. Accessed June 17, 2024. 

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

3. Papp KA, Lebwohl MG, Thaçi D, et al. Efficacy and safety of candidate biosimilar CT-P43 versus originator ustekinumab in moderate to severe plaque psoriasis: 28-week results of a randomized, active-controlled, double-blind, phase III study. 

. 2024;38:121-131. doi: 10.1007/s40259-023-00630-5

Celltrion's FDA approval of Steqeyma enhances pediatric psoriasis treatment, offering flexible dosing options for children with chronic inflammatory conditions.

FDA Approves Steqeyma for Children With Plaque Psoriasis, Psoriatic Arthritis

Alvotech and Dr. Reddy's to Partner on Pembrolizumab

Alvotech and Dr. Reddy’s Laboratories have announced a strategic partnership to co-develop, manufacture, and commercialize a biosimilar candidate referencing Keytruda (pembrolizumab), one of the world’s top-selling cancer immunotherapies.

 Keytruda, which is expected to lose market exclusivity in 2028, generated $29.5 billion in global sales in 2024 and is used to treat multiple cancer types, including melanoma, non-small cell lung cancer, and classical Hodgkin lymphoma. Making a biosimilar version creates a significant opportunity to improve patient access to life-saving treatments.

Under the agreement, both companies will jointly manage development and manufacturing responsibilities and share associated costs. Subject to certain exceptions, each partner will retain rights to commercialize the biosimilar globally.

The collaboration leverages Alvotech’s biosimilar research and development and manufacturing expertise alongside Dr. Reddy’s global commercialization strength and oncology focus. Executives from both companies emphasized their shared goal of delivering high-quality, affordable cancer therapies and expanding patient access to critical biologics across international markets.

German Court Bans Humira Biosimilar Over Patent Dispute

Samsung Bioepis and its European commercialization partner Biogen have been dealt a major legal blow in Germany, according to 

 The Düsseldorf Higher Regional Court ruled that their adalimumab biosimilar, Imraldi, infringes on a formulation patent held by Fresenius Kabi, which covers liquid versions of adalimumab—the active ingredient in AbbVie’s blockbuster anti-inflammatory drug. The decision reversed a 2022 lower court ruling that had favored Samsung Bioepis and Biogen.

The ruling has immediate consequences: it bans the sale of Imraldi in Germany, orders Biogen to recall and destroy existing inventory, and imposes financial penalties along with a disclosure of sales data. This raises the stakes for Samsung Bioepis, as Europe is a key market for biosimilars, and Imraldi had captured 62% of Germany’s adalimumab biosimilar market just 1 month after its 2018 launch.

The legal victory for Fresenius Kabi, which markets its own adalimumab biosimilar, Idacio, reflects intensifying competition in Europe’s adalimumab space. Although Samsung Bioepis and Biogen previously challenged the validity of the formulation patent at the European Patent Office, that effort failed, and the patent remains in force across the European Union—potentially opening the door to similar enforcement in other countries. The companies are already defending against related claims in France.

The court did not automatically grant Biogen leave to appeal to Germany’s Federal Court of Justice, though an appeal may still be requested. In the meantime, the injunction and penalties stand, putting pressure on the companies to either reformulate or reach a settlement if they want to avoid broader sales disruptions in Europe.

Samsung Bioepis has entered into a strategic agreement with NIPRO Corporation to license, develop, and commercialize multiple biosimilar candidates in the Japanese market.

 Under the terms of the deal, Samsung Bioepis will be responsible for development, manufacturing, and supply, while NIPRO will lead commercialization efforts within Japan.

Among the biosimilars included in the agreement is SB17, Samsung Bioepis’ biosimilar candidate referencing ustekinumab—a monoclonal antibody used to treat autoimmune conditions such as plaque psoriasis, psoriatic arthritis, and Crohn disease. The introduction of an ustekinumab biosimilar in Japan could provide a more affordable alternative to the originator product (Stelara), helping to lower treatment costs and expand access for patients managing chronic immune-mediated diseases.

In its statement on the new partnership, Samsung Bioepis noted that the partnership reflects growing momentum in Japan’s biosimilar market, where the government is encouraging adoption to reduce healthcare spending amid a rapidly aging population.

1. Alvotech and Dr. Reddy’s enter into collaboration to co-develop biosimilar candidate to Keytruda (pembrolizumab). Press release; Alvotech. June 5, 2025. Accessed June 17, 2025. 

https://investors.alvotech.com/news-releases/news-release-details/alvotech-and-dr-reddys-enter-collaboration-co-develop-biosimilar

2. Samsung Bioepis, Biogen lose Humira biosimilar patent fight in Germany. Korea Biomedical Review. June 16, 2025. Accessed June 17, 2025. 

https://www.koreabiomed.com/news/articleView.html?idxno=27912

3. Samsung Bioepis enters into a strategic partnership with NIPRO for commercialization of multiple biosimilars in Japan. Press release; Samsung Bieopis;

https://www.businesswire.com/news/home/20250608582351/en/Samsung-Bioepis-Enters-into-a-Strategic-Partnership-with-NIPRO-for-Commercialization-of-Multiple-Biosimilars-in-Japan

Alvotech and Dr. Reddy's partner to develop a Keytruda biosimilar, a German court bans Humira biosimilar over patent dispute, and Samsung Bioepis enters a strategic agreement with NIPRO Corporation in Japan. 

Eye on Pharma: Keytruda Biosimilar Deal; German Court Bans Imraldi; New Biosimilars for Japan

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 response to the need for more real-world evidence on adalimumab biosimilars, new findings from a large cross-sectional survey across France, Germany, Italy, Spain, and the UK offer compelling insights into the practical benefits of ABP 501 (Amgevita/Amjevita), a leading adalimumab biosimilar.

New research highlights the effectiveness and high patient satisfaction of adalimumab biosimilars in treating inflammatory diseases. | Image credit: garrykillian - stock.adobe.com

The treatment of debilitating immune-mediated inflammatory diseases (IMIDs) like rheumatoid arthritis (RA), axial spondyloarthritis (axSpA), psoriatic arthritis (PsA), and psoriasis (PsO) has seen a dramatic shift with the introduction of adalimumab biosimilars.

, involving 1296 patients who either started on ABP 501 or switched from the reference product (Humira), directly tackled critical questions about its real-world effectiveness, patient satisfaction, and impact on daily life.

The data emphatically demonstrated that ABP 501 delivered positive treatment outcomes, earning high satisfaction marks from both patients and their treating physicians, regardless of prior exposure to the reference product. Physicians reported overwhelming satisfaction with disease control provided by ABP 501. Among patients who initiated ABP 501 as their first advanced therapy, physician satisfaction rates exceeded 89% across all disease cohorts, even reaching more than 95% in AS, PsA, and PsO.

For those initiating ABP 501, a significant majority of patients across all IMIDs were assessed by their physicians as having mild disease at the time of consultation—ranging from 63.2% in AS to an impressive 83.0% in PsO after a median of 10.4 to 12.3 months on the biosimilar. Pain levels also showed remarkable improvement, with a large proportion of patients experiencing mild or no pain.

Patients echoed their physicians' positive assessments. A substantial majority of ABP 501 initiators, more than 86% across all indications, reported high satisfaction with their treatment regimen. Importantly, their health-related quality of life (HRQOL) measures consistently indicated minimal disease impact on their daily lives. Low scores for work productivity and activity impairment further emphasized the biosimilar's positive effect on patients' ability to participate in daily activities and work.

The study also shed light on the experiences of patients who transitioned from the reference product to ABP 501. The drivers for these switches were often pragmatic, with physicians citing formulary-driven switches, financial considerations, and insurance restrictions as primary reasons. Crucially, these non-clinical motivations did not translate into compromised patient care or satisfaction. Both physicians and patients maintained high satisfaction levels with ABP 501 after the switch, exceeding 93% for physicians and at least 94.7% for patients across indications. Moreover, patient-reported HRQOL remained strong following the switch, demonstrating a seamless transition without any discernible negative impact on patient well-being or treatment efficacy. This finding is particularly significant for managed care organizations, as it helps to alleviate concerns about potential "nocebo effects" sometimes associated with biosimilar transitions.

This robust real-world evidence provides compelling arguments for managed care organizations to fully embrace adalimumab biosimilars like ABP 501. Driven by financial and administrative advantages, these biosimilars offer a significant opportunity to reduce health care expenditures for IMID management, leading to more efficient resource allocation and benefiting a broader patient population.

The high satisfaction among both physicians and patients, coupled with positive clinical outcomes, should bolster confidence in prescribing biosimilars, especially for extrapolated indications. The sustained high HRQOL and satisfaction reported by patients after switching underscore that biosimilars maintain positive patient experiences and promote adherence.

Another real-world analysis focusing on nonmedical switching from the adalimumab originator to adalimumab biosimilars revealed that patient-reported outcomes were maintained post-switch, showing the continued safety and efficacy for patients with chronic inflammatory conditions.

The authors of the present study concluded, “Our findings add to the growing body of real-world experience with biosimilar use which help address barriers to utilization due to lack of awareness and concerns about inadequate efficacy from both patients and physicians, especially for indications approved on the principle of extrapolation and for patients who switch from the reference product.”

1. Jin R, Haughton JM, Goddard EJ, et al. Real-world experience with an adalimumab biosimilar (ABP 501) in patients with rheumatoid arthritis, ankylosing spondylitis, psoriatic arthritis and psoriasis in Europe: results from the Adelphi Disease Specific Programme. 

. 2025;12(3):469-492. doi:10.1007/s40744-025-00755-9

2. Jeremias S. Study on nonmedical switching for adalimumab biosimilars warns about nocebo effect. The Center for Biosimilars

. April 27, 2023. Accessed June 2, 2025. 

https://www.centerforbiosimilars.com/view/study-on-nonmedical-switching-for-adalimumab-biosimilars-warns-about-nocebo-effect

New research highlights the efficacy and high patient satisfaction of adalimumab biosimilars in treating inflammatory diseases.

European Data Confirm Real-World Benefits of Adalimumab Biosimilars

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

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