Maggie L. Shaw

Patients with ankylosing spondylitis may be able to get the same benefits as Humira (adalimumab) at a lower cost by using the biosimilar IBI303, based on 

The retrospective analysis out of Shenzhen Luohu People’s Hospital in China adds to the growing body of real-world evidence showing that the adalimumab biosimilar IBI303 delivers comparable effectiveness to Humira while offering significant cost savings in the treatment of ankylosing spondylitis. | Image credit: peterschreiber.media - stock.adobe.com

Drawing on data from 106 patients treated between May 2020 and December 2023, the study highlights how biosimilars like IBI303 can ease financial pressure on patients and health care systems without sacrificing quality of care.

The retrospective analysis out of Shenzhen Luohu People’s Hospital in China adds to the growing body of real-world evidence showing that the adalimumab biosimilar IBI303 delivers comparable effectiveness to Humira while offering significant cost savings in the treatment of ankylosing spondylitis.

Ankylosing spondylitis is a chronic inflammatory disease that primarily targets the spine, often resulting in persistent pain and mobility issues. The condition affects an estimated 0.2% to 0.5% of the US population.

 Globally, its occurrence ranges from 0.4 to 14 new cases per 100,000 people each year. Symptoms typically begin early in adulthood, with the onset peaking in a person's 20s and 30s. A significant majority, around 80% of patients, experience symptoms by age 30 or younger, while only a small fraction (5%) will see symptoms emerge after age 45.

Adalimumab has been a mainstay in ankylosing spondylitis management, but the high cost of originator products such as Humira has posed major access challenges—especially in resource-constrained settings.

 Biosimilars offer a lower-cost alternative, but real-world data are essential to understanding their performance outside the controlled environment of clinical trials.

In this analysis, 38 patients received Humira and 68 received IBI303. The researchers looked at adalimumab retention rates at 52 weeks as the primary outcome. At 1 year, retention was higher in the IBI303 group (63%) than the Humira group (44%). IBI303 also showed stronger early retention at 24 weeks (82% vs 67%).

Safety outcomes were nearly identical. Just 2 patients in each group experienced mild infusion-related reactions, with no statistically significant differences between the arms.

Cost differences were notable. Median treatment costs were significantly lower for patients on IBI303 compared with those on Humira, both at 12 weeks ($762.20 vs $903.70; 

 = .042) and at 52 weeks ($2543.00 vs. $2982.30; 

 = .004). The data suggest IBI303 may be a more cost-effective option for long-term disease management.

According to the authors, IBI303 demonstrated not only comparable effectiveness and safety but also higher retention and lower overall cost—key considerations in chronic disease treatment.

Although this study was conducted in China, its implications are far-reaching. As the US health care system continues to wrestle with drug pricing and access, real-world data like these bolster the case for broader adoption of biosimilars. IBI303’s strong performance supports the notion that biosimilars aren’t just budget alternatives—they’re viable first-line options that can help expand access to care while controlling costs.

The study also provided insight into dosing, with data suggesting that a maintenance dose of 40 mg every 4 weeks may be sufficient for many patients, potentially offering further savings.

The authors concluded, “From a Chinese perspective, there is no difference in retention rate and safety between IBI303 and Humira in real-world use [in patients with ankylosing spondylitis], but because IBI303 has [a] lower price, it will lighten patients’ economic burden, and our drug exposure results can provide data support for tapering of biological therapy.”

1. Cheng X, Fu Z, Liu J, et al. Comparative real-world retention rate and safety of biosimilar IBI303 versus Humira in ankylosing spondylitis: a retrospective study. 

. 2025;104(26):e43010. doi:10.1097/MD.0000000000043010

2. Ankylosing spondylitis. Johns Hopkins Arthritis Center. Accessed July 17, 2025. 

https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/

Articles

Biosimilar IBI303 offers comparable effectiveness to Humira for ankylosing spondylitis, providing significant cost savings and improved patient retention rates.

Data Show Comparable Efficacy, Added Cost Benefit With Adalimumab Biosimilar vs Humira

Despite the recognized potential of biosimilars to expand patient access to critical biologic medicines and significantly reduce health care costs, their uptake in Latin American (LatAm) countries has remained notably slow.

 A recent manuscript, drawing on a comprehensive analysis involving key opinion leaders and industry representatives across Latin America and Europe, shed light on the multifaceted barriers hindering biosimilar adoption and proposed strategic initiatives to accelerate their use.

Biosimilars promise cost savings and improved patient access in Latin America, yet face significant regulatory and educational barriers hindering their uptake. | Image credit: Olsek - stock.adobe.com

, underscored the urgent need for harmonized regulatory processes, robust education, and coordinated regional efforts to unlock the full benefits of biosimilars for patients and health care systems in the region.

“The impact of high-cost biologics is felt greatly in the LatAm region, where most of the population depends on underfunded public health systems. Moreover, there are considerable differences in the epidemiology and burden of cancer among countries in this region that further impact on patient outcomes…. The development and implementation of a standardized and streamlined regulatory process for biosimilars across the LatAm region, including translation into daily practice in a timely manner, is crucial,” wrote the authors.

Health care expenditures in LatAm countries have been on a sharp upward trajectory, fueled by demographic shifts such as population growth and aging, alongside the increasing prevalence of chronic diseases like cancer. Biologic medicines, although vital, represent a disproportionately high share of drug budgets, creating significant access barriers for patients. Biosimilars offer a powerful solution by fostering price competition and enhancing affordability.

However, despite their proven benefits in regions like Europe and the US, their integration into LatAm health care systems has been sluggish, prompting this investigation into the underlying causes and potential remedies. According to a 2022 study, the LatAm biosimilar market had the potential to grow at a 33% rate annually to reach $3.9 billion by 2025.

To understand the complexities of biosimilar uptake in Latin America, researchers convened an online forum of 6 key opinion leaders from Brazil, Chile, Mexico, and the UK, encompassing expertise in pharmacology, hematology, oncology, and health economics.

 Two industry representatives from Latin America and Europe also participated, moderating discussions and providing crucial context. The group offered perspectives on the barriers impacting biosimilar acceptance in Latin America, drawing comparisons to European experiences.

Complementing these expert discussions, industry representatives from 12 LatAm countries completed a survey detailing their national biosimilar policies. The insights gathered from these discussions and survey results ultimately led to the identification of 6 key themes affecting biosimilar acceptance, which formed the core of the expert opinion.

Main Findings Highlight Critical Barriers

The analysis revealed a fragmented and inconsistent landscape for biosimilars across Latin America. Lack of harmonized regulatory processes was a significant challenge identified. Unlike the more uniform approach seen in Europe, LatAm countries often have unique and sometimes nonstandardized regulatory pathways, leading to delays in approval or, in some cases, the approval of "intended copy biologics" (ICBs) that do not meet rigorous international biosimilarity standards. For instance, the rituximab ICB Kikuzubam in Mexico was withdrawn due to higher-than-expected serious adverse effects, undermining trust in biosimilars.

Beyond regulatory hurdles, the study highlighted a scarcity of policies to actively incentivize biosimilar use. While some public health tenders in Chile favored biosimilars, a widespread lack of national policies and incentives for prescribers, particularly in the private sector, limited uptake.

This contrasts sharply with Europe, where initiatives like Ireland's "best-value biologic" program, offering enhanced prescriber payments, dramatically increased biosimilar market share and generated estimated cost savings of €22.7 million. Furthermore, confusion surrounding terminology like 

, coupled with a lack of specific naming policies for biosimilars, contributed to misinformation among health care professionals (HCPs) and patients. This absence of clear national guidelines often left clinicians and patients to make individual decisions about switching.

Implications for the Biosimilar Industry and US Health Care

For the biosimilar industry, the study underscored the immense, yet largely untapped, market potential in Latin America, estimated to reach $3.9 billion by 2025. However, realizing this potential demands a proactive approach to advocating for policy reforms and investing in comprehensive stakeholder education.

For US health care, the challenges in the LatAm region serve as a reminder of the foundational importance of clear, harmonized regulatory pathways and robust educational efforts in fostering biosimilar trust and uptake. The FDA's recent clarification on biosimilar interchangeability, affirming confidence in all approved biosimilars, directly addresses some of the informational barriers identified in Latin America, demonstrating how regulatory clarity can empower prescribers.

Ultimately, the study reinforced that although biosimilars offer a powerful tool for health care sustainability, their full benefit can only be realized through concerted efforts that address regulatory consistency, stakeholder education, and strategic incentive programs that prioritize both affordability and patient confidence.

The authors concluded, “We can envision a future scenario for the position of biosimilars in [Latin America] based on what is currently taking place in Europe…. It is crucial to continue discussing and considering these future developments throughout [Latin America], especially as an increasing number of biologic reference drugs lose their patents and become targets for biosimilar development.”

1. Feijó Azevedo V, Mysler E, Aceituno Álvarez A, et al. Recommendations for the regulation of biosimilars and their implementation in Latin America. 

. 2014;3(3):143-148. doi:10.5639/gabij.2014.0303.032

2. Schaffel R, Cornes P, Espinoza MA, et al. The potential role of biosimilars in healthcare sustainability in Latin America. 

. 2025;25(6):633-647. doi:10.1080/14712598.2025.2507173

3. Teran E, Gomez H, Hannois D, et al. Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective. 

. 2022;23(7):e348–e358. doi:10.1016/S1470-2045(22)00121-8

Biosimilars promise cost savings and improved patient access in Latin America, yet face significant regulatory and educational barriers hindering their uptake.

Slow Biosimilar Uptake in Latin America Signals Missed Opportunities for Patient Access, Cost Savings

The FDA has announced a significant advancement in diabetes care with the approval of Kirsty (insulin aspart-xjhz), marking it as the first rapid-acting interchangeable biosimilar product to Novolog (insulin aspart).

 This pivotal approval is a crucial step toward enhancing access to more affordable insulin options for the over 8.4 million Americans who depend on insulin therapy to manage their condition.

The approval also makes Kirsty the second insulin aspart biosimilar to receive FDA clearance. It follows Merilog (insulin-aspart-szjj), approved in February 2025, the first biosimilar to reference Novolog.

 Merilog was the third overall insulin biosimilar approved, after 2 insulin glargine products: Semglee (insulin glargine-yfgn) and Rezvoglar (insulin glargine-aglr).

Upon launch, Kirsty will be available as a 3-mL single-patient-use prefilled pen and a 10-mL multiple-dose vial.

 It is indicated to improve glycemic control in both adult and pediatric patients with diabetes. Similar to Novolog, Kirsty can be administered subcutaneously into the abdomen, buttocks, thighs, or upper arms, typically within 5 to 10 minutes before a meal.

The 10-mL vial can also be used for continuous subcutaneous infusion or intravenously. Dosing must be individualized, and the medication should not be used during hypoglycemia or in patients with hypersensitivity to insulin aspart products. Serious adverse effects include hypoglycemia, severe allergic reactions, and hypokalemia. Common adverse effects may include injection site reactions, rash, lipodystrophy, weight gain, and swelling in the hands and feet.

What’s the Deal With Interchangeability?

The designation of "interchangeable biosimilar" is particularly significant for patient access and market dynamics. The added benefit of an interchangeable biosimilar is that it may be substituted for the reference product (Novolog) at the pharmacy without the need for a new prescription, depending on state laws.

 This capability is expected to streamline patient access and further drive competition.

The high cost of reference insulin products has long been a critical issue in the US, which has over 37 million people diagnosed with diabetes.

 This financial burden often forces patients to skip or ration their insulin treatments to save money. A 

 study highlighted this challenge, finding that 1 in 5 US adults under 65 years with diabetes who use insulin rationed their supply due to cost.

 Notably, nearly 71% of adults reporting insulin rationing for financial reasons were under 65 years, making them ineligible for the out-of-pocket cost limits established by the Inflation Reduction Act.

The FDA's ongoing approval of additional insulin biosimilars, especially interchangeable ones, underscores its commitment to fostering a competitive marketplace for insulin products.

Increasing access to safe, effective, and high-quality medications at potentially lower price points remains an ongoing priority for the FDA. In a statement touting the approval of Miralog, Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars, further emphasized that "having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications."

The availability of biosimilar and interchangeable insulin products is expected to provide more treatment options, potentially lowering costs, and ultimately enabling greater access for more patients.

1. FDA approves first interchangeable biosimilar insulin product to Novolog (insulin aspart). News release. FDA. July 15, 2025. Accessed July 15, 2025. 

https://content.govdelivery.com/accounts/USFDA/bulletins/3e995f3

2. American Diabetes Association announces support for INSULIN Act at Senate press conference. News release. ADA. June 22, 2022. Accessed July 15, 2025. 

https://diabetes.org/newsroom/american-diabetes-association-announces-support-for-insulin-act-at-senate-press-conference

3. Jeremias S. FDA approves first insulin aspart biosimilar. The Center for Biosimilars

. February 17, 2025. Accessed July 15, 2025. 

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

4. Fang M, Selvin E. Cost-related insulin rationing in US adults younger than 65 years with diabetes. 

. 2023;329(19):1700-1702. doi:10.1001/jama.2023.5747

The FDA has approved Kirsty, the first interchangeable insulin aspart biosimilar, enhancing access to affordable diabetes care for millions.

FDA Approves Kirsty as First Interchangeable Insulin Aspart Biosimilar

The US biosimilar market recently saw the introduction of 2 pairs of denosumab biosimilars from Fresenius Kabi and Celltrion USA, significantly expanding treatment options for individuals living with bone-related conditions.

The pairs of denosumab competitors follow the launches of Sandoz’ Wyost and Jubbonti (denosumab-bbdz for both), which launched in March 2025. | Image credit: SoftSheep - stock.adobe.com


 the commercial availability of Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). Conexxence is a biosimilar referencing Prolia (denosumab), and Bomyntra is a biosimilar referencing Xgeva (denosumab). The biosimilars 

 from the FDA for all indications of their respective reference products in March 2024.

Conexxence is indicated for various adult patient populations at high risk for fractures.

 This includes individuals with osteoporosis, people undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy. It is available in a 60-mg/mL single-use prefilled syringe. Fresenius Kabi noted that Conexxence carries a black box warning and is part of a Risk Evaluation and Mitigation Strategy program designed to inform prescribers and patients about the risk of severe hypocalcemia in individuals with advanced chronic kidney disease, including those on dialysis. The biosimilar is contraindicated in patients with hypocalcemia, during pregnancy, and in cases of known hypersensitivity to denosumab products.

Bomyntra is approved for the prevention of skeletal-related events in patients with multiple myeloma and in individuals with bone metastases from solid tumors. It is also indicated for the treatment of hypercalcemia of malignancy that is refractory to bisphosphonate therapy and for the treatment of adults and skeletally mature adolescents with giant cell tumor of the bone that is unresectable or where surgical resection is likely to result in severe morbidity. Bomyntra is available in a 120-mg/1.7-mL vial and a 120-mg/1.7-mL single-use prefilled syringe. It is contraindicated in patients with hypocalcemia and those with known hypersensitivity to denosumab products.

Sang Jin Pak, PhD, president of Fresenius Kabi Biopharma, expressed the company’s commitment to consistent biosimilar launches, stating, “Access to high-quality biological medicines creates the opportunity to provide more affordable therapies to patients and as our biosimilar portfolio expands, we will be able to provide access for even more patients.” Earlier this year, Fresenius Kabi reached a global settlement with Amgen regarding its denosumab biosimilars.

 the commercial availability of its denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo). Stoboclo references Prolia (denosumab), while Osenvelt references Xgeva (denosumab).

Stoboclo is available as a 60-mg/mL injection. It is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, and to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture. Additionally, it is indicated to increase bone mass in men at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Osenvelt, available as a 120-mg/1.7-mL (70 mg/mL) injection, is indicated to prevent skeletal-related events in patients with multiple myeloma and in individuals with bone metastases from solid tumors. It is also approved to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

Thomas Nusbickel, chief commercial officer at Celltrion USA, highlighted the significance of the launches, stating, "We are proud to introduce our denosumab biosimilars to the U.S. market, offering patients and professionals a valuable alternative treatment option." Celltrion also reached a global settlement with Amgen concerning its denosumab biosimilars. To support patients, Celltrion offers comprehensive patient support programs, including the Celltrion Connect patient support program and the Celltrion Cares co-pay assistance program, with options for uninsured patients to potentially receive treatment at no cost.

The pairs of denosumab competitors follow the launches of Sandoz’ Wyost and Jubbonti (denosumab-bbdz for both), which launched in March 2025, nearly a year after they became the first denosumab biosimilars to be greenlit by the FDA.

Now that Xgeva and Prolia have 3 competitors each, the market is starting to stack up, with 

 (denosumab-dssb for both), which were developed by Samsung Bioepis are waiting in the wings to launch next.

“By providing quality-proven biosimilars, we are helping to address a critical healthcare need and reduce the burden of skeletal fractures that impact patients’ quality of life,” Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, commented.

1. Fresenius expands biosimilars portfolio with the launch of denosumab biosimilars in the U.S. News release. Fresenius Kabi. July 1, 2025. Accessed July 9, 2025. 

https://www.businesswire.com/news/home/20250701511446/en/Fresenius-Expands-Biosimilars-Portfolio-With-The-Launch-of-Denosumab-Biosimilars-in-the-U.S

2. Celltrion USA announces U.S. launch of denosumab biosimilars, Stoboclo and Osenvelt (denosumab-bmwo). News release. Celltrion USA. July 7, 2025. Accessed July 9, 2025. 

https://www.prnewswire.com/news-releases/celltrion-usa-announces-us-launch-of-denosumab-biosimilars-stoboclo-and-osenvelt-denosumab-bmwo-302499495.html

3. Santoro C. FDA approves another pair of denosumab biosimilars, Conexxence and Bomyntra. The Center for Biosimilars

. March 27, 2025. Accessed July 9, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-another-pair-of-denosumab-biosimilars-conexxence-and-bomyntra

4. Jeremias S. FDA approves third pair of denosumab biosimilars. The Center for Biosimilars. March 4, 2025. Accessed July 9, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-third-pair-of-denosumab-biosimilars

5. Jeremias S. Wyost and Jubbonti launch as first denosumab biosimilars in the US. The Center for Biosimilars. June 2, 2025. Accessed July 9, 2025. 

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

6. Jeremias S. FDA, EMA approve second pair of denosumab biosimilars. The Center for Biosimilars. February 17, 2025. Accessed July 9, 2025. 

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

The US biosimilar market expands with new denosumab options, enhancing treatment for patients with osteoporosis and bone-related metastases.

Two More Pairs of Denosumab Biosimilars Enter US Market

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/

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. 

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.

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