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

Skylar Jeremias

The growing adoption of biosimilars for complex retinal diseases is heavily dependent on confirmation of the drug’s stability under realistic clinical handling conditions. A recent study, 

 provided critical data supporting the extended physicochemical and biological stability of XSB-001 (Ximluci; STADA Arzneimittel AG), a biosimilar referencing Lucentis (reference ranibizumab), which has been available in Europe since 2023.

A recent study confirms the stability of XSB-001 biosimilar for retinal diseases, ensuring quality during clinical handling and enhancing patient care efficiency. | Image credit: 61766578 - stock.adobe.com

Ranibizumab, an anti–vascular endothelial growth factor (VEGF)–A fragment, is a cornerstone treatment for serious retinal conditions, including neovascular age-related macular degeneration (nAMD) and diabetic macular edema. While XSB-001 previously demonstrated equivalent efficacy and safety to the reference product in clinical trials, the question of its stability following preparation for injection remained a key consideration for health care providers and payers.

Ophthalmic practices often draw up injectable medications into syringes days or weeks in advance for efficiency and logistical planning. This “in-use” preparation exposes the drug to variables like container materials, temperature fluctuations, and light. As such, researchers decided to conduct this study, which evaluated XSB-001 under real-world handling conditions for 30 days. They specifically sought to confirm that prefilled syringes stored long-term and subsequently exposed briefly to ambient temperature and light (simulating transportation and preparation time) would maintain their required quality specifications.

Key Data Points Confirming Extended Quality

The stability study examined XSB-001 stored in its original vials at 5±3°C and subsequently prepared into 2 different types of commonly used syringes. Samples were maintained for 30 days, with a critical subset then exposed to 48 hours of room temperature, humidity, and ambient room lighting to replicate actual clinical use prior to injection.

Across all test conditions and both syringe types, the biosimilar maintained all required physicochemical and biological criteria.

 Size exclusion–high-performance liquid chromatography (SE-HPLC) analysis confirmed high monomer purity, averaging 99.6%. This surpassed the required threshold of 99.0% or greater.

 Low molecular weight species were consistently observed to be below the detection limit (<0.35%), satisfying the requirement of 1.0% or less.

 Reverse-phase high-performance liquid chromatography (RP-HPLC) analysis showed consistent main peak purity of 97.3%, exceeding the 97.0% or higher criterion.

 The study confirmed that the biological activity of XSB-001 remained fully intact across all conditions. The potency, which was tested using a VEGF$_{165}$ reporter gene assay, fell within the acceptable range of 85% to 120%. Furthermore, subvisible particulate analysis indicated particle counts were well within acceptable limits, a critical safety measure for intravitreal injections.

The collective findings demonstrated that XSB-001 maintained its quality and biological activity under extended storage for up to 30 days in prepared syringes. This stability is pivotal for optimizing patient flow and ensuring the most efficient use of health care resources by minimizing drug waste associated with just-in-time preparation.

The authors concluded that this confirmed stability makes XSB-001 "a reliable option for planned hospital use and compounding manufacturing and intravitreal administration without compromising efficacy."

However, as with any laboratory study, certain limitations should be noted. Although the study rigorously monitored light and temperature exposure during the 48-hour ambient period, these factors can vary widely in real-world clinical settings, such as during transport between clinics. Furthermore, the study was not designed to evaluate clinical outcomes; it solely focused on the molecular integrity of the drug substance.

Ultimately, these data reinforce the utility of XSB-001 in managed care settings by demonstrating that the biosimilar's complex molecular structure withstands the practical demands of compounding and extended preadministration storage.

Björnestedt R, Waters S, Paišytė A, et al. Evaluation of XSB-001 (ranibizumab biosimilar) physicochemical and biological stability in prepared syringes for intravitreal injection. 

. 2025;42(9):4597-4610. doi:10.1007/s12325-025-03319-z

Ximluci, a Lucentis biosimilar, launches in Europe. The Center for Biosimilars

. April 4, 2023. Accessed October 9, 2025. 

https://www.centerforbiosimilars.com/view/ximluci-a-lucentis-biosimilar-launches-in-europe

Articles

A recent study confirms the stability of XSB-001 biosimilar for retinal diseases under realistic clinical handling conditions.

Real-World Stability Confirmed for Biosimilar Ximluci in Prefilled Syringes

As biosimilar disease-modifying antirheumatic drugs (DMARDs) become increasingly integrated into autoimmune disease management, questions remain about their safety during pregnancy. A recent scoping review 

 examined the existing literature on biosimilar DMARD exposure in pregnancy and revealed significant evidence gaps that limit clinicians’ ability to provide data-driven guidance for individuals of childbearing potential.

A review of the safety of biosimilar DMARDs during pregnancy reveals critical evidence gaps and the need for informed clinical guidance. | Image credit: pressmaster - stock.adobe.com

Biologic DMARDs have transformed treatment for autoimmune and autoinflammatory conditions such as rheumatoid arthritis, inflammatory bowel disease, and ankylosing spondylitis by controlling inflammation, reducing flares, and slowing disease progression. However, their high cost—averaging $10,000 to $30,000 annually per person—has led to the development and adoption of biosimilars, which offer similar efficacy and safety at lower prices. 

Despite this, biosimilars are not automatically deemed equivalent to their reference biologics in all clinical situations. Their use during pregnancy remains an area of uncertainty, with no specific recommendations included in the most recent American College of Rheumatology (ACR) or European Alliance of Associations for Rheumatology (EULAR) reproductive health guidelines.

The scoping review sought to address this knowledge gap by mapping and synthesizing available data on the reproductive health outcomes associated with biosimilar DMARD exposure during pregnancy.

 Researchers searched 3 major databases—Embase, MEDLINE, and CENTRAL—through June 2025 for observational studies examining biosimilar DMARD exposure among mothers during pregnancy, fathers prior to conception, or fetuses in utero. Study characteristics, exposure timing, and pregnancy outcomes were extracted and analyzed using a newly developed Reproductive Health Outcomes Reporting Framework designed to improve standardization in perinatal research.

Out of more than 7800 records screened, only 6 studies met inclusion criteria. These consisted of 5 descriptive studies—2 case reports, 1 case series, and 2 cross-sectional studies—and 1 analytical cohort study. Together, the studies described 63 mothers with autoimmune diseases who were treated with biosimilar DMARDs, primarily tumor necrosis factor inhibitors such as infliximab, etanercept, and adalimumab. One study examined a biosimilar of the B-cell inhibitor rituximab.

The studies collectively reported 24 reproductive outcomes, including 12 fetal or neonatal outcomes, 5 maternal outcomes, and 4 outcomes that involved both mother and infant. No studies evaluated paternal exposure. In most cases, women who continued biosimilar therapy through pregnancy experienced favorable outcomes, including live births and healthy infants.

For instance, 1 study involving 20 women treated with the infliximab biosimilar CT-P13 reported 19 live births (95%), with a mean gestational age of 39 weeks and 1 congenital anomaly (cleft palate). Another study of 18 women exposed to biosimilars of infliximab, adalimumab, or etanercept found that all pregnancies resulted in live births, with no major congenital anomalies reported. About half of the women in that study experienced disease flares during or shortly after pregnancy.

The only analytical study compared pregnancy outcomes among patients treated with infliximab biosimilars vs the originator product. No significant differences were found for neonatal intensive care unit admissions (OR, 1.00; 95% CI, 0.11-9.05) or congenital malformations (OR, 1.38; 95% CI, 0.63-3.00). However, wide CIs indicated limited precision due to small sample sizes.

Although findings across the available studies were generally reassuring, the evidence base was too small and methodologically inconsistent to draw firm conclusions. The review identified notable variability in how studies reported biosimilar exposure and pregnancy outcomes. Many did not specify biosimilar brand names or clarify whether treatment was initiated before or during pregnancy. Information on maternal disease activity—an important predictor of adverse outcomes—was often incomplete or omitted.

The review’s authors proposed the use of a standardized framework for reporting reproductive health outcomes in future studies, categorizing outcomes by who experienced them (mother, fetus, or both) and when they occurred (before, during, or after pregnancy). 

“The current literature is insufficient to inform evidence-based guidance on biosimilar DMARD use in pregnancy,” the authors stated, emphasizing that more robust analytical studies are needed to establish causal relationships between biosimilar exposure and pregnancy outcomes.

These evidence gaps have important implications for clinical practice, particularly as many jurisdictions expand mandatory biosimilar switching programs to reduce health care costs. In the absence of definitive data, clinicians must rely on shared decision-making and individualized care planning to guide treatment choices for patients who are pregnant or planning pregnancy. Maintaining disease control remains critical, as uncontrolled autoimmune activity is itself associated with increased risk of miscarriage, preterm birth, and low birth weight.

Until stronger evidence emerges, experts recommend that patients and clinicians engage in early prepregnancy counseling to balance the benefits of disease control with the limited data available on biosimilar safety. Continued postmarket surveillance and pregnancy registries will also be key to expanding the evidence base.

The review concluded that while biosimilars have helped improve access and affordability in autoimmune disease care, the lack of comprehensive perinatal data represents a significant gap in ensuring safe and informed treatment decisions.

Cheng V, Amiri N, Cheng V, et al. Scoping review of biosimilar disease-modifying antirheumatic drugs in pregnancy: evidence gaps and proposed outcome reporting framework. 

. 2025;45(10):241. doi:10.1007/s00296-025-05968-3

Rüegg L, Pluma A, Hamroun S, et al. EULAR recommendations for use of antirheumatic drugs in reproduction, pregnancy, and lactation: 2024 update. 

. 2025;84(6):910-926. doi:10.1016/j.ard.2025.02.023

Sammaritano LR, Bermas BL, Chakravarty EE, et al. 2020 American College of Rheumatology guideline for the management of reproductive health in rheumatic and musculoskeletal diseases. 

. 2022;72(4):461-488. doi:10.1002/acr.24130


A review of the safety of biosimilar DMARDs during pregnancy reveals critical evidence gaps and the need for informed clinical guidance.

Review Identifies Gaps in Evidence on Biosimilar DMARD Use During Pregnancy

The global biosimilar industry experienced significant momentum in early October 2025, driven by a key US product launch, strategic international partnerships aimed at improving affordability, and major regulatory filings for a high-value asthma and allergy treatment. These updates reflect continued efforts by biopharmaceutical companies to increase patient access and reduce the economic burden on health care systems worldwide.

On October 2, 2025, Celltrion announced the launch of its Avtozma (tocilizumab-anoh) intravenous (IV) formulation in the US, providing a new treatment option for people living with serious immune-mediated conditions. Avtozma, a proposed biosimilar to the reference product Actemra (tocilizumab), had received approval from the FDA in January 2025. Following the initial approval, the FDA approved an expanded indication for the IV formulation in July 2025 for the treatment of adult and pediatric patients 2 years and older experiencing cytokine release syndrome.

The biosimilar is now available to patients across all the same indications as the reference product, including individuals with rheumatoid arthritis, giant cell arteritis, polyarticular juvenile idiopathic arthritis, and systemic juvenile idiopathic arthritis. It also treats hospitalized adult patients with COVID-19 who require supplemental oxygen or more intensive support, such as mechanical ventilation or extracorporeal membrane oxygenation.

This launch marked Celltrion’s seventh FDA-approved biosimilar and its fifth immunology biologic. The drug acts as an IL-6 receptor antagonist, which expanded Celltrion’s immunology portfolio beyond tumor necrosis factor-α and IL-12/23 inhibitors. 

Celltrion’s news release noted that the availability of a tocilizumab biosimilar offers clinicians additional options for managing disease and maintaining continuity of care for people living with these conditions. The company says it is committed to supporting patients receiving Avtozma IV with comprehensive patient support resources and co-pay assistance for eligible individuals with commercial insurance.

Partnership Boosts Affordability in MENA Region

In a key move to expand biosimilar availability across the Middle East and North Africa (MENA) region, Hikma Pharmaceuticals and its long-standing partner Celltrion signed exclusive licensing agreements. The agreements focused on introducing 6 new biosimilar treatments to MENA markets. These products were aimed at broadening access to affordable biologics for people requiring treatment in key therapeutic areas, including allergic diseases, oncology, immune diseases, ophthalmology, and skeletal-related disorders.

Hikma secured exclusive commercialization rights for all MENA markets under the deal, while Celltrion maintained responsibility for the treatments’ manufacturing, supply, and development. Hikma’s executive vice chairman noted that these high-quality biosimilar treatments had the potential to significantly improve the quality of life for patients living with chronic, debilitating, or life-threatening conditions. By offering cost-effective alternatives, the partnership aims to reduce burdens on health care systems and enhance outcomes for people in the region.

Omalizumab Biosimilar Submissions Signal Market Competition

In October 2025, Kashiv BioSciences announced an advance in its pipeline, submitting a biologics license application (BLA) for ADL-018, a proposed biosimilar to Xolair (omalizumab), to the FDA. Simultaneously, the European Medicines Agency accepted the marketing authorization application for ADL-018. Omalizumab, a humanized monoclonal antibody, is indicated for individuals experiencing conditions such as chronic spontaneous urticaria, moderate to severe persistent asthma, chronic rhinosinusitis with nasal polyps, and IgE-mediated food allergy.

This therapeutic market is large, with global annual sales for the reference product totaling approximately $5.5 billion for the 12 months ending in June 2025, including $4.1 billion in the US and $1.0 billion in the European Union.

Kashiv is developing ADL-018 in partnership with Alvotech. Kashiv’s BLA submission positions ADL-018 to be among the first wave of biosimilar entrants in this large market. Amneal Pharmaceuticals, a partner, anticipated that the product would serve as a significant growth catalyst and announced plans to launch 5 additional biosimilars between 2026 and 2027, highlighting biosimilars as a critical growth driver for the company.

Celltrion launches Avtozma (tocilizumab-anoh) intravenous (IV) formulation in the United States. News release. Celltrion. Oct 02, 2025. Accessed October 7, 2025. 

https://www.prnewswire.com/news-releases/celltrion-launches-avtozma-tocilizumab-anoh-intravenous-iv-formulation-in-the-united-states-302570229.html

Kashiv Biosciences announces submission of biologics license application to U.S. FDA and acceptance of market authorization application by european medicines agency for ADL-018, a proposed biosimilar to Xolair (omalizumab). News release. Kashiv Biosciences. October 6, 2025. Accessed October 7, 2025. 

https://www.businesswire.com/news/home/20250930481480/en/Kashiv-Biosciences-Announces-Submission-of-Biologics-License-Application-to-U.S.-FDA-and-Acceptance-of-Market-Authorization-Application-by-European-Medicines-Agency-for-ADL-018-a-Proposed-Biosimilar-to-XOLAIR-omalizumab

Hikma, Celltrion boost partnership to expand biosimilar access in MENA. News release. Hikma Pharmaceuticals. July 10, 2025. Accessed October 7, 2025. 

https://www.middle-east-online.com/en/hikma-celltrion-boost-partnership-expand-biosimilar-access-mena

The latest advancements in global biosimilar access include new treatments, strategic partnerships, and competitive market entries enhancing patient care.

Global Biosimilars Market Sees Gains in Access and Pipeline Expansion 

AVT06, a proposed biosimilar to aflibercept (Eylea; Regeneron Pharmaceuticals), demonstrated comparable efficacy, safety, and immunogenicity to the reference product in people with neovascular age-related macular degeneration (nAMD), according to a recently published phase 3 trial.

 The findings may help expand patient access to vision-preserving therapies by supporting regulatory approval of a lower-cost alternative.

AVT06, a promising biosimilar to Eylea, shows comparable efficacy and safety for treating neovascular age-related macular degeneration (AMD), enhancing patient access. | Image credit: Coetzee/peopleimages.com - stock.adobe.com

The trial was designed to address the high cost of biologic therapies such as aflibercept, which remain a barrier for many patients worldwide. Researchers sought to determine whether AVT06 could match the clinical benefits of aflibercept, a mainstay of treatment for nAMD, while offering a potentially more sustainable option for health systems.

AVT06 is currently under review with the FDA and the European Medicines Agency (EMA), with the EMA’s Committee for Medicinal Products for Human Use adopting a positive opinion recommending approval of AVT06 for several indications, including nAMD, and the European Commission still left to make a final decision.

The study was a double-masked, randomized, parallel-group, multicenter investigation conducted across 117 sites in 14 countries between June 2022 and September 2024. A total of 410 participants, all aged 50 years or older and diagnosed with treatment-naive nAMD, were enrolled. Participants were randomized 1:1 to receive intravitreal injections of AVT06 or reference aflibercept (2 mg) over 48 weeks, with follow-up at Week 52.

The primary endpoint was the change in best-corrected visual acuity at Week 8, measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores. Both groups achieved clinically meaningful gains in vision, with AVT06 showing a least squares mean change of 5.11 letters compared with 4.34 letters in the aflibercept group. The difference of 0.77 letters fell well within the pre-specified equivalence margin of –3.5 to 3.5 letters, confirming comparable efficacy. Sensitivity analyses reinforced these results.

Secondary outcomes, including changes in central subfield thickness, lesion size, and the presence of intraretinal or subretinal fluid, were also similar between treatment arms through week 52. Both groups maintained consistent improvements in retinal anatomy and vision across all timepoints.

The pharmacokinetic substudy revealed comparable systemic exposure for both treatments, with overall low concentrations supporting systemic safety. Immunogenicity testing found that, although antidrug antibodies (ADAs) and neutralizing antibodies developed in some participants, the overall rates were low and consistent with aflibercept’s established profile. Interestingly, the proportion of ADA-positive participants was numerically lower in the AVT06 group compared with the reference arm by week 52 (66.8% vs 80.5%).

Safety findings further underscored comparability. The incidence of treatment-emergent adverse events (TEAEs) was similar between groups—67.8% in AVT06 and 56.1% in the aflibercept arm—with most events being mild, transient, and unrelated to study treatment. Severe TEAEs were reported in 2% of AVT06 participants and 4.9% of aflibercept participants. Three deaths occurred during the trial, none deemed related to study drugs. The most frequently reported adverse events were nasopharyngitis and ocular events such as conjunctival hemorrhage and cataract.

The participant population had a mean age of 74 years, with balanced gender distribution (53.4% female, 46.6% male). The majority of participants were White (76.1%), with 6.8% Japanese and 16.3% Asian. Most participants (85.4%) presented with unilateral nAMD, and baseline vision was moderately impaired, averaging 55 ETDRS letters. Disease characteristics, including the presence of intraretinal and subretinal fluid, were comparable across groups.

The authors acknowledged several limitations. As a tightly controlled clinical trial, the study may not fully reflect outcomes in real-world practice, where adherence and monitoring can differ significantly. Additionally, the trial was not designed to evaluate cost-effectiveness directly, though the biosimilar pathway inherently aims to improve affordability.

In discussing the implications of the findings, the study authors noted, “The primary outcome of this study supports the demonstration of comparable efficacy of AVT06 and reference aflibercept, contributing to the totality of evidence needed for biosimilar approval.” They added that the results provide a strong foundation for potential extrapolation to other aflibercept-approved indications, such as diabetic macular edema and retinal vein occlusion.

The study’s rigorous design, international scope, and comprehensive evaluation of visual function, retinal anatomy, pharmacokinetics, and safety lend credibility to the findings. If approved, AVT06 could represent a meaningful addition to the ophthalmology biosimilar landscape, helping reduce financial barriers to care and broadening treatment access for people with nAMD and related retinal diseases.

1. Agostini H, Baumane K, Balčiūnienė, et al. A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration. 

. 2025;25(7):773-787. doi:10.1080/14712598.2025.2519531

2. European Medicines Agency recommends market approval of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept). News release.  Alvotech. June 23, 2025. Accessed September 22, 2025. 

https://investors.alvotech.com/news-releases/news-release-details/european-medicines-agency-recommends-market-approval-avt06

3. Alvotech and Teva announce filing acceptance of U.S. biologics license application for AVT06, a proposed biosimilar to Eylea (aflibercept). News release. Alvotech. February 18, 2025. Accessed September 22, 2025. 

https://ir.tevapharm.com/news-and-events/press-releases/press-release-details/2025/Alvotech-and-Teva-Announce-Filing-Acceptance-ofU.S.-Biologics-License-Application-for-AVT06a-Proposed-Biosimilar-to-Eylea-aflibercept/default.aspx

AVT06, a promising biosimilar to aflibercept (Eylea), shows comparable efficacy and safety for treating neovascular age-related macular degeneration (AMD), enhancing patient access.

Proposed Aflibercept Biosimilar Shows Comparable Safety, Efficacy in Phase 3 AMD Trial

In September 2025, biosimilars continued to demonstrate their global impact, with AAM reporting $20.2 billion in US savings in 2024 despite a concerning development void, new FDA and European approvals expanding access to denosumab and aflibercept therapies, and real-world studies from Australia, Ireland, and China confirming that switching to biosimilars maintains safety and efficacy while reducing costs and enhancing patient access worldwide.

Biosimilar approvals surge in the US and Europe, enhancing access to denosumab and aflibercept therapies while driving significant health care savings.

AAM Report Reveals Startling Development Void Despite Biosimilar Success

Biosimilars generated $20.2 billion in savings in 2024 alone, contributing to a total of $56.2 billion since the first biosimilar entered the US market, according to the Association for Accessible Medicines (AAM).

 Collectively, generic and biosimilar medicines saved the US health care system $467 billion in 2024, adding to nearly $3.4 trillion in savings over the past decade. Increased biosimilar competition has expanded patient access, providing an estimated 460 million additional days of therapy, and second-to-market biosimilars entering within 3 years of the first have been shown to accelerate price reductions. However, the report highlighted a concerning “biosimilar void,” noting that 90% of biologics expected to lose patent exclusivity over the next decade currently lack a biosimilar in development.

The analysis also underscored ongoing challenges in the generics market. Generics made up roughly 90% of US prescriptions in 2024 yet only 12% of spending, with average out-of-pocket costs for generics remaining far below brand name drugs. Despite consistent savings, the report warned of price deflation creating unsustainable conditions for manufacturers. AAM leaders emphasized that coordinated action across manufacturers, providers, payers, and policymakers is essential to normalize biosimilar adoption, confront systemic barriers, and fully realize the cost and access benefits of these medicines.

American and European Biosimilar Approvals

The FDA has approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), marking the sixth pair of denosumab biosimilars cleared in the US.

 These approvals, granted to Biocon Biologics, expand affordable treatment options for patients with osteoporosis and cancer-related bone conditions. Bosaya, a biosimilar to Prolia, and Aukelso, a biosimilar to Xgeva, were both granted provisional interchangeability and demonstrated comparable quality, safety, and efficacy to their reference products.

Bosaya is indicated for postmenopausal women and men at high risk for fracture, glucocorticoid-induced osteoporosis, and certain patients receiving hormone ablation therapy for nonmetastatic prostate or breast cancer. Aukelso is approved to prevent skeletal-related events in multiple myeloma and bone metastases, treat giant cell tumors of bone, and manage refractory hypercalcemia of malignancy. These approvals continue a rapid expansion of denosumab biosimilars in the US, following 5 prior pairs that have launched since March 2024.

Following the US, the European Commission (EC) granted marketing authorizations for several new biosimilars, expanding affordable treatment options for patients with bone and retinal conditions.

 The approvals include 2 denosumab biosimilars, Bildyos and Bilprevda, from Organon and Shanghai Henlius Biotech, which are biosimilars to Prolia and Xgeva, respectively.

In addition, Germany-based STADA Arzneimittel received EC approval for Afiveg, an aflibercept biosimilar to Eylea, indicated for multiple retinal diseases including wet age-related macular degeneration. Afiveg marks STADA’s second ophthalmology biosimilar and eighth biosimilar overall in Europe, with a planned launch in Germany in Q4 2025. STADA executives emphasized the approvals as a way to expand patient access while supporting sustainable health care, building on the company’s growing specialty biosimilar portfolio.

Building Global Trust in Biosimilar Safety and Cost-Effectiveness

 highlighted the economic impact of biosimilars on the Australian health care system, demonstrating their role in reducing costs and driving price competition.

 Using a decade of sales data (2010-2020), researchers found that just 12 months after biosimilar entry, expenditure for reference biologics dropped by 38%, whereas per-unit prices fell 30% to 40%. Biosimilars themselves were priced up to 40% lower than reference products, and by 2020 they accounted for 30% of Australia’s biologics market. These findings emphasize that cost savings were primarily driven by price reductions rather than changes in overall use.

The study also underscored the importance of timing, policy, and clinician confidence for biosimilar adoption, with newer introductions like rituximab and trastuzumab capturing higher market shares than earlier entrants. Although patient-level uptake remains limited, with many unaware of biosimilar options, evidence shows that specialist recommendations strongly influence acceptance.

A prospective cohort study at Galway University Hospitals in Ireland found that patients with inflammatory bowel disease (IBD) who switched from reference adalimumab (Humira) to the biosimilar Amgevita (adalimumab-atto) maintained stable disease control and quality of life.

 Objective measures, including biomarkers and disease activity indices, showed no significant changes after the switch, and patient-reported symptoms improved slightly. Adverse events were generally mild, with only 2 patients reverting to Humira due to intolerance, and health anxiety was identified as a key predictor of perceived side effects.

The structured switching clinic also generated substantial cost savings, reducing drug expenditures by €143,958 over 8 weeks for the cohort, translating to an estimated €864,000 annually. Even after accounting for clinic costs and unscheduled care, net savings averaged €2,091 per patient. The study highlights that biosimilar switching can be safe, effective, and financially beneficial, particularly when accompanied by patient education and structured support to address psychological factors and optimize outcomes.

A real-world study from Fudan University Shanghai Cancer Center found that HLX02, a trastuzumab biosimilar, was as safe and effective as the originator in patients with HER2-positive metastatic breast cancer, including those who switched mid-treatment.

 Among 124 women, response rates and progression-free survival were comparable regardless of whether patients started on HLX02 or switched from Herceptin. Safety outcomes were consistent with prior clinical trials, and no new concerns emerged. The study reinforces HLX02 as a cost-effective option that could expand treatment access in resource-limited settings.

Recent regulatory and reimbursement milestones are broadening access to aflibercept biosimilars for retinal diseases worldwide.

 In the US, Sandoz settled patent disputes with Regeneron, clearing the path for Enzeevu to launch in late 2026. In Europe, Alteogen’s Eyluxvi received EC approval for multiple ophthalmic indications, demonstrating comparable efficacy and safety to Eylea in phase 3 trials. Meanwhile, Canada’s Ontario Drug Benefit Formulary added Biocon Biologics’ Yesafili, enabling public funding for over 2 million patients with retinal conditions. These developments collectively enhance global access to affordable, effective biosimilar therapies for vision-threatening diseases.

1. Jeremias S. Biosimilars drive savings and access, yet looming development gap threatens future. The Center for Biosimilars

. September 23, 2025. Accessed September 23, 2025. 

https://www.centerforbiosimilars.com/view/biosimilars-drive-savings-and-access-yet-looming-development-gap-threatens-future

2. Jeremias S. FDA approves Biocon Biologics' denosumab biosimilars: Bosaya and Aukelso. The Center for Biosimilars. September 18, 2025. Accessed September 22, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-biocon-biologics-denosumab-biosimilars-bosaya-and-aukelso

3. Jeremias S. EC approves new biosimilars for bone and eye conditions. The Center for Biosimilars. September 19, 2025. Accessed September 22, 2025. 

https://www.centerforbiosimilars.com/view/ec-approves-new-biosimilars-for-bone-and-eye-conditions

4. Jeremias S. Australian study reveals significant cost savings and market impact from biosimilars. The Center for Biosimilars. September 10, 2025. Accessed September 22, 2025. 

https://www.centerforbiosimilars.com/view/australian-study-reveals-significant-cost-savings-and-market-impact-from-biosimilars

5. Jeremias S. Switch to biosimilar adalimumab found safe and cost-saving for patients with IBD. September 9, 2025. Accessed September 22, 2025. 

https://www.centerforbiosimilars.com/view/switch-to-biosimilar-adalimumab-found-safe-and-cost-saving-for-patients-with-ibd

6. Jeremias S. Real-world evidence supports biosimilar HLX02 in metastatic breast cancer. The Center for Biosimilars. September 11, 2025. Accessed September 22, 2025. 

https://www.centerforbiosimilars.com/view/real-world-evidence-supports-biosimilar-hlx02-in-metastatic-breast-cancer

7. Jeremias S. Global aflibercept biosimilar progress signals rising access for retinal disease care. The Center for Biosimilars. September 22, 2025. Accessed September 22, 2025. 

https://www.centerforbiosimilars.com/view/global-aflibercept-biosimilar-progress-signals-rising-access-for-retinal-disease-care

Biosimilars News Roundup: September 2025

Biosimilars have been touted for years as a way to curb the soaring cost of biologic therapies—and fresh data suggest just how big that impact could be. A new 

 projects that an omalizumab biosimilar could save European health systems hundreds of millions of euros while widening access to care.

Omalizumab biosimilars promise significant savings for European health systems, enhancing access to vital therapies for patients with severe allergies. | Image credit: Alix - stock.adobe.com

Omalizumab, prescribed for severe allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP), represents a significant budgetary burden for European health systems. Currently, the US, European Union, and Canada each have 1 omalizumab biosimilar approved, all of which have approved 

At the time of the analysis, annual spending on the originator exceeded €787 million.

 To assess the economic implications of biosimilar entry, investigators developed a 5-year budget impact model comparing scenarios with and without a biosimilar option.

The model compared 2 scenarios: one without biosimilar entry and another that incorporated a gradual uptake of an omalizumab biosimilar. Inputs for the analysis were drawn from national drug price databases, with initial assumptions including a modest market share uptake and a 30% discount relative to the originator.

Even under these conservative assumptions, the projections were significant. The analysis estimated savings of €40 million in the first year of biosimilar availability, growing to €640 million cumulatively over 5 years. Moreover, these savings could be reinvested to expand access, supporting treatment for an estimated 96,000 additional patients annually. At higher discount levels, the impact was even more pronounced. With a 50% discount, projected savings rose to €1.04 billion over 5 years, while a 70% discount scenario produced cumulative savings of €1.44 billion.

The authors noted that the model likely underestimates the true economic potential of an omalizumab biosimilar. Notably, it did not incorporate competitive price erosion from the originator, which typically follows biosimilar entry and can further reduce costs. In addition, the model did not account for indirect savings, such as reduced hospitalizations or decreased reliance on rescue medications, that may result from broader patient access to effective therapy. As a result, real-world outcomes could surpass the study’s baseline projections.

“This analysis supports biosimilars as a strategic tool for sustainable biologic therapy access in Europe,” the study authors concluded, emphasizing the link between cost efficiency and improved patient outcomes. By highlighting both the fiscal and clinical benefits, the research provides a data-driven rationale for payers and policymakers to prioritize biosimilar adoption strategies.

For health care systems under pressure to balance innovation with affordability, the implications are clear. Biosimilars such as omalizumab not only alleviate budgetary strain but also create opportunities to extend care to underserved patient populations. As the European market continues to evolve, proactive measures to encourage biosimilar uptake will be critical to achieving financial sustainability and ensuring equitable access to advanced biologic therapies.

1. Jang M, Lee J, Yi S, Kwon TS. Budget impact of introducing an omalizumab biosimilar in 23 European countries. 

. 2025;28(1):1639-1650. doi:10.1080/13696998.2025.2558450

2. Jeremias S. FDA approves first omalizumab biosimilar. The Center for Biosimilars

. March 7, 2025. Accessed September 24, 2025. 

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

3. Jeremias S. Eye on pharma: biosimilar Ozempic; Celltrion omalizumab biosimilar submission. The Center for Biosimilars. April 4, 2024. Accessed September 24, 2025. 

https://www.centerforbiosimilars.com/view/eye-on-pharma-biosimilar-ozempic-biocon-mylan-merger-celltrion-omalizumab-biosimilar-submission

4. Jeremias S. Health Canada approves first omalizumab biosimilar. The Center for Biosimilars. December 16, 2024. Accessed September 24, 2025. 

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

Omalizumab biosimilars promise significant savings for European health systems, enhancing access to vital therapies for patients with severe allergies.

Analysis Highlights Fiscal, Access Benefits of Omalizumab Biosimilars in Europe

A recent pharmacoeconomic analysis has found that subcutaneous biosimilar tocilizumab offers a cost-effective and cost-saving option for individuals with moderate to severe rheumatoid arthritis (RA) in Spain compared with commonly used biologic and targeted synthetic disease-modifying antirheumatic drugs (DMARDs).

Biosimilar tocilizumab proves to be a cost-effective treatment for rheumatoid arthritis in Spain, enhancing access to advanced therapies. | Image credit: 

RA is the most prevalent chronic inflammatory rheumatic condition, with an estimated prevalence of 0.82% among adults in Spain, disproportionately affecting women aged 40 to 59 years—an age group typically in active employment.

 Advances in biologic therapies have dramatically improved disease outcomes, but their high costs have limited widespread adoption. The introduction of biosimilars, which maintain the same benefit-risk profile at reduced prices, has prompted the need for updated cost-effectiveness assessments. Tocilizumab, an IL-6 receptor inhibitor, has been approved for RA in the European Union since 2009, and the launch of its biosimilar version created an opportunity to reexamine treatment value within Spain’s national health system.

Investigators developed a Markov model simulating a lifetime horizon with 3-month cycles. The model considered 5 health states: remission, low disease activity, moderate disease activity, high disease activity, and death. Effectiveness data were derived from a systematic literature review, including meta-analyses, network meta-analyses, and clinical trials. Transition probabilities between health states were estimated from published data, while pharmacologic costs were sourced from Spain’s BotPlus database and regional tariffs.

The baseline patient population reflected real-world Spanish demographics: individuals with RA had a mean age of 52.7 years, 80.6% were women, and the mean disease duration was 7.45 years. Quality-adjusted life-year (QALY) utilities were assigned based on disease activity, and a 3% discount rate was applied to costs and outcomes.

The analysis showed that lifetime treatment with biosimilar tocilizumab resulted in the lowest total cost per patient (€183,741), compared with €184,317 for infliximab and €201,972 for certolizumab, the most expensive comparator. In terms of effectiveness, QALYs ranged from 13.53 for rituximab to 13.74 for upadacitinib, with biosimilar tocilizumab yielding 13.73—on par with reference tocilizumab and sarilumab. The percentage of patients achieving remission was highest with upadacitinib (12.67%), followed closely by tocilizumab (12.61%) and sarilumab (12.58%). Incremental cost-effectiveness ratio analyses demonstrated that biosimilar tocilizumab was either dominant (less costly and more effective) or cost-effective across all comparisons. Sensitivity analyses further reinforced the robustness of the findings, with biosimilar tocilizumab maintaining a 100% probability of being cost-effective at Spain’s willingness-to-pay thresholds of €22,000 and €30,000 per QALY.

By providing equal clinical benefit at a lower cost, biosimilar tocilizumab has the potential to expand access to advanced RA therapy. The study authors emphasized, “What is more important about the introduction of biosimilars is that [the] efficacy of the treatment remains stable while costs are drastically reduced, entailing great benefits for the healthcare system and improving its efficiency.”

The study authors acknowledged several limitations. Assumptions were made regarding the distribution of patients across disease activity states, and long-term treatment effects were extrapolated beyond the duration of clinical trial data. Pricing was based on ex-factory costs rather than final reimbursed prices, which may have introduced uncertainty. Additionally, while the analysis was specific to Spain, external generalizability may be limited.

The evaluation concluded that biosimilar tocilizumab represents the most cost-effective and, in many cases, cost-saving option for treating moderate to severe RA in Spain. These findings may support broader biosimilar adoption as a strategy to balance clinical outcomes with economic sustainability in managed care.

1. Pérez-Ruiz F, Crespo-Diz C, Schoenenberger-Arnaiz JA, et al. Cost-effectiveness analysis of subcutaneous biosimilar tocilizumab in patients with rheumatoid arthritis in Spain. 

. 2025;49(5):278-285. doi:10.1016/j.farma.2024.11.004

2. Silva-Fernández L, Macía-Villa C, Seoane-Mato D,

 The prevalence of rheumatoid arthritis in Spain. 

. 2020;10(1):21551. doi:10.1038/s41598-020-76511-6

Biosimilar tocilizumab proves to be a cost-effective treatment for rheumatoid arthritis in Spain, enhancing access to advanced therapies.

Biosimilar Tocilizumab Shows Cost-Effectiveness Advantage in Spanish RA Population

Here are the top 5 biosimilar articles for the week of September 22, 2025.

The Top 5 Biosimilar Articles for the Week of September 22

 Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), the sixth pair of denosumab biosimilars to receive the green light from the agency. The approvals, granted to Biocon Biologics, will provide more affordable treatment options for people with osteoporosis and cancer-related bone conditions.

, a trastuzumab biosimilar that may help expand access to treatment for people with HER2-positive metastatic breast cancer, as a new real-world study from Fudan University Shanghai Cancer Center found it worked as well and was just as safe as the originator, even for patients who switched mid-treatment.

Number 3: Patients with inflammatory bowel disease (IBD) who transitioned from reference adalimumab (Humira) to the biosimilar Amgevita (adalimumab-atto) maintained stable disease control and generated substantial drug cost savings, according to a single-center 

 from Galway University Hospitals in Ireland.


Number 2: A new biosimilar, SYSA1902, shows 

 to ustekinumab for treating moderate-to-severe plaque psoriasis, expanding patient options.

Number 1: Sarfaraz K. Niazi, PhD, highlights the FDA’s move to 

 for biosimilars as a turning point that will lower development costs, drive big pharma out, and open the market to smaller companies, making biosimilars more affordable and accessible like generics.

Videos

In 2025, European, Asian, and African biosimilar markets saw major developments as Celltrion announced updates for several biosimilars in development, STADA Arzneimittel saw progress for its denosumab biosimilars, and Polpharma Biologics partnered with MS Pharma to commercialize 3 biosimilars in emerging markets.

Major advancements in biosimilars emerge in Europe and Middle East and North Africa (MENA) region, enhancing patient access and affordability in critical therapeutic areas.

Celltrion Updates on Omalizumab, Secukinumab, and Daratumumab

Celltrion announced several milestones at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, underscoring its growing dermatology and immunology portfolio. Omlyclo, the first and only omalizumab biosimilar approved in Europe, will launch in Norway, with further rollouts across the region. The company also presented global Phase III results for Omlyclo in chronic spontaneous urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, showing comparable efficacy and safety to the reference product during both treatment and observation periods. Experts emphasized the biosimilar’s significance in expanding patient access and improving quality of life for those with immuno-dermatologic conditions.

In addition, Celltrion highlighted positive early-stage results for CT-P55, a proposed secukinumab biosimilar, which demonstrated similarity in efficacy and safety in healthy subjects. With Omlyclo, Celltrion’s dermatology portfolio now includes 5 products: infliximab, adalimumab, ustekinumab, and omalizumab biosimilars.

Separately, Celltrion received European Medicines Agency approval to begin a phase 3 trial of CT-P44, a biosimilar candidate referencing daratumumab and hyaluronidase (Darzalex Faspro), in relapsed or refractory multiple myeloma. The randomized, 2-year trial will evaluate efficacy and safety in combination with lenalidomide and dexamethasone.

CHMP Opinion for STADA Denosumab Biosimilars

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of STADA Arzneimittel’s denosumab biosimilar candidates Kefdensis and Zvogra, referencing Amgen’s Prolia and Xgeva, respectively.

 The recommendations cover all indications of the reference products, including osteoporosis and fracture prevention for Kefdensis and skeletal-related event prevention in oncology and treatment of giant cell tumor of bone for Zvogra. If approved by the European Commission, the products would mark STADA’s tenth approved biosimilar in Europe, complementing its teriparatide, bevacizumab, epoetin, adalimumab, tocilizumab, ustekinumab, aflibercept, and ranibizumab biosimilars.

Denosumab biosimilar entry is anticipated following the European Union exclusivity expiry in late 2025, with the market valued at approximately €1 billion. Increased competition is expected to expand access and reduce overall treatment costs. Ian Henshaw, STADA’s global specialty head, stated that the CHMP opinion “marks a significant milestone in broadening access to a blockbuster biologic medicine for bone conditions affecting millions of people in Europe.”

The denosumab biosimilars, also known as AVT03, were developed and manufactured by Alvotech, which partnered with STADA for commercialization in Europe, Central Asia, and the Middle East. Specialty, including biosimilars, was STADA’s fastest-growing segment in the first half of 2025, with revenues rising 18% to €486 million.

Polpharma Biologics and MS Pharma Partner for MENA Region

Polpharma Biologics has entered into licensing agreements with MS Pharma for the commercialization of 3 biosimilar candidates—vedolizumab (PB016), ocrelizumab (PB018), and guselkumab (PB019)—across the Middle East and North Africa (MENA) region.

 Under the deal, MS Pharma will handle registration, marketing, and distribution, while Polpharma Biologics will oversee development, manufacturing, and supply. Fill-and-finish activities will be localized to MS Pharma’s new biologics facility in Saudi Arabia.

The biosimilars target high-need therapeutic areas: vedolizumab for ulcerative colitis and Crohn disease, ocrelizumab for multiple sclerosis, and guselkumab for moderate to severe plaque psoriasis and psoriatic arthritis. According to the companies, these partnerships are expected to broaden access to affordable biologics in gastroenterology, neurology, and dermatology.

“Expanding our biosimilar portfolio in high-need therapeutic areas…is a strategic priority,” said MS Pharma CEO Kalle Känd, noting the collaboration reinforces the company’s regional leadership. Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics, added that MS Pharma’s “deep regional expertise and strong commercial network” make it an ideal partner to improve patient access.

The agreement builds on an established relationship between the companies and supports efforts to strengthen biologics manufacturing capacity and health care sustainability in the MENA region.

1. Celltrion announces commercial availability of Omlyclo across Europe at EADV 2025. News release. Celltrion. September 18, 2025. Accessed September 23, 2025. 