Christina Mattina

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 

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

The European Commission (EC) has recently granted marketing authorizations for several new biosimilar medications, expanding treatment options for patients with a range of conditions from osteoporosis and cancer-related bone disease to serious retinal disorders. The approvals include 2 denosumab biosimilars from Organon and its licensing partner Shanghai Henlius Biotech and an aflibercept biosimilar from STADA Arzneimittel.

The European Commission approves new biosimilars for osteoporosis and eye conditions, enhancing treatment options and patient access across Europe. | Image credit: Andrzej - stock.adobe.com

Denosumab Biosimilars to Enhance Bone Care

Bildyos (denosumab) and Bilprevda (denosumab)

, developed by Shanghai Henlius Biotech and Organon.

 These drugs are biosimilars to the reference products Prolia (denosumab) and Xgeva (denosumab), respectively, and are approved for all of the reference products' indications.

 in postmenopausal women and men at increased risk for fracture. It is also approved for treating bone loss associated with hormone ablation in men with prostate cancer and for bone loss linked to long-term systemic glucocorticoid therapy in high-risk adult patients.

 in adults with advanced malignancies involving bone. Additionally, it is approved to treat adults and skeletally mature adolescents with giant cell tumors of bone where surgical resection is not feasible or would likely result in severe morbidity.

The approval was based on a comprehensive data package demonstrating that the biosimilars are highly similar to their reference medicines in terms of structure, efficacy, safety, and immunogenicity. Nico Van Hoecke, head of international commercial at Organon, stated that the approvals mark a "pivotal moment in expanding access to essential bone care treatments for millions of Europeans" and may help support the sustainability of Europe's health care systems. The EC approvals for these treatments follow recent authorizations in the US. The partnership between the 2 companies dates back to a 2022 agreement granting Organon exclusive global commercialization rights, excluding China.

These biosimilars were also recently approved by the FDA for the same indications earlier this month.

STADA Gains Approval for Aflibercept Biosimilar

Adding to the recent wave of biosimilar approvals, Germany-based company STADA Arzneimittel announced that the EC granted marketing authorization for 

, a biosimilar to the reference product Eylea (aflibercept).

 Afiveg is approved as a 40 mg/mL solution for injection in both prefilled syringes and vials.

Afiveg is indicated for the treatment of multiple retinal diseases, including neovascular (wet) age-related macular degeneration. This marks STADA’s second approved biosimilar in the ophthalmology space, following Ximluci (ranibizumab), and its eighth approved biosimilar in Europe overall. STADA plans to launch Afiveg in Germany during the fourth quarter of 2025, coinciding with the expected loss of market exclusivity for its reference product, Eylea.

Ian Henshaw, STADA’s global specialty head, commented on the approval, stating, "We look forward to building on the credibility in the specialty ophthalmology sector we have built with biosimilar ranibizumab to expand patient access to aflibercept." The approval comes as STADA's specialty business segment reports strong growth, with biosimilars being a significant driver of its 18% revenue increase in the first half of 2025.

1. European Commission (EC) approves Henlius and Organon’s Bildyos (denosumab) and Bilprevda (denosumab), biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively. News release. Organon. September 19, 2025. Accessed September 19, 2025. 

https://www.organon.com/news/european-commission-ec-approves-henlius-and-organons-bildyos-denosumab-and-bilprevda-denosumab-biosimilars-to-prolia-denosumab-and-xgeva-denosumab-respectively/

2. STADA expands specialty biosimilars portfolio through European approval for Afiveg (aflibercept). News release. STADA Arzneimittel. September 16, 2025. Accessed September 19, 2025. 

https://www.stada.com/blog/posts/2025/september/stada-expands-specialty-biosimilars-portfolio-through-european-approval-for-afiveg-aflibercept

3. Jeremias S. FDA greenlights fifth pair of denosumab biosimilars: Bildyos and Bilprevda. The Center for Biosimilars

. September 2, 2025. Accessed September 19, 2025. 

https://www.centerforbiosimilars.com/view/fda-greenlights-fifth-pair-of-denosumab-biosimilars-bildyos-and-bilprevda

The European Commission (EC) approves new biosimilars for osteoporosis and eye conditions, enhancing treatment options and patient access across Europe.

EC Approves New Biosimilars for Bone and Eye Conditions

Doctors in China are seeing encouraging results with HLX02, a trastuzumab biosimilar that may help expand access to treatment for people with HER2-positive metastatic breast cancer (MBC).

 A new real-world study from Fudan University Shanghai Cancer Center found the drug worked as well and was just as safe as the originator, even for patients who switched mid-treatment.

HLX02 shows promise as a safe, effective trastuzumab biosimilar for HER2-positive metastatic breast cancer, enhancing treatment access and affordability. | Image Credit: shidlovski - stock.adobe.com

, analyzed outcomes for 124 women treated between April 2021 and October 2022. HLX02, launched in China in 2020 under the brand name Zercepac, is the first domestically manufactured trastuzumab biosimilar. Because the high cost of Herceptin (reference trastuzumab) has long limited treatment access,

 researchers set out to evaluate whether HLX02 could provide comparable outcomes in routine practice, and whether switching from originator to biosimilar raised any concerns.

Among the participants, 80 were treated with HLX02 from the start, while 44 switched from Herceptin after several months. The median age was 53 years, and more than 60% of patients were postmenopausal. Nearly half were estrogen receptor–positive, and more than one-third had 3 or more sites of metastasis.

Results showed that HLX02 delivered similar effectiveness in both groups: 57.5% of patients who started with HLX02 responded to treatment, compared with 54.5% of those who switched (

 = .751). Median progression-free survival (PFS) was 14.2 months across the full cohort, with no significant differences between groups. Instead, outcomes were more strongly influenced by factors such as brain metastases and the number of prior treatment lines.

Safety findings were also consistent across groups. More than 90% of patients experienced treatment-emergent adverse events, most of which were mild to moderate. Severe events occurred in 29% of patients, with anemia, liver enzyme elevations, leukopenia, and neutropenia among the most common. Infusion-related reactions and cardiotoxicity were rare, and no new safety signals emerged.

The authors emphasized that HLX02 performed on par with previous clinical trial results, reinforcing its role as a viable and cost-effective alternative to Herceptin. “Our findings support the use of HLX02 as a safe and effective treatment option for HER2-positive metastatic breast cancer,” they wrote, noting that the ability to switch safely between the originator and biosimilar could help reduce costs and expand access in resource-limited settings.

As with any retrospective single-center analysis, the study had limitations. The sample size was modest, and most patients received HLX02 alongside other antitumor drugs, complicating attribution of some adverse events. The results also may not be generalizable outside China. Still, the research adds meaningful evidence at a time when health systems are weighing substitution policies for oncology biologics.

For managed care decision-makers, the findings offer reassurance that transitioning patients from Herceptin to HLX02 is unlikely to compromise efficacy or safety. In countries where affordability remains a major barrier, biosimilars such as HLX02 may be key to making life-extending therapies more widely available.

1. Ye X, Wang L, Liu W, et al. Efficacy and safety of biosimilar trastuzumab (HLX02) in patients with HER2-positive advanced breast cancer: a retrospective real-world analysis. 

. Published online August 1, 2025. doi:10.3389/fonc.2025.1622854

2. Lammers P, Criscitiello C, Curigliano G, and Jacobs I. Barriers to the use of trastuzumab for HER2+ breast cancer and the potential impact of biosimilars: a physician survey in the United States and emerging markets. 

HLX02 shows promise as a safe, effective trastuzumab biosimilar for HER2-positive metastatic breast cancer, enhancing treatment access and affordability.

Real-World Evidence Supports Biosimilar HLX02 in Metastatic Breast Cancer

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.

Results showed no significant differences in objective disease activity or biomarkers before and after the switch. | Image credit: eddows - stock.adobe.com

Biologic therapies such as adalimumab account for a large portion of pharmaceutical expenditures, and biosimilars have been introduced as lower-cost alternatives with comparable efficacy and safety. In Ireland, national health authorities recommend nonmedical switching to biosimilars to improve affordability and expand access. Despite these policy shifts, concerns remain that a “

”—in which patients anticipate worse outcomes due to their negative perceptions about a drug

—could undermine confidence in biosimilars. Researchers sought to explore these clinical, psychological, and economic dynamics during a structured switch to Amgevita.

Seventy-one individuals with IBD were initially recruited, of whom 64 were included in the final analysis. Participants ranged in age from 18 to 67 years, with an average disease duration of 12 years and mean Humira use of nearly 4 years. Most participants had Crohn disease (78%), while others had ulcerative colitis (17%) or indeterminate colitis (5%). Clinical status was measured with standard indices, including the Harvey–Bradshaw Index and partial Mayo score, as well as fecal calprotectin and C-reactive protein. Patient-reported outcomes included the Inflammatory Bowel Disease Control Questionnaire (IBDCQ) and EQ-5D-5L quality-of-life scale, and psychosocial variables were assessed with validated health anxiety and medication belief instruments.

Results showed no significant differences in objective disease activity or biomarkers before and after the switch. Patient-reported symptoms measured by the IBDCQ improved slightly, from 13.3 before switching to 12.5 afterward (

 = .043), though this change was small and of uncertain clinical importance. Quality-of-life measures did not meaningfully change.

Adverse events were reported by 25% of participants, with headaches, joint pain, nausea, fatigue, and injection site reactions among the most common. Importantly, statistical analysis indicated that health anxiety was a strong predictor of adverse event reporting, with each 1-point increase in health anxiety score raising the likelihood of an event by 21% (

 = .0079). Only 2 patients reverted to Humira because of intolerance.

Cost analysis revealed meaningful financial benefits. Switching reduced drug expenditures by €143,958 over 8 weeks for the cohort, amounting to an estimated €864,000 in annual savings. Even after accounting for switching clinic costs (€133 per patient) and unscheduled care needs, net savings averaged €2091 per patient over 2 months.

The authors noted that the structured switching clinic was resource intensive but effective in minimizing uncertainty and ensuring patients received adequate support. They suggested that scaling such clinics could further reduce per-patient costs and improve uptake.

Study limitations included its single-center design, short follow-up period, and open-label structure, which prevented a definitive distinction between true adverse effects and nocebo responses. The lack of blinded comparators and the potential influence of the COVID-19 pandemic on response rates were also acknowledged.

Still, the results reinforce international evidence supporting biosimilar adalimumab as a safe and effective alternative to the reference product. “With biosimilar switching, prescribers may expect some patients to develop new side effects, particularly those with high levels of health anxiety,” the authors wrote.

Overall, the study demonstrated that a nonmedical switch to Amgevita preserved disease control and quality of life while delivering significant cost savings, highlighting the importance of patient education and structured implementation to address psychological factors and optimize outcomes.

1. Rabbitt L, Keogh Á, Duane L, et al. A single-centre analysis of a biosimilar switching programme for adalimumab in inflammatory bowel disease. 

. 2025;91(9):2628-2635. doi:10.1002/bcp.70086

2. Jeremias S. 13 strategies to avoid the nocebo effect during biosimilar switching. The Center for Biosimilars

. December 18, 2024. Accessed September 8, 2025. 

https://www.centerforbiosimilars.com/view/13-strategies-to-avoid-the-nocebo-effect-during-biosimilar-switching

A study reveals that switching from Humira to Amgevita for IBD maintains disease control and offers significant cost savings.

Switch to Biosimilar Adalimumab Found Safe and Cost-Saving for Patients With IBD

August 2025 proved to be another dynamic month for the biosimilar landscape, characterized by significant financial milestones, new product launches, reinforcing clinical data, and ongoing battles over market access. These developments underscore the growing impact of biosimilars on health care affordability and treatment options, even as persistent challenges continue to shape their adoption.

August 2025 highlights significant advancements in biosimilars, showcasing financial successes, new product launches, and ongoing challenges in market access.

, showcasing a remarkable financial turnaround.

 The Iceland-based biotech company swung from a $153.5 million net loss in the first half of 2024 to a 

 for the same period in 2025. This success was largely fueled by a 

more than 200% year-on-year increase in product revenues

, reaching $204.7 million, and marking the company's first-ever quarterly positive cash flow from operations. 

Key drivers included the strong commercial performance of its high-concentration adalimumab biosimilar, Simlandi (marketed as Hukyndra in Europe), and its ustekinumab biosimilar, Selarsdi (Uzpruvo in Europe). 

Selarsdi, which gained interchangeable status from the FDA in April 2025, achieved more than 20% of the overall Stelara market share in the US by July 2025. Alvotech is also advancing its pipeline, with biologics license applications for proposed denosumab and aflibercept biosimilars accepted by the FDA, and its aflibercept biosimilar, Mynzepli, recently secured European approval.

Accord BioPharma commercially launched Imuldosa

, its biosimilar to Stelara, approved for various indications including plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

 Accord BioPharma priced Imuldosa at the 

 among branded ustekinumab biosimilars and offered a $0 co-payment program for eligible patients, aiming to expand access to cost-effective biologic therapies.

Clinical Data Reinforce Biosimilar Equivalence and Safety

Several studies published in August bolstered the scientific evidence for biosimilars. A 

year-long phase 3 clinical trial in Poland

, to the reference product Actemra/RoActemra for rheumatoid arthritis (RA).

comparable efficacy, safety, and immunogenicity

, even for patients who switched from the originator biologic, with consistent disease activity scores and no new safety concerns identified. This adds to the growing confidence in biosimilars for RA management, alongside other FDA-approved tocilizumab biosimilars like Tofidence and Tyenne.

equivalence of denosumab biosimilar LY01011 to the reference product Xgeva

 for treating bone metastases in solid tumors.

 LY01011 demonstrated similar efficacy in reducing bone metabolism biomarkers, comparable safety profiles, and a lack of unexpected adverse reactions across 850 patients. This evidence supports the use of denosumab biosimilars, such as Wyost/Jubbonti, which were approved in the US in March 2024. Long-term safety data also emerged for Sandoz’s biosimilar filgrastim. 

10-year prospective follow-up of 244 healthy stem cell donors

 who received Zarzio (marketed as Filgrastim Hexal in Germany) 

 for hematopoietic stem and progenitor cell mobilization.

 While most donors experienced adverse events during initial mobilization, serious adverse events documented over the decade were not deemed related to the biosimilar filgrastim, and donors maintained superior physical health scores. This study reinforces the established safety profile of filgrastim biosimilars, including Zarxio (filgrastim-sndz), which was the first FDA-approved biosimilar in the US in 2015.

 found comparable outcomes between etanercept biosimilars (Brenzys or Erelzi) and the originator, Enbrel

, for patients with rheumatoid arthritis.

 The analysis revealed no significant differences in time to first remission or sustained remission rates, aligning with findings from randomized controlled trials and European registry data. This highlights the clinical interchangeability of these products, in stark contrast to the 

delayed market entry of etanercept biosimilars in the US due to ongoing patent litigation

Battles Over Market Entry and Access Innovation

The ongoing challenge of patent disputes continues to affect biosimilar market entry. Genentech and Hoffman-La Roche initiated the 

first patent infringement case (BPCIA complaint) concerning a pertuzumab biosimilar

, filing against Shanghai Henlius Biotech and Organon.

 The complaint alleges infringement of 24 patents related to Genentech’s originator, Perjeta, following a pattern of litigation that has previously delayed market launches for other biosimilars.

However, innovative strategies are emerging to enhance access. 

MedImpact Holdings announced plans to provide access to an unbranded ustekinumab-aekn biosimilar

. This unbranded interchangeable biosimilar to Stelara is anticipated to be available at a significantly lower cost, aiming to bypass traditional supply chain costs, enhance price transparency, and reduce reliance on rebates, thus offering a more affordable treatment option for patients.

Despite the clear benefits, challenges in biosimilar adoption persisted. A comprehensive analysis of primary care prescribing data from 2020 to 2024 revealed that 

low prices failed to boost insulin glargine biosimilar uptake

 Even after the MHRA declared all biosimilars interchangeable with their reference products in 2022, originator Lantus continued to dominate prescriptions and, by 2024, became the least expensive option in all 4 UK nations. 

Biosimilars like Abasaglar and Semglee achieved only modest market shares (eg, 24% in England and Scotland, 5% in Northern Ireland, 11% in Wales). Key barriers identified include Lantus's price reductions, prescriber inertia, and national prescribing guidelines that require prescribers to initiate brand switching.

1. Jeremias S. Alvotech reports record-breaking first half of 2025 amid strong biosimilar sales. The Center for Biosimilars

. August 27, 2025. Accessed September 2, 2025. 

https://www.centerforbiosimilars.com/view/alvotech-reports-record-breaking-first-half-of-2025-amid-strong-biosimilar-sales

2. Jeremias S. Litigation, launch, and lower costs: 3 big moves in the US biosimilar space. The Center for Biosimilars. August 19, 2025. Accessed September 2, 2025. 

https://www.centerforbiosimilars.com/view/litigation-launch-and-lower-costs-3-big-moves-in-the-us-biosimilar-space

3. Jeremias S. Year-long phase 3 study confirms tocilizumab biosimilar comparability with Actemra. The Center for Biosimilars. August 6, 2025. Accessed September 2, 2025. 

https://www.centerforbiosimilars.com/view/year-long-phase-3-study-confirms-tocilizumab-biosimilar-comparability-with-actemra

August 2025 brought significant advancements in biosimilars, including financial successes, new product launches, and research on ongoing challenges in market access.