Rose McNulty

Approximately 1 in 5 patients with rheumatoid arthritis (RA) or axial spondyloarthritis (axSpA) in Turkey were prescribed biosimilars rather than originator biologics, according to a new retrospective analysis from Erciyes University in Kayseri.

, highlight how biosimilar use patterns remain modest overall but tend to increase in later treatment lines—offering insight into prescribing behavior in a country where biologics are fully reimbursed under national health insurance.

Researchers report that biosimilar use was not influenced by disease type but correlated with treatment sequence, shorter disease duration, and female sex. | Image credit: Zerophoto - stock.adobe.com

The study aimed to quantify biosimilar (BS) prescription rates and identify factors influencing clinicians’ decisions between biosimilars and reference biologic or targeted synthetic disease-modifying antirheumatic drugs (b/tsDMARDs). Although biosimilars have been available in Turkey for a decade, data on their uptake in rheumatology practice have been limited.

“Our results indicate that disease duration, female sex, and the order of current therapy were the most important predictors of biosimilar prescription,” the authors wrote. “The use of biosimilars increased significantly as treatment lines progressed, reflecting both growing clinician familiarity and broader market availability.”

The investigators reviewed manual and electronic health records of 647 adults diagnosed with axSpA (n = 436) or RA (n = 211) who received at least 1 b/tsDMARD between May 1, 2023, and December 31, 2023. Patient inclusion required meeting the Assessment of SpondyloArthritis International Society or ACR/EULAR diagnostic criteria. Demographic, laboratory, and treatment-related data—including disease activity scores, duration of treatment, and medication sequence—were extracted.

Participants’ mean (SD) age was 48.1 (12.6) years, and 66% were women. All patients were insured through Turkey’s Social Security Institution, ensuring cost-free access to biologic and targeted synthetic therapies when clinically indicated. Available biosimilars during the study period included infliximab, etanercept, adalimumab, and rituximab, while a generic version of tofacitinib was also listed though not prescribed to any patient.

Across all patients, 21.2% received a biosimilar as their most recent b/tsDMARD prescription. Rates were similar between disease types—22.2% in axSpA and 19.0% in RA (

 = .337)—suggesting that diagnosis did not significantly influence biosimilar uptake.

Patients with RA tended to be older and had a longer median disease duration (13 years vs 7 years; 

 < .001) than those with axSpA. Comorbidities, including hypertension, osteoporosis, diabetes, and dyslipidemia, were also more common in the RA group (all 

 < .05). The total duration of all b/tsDMARD use was significantly longer among individuals with RA (6.3 years) than those with axSpA (3 years; 

Among all biologic users, tumor necrosis factor (TNF) inhibitors dominated prescribing patterns, representing 80.7% of current treatments. Adalimumab was most frequently used in axSpA, while etanercept predominated in RA. In contrast, Janus kinase inhibitors such as tofacitinib or baricitinib were prescribed primarily for RA (16.6% of RA patients vs 0.2% of axSpA patients; 

Biosimilar use increased substantially with each successive treatment line. Patients who had received 5 or more distinct b/tsDMARDs showed the highest biosimilar prescription rate (39.7%), compared with just over 20% among those treated with their first biologic. Logistic regression revealed that female sex (OR, 1.70; 95% CI, 1.06-2.75), shorter disease duration (OR, 0.96; 95% CI, 0.92-0.99), and later treatment order (OR, 3.51; 95% CI, 1.06-11.60 for fifth-line or later use) were independently associated with biosimilar preference.

Interestingly, biosimilar users demonstrated higher disease activity measures at the time of data collection, including C-reactive protein and erythrocyte sedimentation rate levels. However, the researchers cautioned that these findings likely reflected the initiation of new therapy rather than reduced biosimilar efficacy. The median treatment duration for patients on biosimilars was zero years, indicating that many had recently started therapy.

Turkey represents one of the largest and fastest-growing pharmaceutical markets in the region, with national reimbursement policies facilitating broad access to biologic therapies. However, despite full coverage, prescriber behavior continues to favor reference biologics in early treatment stages. The authors suggested that clinician familiarity, patient comfort, and timing of biosimilar availability likely play roles in these trends.

Biosimilars have been shown globally to deliver comparable efficacy and safety to their originator counterparts while generating cost savings that expand patient access. In Europe, biosimilars account for roughly 70% of the TNF inhibitor market share, compared with far lower proportions in emerging markets. The Turkish findings therefore mirror an early stage of biosimilar integration into routine rheumatology practice.

“The increase in biosimilar use with subsequent therapy lines may reflect both increased physician confidence and accumulated experience over time,” the authors stated. “Wider education and awareness efforts could help normalize biosimilar prescribing earlier in the treatment sequence.”

The authors acknowledged several limitations, including the retrospective single-center design, lack of follow-up data on drug survival or switching outcomes, and exclusion of rheumatic diseases other than RA and axSpA. In addition, no socioeconomic analysis was performed, although uniform insurance coverage minimized cost disparities.

Future multicenter and longitudinal studies could clarify national trends and evaluate how biosimilar adoption impacts clinical outcomes and health care spending. As biosimilar availability expands, continued monitoring of prescription behaviors may help guide policy strategies to optimize equitable, cost-effective access to advanced therapies for inflammatory rheumatic diseases.

Kaplan H, Cengiz G, Kara H, Cüce İ, Kirnap M, Çaliş M. Analysis of data on biosimilar prescription rates in rheumatology practice from a reference center in Turkey. 

. 2025;15(1):28853. doi:10.1038/s41598-025-14816-0

Iskit AB. Key concepts in biosimilar medicines: What physicians must know. 

. 2022;9(1):86-91. doi:10.14744/nci.2021.84669

Articles

Researchers report that biosimilar use was not influenced by disease type but correlated with treatment sequence, shorter disease duration, and female sex.

Later-Line Therapies Drive Biosimilar Prescriptions in Turkish Rheumatology Practices

Stivant, demonstrated similar efficacy and safety to the reference biologic Avastin (reference bevacizumab; Genentech) in treating prethreshold type 1 retinopathy of prematurity (ROP), according to a recent analysis.

A new study reveals Stivant, a bevacizumab biosimilar, matches Avastin in safety and efficacy for treating retinopathy of prematurity in infants. | Image credit: Photographee.eu - stock.adobe.com

, suggest that biosimilar anti-vascular endothelial growth factor (VEGF) therapies could provide a cost-effective and accessible treatment option for premature infants at risk of severe vision loss.

ROP remains a leading cause of childhood blindness, resulting from abnormal retinal blood vessel growth in premature infants, affecting about 31.9% of infants globally, with greater prevalence in lower- and middle-income nations.

 As neonatal survival improves worldwide, the burden of ROP continues to grow, underscoring the need for affordable, safe, and effective therapies.

 Although laser photocoagulation remains a standard intervention, it can cause peripheral visual field loss and other complications. Anti-VEGF agents such as bevacizumab have emerged as effective alternatives but may be cost-prohibitive in some settings, an issue that biosimilar options can help address.

Conducted at the Khatam Eye Hospital in Mashhad, Iran, the study aimed to evaluate the noninferiority, safety, and efficacy of Stivant compared with Avastin in premature infants with bilateral prethreshold type 1 ROP. Investigators used a nonrandomized contralateral-eye design, administering Stivant to one eye and Avastin to the other. Infants were followed weekly for 4 weeks and biweekly thereafter until complete retinal vascularization.

The primary endpoint was the number of eyes achieving full vascularization without rescue laser photocoagulation. Secondary endpoints included the time between injection and full vascularization and the occurrence of ocular complications such as inflammation or infection.

A total of 44 infants (88 eyes) were included in the study, comprising 20 males and 24 females. The mean (SD) gestational age at birth was 27.6 weeks (1.8 weeks; range, 24-32 weeks), and the mean birth weight was 1737.7 g (554.9 g; range, 760-2200 g). The average age at injection was 34.5 weeks, with follow-up continuing until a mean age of 60 weeks.

Both treatments produced comparable outcomes. Thirty-nine eyes (88.4%) in each group achieved complete retinal vascularization after a single intravitreal injection. Five infants (11.3%) in both groups required bilateral rescue laser photocoagulation because of persistent or worsening disease.

The mean time to full retinal vascularization was nearly identical—25.55 weeks for Stivant and 25.46 weeks for Avastin (

 = .59). Kaplan-Meier survival analysis also found no significant difference between groups (

 = .928). Regression of plus disease, a clinical marker of active ROP, occurred at equivalent rates, further supporting comparable efficacy.

No ocular or systemic adverse events—including endophthalmitis, uveitis, vasculitis, or retinal detachment—were reported. “Our results demonstrated that Stivant was noninferior to Avastin in terms of efficacy and safety in treating prethreshold type I ROP,” the authors wrote. “However, due to the small sample size and pilot design, a definitive conclusion requires larger randomized studies.”

Bevacizumab has been a cornerstone in ROP management since the BEAT-ROP trial established its ability to prevent disease progression while sparing the peripheral retina. The introduction of biosimilar formulations may expand access to this therapy, particularly in regions where biologic cost is a barrier to care.

Stivant, the first bevacizumab biosimilar manufactured in Iran, has already been studied for systemic malignancies and retinal conditions such as diabetic macular edema, retinal vein occlusion, and neovascular age-related macular degeneration. Early evidence from animal models and small clinical case series supported its ophthalmic safety profile, paving the way for pediatric evaluation in ROP.

Investigators acknowledged several limitations, including the nonrandomized contralateral-eye design, which may have introduced selection bias, and the small sample size, which limited statistical power to detect rare adverse events. Functional assessments such as electroretinography and visual acuity could not be performed in the neonatal population, and long-term neurodevelopmental outcomes were not evaluated.

Despite these constraints, the findings provide meaningful preliminary data to inform future large-scale randomized controlled trials. The authors emphasized the importance of expanding research to include long-term follow-up and comprehensive visual function testing.

The study underscores the potential for biosimilars to broaden treatment access and reduce healthcare costs in pediatric ophthalmology.

“Given the growing global burden of ROP and the financial constraints of many health systems, biosimilars like Stivant could play a critical role in ensuring that effective treatments reach every infant who needs them,” the authors concluded.

1. Abrishami M, Golmohammadi Z, Shoeibi N, et al. Comparative efficacy and safety of biosimilar bevacizumab (Stivant) versus reference product (Avastin) in prethreshold type I retinopathy of prematurity. 

. 2025;36(4):407-412. doi:10.4103/joco.joco_178_24

2. García H, Villasis-Keever MA, Zavala-Vargas G, Bravo-Ortiz JC, Pérez-Méndez A, Escamilla-Nùñez A. Global prevalence and severity of retinopathy of prematurity over the last four decades (1985–2021): a systematic review and meta-analysis. 

A new study reveals Stivant, a bevacizumab biosimilar, matches Avastin in safety and efficacy for treating retinopathy of prematurity in infants.

Biosimilar Bevacizumab Matches Avastin in Treating Retinopathy of Prematurity

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. 

https://www.businesswire.com/news/home/20250903480207/en/Celltrion-Announces-Commercial-Availability-of-Omlyclo-Across-Europe-at-EADV-2025

2. Kim J-h. Celltrion gets EMA nod for phase 3 trial of Darzalex biosimilar. Korea Biomedical Review. September 1, 2025. Accessed September 22, 2025. 

https://www.koreabiomed.com/news/articleView.html

3. STADA further builds its bone-health and oncology offering with positive CHMP opinion on denosumab biosimilars. News release. STADA Arzneimittel. September 19, 2025. Accessed September 22, 2025. 

https://www.stada.com/blog/posts/2025/september/stada-further-builds-its-bone-health-and-oncology-offering-with-positive-chmp-opinion-on-denosumab-biosimilars

4. Polpharma Biologics and MS Pharma sign licensing agreements for proposed vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) biosimilars. News release. Polpharma Biologics. September 2, 2025. Accessed September 22, 2025. 

https://www.biospace.com/press-releases/polpharma-biologics-and-ms-pharma-sign-licensing-agreements-for-proposed-vedolizumab-pb016-ocrelizumab-pb018-and-guselkumab-pb019-biosimilars

Eye on Pharma: Europe and MENA Region See Expanding Biosimilar Pipelines

Although Australia has one of the highest global rates of rheumatoid arthritis (RA), with an estimated 2000 cases per 100,000 people, the country has been an early adopter of biosimilars to help reduce costs and expand patient access to biologic therapies.

A new nationwide real-world study published in 

 assessed whether the availability of the etanercept biosimilar Brenzys, listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in 2017, influenced treatment persistence among people living with severe RA.

Australia's adoption of etanercept biosimilars enhances access to rheumatoid arthritis treatments, maintaining treatment persistence and patient care quality. | Image credit: Manual - stock.adobe.com

Reference etanercept, marketed as Enbrel, has been a cornerstone biologic disease-modifying antirheumatic drug (bDMARD) for patients with severe RA since 2003. With the biosimilar Brenzys introduced in 2017, policymakers and clinicians sought evidence on whether integrating a biosimilar into practice would affect long-term treatment effectiveness, as measured by treatment persistence. Clinical trials had already established biosimilar efficacy and safety, but their short duration and selective populations limited insights into real-world use.

“Concerns have been raised among clinicians about whether biosimilars perform as well as originators outside of trial settings,” study authors noted. “Our study provides reassuring evidence that biosimilar entry has not negatively affected treatment continuity in routine care.”

Researchers conducted a retrospective cohort study using national PBS claims data linked to the National Death Index. Adults aged 18 years and older who initiated etanercept for severe RA between April 2013 and March 2022 were included. Participants were stratified into:

 (2013-2016): 4461 individuals who started etanercept before biosimilar entry

 (2018-2022): 5773 individuals who began therapy after the biosimilar was listed

The analysis excluded those using the 25 mg/mL formulation, as no biosimilar existed for that strength. Approximately 40% of contemporary cohort patients were estimated to have received the biosimilar.

Baseline characteristics showed the contemporary cohort was slightly older (mean age, 59.0 years vs 55.9 years) and had a higher proportion of men (27.8% vs 24.7%). Both groups had high comorbidity scores, reflecting the burden of chronic disease in this population. Most patients received conventional synthetic DMARDs (csDMARDs) prior to etanercept initiation, although this was somewhat lower in the contemporary group (85.8% vs 90.4%).

Treatment persistence was similar across groups:

 10.0 months (95% CI, 9.7-10.6) in the contemporary cohort vs 10.6 months (95% CI, 10.0-11.4) in the historical cohort (

 46.3% in the contemporary group vs 47.7% in the historical group

 1.00 (95% CI, 0.96-1.05), showing no significant differences in discontinuation risk

Subgroup analyses of older adults (≥ 65 years) and biologic-naïve individuals mirrored the main findings. For biologic-naïve patients, median persistence was slightly longer (11.7-12.7 months) but again showed no meaningful difference between cohorts.

Drug utilization after discontinuation was also consistent between groups. Nearly half of patients transitioned to another bDMARD, most often adalimumab, and about 19% reinitiated etanercept within 6 months.

This investigation is notable as the first population-level analysis in Australia using national claims data to evaluate real-world treatment persistence with etanercept before and after biosimilar entry. The large sample size of more than 10,000 patients strengthens the reliability of results.

However, several limitations were acknowledged. PBS data do not capture brand names, preventing direct comparisons between originator and biosimilar users. Thus, the contemporary cohort included a mix of both products. Additionally, the claims database lacked clinical measures of disease activity, laboratory markers, or reasons for treatment discontinuation, limiting insights into patient-level decision-making. Evolving treatment guidelines over time could also have influenced prescribing patterns.

These findings suggest that biosimilar entry has not disrupted treatment continuity among people living with severe RA in Australia. “Rather than adversely impacting patient care, biosimilar availability supports broader access to effective therapies at a reduced cost,” the authors concluded. They emphasized that future work should focus on brand-specific comparisons and safety outcomes to inform clinical and policy decisions.

The Australian experience offers timely reassurance for health care systems worldwide considering strategies to expand biosimilar adoption. Real-world data show that the introduction of the etanercept biosimilar has maintained stable treatment persistence.

1. Yiu CH, Ianni BD, Day RO, Raubenheimer J, Lu CY. Treatment persistence in rheumatoid arthritis before and after etanercept biosimilar introduction: a nationwide Australian real-world study. 

. 2025;39:369-381. doi:10.1007/s40290-025-00577-8

2. Treatment persistence in rheumatoid arthritis before and after etanercept biosimilar introduction: a nationwide Australian real-world study. 2025;39(5):369-381. doi:10.1007/s40290-025-00577-8

Australia's adoption of etanercept biosimilars enhances access to rheumatoid arthritis treatments, maintaining treatment persistence and patient care quality.

Stable Treatment Persistence in RA After Etanercept Biosimilar Introduction in Australia

The romiplostim biosimilar GP40141 showed equivalent efficacy and was a comparable option to reference romiplostim (Nplate; Amgen) in immune thrombocytopenia (ITP), a rare autoimmune disorder.

confirmed its efficacy and safety, with adverse events (AEs) similar between groups in the study.

Thrombopoietin receptor agonists such as romiplostim have become a cornerstone of ITP treatment by stimulating platelet production, and biosimilars offer a more affordable option. | Image Credit: Anusorn - stock.adobe.com

The multicenter, single-blind, randomized controlled trial (

) evaluated the biosimilar’s performance in adult patients with persistent or chronic ITP. The results showed the biosimilar romiplostim to be analytically and clinically comparable to its reference drug, a significant finding for both patients and health care systems grappling with rising drug costs.

Immune thrombocytopenia is characterized by the destruction of platelets, which can lead to increased bleeding risks and a reduced quality of life.

 The condition affects approximately 2.9 to 6.4 people per 100,000 adults annually.

 For many, ITP becomes a chronic, lifelong condition requiring sustained management.

Thrombopoietin receptor agonists such as romiplostim have become a cornerstone of ITP treatment by stimulating platelet production. Although effective, the high cost of these therapies, particularly the injectable romiplostim, has been a major barrier to widespread adoption, especially in resource-constrained regions.

“The development of biosimilar romiplostim aims to enhance the accessibility and affordability of this critical therapy, providing a lower-cost alternative that can reduce the financial burden on healthcare systems and improve patient access to essential medications,” the authors wrote.

Early in vitro studies confirmed GP40141’s comparability across 23 quality parameters, the authors explained. Preclinical trials in both rats and cynomolgus monkeys further demonstrated similar pharmacokinetics and pharmacodynamics, reinforcing the biosimilar's profile. A subsequent Phase 1 trial in healthy volunteers also validated its similarity to the reference product.

The phase 3 trial, which is the focus of the new report, confirmed these earlier findings in a population of 136 adults with ITP. The study, funded by GP40141 developer Geropharm, randomized patients 1:1 to receive either GP40141 or reference romiplostim for 26 weeks. The main end point in the trial was the proportion of patients achieving a platelet response (≥ 50 × 10

In the test group, 78% of patients showed platelet response after 10 weeks, compared with 85% in the comparison group. Between groups, the absolute difference in proportion was −0.06 (95% CI, −0.196 to 0.068), which falls within equivalence limits (−0.225 to 0.225). There were no significant differences in durable response rates, bleeding events, or safety profiles between the biosimilar and reference drug groups.

There were a total of 46 AEs in 22 patients reported during the study period in the test group vs 38 AEs affecting 18 patients in the reference drug group. The number of AEs and proportion of patients who experienced AEs did not significantly differ between the groups. The most frequent AE was petechiae, with mucosal bleeding also common. Most cases were mild, the authors noted.

The authors concluded that the biosimilar is not only effective but also safe, with no clinically meaningful differences in terms of quality, biological activity, or efficacy when compared with the reference drug.

The study had several limitations, including an incomparably low number of AEs compared with pivotal studies of romiplostim and its biosimilar. Underreporting cannot be ruled out, the authors explained. The single-blinded nature of the study was another limitation.

“Although the study was single-blinded, all efficacy end points were assessed using objective measures, therefore, the results can be considered reliable,” the authors wrote. “… Our aim was to provide evidence that treatment with biosimilar has equal efficacy and comparable safety, because the safety profile of romiplostim was already described elsewhere.”

1. Melikyan AL, Protsenko EA, Salogub GN, et al. Multicenter single-blind randomized controlled trial of the romiplostim biosimilar. 

. 2025;6(4):e70105. doi:10.1002/jha2.70105

2. Pietras NM, Gupta N, Justiz Vaillant AA, et al. Immune thrombocytopenia. StatPearls [Internet]. Updated May 5, 2024. Accessed August 22, 2025. 

https://www.ncbi.nlm.nih.gov/books/NBK562282/

New research confirms the romiplostim biosimilar GP40141 offers comparable efficacy and safety for treating immune thrombocytopenia, enhancing treatment accessibility.

Biosimilar Romiplostim Shows Equivalence to Reference Product for Chronic ITP

Discover the latest advancements in the biosimilar landscape, including the first patent lawsuit regarding a petuzumab biosimilar, a new ustekinumab biosimilar launch, and a new strategy for unbranded biosimilar access.

Explore groundbreaking developments in biosimilars, including patent lawsuits, new ustekinumab launches, and innovative access strategies for patients. | Image credit: MohamadFaizal - stock.adobe.com

Genentech Initiated First Pertuzumab BPCIA Complaint

Genentech and Hoffman-La Roche have filed the first patent infringement case concerning another manufacturer developing a pertuzumab biosimilar.

 The complaint was filed in the US District Court of New Jersey against Shanghai Henlius Biotech and Organon. According to the filing, Genentech alleges that Henlius’s proposed pertuzumab biosimilar, for which Organon holds commercialization and distribution rights, could reasonably infringe 24 patents for Gentench’s originator (Perjeta). Genentech is seeking various forms of relief, including:

The case marks the first for the pertuzumab market but follows the litigation patterns seen in the adalimumab, ustekinumab, and etanercept markets that have led to delayed market launches and prolonged monopolies.

Accord BioPharma Launches Imuldosa (Ustekinumab-srlf)

Accord BioPharma, the US specialty division of Intas Pharmaceuticals, announced the commercial launch of Imuldosa (ustekinumab-srlf).

 This biosimilar to Stelara (ustekinumab) marked Accord BioPharma’s third in-market biosimilar and received FDA approval for all the same indications as the reference product, including:

Moderate to severe plaque psoriasis in adult and pediatric patients (6 years and older)

Active psoriatic arthritis in adult and pediatric patients (6 years and older)

Moderately to severely active Crohn disease in adult patients

Moderately to severely active ulcerative colitis in adult patients

Imuldosa prefilled syringes were priced at the lowest wholesaler acquisition cost among all branded ustekinumab biosimilars, offering a significant discount from Stelara. The vial formulation also offered a considerable discount. The company also offered a $0 co-pay program for eligible patients so that more people living with plaque psoriasis, psoriatic arthritis, and Crohn disease and ulcerative colitis could receive a proven targeted biologic therapy. Accord BioPharma aimed to expand access to high-quality, more cost-effective biologic therapies, furthering its commitment to the immunology franchise.

MedImpact Introduced Unbranded Ustekinumab-aekn Biosimilar

MedImpact Holdings Inc. revealed its plan to provide access to an unbranded ustekinumab-aekn biosimilar, an interchangeable biosimilar to Stelara.

 This biosimilar would be available at a significantly lower cost than the reference product. Distributed by Anda, an affiliate of Teva Pharmaceuticals USA, the biosimilar would be directly purchasable by any licensed specialty pharmacy from MedImpact’s preferred partner, Birdi.

The unbranded strategy was designed to bypass traditional supply chain costs, aiming to deliver greater value to pharmacies and payers, and to offer a more affordable treatment option for patients by enhancing price transparency and reducing reliance on rebates. The unbranded ustekinumab-aekn biosimilar was anticipated to be available for purchase.

1. Genentech files first pertuzumab BPCIA complaint against Shanghai Henlius and Organon. Big Molecule Watch. August 18, 2025. Accessed August 18, 2025. 

https://www.jdsupra.com/legalnews/genentech-files-first-pertuzumab-bpcia-3305474/

2. Jeremias S. Breaking down biosimilar barriers: the patent system. The Center for Biosimilars

. November 11, 2025. Accessed August 18, 2025. 

https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-the-patent-system

3. Accord BioPharma announces commercial launch of Imuldosa (ustekinumab-srlf) prefilled syringes at lowest WAC price among branded biosimilars to Stelara (ustekinumab). News release. Accord Biopharma. August 18, 2025. Accessed August 18, 2025. 

https://www.prnewswire.com/news-releases/accord-biopharma-announces-commercial-launch-of-imuldosa-ustekinumab-srlf-prefilled-syringes-at-lowest-wac-price-among-branded-biosimilars-to-stelara-ustekinumab-302531289.html

4. MedImpact offers low cost, unbranded ustekinumab-aekn biosimilar. News release. MedImpact. August 18, 2025. Accessed August 18, 2025. 

https://www.medimpact.com/clients/resources/press-releases/medimpact-offers-low-cost-unbranded-ustekinumab-aekn-biosimilar

Explore groundbreaking developments in biosimilars, including patent lawsuits, new ustekinumab launches, and innovative access strategies for patients.

Litigation, Launch, and Lower Costs: 3 Big Moves in the US Biosimilar Space

The dulaglutide biosimilar LY05008 demonstrated equivalent efficacy in reducing HbA1c, along with comparable safety and immunogenicity profiles, to the reference drug dulaglutide in Chinese adults with type 2 diabetes. | Image Credit: MQ-Illustrations - stock.adobe.com

The biosimilar LY05008 demonstrated equivalent efficacy to dulaglutide in reducing hemoglobin A1c (HbA1c) levels, with comparable safety, pharmacokinetic, and immunogenicity profiles in Chinese adults with 

Several Chinese companies are developing biosimilars for dulaglutide, a weekly GLP-1 receptor agonist approved for type 2 diabetes.

 Boan Biotech's dulaglutide biosimilar (BA5101) has demonstrated effectiveness in controlling blood glucose and HbA1C.

 It also helps manage cardiovascular risk factors, such as weight gain and hyperlipidemia, with a lower risk of hypoglycemia.


Researchers conducted a phase 3 clinical trial to confirm that LY05008 biosimilar is therapeutically equivalent to the original dulaglutide by comparing the 2 products' efficacy, safety, pharmacokinetics, and immunogenicity in Chinese adults with type 2 diabetes whose condition is not adequately managed by metformin alone.


The study screened 536 patients with type 2 diabetes, with 440 ultimately enrolled and randomized into either the LY05008 group (n = 222 patients) or the dulaglutide group (n = 218 patients). Both groups received a weekly subcutaneous injection of 1.5 mg. The per-protocol set included 95.5% of all patients, with similar percentages in each treatment group.


The majority of participants were Chinese men (59.1%). The average age, weight, and BMI were comparable between both groups. For example, the LY05008 group had a mean age of 52.9 years, while the dulaglutide group had a mean age of 52 years.


Additionally, the baseline HbA1c levels were similar across both groups, with about 56% of patients having an HbA1c level below 8.5% and the remaining having an HbA1c level of 8.5% or higher. Overall, no significant differences in baseline characteristics were observed between the 2 groups.


At week 24, the mean HbA1c reduction from baseline was –1.44% for the LY05008 group and –1.41% for the dulaglutide group. The difference in the least square mean change between the 2 groups was 0.06%, falling within the -0.4% to 0.4% equivalence margin. These results confirm that there was no statistically significant difference in clinical efficacy between LY05008 and dulaglutide (


After 12 weeks, both the LY05008 and dulaglutide groups showed significant reductions in average HbA1c levels, with mean changes of −1.47% and −1.39%, respectively. The difference between the 2 groups was not statistically significant. At this time point, a similar percentage of patients in both groups achieved the HbA1c goals of 6.5% or less (40.1% for LY05008 vs 42.2% for dulaglutide) and less than 7% (60.4% vs 60.6%).


By week 24, the results remained comparable. The percentage of patients reaching the HbA1c goal of 6.5% or less was 41% for the LY05008 group and 43.6% for the dulaglutide group. Additionally, 55.9% of patients on LY05008 and 66.5% on dulaglutide achieved an HbA1c level below 7%.


Both LY05008 and dulaglutide showed a significant reduction in fasting plasma glucose (FPG) levels. At week 12, the FPG reduction was comparable between the 2 groups. However, at week 24, dulaglutide demonstrated a slightly greater reduction. For postprandial glucose (2-hour PPG), both treatments reduced levels, with no significant difference between the 2 groups at either week 12 or week 24.


Regarding weight loss, both groups experienced similar reductions. At week 12, patients on LY05008 lost an average of 2.01 kg, while those on dulaglutide lost 1.71 kg. By week 24, the weight loss was 2.68 kg for the LY05008 group and 2.42 kg for the dulaglutide group.


Overall, the safety profiles of LY05008 and dulaglutide were comparable. In the LY05008 group, 91% of patients experienced at least 1 treatment-emergent adverse event (TEAE), compared with 89.9% in the dulaglutide group. The number of TEAEs related to the study drug was similar between both groups: 57.7% for LY05008 and 61.5% for dulaglutide.


The most common side effects, occurring in at least 10% of patients, were also similar for both drugs. These included decreased appetite, diarrhea, nausea, and vomiting. Hypoglycemia occurred less frequently in the LY05008 group (0.9%) than in the dulaglutide group (3.7%). The rate of serious adverse events was also similar between the 2 groups, at 4.1% and 3.7%, respectively.


Trough plasma concentrations at steady state were comparable between the LY05008 and dulaglutide groups. Only 1 patient, who was in the LY05008 group, tested positive for neutralizing antibodies. All other patients with positive antidrug antibodies in both groups tested negative.


“In Chinese patients with T2DM [type 2 diabetes mellitus] following multiple subcutaneous injections, efficacy equivalence was achieved between LY05008 and dulaglutide with respect to change from baseline in HbA1C reduction to week 24,” study authors concluded.

Liu L, Cheng Z, Wang L, et al. Efficacy and safety of dulaglutide biosimilar LY05008 versus the reference product dulaglutide (Trulicity) in Chinese adults with type 2 diabetes mellitus: a randomized, open‐label, active comparator study. 

. 2025;17(4). doi:10.1111/1753-0407.70077

Jeremias S. Phase 1 study shows promise for dulaglutide biosimilar. The Center for Biosimilars

. July 25, 2024. Accessed August 6, 2025. 

https://www.centerforbiosimilars.com/view/phase-1-study-shows-promise-for-dulaglutide-biosimilar

Boan Biotech announces publication of phase 1 clinical study results of BA5101 in the Journal of Expert Opinion on Biological Therapy. News release. Boan Biotech. March 15, 2023. Accessed August 6, 2025. 

https://www.boan-bio.com/en/info.php?id=197

The dulaglutide biosimilar LY05008 demonstrated equivalent efficacy in reducing HbA1c, along with comparable safety and immunogenicity profiles, to the reference drug dulaglutide in Chinese adults with type 2 diabetes.

Dulaglutide Biosimilar LY05008 Shows Efficacy and Safety in Treating Type 2 Diabetes

Government price negotiations for certain products under the Inflation Reduction Act (IRA) that aimed to rein in high drug costs may have had unintended consequences for biosimilar development, according to a new report from Matrix Global Advisors (MGA).

Government price negotiations under the Inflation Reduction Act may hinder biosimilar development, impacting drug costs and patient access to affordable therapies. | Image credit: japhoto - stock.adobe.com

The report comes after a separate IQVIA Institute for Human Data Science report claimed that the globe could face what the report called a “biosimilar void.”

 Essentially, 90% of the biologics scheduled to lose exclusivity in the next decade, valued at $234 billion, do not currently have biosimilars in development, showcasing a large, missed opportunity for developers.

Although the negotiated prices don’t go into effect until 2026, the first 10 products chosen for the program have been announced.

 Only products that were not at risk of having biosimilars enter the market in the next few years were supposed to be eligible for Medicare price negotiation. However, the initial list includes Stelara (ustekinumab) and Enbrel (etanercept). Several biosimilars for Stelara are currently on the market, and 2 biosimilars for Enbrel (etanercept) have been approved by the FDA, with potential launches scheduled for 2029.

“Almost all the Medicare negotiated drugs have a generic or biosimilar equivalent in the pipeline, which in turn have a significantly lower cost,” said John Murphy III, president and CEO of the Association for Accessible Medicines, in a statement on the report.

 “The Medicare drug price negotiation program artificially extends the lifecycle of the brand version, resulting in higher costs for seniors.

The MGA analysis quantified the real-world implications not only on the cost of medicines but also on the long-term negative impact on future development of generics and biosimilars, which will result in fewer competitors and more delayed competition. The better option is the proven success of reducing drug prices through generic and biosimilar competition.”

The analysis revealed that the threat of price negotiations might deter manufacturers from launching biosimilars, especially for high-sales biologics.

 A 2024 Samsung Bioepis report indicated that after entering the market, biosimilars typically achieved a 53% market share with an average 53% decline in sales price relative to the reference biologic over 5 years.

 However, given the risks and costs involved, the MGA report estimated that for each biologic with $3.5 billion in annual sales, potentially $1.9 billion in annual savings could be lost if biosimilar entry was delayed due to government negotiations.

“In the current environment, the threat of government intervention appears to be chilling the incentives for biosimilar manufacturers to enter and compete effectively in the market,” noted the report. Unlike generics, biosimilars require steep investment, and future revenues often remain uncertain. That long timeline and financial risk, combined with government pricing uncertainty, appeared to be making some manufacturers think twice before investing.

Long-term Implications for Access and Cost

The report highlighted that these delays could impact patient access to affordable biologic therapies. Biosimilars serve as a crucial mechanism to lower treatment costs for complex conditions such as rheumatoid arthritis and certain cancers. Yet, the hesitancy among manufacturers resulting from the policy environment could blunt this potential.

According to Samsung Bioepis’ report, biosimilars continued to reduce prices by 24% to 76%, depending on therapeutic areas, but the “chilling effect” posed a threat to widespread continued price declines and broader market penetration in the future.

 “The reluctance of firms to develop biosimilars due to the risk of government price negotiations will hinder the full realization of biosimilar cost savings,” the present report stressed.

Government price negotiations under the Inflation Reduction Act may hinder biosimilar development, impacting drug costs and patient access to affordable therapies.