Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

The top 5 biosimilar articles for the week of August 11, 2025

 struggles for market share in the UK, facing pricing challenges and prescriber inertia despite regulatory support and cost-saving potential.

 Explore the latest biosimilar developments, including legislative changes, new approvals, and challenges in understanding, 

 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.

 in HER2-positive advanced gastric cancer, achieving an 82% disease control rate in real-world settings.

, demonstrating comparable efficacy and safety in rheumatoid arthritis treatment, enhancing access and affordability.

To read all of these articles and more, visit 

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Here are the top 5 biosimilar articles for the week of August 11, 2025.

The Top 5 Biosimilar Articles for the Week of August 11

Biosimilar LY01011 is equivalent to the reference product denosumab for treating bone metastases in solid tumors, demonstrating similar efficacy in reducing bone metabolism biomarkers, comparable safety profiles, and a lack of unexpected adverse reactions. | Image Credit: Nasr - stock.adobe.com

 biomarker NTX was equivalent to that of the reference product denosumab (Xgeva; Amgen), thus meeting the primary end point with safety characteristics of LY01011 and denosumab similar, and no unexpected adverse reactions were reported, according to a study published in the 

Bone metastases, which cause an estimated 35,000 deaths in the US each year, have seen evolving treatment options for patients with cancer.

 However, these treatments often come with a significant socioeconomic burden.

Treatments for bone metastases are diverse, encompassing external-beam radiation, surgery, endocrine therapies, chemotherapy, and targeted and immunological therapies.

 Of the available bone-targeted agents, bisphosphonates and denosumab are the most frequently used.

Denosumab received FDA approval in 2010 for the treatment of skeletal-related events (SREs) in patients with bone metastases.

 More recently, the first US biosimilars referencing denosumab, Wyost/Jubbonti (denosumab-bddz), were approved to treat osteoporosis and hypercalcemia, in addition to preventing SREs caused by bone metastases from solid tumors.

LY01011, a denosumab biosimilar developed by Shandong Boan Biotechnology Co, Ltd, was shown to have comparable pharmacokinetic, pharmacodynamic, safety, tolerability, and immunogenicity profiles.

 To establish its clinical equivalence, researchers conducted a multi-center, randomized, double-blind phase 3 clinical trial in patients with bone metastasis from solid tumors.

Following screening, 850 eligible patients were enrolled and randomized at a 1:1 ratio into a LY01011 group (n = 424) and a denosumab group (n = 426). The full analysis set (FAS) included all randomized participants, whereas the per-protocol set (PPS) included 739 patients. The mean age was 57.2 years, 42.5% identified as men, and 54.2% had lung cancer. No significant differences were observed between the treatment groups regarding the time frame from baseline to weeks 25 and 53 (uNTx/uCr ratios) and the time frame from baseline to weeks 13, 25, and 53 (s-BALP levels).

Equivalence between the LY01011 and denosumab groups was established, meeting the primary end point. Both treatments resulted in significant and sustained decreases in uNTX/uCr ratios, with a maximum median reduction of approximately 80% from baseline within 1 week. The least-squares mean difference of the logarithmic change in uNTX/uCr ratios was well within the prespecified equivalence margins for the FAS at week 13 from baseline (LY01011 group, –1.810 [0.0404]; denosumab group, –1.791 [0.0406]) and the PPS also met the predefined equivalence margins.

Subgroup analyses confirmed this equivalence across different patient demographics and tumor types. Both treatment groups also exhibited a continuous reduction in s-BALP levels over the course of the study. At weeks 13, 25, and 53, the median percent change in s-BALP levels from baseline was comparable between the 2 treatment groups. The changes for LY01011 were –36.980%, –46.853%, and –43.551%, while for denosumab, they were –37.674%, –48.681%, and –37.598%, respectively. The incidence of SREs was comparable between the 2 groups, with no statistically significant difference observed.

Adverse events (AEs) were monitored during both the double-blind treatment period and the entire study. During the double-blind treatment period, 91.3% of all patients experienced at least 1 treatment-emergent AE (TEAE), with comparable proportions in the LY01011 (91.7%) and denosumab (90.8%) groups.

The 2 study groups, LY01011 and denosumab, had similar rates of TEAEs throughout the study (97.4% vs 96.7%). The most frequent TEAEs ( ≥ 20%) were a decreased white blood cell count (32.5% vs 34.8%), a decreased neutrophil count (32.1% vs 33.6%), anemia (30.7% vs 28.7%), and hypocalcemia (20.3% vs 18.4%). The proportion of patients experiencing more severe TEAEs (≥ grade 3) and serious TEAEs was also comparable between the groups (54.7% vs 57.9% and 28.1% vs 30.4%, respectively). The proportions of patients with TEAEs (38.4% in both groups) and treatment-emergent serious AEs (TESAEs, 13.2% vs 14.1%) were similar. Hypocalcemia was the most common treatment-related AE (20% vs 18.1%). Over the entire study, the safety profile remained consistent, with no cases of osteonecrosis of the jaw or any other adverse events of special interest identified.

In both drug groups, predose plasma concentrations increased through week 13, then slowed between weeks 16 and 17, and reached a steady state by week 21. Before each dose, blood concentrations were similar in both groups. A 2 compartment pharmacokinetic model showed no significant differences between the LY01011 and denosumab groups in key parameters like clearance (

 = .6879) or central volume of distribution (

All patients in the study were antidrug antibody (ADA) negative at the start. In the LY01011 group, 1 patient tested positive for ADAs with a titer of 80 at week 5, but subsequent tests were negative. Similarly, 1 patient in the denosumab group had a positive ADA test at week 21 with a titer of less than 5. No patients developed neutralizing antibodies.

This study's limitations include the absence of long-term follow-up data for patients with bone metastasis from solid tumors. However, given denosumab's established mechanism of action and existing clinical evidence, extended observation for SREs and overall survival may not be a prerequisite for a comparable biosimilar study. Furthermore, the exclusion of non-Chinese participants provides no data on the safety and efficacy of LY01011 in a global patient population.

“Switching therapeutic drugs after week 13 did not affect the efficacy, safety, or immunogenicity profiles of either group,” study authors concluded.

Zhao M, Hu X, Zhuang P, et al. A multicenter, randomized, double-blind trial comparing LY01011, a biosimilar, with denosumab (Xgeva) in patients with bone metastasis from solid tumors. 

. 2025;51:100661. doi:10.1016/j.jbo.2025.100661

Long N, Woodlock D, D'Agostino R, et al. Incidence and prevalence of bone metastases in different solid tumors determined by natural language processing of CT reports. 

. 2025;17(2):218. doi:10.3390/cancers17020218

FDA approves Amgen’s Xgeva (denosumab) for the prevention of skeletal-related events in patients with bone metastases from solid tumors. Press release. Amgen. November 18, 2010. Accessed August 13, 2025. 

https://www.amgen.com/newsroom/press-releases/2010/11/fda-approves-amgens-xgevatm-denosumab-for-the-prevention-of-skeletalrelated-events-in-patients-with-bone-metastases-from-solid-tumors

Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars

. March 5, 2024. Accessed August 13, 2025. 

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

Articles

Biosimilar LY01011 is equivalent to the reference product denosumab for treating bone metastases in solid tumors, demonstrating similar efficacy in reducing bone metabolism biomarkers, comparable safety profiles, and a lack of unexpected adverse reactions.

Denosumab Biosimilar LY01011 Shows Equivalence to Reference Product for Bone Metastases

Here are the top 5 biosimilar articles for the week of August 4, 2025.

 Biosimilars promise cost savings and improved patient access in Latin America, yet face significant 

 Patients with rheumatoid and psoriatic arthritis maintained stable disease activity and functional capacity, with even some improvement in ultrasound findings, after switching from 

 in biosimilars enhance access to affordable treatments for autoimmune disorders, bone diseases, and ophthalmic conditions.

, driving up costs and delaying affordable treatments. Discover legislative solutions to enhance competition and patient care.

 Real-world data confirm Mvasi's safety as a 

 to reference bevacizumab (Avastin) for treating retinal conditions.

The Top 5 Biosimilar Articles for the Week of August 4

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

Here are the top 5 biosimilar articles for the week of July 28, 2025.

 Global regulatory advancements in biosimilars 

 to affordable treatments for autoimmune disorders, bone diseases, and ophthalmic conditions.

 Government price negotiations under the 

 may hinder biosimilar development, impacting drug costs and patient access to affordable therapies.

 Real-world data confirm Mvasi's safety as a cost-effective alternative to reference 

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

The Top 5 Biosimilar Articles for the Week of July 28

Patients with rheumatoid and psoriatic arthritis maintained stable disease activity and functional capacity, with even some improvement in ultrasound findings, after switching from original adalimumab to its biosimilar, GP2017. | Image Credit: japhoto - stock.adobe.com

Switching from original adalimumab to its biosimilar (GP2017) demonstrated comparable effectiveness in managing 

, with stable disease activity, functional capacity, and radiographic progression, alongside an observed improvement in power Doppler findings on ultrasonography, according to a study published in 

Biologic disease-modifying antirheumatic medications (bDMARDs) have become a mainstay in the treatment of moderate to severe rheumatoid arthritis, especially for patients who do not respond well to conventional synthetic DMARDs.

 These biologics have shown impressive success in reducing disease activity and improving patients’ quality of life. Biosimilars provide significant cost savings potential since they typically enter the market between 20% and 40% less expensive than their originator biologics. As the patents on some well-known biologics—including adalimumab, etanercept, and infliximab—have expired, a number of biosimilars have already been approved and introduced into certain international markets.

Studies show that most patients with stable inflammatory rheumatic joint diseases successfully switched to an adalimumab biosimilar.

 This positive outcome suggests that biosimilars can not only improve patient health but also provide significant cost savings compared with the reference drug, benefiting health care systems and patients alike.

Imaging, especially ultrasonography, is increasingly vital in rheumatology for assessing disease activity and treatment response.

 However, the effect of switching from original adalimumab to a biosimilar on these imaging parameters hasn't been thoroughly studied. To address this gap, researchers conducted a prospective cohort study to evaluate the clinical, functional, ultrasonographic, and radiological responses in patients with rheumatoid arthritis and psoriatic arthritis who transitioned from original adalimumab to the biosimilar GP2017.

From a group of 270 patients with rheumatoid arthritis, 35 who switched to the biosimilar adalimumab (GP2017) had complete pre- and post-switch disease control data. This was also true for 15 patients with psoriatic arthritis. There were no statistically significant changes in either median disease activity (Disease Activity Score-28, 3.7 vs 3.5; 

 = .6) or functional capacity (HAQ, 0.8 vs 1.1; 

Looking at imaging, X-rays showed no change in erosions (47% vs 48%; 

 = .7). However, ultrasound examinations indicated decreased disease activity after the switch, specifically by power Doppler (27% vs 12%; 

= .03), though not by greyscale evaluation. Other measures, including acute phase reactants, tender and swollen joint counts, and patient-reported Visual Analog Scale for activity, remained consistent between visits.

This study's findings are limited by its small sample size from a single center, focusing only on patients starting biological therapies. This introduces selection and indication biases, making it difficult to generalize the results to a wider patient population. The small sample also reduces the study's ability to detect subtle differences from biosimilar switching, highlighting the need for larger, multicenter studies. Furthermore, the lack of a control group that continued on the original adalimumab makes it hard to determine if observed outcomes were due to the biosimilar switch or other factors. Finally, the study's limited 1-year evaluation period and lack of ongoing follow-up constrain its long-term insights.

“The study suggests that transitioning from original adalimumab to biosimilar adalimumab (GP2017) as the first-line biological treatment for rheumatoid arthritis and psoriatic arthritis patients does not appear to lead to significant alterations in disease activity or functional capacity,” study authors concluded.

Garcia-Salinas R, Magri S, Ruta A, Ruta S. A comprehensive evaluation of the transition to a biosimilar of adalimumab in rheumatoid arthritis and psoriatic arthritis: a single-center experience with a focus on imaging outcomes. 

. Published online May 8, 2025. doi:10.4081/reumatismo.2025.1748

Ntais C, Kontodimopoulos N, Fanourgiakis J, Talias MA. Fostering healthcare system sustainability through efficient practices: can adopting biosimilars ease the financial burden of rheumatoid arthritis? 

. 2025;13:1128. doi:10.12688/f1000research.156983.2

van Adrichem RCS, Voorneveld HJE, Waverijn GJ, Kok MR, Bisoendial RJ. The non-medical switch from reference adalimumab to biosimilar adalimumab is highly successful in a large cohort of patients with stable inflammatory rheumatic joint diseases: a real-life observational study. 

. 2022;9(4):1109-1118. doi:10.1007/s40744-022-00465-6

Patients with rheumatoid and psoriatic arthritis maintained stable disease activity and functional capacity, with even some improvement in ultrasound findings, after switching from original adalimumab to its biosimilar, GP2017.

Adalimumab Biosimilar Maintains Effectiveness for Patients With Arthritis and Health Care Costs

Here are the top 5 biosimilar articles for the week of July 21, 2025.

 Sarfaraz K. Niazi, PhD, argues that the FDA can accelerate biosimilar entry by changing guidance under the 

Biologics Price Competition and Innovation Act (BPCIA)

 Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, supports 

 but foresees challenges adopting an intravenous daratumumab biosimilar, preferring the more convenient subcutaneous option.

the first interchangeable insulin aspart biosimilar

, enhancing access to affordable diabetes care for millions.

The Top 5 Biosimilar Articles for the Week of July 21

Here are the top 5 biosimilar articles for the week of July 14, 2025.

: Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, supports biosimilars for cost savings but foresees challenges adopting an 

, preferring the more convenient subcutaneous option.

: Inpatient biosimilar use is expanding, especially in oncology and supportive care, presenting 

 for health systems while maintaining patient care quality.

safety and efficacy of biosimilar insulins

, addressing concerns and promoting their adoption for diabetes treatment.

 about biosimilars persist among consumers and healthcare professionals, hindering their adoption and potential benefits in health care.

 with new denosumab options, enhancing treatment for patients with osteoporosis and bone-related metastases.

The Top 5 Biosimilar Articles for the Week of July 14

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic.

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, welcomes the advent of biosimilars in multiple myeloma treatment, particularly a potential biosimilar for daratumumab, as a means to reduce costs and increase market competition. However, she foresees significant challenges, especially if an intravenous (IV) biosimilar becomes available before a subcutaneous version.

The FDA approved Celltrion's investigational new drug application for CT-P44, a daratumumab biosimilar, enabling a global phase 3 trial.

 Researchers will evaluate CT-P44's pharmacokinetics, efficacy, and safety against daratumumab in 486 patients with refractory or relapsed multiple myeloma.


Sandahl notes that the original IV daratumumab infusions can take 8 to 10 hours, creating considerable scheduling difficulties. She explains that even with current patient volumes and nursing shortages, switching just a few patients from subcutaneous back to IV has proven challenging for infusion centers.


While acknowledging the clear cost containment benefits of biosimilars, she emphasizes that the cost difference would need to be substantial to justify moving patients from the more convenient and less chair-time-intensive subcutaneous formulation back to an IV one. She questions how centers managed this logistical burden universally before the subcutaneous option became available, highlighting a potential conflict between cost savings and current clinical practice efficiency.

This transcript was lightly edited for clarity.

: Please discuss the potential impact of biosimilars on the treatment paradigm of multiple myeloma. How might the growing availability of biosimilars influence prescribing patterns, cost management, and the role pharmacists play in integrating them into practice?

As a pharmacist, I welcome biosimilars and generic medications, anything we can do to reduce costs and increase competition. I think one thing that I've thought about is a biosimilar for daratumumab because that's probably the first one we would see, based on when things were approved. I'm curious what the adoption of that would look like because you'd see a biosimilar most likely for the IV formulation sooner than you would with the subcutaneous, and that's a huge difference in chair time. The cost difference would have to be pretty substantial for people to say, "Hey, we're putting everyone on the daratumumab biosimilar and abandoning the subcutaneous Darzalex."

I think it'd be an interesting change in practice because the way our things stood, the first infusion for IV daratumumab can take 8 to 10 hours, and scheduling that can be really challenging. We've had a few patients in the last couple of months who have needed to be switched from subcutaneous to IV for some reason or another, and even just finding them a space in the infusion center to get those first couple infusions has been a huge challenge. Where I've gone back, I'm like, "Gosh, how did we do this for everyone before we had subcutaneous? How did we make this work before because now we can't seem to?"

Some of that is an increase in patient volumes and differences in nursing shortages that maybe we didn't have 5 to 6 years ago. I think from a cost containment standpoint, biosimilars would be great but then when we look at like clinical practice and how that fits with current practice, going from subcutaneous back to IV would be a challenge.

FDA approves global phase 3 trial for Celltrion’s daratumumab biosimilar. Pearce IP. December 27, 2024. Accessed July 14, 2025. 

https://www.pearceip.law/2024/12/27/fda-approves-global-phase-3-trial-for-celltrions-daratumumab-biosimilar/

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, supports biosimilars for cost savings but foresees challenges adopting an intravenous daratumumab biosimilar, preferring the more convenient subcutaneous option.

Balancing Cost Savings With Clinical Practice for Multiple Myeloma Biosimilars: Tyler Sandahl, PharmD

Here are the top 5 biosimilar articles for the week of July 7, 2025.

: Long-term data from the SAME study confirm that 

 is safe and effective for patients with inflammatory bowel disease (IBD).

 persist among consumers and health care professionals, hindering their adoption and potential benefits in health care.

, including FDA approvals, patient switching trends, and real-world efficacy insights.

 demonstrated comparable efficacy and safety for paroxysmal nocturnal hemoglobinuria (PNH) to its reference drug, showing similar outcomes across diverse patient groups.

 switch back to the originator, according to research from Truveta. However, the presented data may not tell the full story.