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

Skylar Jeremias

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

Articles

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

The FDA has approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), the sixth pair of denosumab biosimilars to receive the green light from the agency.

 The approvals, granted to Biocon Biologics, will provide more affordable treatment options for people with osteoporosis and cancer-related bone conditions.

The FDA has approved Bosaya and Aukelso, expanding affordable denosumab biosimilars for osteoporosis and bone-related cancers, enhancing treatment options. | Image Credit: wladimir1804 - stock.adobe.com

Bosaya is a biosimilar to the reference product Prolia, and Aukelso is a biosimilar to Xgeva. The FDA also granted a provisional interchangeability designation for both biosimilars. Clinical data demonstrated that both products had comparable quality, safety, and efficacy to their reference products.

Shreehas Tambe, CEO and managing director of Biocon Biologics, stated that the approvals were a significant milestone. "With Bosaya, we are proud to offer a more affordable treatment option for patients with osteoporosis, and with Aukelso, we are further expanding our oncology care portfolio," he said.

Bosaya was approved for treating postmenopausal women with osteoporosis at high risk for fracture and to increase bone mass in men with osteoporosis at high risk for fracture. It was also indicated for people with glucocorticoid-induced osteoporosis and for increasing bone mass in certain individuals receiving hormone ablation therapy for nonmetastatic prostate or breast cancer. Like its reference product, Bosaya carries a boxed warning for severe hypocalcemia in patients with advanced chronic kidney disease (CKD).

Aukelso was approved to prevent skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors. It was also indicated to treat adults and skeletally mature adolescents with a giant cell tumor of bone and to treat hypercalcemia of malignancy that is refractory to bisphosphonate therapy. Key warnings include the risk of hypersensitivity reactions, severe symptomatic hypocalcemia, and osteonecrosis of the jaw (ONJ).

Denosumab is a human monoclonal antibody that works by targeting RANKL, a protein essential for the formation and survival of osteoclasts, which are the cells responsible for bone resorption. By inhibiting RANKL, denosumab reduces bone breakdown and increases bone mass and strength. In 2024, US sales for denosumab products totaled nearly $5 billion.

The approval of Bosaya and Aukelso followed a series of denosumab biosimilar approvals over the past year and a half, intensifying competition in the market for bone health treatments.

Previous denosumab biosimilar approvals included:

 (denosumab-bddz) from Sandoz were the first biosimilars approved, referencing Xgeva and Prolia, respectively.

 They were also granted interchangeability and launched in the US in June 2025.

 (referencing Xgeva) from Samsung Bioepis (denosumab-dssb) gained approval with an interchangeability designation.

 (referencing Xgeva) from Celltrion (denosumab-bmwo) were approved and launched in the US in July 2025.

 (referencing Xgeva) from Fresenius Kabi (denosumab-bnht) were approved for all indications of their reference products and became commercially available on July 1, 2025.

 (referencing Xgeva) from Shanghai Henlius Biotech and Organon (denosumab-nxxp) received approval, marking the fifth pair cleared by the FDA.

1. Biocon Biologics receives U.S. Food and Drug Administration approval for Bosaya and Aukelso, denosumab biosimilars. News release. Biocon Biologics. September 17, 2025. Accessed September 18, 2025. 

https://www.prnewswire.com/news-releases/biocon-biologics-receives-us-food-and-drug-administration-approval-for-bosaya-and-aukelso-denosumab-biosimilars-302559101.html

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

. March 5, 2024. Accessed September 2, 2025. 

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

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

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

4. Jeremias S. Two more pairs of denosumab biosimilars enter US market. The Center for Biosimilars. July 9, 2025. Accessed September 2, 2025.  

https://www.centerforbiosimilars.com/view/two-more-pairs-of-denosumab-biosimilars-enter-us-market

5. Santoro C. FDA approves another pair of denosumab biosimilars, Conexxence and Bomyntra. The Center for Biosimilars. March 27, 2025. Accessed September 2, 2025. 

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

6. Jeremias S. FDA greenlights fifth pair of denosumab biosimilars: Bildyos and Bilprevda. The Center for Biosimilars. September 2, 2025. Accessed September 18, 2025. 

The FDA has approved Bosaya and Aukelso, expanding affordable denosumab biosimilars for osteoporosis and bone-related cancers and enhancing treatment options.

FDA Approves Biocon Biologics' Denosumab Biosimilars: Bosaya and Aukelso 

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

The economic impact of biosimilars on the Australian health care system is now clearer, with data revealing their role in reducing market expenditure and driving price competition, a finding detailed in a new study published

Biosimilars significantly reduce healthcare costs in Australia, enhancing access to biologics while driving price competition in the pharmaceutical market. | Image credit: Zerophoto - stock.adobe.com

Researchers conducted the analysis to address a critical challenge facing health care payers: balancing the rapid growth in indications and costs of biologic medicines with finite health budgets. The researchers recognized that once patents for reference products expire, the introduction of biosimilar medicines is a key strategy to provide continued patient access to necessary treatments while ensuring the long-term affordability of funding schemes.

Monoclonal antibodies (mAbs) and Fc-fusion proteins, often referred to as biologics, have revolutionized the treatment of previously difficult-to-treat chronic inflammatory diseases and cancers.

 Since the late 1990s, when the first mAb, rituximab, was launched, these medicines have come to dominate the global pharmaceutical market. The global market for biologics was valued at an estimated $320 billion in 2020, representing 40% of the total pharmaceutical market in Europe.

 In Australia, this trend is mirrored, with mAbs accounting for a quarter of the total expenditure on the national Pharmaceutical Benefits Scheme (PBS) in 2022.

 Given the significant and growing expenditure on these medicines, there is a clear need to understand how the introduction of less expensive biosimilar alternatives impacts the market.

The primary objective of the present study was to describe the specific impact of biosimilars on the volume and cost of biologics within the Australian market. To achieve this, the research team extracted Australian sales data for selected biologic medicines with at least one biosimilar available for a minimum of 12 months. The data, spanning a decade from 2010 to 2020, was sourced from IQVIA-MIDAS. The researchers measured expenditure in US dollars and volume in standardized units (SUs). They calculated the differences in expenditure, volume, and average SU price for both the reference product and the total market for the 12-month periods before and after biosimilar market entry.

A key finding was the substantial reduction in total expenditure for biologic reference products. Just 12 months after a biosimilar entered the market, the expenditure for the reference product was reduced by 

. This occurred in a market that experienced only a minimal increase in overall use, demonstrating that the savings were primarily driven by price reduction rather than a change in market size.

The price competition was also evident in the per-unit cost. The average price of a standardized unit for reference products decreased by 

. Furthermore, the study confirmed that the price of biosimilar standardized units was as much as 

 than the price of their reference products. By 2020, the cumulative effect of these introductions was clear: biosimilars had grown to account for 

The study also identified differences in market share uptake depending on the timing of the biosimilar’s introduction. Earlier introductions, such as etanercept and infliximab, had a lower short-term market share (2.0% and 1.8%, respectively) compared with more recent introductions like rituximab (21.8%) and trastuzumab (9.3%). This suggests that policy changes and increased clinician confidence over time may have accelerated the adoption of newer biosimilars.

While the study in question did not focus on patient-level data, other research has shown that the acceptance and use of biosimilars are influenced by a variety of factors related to the people receiving the care. A separate study on patients with inflammatory arthritis and inflammatory bowel disease revealed that most people (95%) obtained their medication information from specialists.

However, only a small percentage (4.6%) of respondents in that study reported using a biosimilar, and a significant majority (66.9%) were unsure if biosimilars were even available in Australia. This highlights the ongoing need for patient education and communication from health care providers. The most frequent factor that would influence a person to switch from a reference product to a biosimilar was a specialist’s recommendation.

The study's focus on sales data meant it did not capture patient-level experiences or prescribing habits, which are influenced by factors like policies, incentives, and knowledge among healthcare providers and people receiving care. These limitations may help explain why, despite documented cost savings, Australia's biosimilar uptake has lagged behind that of European markets.

The authors noted the significance of the results for policymakers. "Our data confirms that biosimilar introduction is a powerful tool for reducing market expenditure and driving down the price of reference products. This suggests that targeted policy initiatives can create the potential for greater medicines access for people across Australia by improving the financial sustainability of the healthcare system."

The demonstrated cost savings and increased market penetration indicate that biosimilars are not only viable alternatives but are also essential for maintaining accessible and affordable health care.

1. Hillen JB, Stanford T, Ward M, et al. Medicines policy in action: the impact on volume and cost of biologic medicines after biosimilar introduction. 

. 2025;50:101173. doi:10.1016/j.vhri.2025.101173

2. Ingrasciotta Y, Cutroneo PM, Marcianò I, et al. Safety of biologics, including biosimilars: perspectives on current status and future direction. 

. 2018; 41:1013-1022. doi:10.1007/s40264-018-0684-9

3. Spotlight on biosimilars. IQVIA. 2021. Accessed September 8, 2025. 

https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/spotlight-on-biosimilars

Biosimilars significantly reduce health care costs in Australia, enhancing access to biologics while driving price competition in the pharmaceutical market.

Australian Study Reveals Significant Cost Savings and Market Impact From Biosimilars

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

A new biosimilar may offer a treatment option for patients with moderate-to-severe plaque psoriasis. SYSA1902, a biosimilar of ustekinumab, was found to be clinically equivalent to its reference product, Stelara (Janssen), in a phase 3 study.

 The findings were detailed in a multicenter, randomized study that provides information on the biosimilar's efficacy and safety profile.

Psoriasis. | Image Credit: Daniel Beckemeier - stock.adobe.com .jpeg

In the US, there are 8 FDA-approved ustekinumab biosimilars, most of which launched on the market in 2025.

 Although the market is still new worldwide, ustekinumab biosimilars provide patients with new options at steep discounts, expanding access to rheumatology and immunology medications.

The study's purpose was to compare the efficacy and safety of SYSA1902 with reference ustekinumab in patients with moderate to severe plaque psoriasis.

 The primary endpoint was the percentage improvement from baseline in the Psoriasis Area and Severity Index (PASI) at week 12. Equivalence was established if the 95% confidence interval of the difference in PASI improvement was within 15%.

A total of 446 patients were enrolled at 42 sites in China. Patients were randomized to receive either SYSA1902 (n = 224) or ustekinumab (n = 222). Patients received a 45 mg subcutaneous injection at weeks 0, 4, 16, 28, and 40. The study's authors noted a limitation that the data were specific to Chinese patients.

The study's findings showed that the 2 treatments were comparable in efficacy and safety. At week 12, the mean percentage change from baseline in PASI was 86.4% in the SYSA1902 group and 84.7% in the ustekinumab group. The difference was 1.68%, with a 95% confidence interval of –1.45% to 4.81%, which was within the equivalence margins. Additionally, 83.3% of patients receiving SYSA1902 achieved a PASI 75 score at week 12, compared to 79.3% of those in the ustekinumab group. Secondary efficacy endpoints also indicated a similarity between the treatments.

The safety analysis indicated similar rates of adverse events. The overall rate of treatment-emergent adverse events was 89.3% in the SYSA1902 group and 85.6% in the ustekinumab group. Most of these events were mild to moderate, and upper respiratory tract infection was the most common. Pharmacokinetic profiles and anti-drug antibody positivity were also similar between the 2 groups.

According to the authors of the study, "Our findings indicated that the efficacy of SYSA1902 and ustekinumab were similar in the PASI 75 response rate, and other second efficacy endpoints, which resulted in a significantly improved symptoms and quality of life in patients with moderate-to-severe psoriasis.". The authors stated that additional studies would be conducted to evaluate the efficacy and safety of SYSA1902 in a more diverse patient population.

The results of this phase 3 trial add to the data on biosimilars for the treatment of plaque psoriasis. As biosimilar products continue to become available, they may offer additional treatment options for patients.

1. Xia L, Miao G, Yang X, et al. Efficacy and safety of SYSA1902 versus reference ustekinumab in moderate-to-severe plaque psoriasis: a multicenter, randomized, phase III study. 

. 2025;93(1):115-123. doi:10.1016/j.jaad.2025.03.018

2. Jeremias S. FDA approves Steqeyma for children with plaque psoriasis, psoriatic arthritis. The Center for Biosimilars

. May 27, 2025. Accessed September 4, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-starjemza-as-new-stelara-biosimilar

A new biosimilar, SYSA1902, shows comparable efficacy and safety to ustekinumab for treating moderate-to-severe plaque psoriasis, expanding patient options.

SYSA1902 Biosimilar Proves Equivalent to Reference Ustekinumab in Plaque Psoriasis

The Top 5 Biosimilar Articles for the Week of September 1

 of 244 healthy stem cell donors found no new safety concerns with Sandoz’s filgrastim biosimilar, reinforcing its long-term safety for donor mobilization.

Number 4: A new biosimilar for aflibercept shows 

 in treating neovascular age-related macular degeneration (nAMD), enhancing patient access to treatment.

 in remission outcomes between etanercept biosimilars and the originator, Enbrel, for rheumatoid arthritis patients.


Number 2: Alvotech, an Iceland-based biosimilar-focused biotech company, marked a significant financial milestone in the 

, swinging from a substantial loss to a net profit, driven by the strong commercial performance of its key biosimilar products.

Number 1: The competitive landscape for bone health treatments in the US has intensified with the 

 of Bildyos (denosumab-nxxp) and Bilprevda (denosumab-nxxp), biosimilars to Amgen’s reference products Prolia and Xgeva, respectively.

Videos

Here are the top 5 biosimilar articles for the week of September 1, 2025.

For people with rheumatoid arthritis who have achieved clinical remission, the decision to switch from an originator biologic to a biosimilar is a critical one for both their health and the sustainability of health care costs.

 has provided valuable evidence for this exact scenario, showing that patients who switched from originator infliximab to a biosimilar maintained their remission and stability, with minimal adverse events.

A recent Japanese study confirms that switching from originator infliximab to biosimilars maintains remission in rheumatoid arthritis patients, enhancing treatment accessibility. | Image credit: Valentina - stock.adobe.com

The study, known as the IFX-SIRIUS study I, was a 24-week, open-label, single-arm clinical trial that evaluated the efficacy and safety of a nonmedical switch from originator infliximab to the biosimilar CT-P13. While previous research had explored the safety of such switches using clinical disease activity indices, the authors of the study sought to provide a more robust analysis by incorporating high-sensitivity imaging modalities, such as musculoskeletal ultrasound (MSUS), along with clinical indices and serum biomarkers. According to the study's authors, this approach allowed for a more accurate and objective evaluation of disease activity at the joint level, providing an additional layer of confidence in the outcomes.

The study enrolled 19 patients with rheumatoid arthritis from 19 centers in Japan, with 18 patients included in the final analysis. The patient population had a median age of 63 years, and two-thirds of the participants were female. They had a median disease duration of 9 years and were on originator infliximab for a median of 6.4 years. A key inclusion criterion was that all patients were in a state of clinical remission, defined as a Disease Activity Score 28 (DAS28)-erythrocyte sedimentation rate of less than 2.6 at baseline. All patients were also taking methotrexate at the time of the switch.

The primary end point of the study was the proportion of patients who experienced a clinical relapse during the 24-week follow-up period. Of the 18 patients evaluated, 2 experienced a clinical relapse, which accounted for an 11.1% relapse rate. One patient relapsed at week 11 and the other at week 24, at which point they were discontinued from the study.

Beyond the primary end point, the study's secondary findings provided a compelling case for the biosimilar's efficacy. For the 17 patients who completed the study, there were no significant changes observed in the MSUS scores, including total grayscale and power Doppler scores. Clinical assessments also confirmed sustained remission, with no notable changes in key indices such as DAS28-ESR, DAS28-C-reactive protein, or the Health Assessment Questionnaire-Disability Index. Furthermore, the researchers found no apparent changes in the serum levels of multiple cytokines and chemokines, nor in other biomarkers like rheumatoid factor and anticyclic citrullinated peptide antibodies.

Safety data from the study also supported a positive outcome. Three nonserious adverse events were reported across the 18 patients: 1 case of eczema, 1 of dry dermatitis, and 1 of COVID-19. All were considered moderate in severity, and none resulted in a patient discontinuing the study.

"This study highlighted the potential for cost-effective biosimilars to maintain remission in patients with rheumatoid arthritis, suggesting significant implications for reducing treatment costs and improving accessibility," stated the authors in their conclusion.

From a managed care perspective, these findings are highly valuable. The high cost of originator biologics has been a persistent barrier to access and a driver of health care costs. The Japanese government, for instance, has actively promoted the use of biosimilars, citing the significant cost reduction—up to 38% compared with the originator in Japan as of December 2024—as a key factor in reducing national health care expenditures.

 The IFX-SIRIUS study provides a new layer of clinical data that supports the efficacy and safety of biosimilars in a real-world setting, potentially easing any remaining physician or payer caution about their use and addressing concerns about the nocebo effect.

Although the results are promising, the study's authors acknowledged several limitations. The small sample size of 18 patients meant that the initial plan to test for noninferiority could not be completed, and the analysis was limited to estimations. Additionally, the 24-week follow-up period was relatively short, and further studies are needed to assess long-term outcomes.

Despite these limitations, the authors maintained that the prospective evaluation using multiple assessment methods—clinical, imaging, and biomarkers—gives the results considerable clinical value for managed care organizations and health care providers considering the nonmedical switch to biosimilars for patients who are already in remission.

1. Kvien TK, Betteridge N, Brüchmann I, et al.Beyond cost: observations on clinical and patient benefits of biosimilars in real-world settings. 

. 2025;39(4):537-553. doi:10.1007/s40259-025-00727-z

2. Xia L, Miao G, Yang X, et al. Efficacy and safety of SYSA1902 versus reference ustekinumab in moderate-to-severe plaque psoriasis: a multicenter, randomized, phase III study. 

. 2025;93(1):115-123.  doi:10.1016/j.jaad.2025.03.018

3. Shimizu T, Kawashiri S-y, Koga T, et al. Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): an interventional, multicenter, open-label, single-arm clinical trial with clinical, ultrasound and biomarker assessments. 

. Published online August 22, 2025. doi:10.5582/ddt.2025.01044

A recent Japanese study confirms that switching from originator infliximab to biosimilars maintains remission in patients who have rheumatoid arthritis, enhancing treatment accessibility.

Japanese Trial Supports Widespread Use, Safety of Infliximab Biosimilar Use

A biosimilar to aflibercept demonstrated comparable efficacy, safety, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD), according to a 

ABP 938 proved equally effective as aflibercept in the treatment of nAMD  | Image credit: eevl - stock.adobe.com

ABP 938, marketed in the US as Pavblu, was developed as a lower-cost alternative to aflibercept (Eylea) to improve access to anti–vascular endothelial growth factor (VEGF) therapy.

 Regulatory authorities such as the FDA and the European Medicines Agency require a totality of evidence to establish biosimilarity, including analytical, nonclinical, and clinical studies.

 Earlier studies had shown structural and functional similarity, and this phase 3 trial was designed to confirm clinical comparability in people with nAMD.

The findings provide additional evidence to support the adoption of biosimilar anti-VEGF agents in ophthalmology. Given the high cost of reference aflibercept and its widespread use in retinal disease, generating $5.97 billion in US sales and $9.5 billion worldwide,

 biosimilars like ABP 938 may play a critical role in expanding patient access while reducing health care spending.

The trial enrolled 579 adults with treatment-naïve nAMD across 102 sites in 16 countries, with 576 included in the analysis. Participants had a mean age of 76 years, 56% were women, and most were White. All patients were randomized to receive either ABP 938 or aflibercept by intravitreal injection, beginning with three monthly doses followed by dosing every 8 weeks. At week 16, patients in the aflibercept arm were rerandomized to either continue aflibercept or transition to ABP 938.

Results showed virtually identical improvements in vision between groups. At week 8, patients treated with ABP 938 gained an average of 6.4 letters on the Early Treatment Diabetic Retinopathy Study scale compared with 6.5 letters for those treated with aflibercept, a difference well within similarity margins defined by regulators. Secondary outcomes, including maintenance of vision, gains of at least 10 or 15 letters, reduction in choroidal neovascularization, and improvement in central subfield thickness, were also comparable across treatment groups.

By week 52, 95.6% of patients who continued on ABP 938, 97.6% of patients who continued on aflibercept, and 95.9% of patients who transitioned from aflibercept to ABP 938 maintained vision. The proportion of patients achieving gains of 15 letters or more ranged from 24% to 30%, depending on the treatment sequence.

Safety findings mirrored the reference product. Adverse events occurred in roughly 39% of ABP 938–treated patients and 37% of aflibercept-treated patients in the first 16 weeks, with most events mild to moderate. The most common ocular adverse event was conjunctival hemorrhage. A total of 6 deaths occurred during the trial, but none were linked to study treatment. The development of antidrug antibodies was infrequent and transient, with similar incidence across groups. A pharmacokinetic substudy also confirmed low systemic exposure for both products.

“[Our] results showed ABP 938 has similar clinical efficacy, safety, and immunogenicity to aflibercept reference product in patients with neovascular age-related macular degeneration,” the study authors wrote, noting that the smaller sample sizes in the re-randomized groups limited some post-transition analyses, but sensitivity testing supported the overall conclusions.

1. Friedman S, London N, Hamouz J, et al. Randomized trial of biosimilar ABP 938 compared with reference aflibercept in adults with neovascular age-related macular degeneration. 

. Published online August 4, 2025. doi:10.1016/j.oret.2025.07.015

2. Jeremias S. FDA approves Pavblu for retinal conditions. The Center for Biosimilars

. September 17, 2024. Accessed September 2, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-pavblu-for-retinal-conditions

3. Regeneron reports fourth quarter and full year 2024 financial and operating results; initiates quarterly dividend and increases total share repurchase capacity to ~$4.5 billion. News release. Regeneron. February 4, 2025. Accessed September 2, 2025. 

https://newsroom.regeneron.com/news-releases/news-release-details/regeneron-reports-fourth-quarter-and-full-year-2024-financial

A new biosimilar for aflibercept shows similar efficacy and safety in treating neovascular age-related macular degeneration (nAMD), enhancing patient access to treatment.

Patients With nAMD Maintain Vision on Aflibercept Biosimilar ABP 938

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 

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