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

Skylar Jeremias

Biosimilar competition was associated with meaningful reductions in out-of-pocket spending for patients with Medicare coverage receiving clinician-administered biologics, according to a new analysis of national claims data.

 The findings suggested that, unlike trends seen in commercially insured populations, lower biologic prices following biosimilar entry were more likely to translate into direct savings for Medicare beneficiaries.

Biosimilar competition significantly reduces out-of-pocket costs for Medicare patients, enhancing affordability for biologic therapies and improving access. | Image credit: digicomphoto - stock.adobe.com

, evaluated changes in annual out-of-pocket spending among Medicare Advantage enrollees who received 1 of 7 biologic drugs that later faced biosimilar competition. The analysis included filgrastim, infliximab, epoetin alfa, pegfilgrastim, bevacizumab, rituximab, and trastuzumab, which first encountered biosimilar competitors between 2013 and 2019.

The study was conducted amid ongoing questions about whether biosimilar-related price reductions meaningfully benefit patients. 

 among commercially insured populations found that out-of-pocket costs did not consistently decline after biosimilar entry, largely because patient cost sharing is often based on negotiated reimbursement rates rather than drug prices.

 In contrast, Medicare reimbursement for clinician-administered biologics is closely tied to average sales prices, raising the possibility that biosimilar competition could more directly reduce patient spending.

Using Optum’s deidentified Clinformatics Data Mart Database, the investigators identified 273,774 patient-years from 2009 through 2022. Patients had a mean age of 76 years, 57.6% were female, and more than half received biologic therapies as part of cancer care. Nearly half of administrations occurred in outpatient clinics, and 13.0% of patient-years involved receipt of a biosimilar. Patients receiving low-income subsidies or who were dually eligible for Medicare and Medicaid were excluded because of their substantially lower cost-sharing requirements.

Across all 7 biologics, mean annual out-of-pocket spending declined after biosimilar competition began. In the composite analysis, adjusted mean annual spending decreased by $94, from $233 in the year before biosimilar entry to $165 by 4 years after competition. Declines were observed for each drug, although the magnitude varied. Rituximab was associated with the largest reduction, while filgrastim showed the smallest change.

The proportion of patient-years with zero out-of-pocket costs remained stable at approximately 41% before and after biosimilar entry, indicating that savings were concentrated among patients who already incurred cost sharing. Among patient-years with nonzero out-of-pocket spending, mean annual costs declined by $163 over the 4-year postcompetition period.

Reductions were most pronounced among patients who paid coinsurance or deductibles, whose cost sharing is directly tied to drug prices. In this group, mean annual out-of-pocket spending decreased by nearly $200 after biosimilar competition. By contrast, patients who paid only flat copayments did not experience significant changes in out-of-pocket costs, a finding consistent with the structure of fixed-fee cost sharing.

Sensitivity analyses showed that reductions in out-of-pocket spending occurred across most of the spending distribution, with the largest absolute decreases among patients with higher baseline costs. Trends in Medicare average sales prices mirrored these findings, with prices for originator biologics generally declining after biosimilar entry while biosimilar prices remained lower and continued to decrease over time.

The authors noted several limitations. Claims data did not capture manufacturer assistance programs, which may have led to overestimation of patient spending. The analysis was limited to Medicare Advantage enrollees and may not generalize to patients in traditional fee-for-service Medicare. Changes in plan design over time could also have influenced out-of-pocket costs independently of biosimilar competition. Additionally, the findings were specific to clinician-administered biologics and do not apply to pharmacy-dispensed biologics covered under Medicare Part D.

Overall, the results suggested that biosimilar competition was associated with lower out-of-pocket spending for Medicare patients, particularly for those whose cost sharing reflected drug prices. The findings highlighted the potential for timely biosimilar entry and sustained competition to improve affordability and access to biologic therapies for older adults.

Riegler JS, Kesselheim AS, Rome BN. Out-of-pocket spending for biologic drugs after biosimilar competition for Medicare patients. 

. 2026;9(1):e2554235. doi:10.1001/jamanetworkopen.2025.54235

Biosimilar approvals. The Center for Biosimilars

. Updated December 22, 2025. Accessed January 21, 2026. 

https://www.centerforbiosimilars.com/biosimilar-approvals

Feng K, Russo M, Maini L, et al. Patient out-of-pocket costs for biologic drugs after biosimilar competition. 

. 2024;5(3):e235429. doi:10.1001/jamahealthforum.2023.5429

Articles

Biosimilar competition significantly reduces out-of-pocket costs for Medicare patients, enhancing affordability for biologic therapies and improving access.

Biosimilar Competition Linked to Lower Out-of-Pocket Costs for Medicare Patients

For people who rely on insulin every day, even small changes can carry outsized weight, a reality that has complicated efforts to expand use of lower-cost biosimilar insulins across health systems.

 More than a decade after biosimilar insulins entered the market, uptake has grown slowly, shaped not only by regulatory frameworks and pricing policies but also by the perceptions and experiences of those most directly affected by switching.

globe health | Image credit: C Malambo:peopleimages.com - stock.adobec.om

, sought to clarify how health care professionals, people treated with insulin, and health service administrators have viewed and experienced switches from reference insulin products to biosimilars, highlighting persistent gaps in evidence relevant to managed care decision-making.

Biosimilar insulins have been available since 2014 and are approved on the basis of rigorous comparability exercises demonstrating similar quality, efficacy, and safety to reference products. Regulators in Europe, the UK, and the US have stated that biosimilars should be treated as interchangeable with their reference products, yet policies governing substitution and switching vary widely across jurisdictions.

 Despite the potential for meaningful savings in publicly funded and private health care systems, concerns about safety, efficacy, delivery devices, and patient acceptance have continued to limit broader adoption.

 The authors undertook this scoping review to map existing literature on stakeholder perceptions and experiences of biosimilar insulin switching and to identify where evidence remains sparse.

Using a systematic search of PubMed, Web of Science, and CINAHL Ultimate, supplemented by grey literature searches and reference scanning, the authors identified 184 records, with 20 meeting inclusion criteria. Eligible sources included quantitative and qualitative research studies, reviews, guidance documents, and opinion pieces published in English since 2014. Stakeholders of interest were health care professionals (HCPs), health service administrators (HSAs), and people of any age treated with insulin. Findings were synthesized narratively using thematic analysis rather than pooled quantitative outcomes, reflecting the heterogeneity of the literature.

Across multiple studies, awareness of biosimilar principles among HCPs was generally high, particularly among pharmacists. However, practical experience with switching was limited; in one survey, 67% of HCPs reported no direct experience switching people to biosimilar insulins. Levels of concern varied by profession. Diabetologists and nurses expressed higher levels of concern than pharmacists, particularly regarding efficacy and safety when switching established patients. In some studies, up to 32% of physicians and more than half of nurses reported major concerns about efficacy when switching.

Insulin-specific issues distinguished biosimilars from other therapeutic classes. Differences in pen devices, availability of connected or half-unit pens, and varying injection forces were frequently cited as barriers. HCPs also raised concerns about workload associated with education and monitoring after a switch, as well as skepticism toward pharmacy-level substitution without prescriber involvement. Although most HCPs acknowledged regulatory assurances of comparability, questions about long-term safety data and multiple switches between biosimilars persisted.

Evidence on patient perspectives was notably limited, with only 3 primary research studies identified from the US, Canada, and Japan. In a US survey examining a hypothetical future switch, most respondents expressed neutral or positive views toward biosimilar insulin, with only a small minority stating they would definitely refuse a switch. People with type 1 diabetes were slightly more hesitant than those with type 2 diabetes. Concerns centered on perceived brand quality, satisfaction with current therapy, and fears of reduced efficacy or safety.

Real-world experience data were sparse but informative. A Japanese study of people with type 2 diabetes who switched from reference to biosimilar insulin glargine reported no meaningful changes in treatment satisfaction, glycemic control, or adverse events. Similarly, a Canadian analysis of a mandatory switching policy found that only 2.8% of people switched back to the reference product, suggesting general tolerability of the transition.

Guidance directed at HSAs emphasized the need for structured switching programs, including clear criteria, education plans, and processes for informed consent. Administrators expressed concerns about legal responsibility, potential nocebo effects, and the logistical challenges of selecting among multiple biosimilars. Importantly, one Canadian study found no increase in health care resource utilization following mandatory switching, addressing a common concern that switches might drive additional clinical visits or monitoring costs.

Cost considerations were central across stakeholder groups, particularly in publicly funded systems such as the UK, where modest price differences sometimes limited enthusiasm for switching. In contrast, in settings where people bore more out-of-pocket costs, lower prices were a stronger driver of acceptance, though some individuals associated lower cost with lower quality. Factors expected to facilitate switching included robust real-world evidence, consistent education for HCPs and patients, endorsement from professional bodies, and shared decision-making approaches that allowed for switching back if needed.

The analysis did not assess study quality or quantify effect sizes, and the included literature was heterogeneous in design and geography. The authors noted a striking lack of data on stakeholders who had direct experience with biosimilar insulin switching, particularly outside a few high-income countries. As they concluded, “almost no literature related to the experience of stakeholders who have already engaged in biosimilar insulin switching was identified,” underscoring the need for pragmatic, real-world research to inform managed care policies.

For payers and health systems considering broader biosimilar insulin adoption, the findings suggest that clinical equivalence alone is insufficient. Addressing education gaps, device-related concerns, and the lived experiences of people treated with insulin will be critical to translating theoretical savings into sustainable practice.

1. Switching or deprescribing insulins: when & how. Enclara Pharmacia. June 23, 2022. Accessed January 19, 2026. 

https://enclarapharmacia.com/palliative-pearls/switching-or-deprescribing-insulins-when-how

2. Jeremias S. From Amjevita to Zarxio: a decade of US biosimilar approvals. The Center for Biosimilars

. March 6, 2025. Accessed January 19, 2026. 

https://www.centerforbiosimilars.com/view/from-amjevita-to-zarxio-a-decade-of-us-biosimilar-approvals

3. Hindley B, Wright S, Ooi C, Da Costa R, Cope L. Exploring stakeholder perceptions and experience of biosimilar insulin switching: a scoping review. 

 2026;9(1):e70142. doi:10.1002/edm2.70142

4. Biosimilar medicines can be interchanged. EMA. September 19, 2022. Accessed January 19, 2026. 

https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged

5. Guidance on the licensing of biosimilar products. UK MHRA. Accessed January 19, 2026. 

https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products

6. Jeremias S. A closer look at new FDA guidance removing barriers to biosimilar development. The Center for Biosimilars. October 30, 2025. Accessed January 19, 2026. 

https://www.centerforbiosimilars.com/view/a-closer-look-at-new-fda-guidance-removing-barriers-to-biosimilar-development

Explore the complexities of insulin biosimilars, their safety, and the impact on diabetes management in global health systems.

Perceptions Still Play a Central Role in Biosimilar Insulin Switching

As biosimilars move into broader therapeutic areas, osteoporosis has emerged as a key test case for demonstrating equivalence in both bone density outcomes and safety.

Denosumab biosimilars enhance treatment access for postmenopausal osteoporosis, demonstrating equivalent efficacy and safety to reference products in recent trials. | Image credit: Lamina - stock.adobe.com

With 9 and 10 pairs of denosumab biosimilars approved in the US and European Union, respectively, lower-cost biologic alternatives to Prolia and Xgeva (reference denosumab) are increasingly shaping treatment access in osteoporosis, where long-term adherence is essential to prevent fractures and downstream costs.

In a recent randomized phase 3 trial, investigators addressed persistent cost and access barriers associated with denosumab, a monoclonal antibody that inhibits receptor activator of nuclear factor-κB ligand (RANKL) and is widely used for fracture risk reduction.

 Although denosumab has demonstrated durable efficacy and an acceptable long-term benefit–risk profile, its biologic pricing has limited uptake in some settings. Biosimilars are intended to expand access while maintaining equivalent clinical performance, a requirement emphasized by both the FDA and the European Medicines Agency.

The multicenter, double-blind study enrolled women aged 60 to 90 years with postmenopausal osteoporosis across 76 sites in Europe and the US between 2021 and 2023. Participants were randomized 1:1 to receive either the proposed biosimilar RGB-14-P or reference denosumab at a dose of 60 mg administered subcutaneously every 6 months, with follow-up through 52 weeks. All participants also received daily calcium and vitamin D supplementation.

A total of 473 participants were randomized and treated (n = 242 assigned to RGB-14-P and 231 to reference denosumab), and more than 92% completed the 52-week main study period. At baseline, the mean age was 66.7 years, and nearly all participants were White. Mean lumbar spine bone mineral density (BMD) T-scores were approximately −3.0 in both groups, consistent with established osteoporosis. Around 10% of participants in each arm had experienced a fracture within the year prior to enrollment.

The trial included 2 co-primary end points designed to satisfy regulatory expectations for biosimilar equivalence: percentage change from baseline in lumbar spine BMD at week 52 and area under the effect curve for percentage change in serum C-terminal telopeptide of type 1 collagen (CTX) through week 26. Both end points met prespecified equivalence margins.

At week 52, the adjusted mean increase in lumbar spine BMD was 4.89% in the biosimilar group and 4.55% in the reference denosumab group, yielding an estimated between-group difference of 0.34 percentage points (95% CI, −0.40 to 1.09), well within the equivalence margin of ±1.45%. Analyses required by US regulators also demonstrated noninferiority and nonsuperiority of the biosimilar relative to the reference product.

Pharmacodynamic outcomes mirrored these findings. The geometric mean ratio for the CTX area-under-the-curve end point was 1.01 (95% CI, 0.98-1.05; 

 = .49), confirming equivalent suppression of bone resorption. Secondary efficacy end points, including changes in total hip and femoral neck BMD at weeks 26 and 52, did not differ significantly between treatment arms.

Fracture outcomes, although not powered as primary end points, were similar across groups. By week 52, vertebral fragility fractures occurred in 1.7% of participants receiving RGB-14-P and 3.5% of those receiving reference denosumab, while nonvertebral fragility fractures occurred in 1.7% and 4.3%, respectively. Investigators noted that the overall fracture incidence was low, a common limitation in osteoporosis trials of relatively short duration.

Immunogenicity rates were low and comparable. Binding antidrug antibodies were detected in fewer than 1% of participants in either group, and neutralizing antibodies were identified in 0.4% of participants in each arm. Safety profiles were also similar, with approximately two-thirds of participants in each group experiencing at least 1 treatment-emergent adverse event. The most commonly reported events included infections such as COVID-19 and nasopharyngitis, hypocalcemia, headache, and arthralgia. Serious adverse events were uncommon and balanced between groups.

Investigators emphasized that the findings align with regulatory standards for biosimilar development. They wrote that the biosimilar “demonstrated equivalent efficacy and pharmacodynamics and similar immunogenicity and safety” compared with reference denosumab, adding that the results support its ability to “replicate the therapeutic benefit” of the originator in clinical practice.

Several limitations were acknowledged. The study population lacked racial diversity, which may affect generalizability, and follow-up was limited to 1 year, precluding assessment of longer-term fracture outcomes. Additionally, low fracture event rates constrained conclusions regarding comparative fracture prevention, although BMD changes are an accepted surrogate end point for regulatory decision-making.

From a managed care perspective, the results add to a growing body of evidence supporting denosumab biosimilars as clinically comparable options that may reduce drug spending while preserving outcomes. If approved and priced competitively, RGB-14-P could provide payers and health systems with additional leverage to improve access and support sustained osteoporosis treatment adherence.

Biosimilars approvals. The Center for Biosimilars

. Updated December 22, 2025. Accessed January 15, 2026. 

Seefried L, Ferrari S, Páll D, et al. A randomised phase 3 study comparing the efficacy and safety of proposed denosumab biosimilar RGB-14-P and reference denosumab in women with postmenopausal osteoporosis. 

. 2025;36(12):2497-2507. doi:10.1007/s00198-025-07711-x

Denosumab biosimilars enhance treatment access for postmenopausal osteoporosis, demonstrating equivalent efficacy and safety to reference products in recent trials.

Trial Data Support Equivalence of Denosumab Biosimilar in Postmenopausal Osteoporosis

Tighter health care budgets have forced payers to scrutinize how high-cost biologic medicines are financed, particularly as use continues to expand across oncology and chronic inflammatory conditions. In Australia, a combination of pricing reforms and biosimilar entry has been positioned as a way to preserve access while curbing spending growth.

Australia's biosimilar adoption significantly reduces biologic medicine costs, enhancing access while maintaining utilization amid tighter health care budgets. | Image credit: Anton Balazh - stock.adobe.com

A recent analysis evaluated how the introduction of biosimilars affected spending, utilization, and pricing for several widely used biologic medicines within the Australian market. Investigators conducted the study to address a persistent evidence gap: despite years of biosimilar availability, there had been limited public data quantifying how biosimilars influenced reference product prices, overall market expenditure, and volume under Australia’s Pharmaceutical Benefits Scheme (PBS).

Current State of Biosimilars in Australia

Australia’s biosimilar landscape has evolved significantly over the past decade as policy makers, regulators, and industry stakeholders have sought to balance medicines’ affordability with clinical confidence and uptake.

 Regulatory approvals and pricing policies have expanded the number of biosimilars available on the Therapeutic Goods Administration’s (TGA) register and the PBS, but real-world adoption continues to lag behind other Organisation for Economic Cooperation and Development nations.

As of 2025, the TGA has approved a growing number of biosimilars across multiple therapeutic classes, including denosumab biosimilars (Stoboclo and Osenvelt), an aflibercept biosimilar (Eydenzelt), and the first natalizumab biosimilar (Tyruko).

 These approvals represent a broadening of competition into treatment areas such as osteoporosis, oncology supportive care, and neuroimmunology, beyond traditional anti-tumor necrosis factor agents.

To support uptake, the government and PBS have implemented biosimilar uptake drivers that encourage prescribers to initiate treatment with biosimilars in eligible, treatment-naïve patients.

 Prescribing administrative burdens have also been reduced by streamlining PBS authority requirements for biosimilar medicines, making them easier for clinicians to prescribe.

The researchers used Australian sales data from the IQVIA MIDAS database covering both hospital and retail channels from 2010 through 2020. The analysis focused on 4 monoclonal antibodies or Fc-fusion proteins—etanercept, infliximab, rituximab, and trastuzumab—that had at least 1 biosimilar listed on the PBS for a minimum of 12 months. Outcomes included changes in total and reference product expenditure, standardized unit (SU) volume, average SU price, and biosimilar market share before and after biosimilar entry.

Across the 4 biologics, biosimilar introduction was associated with substantial spending reductions. Twelve months after biosimilars entered the market, total expenditure for reference products declined by 38.3%, while combined spending on reference and biosimilar products fell by 33.8%, even as overall use increased modestly. The authors reported that total consumption across products grew by 4.9% during the same period, suggesting that lower prices did not restrict access.

The magnitude of savings varied by molecule. Reference product expenditure fell by 55.6% for rituximab, compared with 17.9% for infliximab. By the most recent 12-month period analyzed, biosimilars accounted for nearly one-quarter of total spending across the 4 medicines, ranging from 20% for trastuzumab to 28% for rituximab.

Differences were also observed in early uptake patterns. In the first year after biosimilar entry, market share remained low for etanercept (2.0%) and infliximab (2.3%), which were among the earliest biosimilars introduced in Australia. In contrast, rituximab and trastuzumab—with more recent biosimilar launches—reached first-year market shares of 32.5% and 14.8%, respectively. Over time, these disparities narrowed. In the most recent year of data, biosimilars represented approximately 26% to 39% of total unit volume across products.

Price erosion appeared to be a key driver of savings. Average SU prices for reference products declined by 30% to 40% following biosimilar entry. For rituximab and trastuzumab, biosimilar SU prices were roughly 40% lower than those of the reference products. The authors attributed these reductions to Australia’s statutory price cuts and price disclosure policies, which require manufacturers to report sales data and trigger subsidy adjustments when competition emerges.

The analysis relied on aggregate sales data rather than patient-level information, meaning it could not estimate how many people received each medicine or assess clinical outcomes. Standardized units also did not always correspond to administered doses, particularly for oncology products such as rituximab and trastuzumab, where vial sharing and chemotherapy preparation practices may underestimate actual patient exposure. Additionally, the PBS is a dynamic system, with evolving indications, formulary changes, and clinical guidelines that may have influenced utilization trends independently of biosimilar entry.

Despite these limitations, the findings suggested that Australia’s policy framework supported meaningful price competition without mandating widespread switching. As the authors noted, “biosimilar introduction reduced overall market expenditure and [the] unit price of reference products,” creating “potential for greater medicines access for patients by reducing expenditure and releasing capital to fund more medicines.”

For managed care stakeholders, the results offered a real-world example of how coordinated pricing policies and biosimilar availability can moderate biologic spending while sustaining utilization. As biologic pipelines continue to expand, the Australian experience may provide insight into how payers can balance affordability and access without relying solely on aggressive switching mandates.

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. V

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

2. Australia biosimilar market size, share, trends and forecast by molecule, manufacturing type, indication, and region, 2025-2033. iMarc Group. Accessed January 15, 2026. 

https://www.imarcgroup.com/australia-biosimilar-market

3. Australia biosimilar approvals in early 2025. GaBi. June 5, 2025. Accessed January 15, 2026. 

https://gabionline.net/biosimilars/news/australia-biosimilar-approvals-in-early-2025

4. December 2023 changes to the PBS listings of medicines for the treatment of ankylosing spondylitis. PBS. December 1, 2023. Accessed January 15, 2026. 

https://www.pbs.gov.au/pbs/news/2023/12/1-december-2023-changes-to-the-pbs-listings-of-medicines

Australia's biosimilar adoption significantly reduces biologic medicine costs, enhancing access while maintaining utilization amid tighter health care budgets.

What Australia’s Experience Reveals About Biosimilar Adoption and Pricing

The biosimilar landscape experienced significant expansion in late 2025 and early 2026, marked by crucial regulatory progress in Europe and strategic moves in North America. These developments enhance access to innovative treatments for people living with chronic conditions in immunology, oncology, and bone health.

European Regulatory Gains in Autoimmune Disease

The European market saw 2 major biosimilar candidates receive positive recommendations from the CHMP, setting the stage for increased access for people living with chronic inflammatory conditions.

 Celltrion received a positive opinion for the autoinjector presentation of SteQeyma (ustekinumab), a biosimilar referencing Stelara. Developed for people with plaque psoriasis, psoriatic arthritis, and Crohn disease, the autoinjector was designed to improve convenience and the individual patient experience through a simple two-step administration process.

Additionally, STADA Arzneimittel and Bio-Thera Solutions received a positive CHMP opinion for their biosimilar candidate, Gotenfia (golimumab), which references Simponi. The recommendation covered marketing authorization for several conditions, including 

rheumatoid arthritis and ulcerative colitis

 in adults, as well as juvenile idiopathic arthritis in people aged 2 years and older. While Bio-Thera retained manufacturing responsibilities, STADA secured exclusive commercialization rights across the European Union and the UK.

Broadening Access in Bone Health and Ophthalmology

Launches in Europe also targeted areas where high treatment costs have historically burdened health care systems. Accord Healthcare launched 2 denosumab biosimilars: Osvyrti, referencing Prolia, and Jubereq, referencing Xgeva.

 These medicines provided alternatives for people with osteoporosis or bone loss linked to cancer treatments. Samsung Bioepis also entered this space, launching its own denosumab biosimilars, Obodence and Xbryk, in December 2025 and January 2026, respectively.

In ophthalmology, Sandoz announced the European launch of Afqlir (aflibercept), a biosimilar to Eylea, for people living with retinal diseases. Furthermore, Samsung Bioepis began direct commercialization of Byooviz (ranibizumab), a biosimilar to Lucentis, in Europe. The company successfully transferred commercial rights back from Biogen and planned to introduce a pre-filled syringe (PFS) presentation in the second quarter of 2026.

US Market Focuses on Affordability and Pediatrics

In the US, CivicaScript, a nonprofit company, announced the availability of 2 significant low-cost products: insulin glargine-yfgn and ustekinumab-aauz.

 Their insulin glargine-yfgn is interchangeable with Lantus and was offered at a transparent, stable price of no more than $55 per box of 5 pre-filled pens for consumers. Similarly, their ustekinumab-aauz, interchangeable with Stelara, was launched with a transparent Wholesale Acquisition Cost (WAC) to help lower costs for health plans and people with chronic inflammatory conditions.

Focusing on specialized needs, Fresenius Kabi introduced a new presentation of Otulfi (ustekinumab-aauz) in a 45 mg/0.5 mL single-dose vial. This addition was specifically intended to provide dosing flexibility for pediatric patients weighing less than 60 kilograms who have plaque psoriasis or psoriatic arthritis. Otulfi previously received an interchangeability designation from the Food and Drug Administration (FDA) in May 2025.

https://www.businesswire.com/news/home/20260106192986/en/Fresenius-Kabi-Introduces-New-Presentation-of-Otulfi-ustekinumab-aauz-a-Biosimilar-to-Stelara

https://www.businesswire.com/news/home/20260102921713/en/Samsung-Bioepis-Begins-Commercialization-of-BYOOVIZ-Biosimilar-to-Lucentis-Ranibizumab-in-Europe

CivicaScript announces availability of low-cost insulin and biosimilar for chronic inflammatory conditions in the US. January 5, 2026. Accessed January 12, 2025. News release. CivicaScript. 

https://www.prnewswire.com/news-releases/civicascript-announces-availability-of-low-cost-insulin-and-biosimilar-for-chronic-inflammatory-conditions-in-the-us-302652087.html

Eye on Pharma: Global Approvals, Launches, and Strategic Partnerships

A growing share of people receiving long-term anti–vascular endothelial growth factor (VEGF) therapy for neovascular age-related macular degeneration (nAMD) face an ongoing challenge: maintaining durable disease control while managing the cumulative cost and burden of chronic intravitreal injections.

 As biosimilars enter ophthalmic practice, clinicians and payers are increasingly focused on whether switching stable patients can preserve outcomes without disrupting disease control.

Switching from aflibercept to ranibizumab biosimilars maintains stability in nAMD treatment, offering a cost-effective solution for long-term management. | Image credit: 61766578 - stock.adobe.com

Researchers in Japan addressed this question in a prospective observational analysis evaluating outcomes after switching from intravitreal aflibercept to a ranibizumab biosimilar in people with well-controlled nAMD.

 The investigators examined both clinical end points and aqueous humor cytokine levels to assess whether the transition maintained stability at the functional, anatomic, and molecular levels.

The study included 38 eyes from 38 adults with nAMD treated at an academic center between July 2022 and May 2024. All participants had been receiving aflibercept under a treat-and-extend regimen and were considered stable, defined as maintaining injection intervals of 16 weeks or longer for more than 1 year. The mean age was 76.5 years, and 71.1% of eyes belonged to male patients. Polypoidal choroidal vasculopathy was the most common nAMD subtype (57.9%), followed by type 1 macular neovascularization (23.7%), type 2 (15.8%), and type 3 (2.6%). On average, patients had received anti-VEGF therapy for just over 60 months before the switch.

At the time of transition, injection intervals were shortened to 12 weeks to reduce the risk of disease reactivation, then gradually extended based on optical coherence tomography findings. Best-corrected visual acuity (BCVA) and central retinal thickness (CRT) were measured before switching, shortly afterward, and again at 12 months. In addition, aqueous humor samples were collected before and after switching to evaluate changes in VEGF-A, placental growth factor (PlGF), and angiopoietin-2 (Ang-2). Eight eyes from individuals undergoing cataract surgery served as controls for cytokine comparisons.

Short-term outcomes showed minimal change after the switch. Mean BCVA remained stable, with no statistically significant difference from baseline, and CRT values were nearly identical before and after the transition. The proportion of eyes with a dry macula decreased slightly, from 94.7% before switching to 89.5% afterward, but most eyes maintained anatomic disease control.

At 1 year, 35 eyes were available for evaluation. Two eyes (5.7%) required a switch back to aflibercept because persistent exudative changes could not be controlled at extended dosing intervals. Among the remaining eyes, disease activity remained controlled in more than 94% of cases. Mean BCVA and CRT did not differ significantly from baseline, and no eye experienced a vision loss greater than 0.3 logMAR. Injection intervals were extended back to a mean of 16 weeks by the end of follow-up, suggesting that treatment burden was not increased after the switch.

Cytokine analyses provided insight into the biologic effects of transitioning therapies. Ang-2 levels did not change significantly after switching and were not statistically different from control eyes. PlGF concentrations also remained stable, though they were consistently higher in eyes with nAMD than in controls both before and after the switch. VEGF-A levels increased significantly following the transition from aflibercept to the ranibizumab biosimilar, reflecting known pharmacologic differences between agents. Despite this increase, VEGF-A concentrations remained lower than those observed in control eyes and were not associated with worsening clinical outcomes.

Summarizing the overall findings, the authors concluded that “switching from aflibercept to ranibizumab BS effectively maintained disease stability and cytokine balance in eyes with nAMD,” supporting the biosimilar as “a viable and cost-effective alternative for long-term treatment.” The investigators also noted that strong VEGF suppression may be most critical during induction therapy, whereas less intensive suppression could be sufficient during the maintenance phase in stable disease.

The study had several limitations. The sample size was relatively small, and all participants were treated at a single center, which may limit generalizability. The control group for cytokine analysis included only 8 eyes, reducing statistical power for biomarker comparisons. Additionally, the cohort consisted exclusively of people with long-standing, stable nAMD receiving extended-interval aflibercept, so the findings may not apply to individuals with more active disease or shorter treatment intervals.

Even with these constraints, the results add to a growing body of real-world evidence suggesting that ophthalmic biosimilars can be integrated into maintenance therapy without compromising outcomes in carefully selected patients.

1. Jeremias S. Swiss analysis shows biosimilars cut costs but longer-interval options lead savings. The Center for Biosimilars

. December 4, 2025. Accessed January 7, 2026. 

https://www.centerforbiosimilars.com/view/swiss-analysis-shows-biosimilars-cut-costs-but-longer-interval-options-lead-savings

2. Jeremias S. Seeing eye to eye: FDA's Dr Sarah Yim discusses efforts to increase confidence in ophthalmology biosimilars. The Center for Biosimilars. January 29, 2023. Accessed January 7, 2025. 

https://www.centerforbiosimilars.com/view/seeing-eye-to-eye-fda-s-dr-sarah-yim-discusses-efforts-to-increase-confidence-in-ophthalmology-biosimilars

3. Ota H, Takeuchi J, Nonogaki R, Tamura K, Kaneko H, Nishiguchi KM. Efficacy of switching from existing anti-vascular endothelial growth factor drugs to ranibizumab biosimilar in neovascular age-related macular degeneration. 

. 2025;69(6):886-893. doi:10.1007/s10384-025-01224-0

Switching from aflibercept to ranibizumab biosimilars maintains stability in nAMD treatment, offering a cost-effective solution for long-term management.

Real-World Study Finds Stable Vision After Switch to Ranibizumab Biosimilar

Access to tumor necrosis factor inhibitors has expanded rapidly across Europe over the past decade, yet lingering questions about whether people can safely and effectively switch from reference biologics to biosimilars have continued to shape prescribing behavior.

 These questions have been especially prominent for etanercept, one of the earliest and most widely used biologic disease-modifying antirheumatic drugs, as health systems have sought savings without compromising outcomes for people living with chronic inflammatory diseases.

Explore the safety and efficacy of switching to etanercept biosimilars, backed by clinical trials and real-world evidence for chronic inflammatory diseases. | Image credit: peterschreiber.media - stock.adobe.com

To address these concerns, investigators conducted a narrative literature review evaluating clinical trial and real-world evidence on switching between reference etanercept and its approved biosimilars.

 The review was a response to persistent variability in biosimilar uptake across countries, which has been driven in part by clinician and patient uncertainty around switching, concerns about immunogenicity, and fears of loss of efficacy or increased adverse events. The authors aimed to synthesize available data to support informed decision-making for clinicians, payers, and people receiving treatment.

The review included evidence from 18 original studies identified through a PubMed search conducted in November 2024. Four were randomized, double-blind phase 3 clinical trials, and 14 were real-world observational studies. The studies evaluated switching from reference etanercept to biosimilars such as SB4, SDZ-ETN, LBEC0101, and YLB113 across multiple indications, including rheumatoid arthritis (RA), psoriatic arthritis, axial spondyloarthritis (AxSpA), plaque psoriasis, and juvenile idiopathic arthritis.

Across the controlled clinical trials, 1091 patients were included in switching populations. Of these, 769 had RA and 531 had plaque psoriasis, reflecting the primary indications studied in phase 3 programs. Trial designs varied, but all compared outcomes among people who continued reference etanercept or a biosimilar with those who switched treatments, typically at week 24 or week 52. One study, EGALITY, specifically evaluated multiple switches between reference etanercept and SDZ-ETN in people with moderate to severe plaque psoriasis.

Efficacy outcomes were consistent across trials. In RA populations, changes in disease activity scores such as DAS28-CRP and DAS28-ESR from baseline through follow-up were similar between continuous-treatment and switched groups. Proportions of patients achieving American College of Rheumatology 20%, 50%, or 70% response criteria and European Alliance of Associations for Rheumatology good or moderate responses were also comparable. In plaque psoriasis, mean changes in Psoriasis Area and Severity Index scores and response rates through 52 weeks did not differ meaningfully between those who underwent multiple switches and those who remained on a single product.

Safety findings from clinical trials showed no increase in treatment-emergent adverse events or serious adverse events following a switch. The proportion of patients experiencing at least 1 adverse event was similar between switched and nonswitched groups across indications. Immunogenicity rates were low overall, and antidrug antibodies were infrequently detected, with no consistent differences attributable to switching.

Real-world evidence reinforced these findings. Observational studies drawn from national registries and multicenter cohorts included thousands of patients across Europe and Canada. The studies captured broader and more heterogeneous populations compared with clinical trials, including people with long disease duration, multiple comorbidities, and prior biologic exposure. In these settings, disease activity measures generally remained stable following nonmedical switching from reference etanercept to a biosimilar. Rates of treatment discontinuation and serious adverse events were comparable to those observed before switching, although some cohorts reported higher discontinuation driven by subjective complaints rather than objective loss of efficacy.

Patient demographics varied widely across real-world studies but were representative of routine clinical practice. Most cohorts included adults with established inflammatory rheumatic disease, with mean ages typically in the fifth or sixth decade of life. Women were overrepresented in RA populations, while AxSpA cohorts included a higher proportion of men. Prior duration of etanercept use ranged from several months to multiple years before switching.

The authors noted several limitations. The review was narrative rather than a formal meta-analysis, and the included studies differed in design, outcomes measured, and length of follow-up. Evidence on multiple switches between different biosimilars was limited, and patient-reported outcomes were not consistently assessed. Most real-world data came from European health systems with established biosimilar policies, which may limit how well the findings apply to other regions.

The review found no evidence that switching between reference etanercept and its biosimilars adversely affected efficacy, safety, or immunogenicity across approved indications. The authors concluded that the accumulated clinical and real-world evidence supported broader adoption of etanercept biosimilars, while underscoring that “these gaps in the literature warrant further research efforts to better understand the long-term effects of biosimilar switching and to develop strategies to optimize patient outcomes.”

1. Mestre-Ferrandiz J, Czech M, Smolen JS, et al. Capturing the holistic value of biosimilars in Europe – part 1: a historical perspective. 

. 2024;24(2):237-250. doi:10.1080/14737167.2023.2297926

2. Biosimilar approvals. The Center for Biosimilars

. Updated November 12, 2025. Accessed January 5, 2026. 

3. Schmalzing M, Askari A, Girolomoni G, Perez-Coleman JCV. Salvati C, Bachinskaya E. Clinical and real-world evidence on etanercept biosimilar switching: a narrative literature review of efficacy and safety. 

. Published online November 18, 2025. doi:10.1007/s12325-025-03367-5

Explore the safety and efficacy of switching to etanercept biosimilars, backed by clinical trials and real-world evidence for chronic inflammatory diseases.

Evidence Supports Safe, Effective Switching to Etanercept Biosimilars

The US biosimilar market officially capped off a high-stakes year for regulatory activity with a final expansion in the denosumab space. The FDA approved 2 new biosimilars from Amneal Pharmaceuticals, Boncresa (denosumab-mobz) and Oziltus (denosumab-mobz), which serve as lower-cost alternatives to the reference biologics Prolia and Xgeva, respectively.

 This move concluded a busy 12 months for the industry, marking the eighth pair of denosumab biosimilars—the ninth pair overall—to receive approvals in 2025.

The flurry of 2025 approvals aligned with the FDA’s ongoing effort to modernize the biosimilar pathway by prioritizing advanced analytical data over repetitive clinical trials. | Image Credit: gguy - stock.adobe.com

A Strategic Partnership for Market Growth

Amneal’s latest approvals were the result of a collaboration with mAbxience, a group majority-owned by Fresenius Kabi.

 Although mAbxience handled the development and manufacturing of the products, Amneal held the exclusive rights for commercialization in the US. This launch brought Amneal’s commercial biosimilar portfolio to 5 products, moving the company closer to its goal of having 6 biosimilars across 8 presentations by 2027.

The entry of Boncresa and Oziltus was particularly significant for managed care stakeholders given the market size of the reference products. As of October 2025, annual US sales for Prolia and Xgeva reached approximately $5.3 billion, highlighting the massive potential for savings as competition intensified.

Closing Out a "Banger Year" for Denosumab

The denosumab landscape saw a rapid influx of products throughout the fall, making the year-end Amneal announcement the final piece of a much larger puzzle. In September, the FDA cleared Hikma Pharmaceuticals’ and Gedeon Richter’s Enoby and Xtrenbo, followed closely by Accord Healthcare’s October approvals for Osvyrti and Jubereq.

The market further evolved in late October when the FDA granted interchangeability (IC) designations to 2 pairs of denosumab products. Fresenius Kabi’s Conexxence and Bomyntra were the first to receive this status, followed by Celltrion’s Stobocclo and Osenvelt. These designations were supported by clinical data from postmenopausal women with osteoporosis, proving that switching between the biosimilar and the reference product did not result in clinically meaningful differences in safety or efficacy.

While 2025 was a win for access, it was also a year of policy-related questions. Federal officials, including HHS Secretary Robert F. Kennedy Jr. and FDA Commissioner Marty Makary, MD, sparked an industrywide discussion by suggesting that all biosimilars should be considered interchangeable with their reference products to simplify the substitution process.

 Despite these statements, the FDA continued to issue formal IC designations based on statutory requirements, leaving some uncertainty regarding how state laws on automatic pharmacy substitution would eventually align with federal guidance.

For health care providers, the new biosimilars brought the same clinical responsibilities as the original biologics. The FDA required that both Boncresa and Oziltus be administered by a professional, with a focus on monitoring serum calcium levels. Patients with advanced chronic kidney disease remained under a boxed warning for severe, life-threatening hypocalcemia, and clinicians were reminded to rule out pregnancy before starting treatment.

The reported adverse events continued to reflect the diverse needs of the treated populations. Men receiving treatment frequently experienced joint pain and back pain, while postmenopausal women were more likely to report musculoskeletal pain and cystitis. In the oncology space, patients with bone metastases often reported nausea and fatigue, while individuals with multiple myeloma frequently dealt with anemia and gastrointestinal issues.

The flurry of 2025 approvals aligned with the FDA’s ongoing effort to modernize the biosimilar pathway by prioritizing advanced analytical data over repetitive clinical trials. This evolution was intended to lower development costs—which historically reached between $100 million and $300 million—and speed up the arrival of new competitors.

However, experts warned that the industry still faces a "biosimilar gap." Only about 10% of biologics expected to lose exclusivity in the next decade have biosimilars currently in development. As Amneal’s new products entered the market, the focus shifted toward whether payer incentives and pharmacy benefit manager transparency would allow these new entries to reach their full potential for cost savings. For now, the successful conclusion of the denosumab approval cycle served as a milestone in the long-term push for affordable medicine in the US.


1. Amneal announces FDA approval of denosumab biosimilars referencing Prolia and Xgeva. News release. Amneal Pharmaceuticals. December 22, 2025. Accessed January 5, 2026. 

https://investors.amneal.com/news/press-releases/press-release-details/2025/Amneal-Announces-FDA-Approval-of-Denosumab-Biosimilars-Referencing-Prolia-and-XGEVA

3. FDA quietly approves denosumab biosimilars, issues interchangeability for others. The Center for Biosimilars. November 13, 2025. Accessed January 4, 2026. 

https://www.centerforbiosimilars.com/view/fda-quietly-approves-denosumab-biosimilars-issues-interchangeability-for-others

FDA approves new denosumab biosimilars, enhancing treatment options for osteoporosis and bone metastases while driving competition and cost savings.

FDA Approves Amneal Denosumab Biosimilars, Capping Year of Market Expansion

Lack of data in certain populations rather than cost impact was identified as the key factor shaping whether children received biosimilars, according to a 

 that examined why pediatric uptake has lagged behind adult use despite expanding biosimilar availability.

 The review mapped clinical, regulatory, operational, and ethical considerations influencing institutional decision-making around biosimilar adoption in pediatric care settings.

Explore the critical gaps in biosimilar adoption for pediatric patients, focusing on safety, regulatory challenges, and the need for more robust data. | Image credit: zinkevych - stock.adobe.com

, was created to address a persistent gap. Although biologic medicines have transformed outcomes for children with complex and chronic diseases, biosimilars have been adopted far more slowly in pediatric populations than in adults. Prior utilization data showed that children younger than 18 years were significantly less likely to initiate a biosimilar than older adults, even as overall US biosimilar use rose to more than one-quarter of biologic initiations by 2022.

 The authors aimed to synthesize published and grey literature to identify recurring themes relevant to pediatric institutions and to inform an evidence- and values-based framework for biosimilar adoption.

Using a PRISMA-ScR–aligned scoping review methodology, investigators searched OVID Medline, Embase, and International Pharmaceutical Abstracts from inception through September 20, 2024, and supplemented results with regulatory, health technology assessment, and professional society documents. Thirty-five articles met inclusion criteria, including prospective and retrospective cohort studies, surveys, qualitative studies, reviews, and commentaries. Twenty-six articles were pediatric-specific, while the remainder addressed broader biosimilar principles applicable to children.

Findings were organized into 14 themes across 2 overarching categories: substantive principles, which addressed what evidence and values matter, and procedural principles, which focused on how institutions operationalize biosimilar use. Substantive principles included clinical trial evidence, real-world experience, regulatory approval, cost and affordability, supply availability, suitability of dosage forms, societal values, and health risks. Procedural principles encompassed stakeholder governance, interchangeability and switching practices, inventory management, electronic prescribing infrastructure, education, and follow-up and monitoring.

Limited pediatric-specific clinical trial data emerged as a central barrier. While randomized controlled trials in adults consistently demonstrated comparable pharmacokinetics, efficacy, safety, and immunogenicity between biosimilars and reference products, most biosimilars entered the pediatric market without dedicated pediatric trials. Regulatory approvals frequently relied on extrapolation from adult data, an approach that raised concerns because developmental differences can affect drug disposition and response in children. The review highlighted particular uncertainty for pediatric conditions without adult equivalents and for children with severe or early-onset disease.

There are critical gaps in biosimilar adoption for pediatric patients, focusing on safety, regulatory challenges, and the need for more robust data.