Maggie L. Shaw

Generic and biosimilar medicines saved the US health care system $496 billion in 2025, according to the Association for Accessible Medicines’ (

) 2026 US Generic & Biosimilar Medicines Savings Report, developed in partnership with the IQVIA Institute. The total is nearly $30 billion higher than the 2024 figure, and it brings the 10-year savings total to $3.6 trillion, AAM said.

AAM represents manufacturers of finished generic pharmaceuticals and biosimilars.

 The organization said the savings extend across the health care system, including patients, employers, and taxpayers,

 and that generic and biosimilar medicines contribute to a stable health care system, economic resilience, and national security.

The report, released by AAM and its Biosimilar Council, is the latest edition of AAM's annual savings analysis,

 and it marks a collaboration between AAM and the IQVIA Institute that has spanned more than 15 years.

 The prior edition, released in 2025, reported $467 billion in savings for 2024 and $3.4 trillion over the preceding 10 years.

 That report tied the outlook for patients to addressing barriers to the development and adoption of lower-cost medicines, and also flagged a "biosimilar void."

 Only 12 of the 118 biologics expected to lose exclusivity over the next decade had biosimilars in development.

The Association for Accessible Medicines reported $25.4 billion in biosimilar savings for the year. | Image credit: @Luluraschi.jpeg

According to AAM, generics made up 89% of all US prescriptions filled in 2025, or about 4 billion prescriptions. However, those prescriptions accounted for only 11.6% of total prescription drug spending, or $106 billion. Branded drugs made up 11% of prescriptions filled, or 485 million. They accounted for 88.4% of spending, or $804 billion.

The report also found that generics represented 1.1% of total US health care spending, according to IQVIA National Prescription Audit data from December 2025. AAM's fact sheet framed the findings as brand name drugs driving costs and generics driving savings. Based on those figures, spending on branded prescriptions was about 7.6 times the spend on generic prescriptions.

Generic savings in Medicare totaled $166 billion in 2025, or $3011 per beneficiary, AAM reported.

 In Medicaid, generic savings totaled $70.2 billion, or $921 per enrollee. Together, the 2 programs accounted for $236.2 billion in generic savings, based on the reported figures. AAM said the savings are particularly valuable to Medicare, employer-sponsored health insurance, and the patients they serve. The organization also noted that many patients still pay too much for their generic prescriptions despite these savings.

Biosimilar savings totaled $25.4 billion in 2025, up from $20.2 billion in 2024 according to the prior edition of the report, for an approximate 26% increase. Since the first biosimilar entered the US market in 2015, biosimilars have generated $81.6 billion in savings. The prior edition reported $56.2 billion through 2024.

Patients have received 3.8 billion days of therapy with biosimilars since 2015. That includes 571 million incremental days that would not have occurred without biosimilar competition.

 AAM characterized those additional days as expanded patient access to care. It also said biosimilar use over the period has occurred with no unique clinical challenges.

Alex Keeton, executive director of the Biosimilars Council and senior vice president of policy at AAM, said biosimilars are among the strongest options for widening access, building resilience in health care, and generating meaningful savings. He said the sector continues to face barriers related to market access, pricing dynamics, pharmacy benefit managers (PBMs), and patent challenges. He added that these barriers persist despite recent regulatory progress.

John Murphy III, president and CEO of AAM, described generic and biosimilar medicines as "an indispensable, unique economic engine capable of driving affordable health care into the future." He said the market that sustains the industry is at risk, and he called for a generics- and biosimilars-first policy framework that eliminates structural obstacles to competition.

Murphy also said the industry faces sustainability pressures. Those pressures could contribute to supply chain disruptions, drug shortages, and manufacturers leaving the US market. AAM is calling for policy changes, including streamlined FDA processes. It also wants measures addressing patent practices, PBM incentives, and federal drug pricing policies.

In July, a House committee reported the Expedited Access to Biosimilars Act, and a Senate committee approved its companion bill, which would codify that comparative clinical efficacy and pharmacodynamic studies are not the default expectation for biosimilar licensure. 

 reported that patent, rebate, and reimbursement roadblocks still stall competition.

AAM has also published a fact sheet, social toolkit, and data deck with the report.

2026 U.S. generic & biosimilar medicines savings report. Association for Accessible Medicines. Accessed September 21, 2026. 

https://accessiblemeds.org/resources/reports/2026-savings-report/

Generic and biosimilar patent settlements save $423 billion. News release. Association for Accessible Medicines. June 3, 2025. Accessed September 21, 2026. 

https://accessiblemeds.org/resources/press-releases/generic-and-biosimilar-patent-settlements-save-423-billion/

Lvy S. AAM: U.S. generic & biosimilar medicines saved $496B in 2025. 

. September 14, 2026. Accessed September 21, 2026. 

https://drugstorenews.com/aam-us-generic-biosimilar-medicines-saved-496b-2025

De Shong T. AAM: generics and biosimilars saved U.S. health system $496 billion in 2025. 

. September 11, 2026. Accessed September 21, 2026. 

https://chaindrugreview.com/aam-generics-and-biosimilars-saved-u-s-health-system-496-billion-in-2025/

2025 U.S. generic & biosimilar medicines savings report. Association for Accessible Medicines. September 3, 2025. Accessed September 21, 2026. 

https://accessiblemeds.org/resources/blog/2025-savings-report/

Jeremias S. Biosimilars drive savings and access, yet looming development gap threatens future. The Center for Biosimilars

. September 23, 2025. Accessed September 21, 2026. 

https://www.centerforbiosimilars.com/view/biosimilars-drive-savings-and-access-yet-looming-development-gap-threatens-future

2026 key facts: generics drive savings and add value. AAM/Biosimilars Council. Accessed September 21, 2026. 

https://accessiblemeds.org/wp-content/uploads/2026/09/2026-Generic-Biosimilar-Medicines-Savings_Key-Advocacy-Takeways_Fact-Sheet.pdf

Jeremias S. Biosimilar bills gain steam in Congress, but key reforms still wait. The Center for Biosimilars

. July 23, 2026. Accessed September 21, 2026. 

https://www.centerforbiosimilars.com/view/biosimilar-bills-gain-steam-in-congress-but-key-reforms-still-wait

Articles

The Association for Accessible Medicines report, prepared with the IQVIA Institute, also reports $25.4 billion in biosimilar savings for the year.

Generic, Biosimilar Medicines Saved US Health Care $496B in 2025

 (IBD) stayed on therapy a year after being switched, without a clinical reason, from the infliximab originator (Remicade; Janssen) to the biosimilar CT-P13, with remission rates and drug levels holding steady through 56 weeks.

A Japanese study found high remission and continuation rates, plus noninferior trough levels, after patients with IBD were switched to the infliximab biosimilar CT-P13. | Image credit: mi_viri - stock.adobe.com

Infliximab, an anti–tumor necrosis factor-alpha antibody, transformed treatment for Crohn disease and ulcerative colitis, but its cost remains a barrier to access worldwide. Japan's Ministry of Health, Labour and Welfare recommends biosimilars to ease that burden, and the biosimilar CT-P13 (Infliximab BS in Japan; Nippon Kayaku, under license from developer Celltrion) has been available there for IBD since 2014. Yet only a handful of postmarketing and retrospective studies have examined nonmedical switching (NMS)—moving stable patients to a biosimilar for nonclinical reasons—in Japanese patients with IBD, leaving physicians and patients hesitant.

The stakes extend beyond Japan: expanding biosimilar use in the US has already reshaped the infliximab market, saving commercial insurers an estimated $259.5 million to $842.2 million from 2018 to 2021 as originator prices fell more than half amid competition, according to a claims analysis of more than 42,000 patients.

 Researchers at Fukuoka University sought prospective, real-world evidence on whether switching can succeed elsewhere without compromising disease control.

 enrolled 167 patients with IBD—136 with Crohn disease, 31 with ulcerative colitis—who underwent NMS from the originator to CT-P13 at Fukuoka University Chikushi Hospital starting in April 2021.

 Patients had a median age of 43 years and median disease duration of 16.1 years, and most had been on originator therapy for nearly a decade (median, 9.8 years).

The primary end point was clinical remission at 56 weeks, defined as a Crohn's Disease Activity Index below 150 or a partial Mayo score of 2 or lower—thresholds below which disease activity is considered quiescent.

The treatment continuation rate at 56 weeks was 95.6% overall: 94.7% among patients with Crohn disease and 100% among those with ulcerative colitis. Of the 132 patients in remission at baseline, 84.1% remained in remission at week 56 in an intention-to-treat analysis, with remission-maintenance rates of 85.7% for Crohn disease and 77.8% for ulcerative colitis.

Adverse events occurred in 22.8% of patients (38 of 167), most commonly infections (14.4%), and only 2 were classified as serious: an infusion reaction after the fourth dose that led the team to withhold a fifth dose and a case of sepsis considered related to CT-P13.

“This adverse event was considered to be related to CT-P13; however, administration was subsequently continued, and it has since been possible to safely maintain the treatment,” the researchers wrote.

Trough Concentrations Remained Noninferior

Among 119 patients in the per-protocol pharmacokinetic analysis, median infliximab trough concentrations were 3.9 µg/mL at baseline, then 4.3, 3.8, and 4.1 µg/mL at weeks 8, 24, and 56, respectively. As a ratio to baseline, trough levels measured 115.6%, 101.2%, and 123.5% at those time points—noninferior to baseline at every measurement above the study's 85% inferiority threshold.

 < .001), and leucine-rich alpha-2 glycoprotein—a biomarker used as a proxy for disease activity since the study omitted endoscopy—dipped at 24 weeks before returning near baseline by week 56, without a matching change in remission rates.

Patients Knew Little About Biosimilars, but Few Objected

A companion questionnaire given to all 167 patients found awareness of biosimilars was strikingly low: 85.0% said they “did not know” about biosimilars at baseline, 9.0% had “heard” of them, and 6.0% said they “knew” about them. No patient proactively requested the switch, but 57.5% said they were “not bothered” by it, and 54.5% agreed with the recommendation vs 3.6% who disagreed.

Anxiety about the switch, scored on an 11-point scale, fell significantly by week 24 and stayed lower through week 56 vs baseline (

 < .001 for both), even as median satisfaction scores dipped slightly, from 10 at baseline to 9 at weeks 24 and 56 (

 < .001). The researchers suggested direct experience with the biosimilar, more than preswitch counseling, is what ultimately reassures patients.

Small, Single-Center Design Limits Generalizability

The authors acknowledged limitations: a single-center design with a relatively small ulcerative colitis subgroup (31 patients), no endoscopy or fecal calprotectin testing, and no measurement of antidrug antibodies, which limited formal assessment of 

. They noted the low rate of loss of response makes it unlikely antidrug antibodies played a major role.

For payers and health systems weighing formulary strategy around infliximab, the findings add to a growing international evidence base—alongside cost data from more competitive markets such as the US—suggesting stable patients can move to a lower-cost biosimilar without sacrificing disease control, even where switching itself doesn't directly lower a patient's costs.

Nomaru R, Takeda T, Takahashi A, et al. Effectiveness, safety, and pharmacokinetics of the infliximab biosimilar CT-P13 after non-medical switch from the infliximab originator in patients with inflammatory bowel disease. 

. 2026;24(3):552-562. doi:10.5217/ir.2025.00118

Paglinco SR, Abdel-Rasoul M, McNicol M, at al. The biosimilar shift: trending infliximab biosimilar utilization and associated cost savings for commercial insurance. 

. 2025;31(10):295. doi:10.37765/ajmc.2025.89811

A Japanese study found high remission and continuation rates, plus non-inferior trough levels, after patients with IBD were switched to the infliximab biosimilar CT-P13.

Infliximab Biosimilar Maintains Remission, Trough Levels After Switch in IBD

Children and young adults with inflammatory bowel disease (IBD) generally maintained stable disease control after an insurance-mandated, nonmedical switch from the adalimumab originator to a biosimilar, according to findings published in 

Most pediatric and young adult patients with IBD maintained stable disease activity and laboratory markers after switching from the adalimumab originator. | Image credit: feng - stock.adobe.com

“Adalimumab biosimilars are as safe and effective compared to the originator. Adult patients with inflammatory bowel disease (IBD) who switched to a biosimilar have comparable outcomes, but pediatric data are limited,” wrote the researchers of the study.

Adalimumab (Humira; AbbVie), an anti–tumor necrosis factor (anti-TNF) biologic, is an established treatment option for pediatric Crohns disease and ulcerative colitis. Infliximab biosimilars have been available in the US since 2016, with established safety and efficacy data in pediatric IBD, and adalimumab biosimilars entered the US market in 2023. Much of the existing evidence has focused on biosimilar-naive patients rather than patients switched from the originator. Ten adalimumab biosimilars had been introduced in the US by June 2024, and payers have increasingly used formulary preferences and step-therapy policies involving adalimumab products.

Researchers at Nationwide Children's Hospital conducted a retrospective chart review of 50 pediatric and young adult patients with IBD who underwent a nonmedical switch from an adalimumab originator to a biosimilar between May 2023 and July 2024.

 The cohort was predominantly male (58%), White (90%), diagnosed with Crohn disease (88%), and covered by commercial insurance (100%). Most patients (92%) were switched to adalimumab-adaz based on payer formularies.

Among the 42 patients with Physician Global Assessment (PGA) data available both before and after the switch, 86% (36 of 42) had stable or improved disease activity. This included 74% who remained in remission and 12% who improved to remission. Six patients (14%) experienced worsening disease activity, although no patients developed severe disease activity. The change in PGA scores before and after the switch was not statistically significant (

Laboratory markers, including albumin, hemoglobin, C-reactive protein, and erythrocyte sedimentation rate, showed no significant differences before and after the switch.

Adalimumab trough levels declined significantly, from a mean of 18.1 µg/mL to 15.0 µg/mL (

= .007). Although levels remained above the 10 µg/mL threshold used by the study authors to define a therapeutic concentration, the decrease may be clinically relevant for some patients, particularly those with perianal disease, for whom higher adalimumab concentrations may be associated with fistula healing.

Detectable antidrug antibodies increased from 4.8% to 14.3% of patients, but the difference did not reach statistical significance (

= .16). Given the small sample size, however, the lack of statistical significance does not necessarily exclude a clinically meaningful change.

Thirty-eight of 50 patients (76%) remained on the biosimilar at least 6 months after the switch. Twelve patients discontinued treatment during follow-up. Five discontinued for reasons considered unrelated to the switch, including insurance changes or persistent baseline disease activity, and the remaining 7 discontinued for reasons considered related to the switch, including adverse effects, disease worsening, or declining drug levels.

The authors also reported that recurrence of symptoms without corresponding biochemical changes could, in some cases, reflect a nocebo effect. This interpretation remains speculative and should not be considered evidence that reported symptoms were not genuine treatment-related events.

The 76% observed 6-month continuation rate was lower than the 93% 6-month durability probability reported in a 2025 European pediatric IBD cohort. However, the populations and study methods differed: the European study include patients initiating a biosimilar and patients switching from the originator, limiting direct comparison between the studies.

The Nationwide Children's study has several limitations. Its retrospective, single-center design; small sample size; predominantly White, commercially insured population; Crohn disease–predominant cohort; and short follow-up limit generalizability. In addition, the absence of a nonswitching control group means the study cannot establish that biosimilar switching is equivalent to continuing the originator product.

“In summary, clinical, laboratory, and pharmacokinetic outcomes were largely maintained over 6 months following a nonmedical switch to adalimumab biosimilars,” wrote the researchers. “While short‐term medication continuation was demonstrated, larger and longer‐term studies are needed to better understand biosimilar use in children—especially as the economic landscape continues to evolve.”

Himelstein D, McNicol M, Abdel-Rasoul M, et al. Outcomes of adalimumab biosimilar nonmedical switches in children and young adults with inflammatory bowel disease. 

. 2026;10.1002/jpr3.70212. doi:10.1002/jpr3.70212

Tesser JRP, Charabaty A, Hebert AA. Switching from adalimumab reference product to and among adalimumab biosimilars outside the USA: insights for US clinicians. 

. 2025;39(4):591-606. doi:10.1007/s40259-025-00719-z

Most pediatric and young adult patients with IBD maintained stable disease activity and laboratory markers after switching from the adalimumab originator. 

Nonmedical Adalimumab Biosimilar Switch Maintains Disease Control in Pediatric IBD

At $150,000 per quality-adjusted life-year (QALY), biosimilar denosumab (Prolia; Amgen) clears the cost-effectiveness bar against every oral bisphosphonate and against zoledronic acid for postmenopausal women at high fracture risk—but drop the threshold to $100,000, and only 1 comparison holds up, according to a 

A Gap Left by Reference Denosumab Modeling

More than 2 million osteoporosis-related fractures occur annually in the US, with direct and indirect costs projected to climb from $57.0 billion in 2018 to more than $95.2 billion by 2040. Oral bisphosphonates remain first-line therapy for postmenopausal osteoporosis (PMO), yet roughly 70% of US patients receive no treatment

at all, largely due to poor compliance, gastrointestinal (

) adverse events (AEs), and high drug costs. Reference denosumab offers better adherence and convenience as a twice-yearly injection, but its price has nearly doubled since FDA approval, limiting affordability.

Sandoz's biosimilar denosumab, marketed in the US as Jubbonti (denosumab-bbdz), became the first FDA-approved denosumab biosimilar in March 2024 and launched commercially in June 2025, positioned by Sandoz as a lower-cost option intended to expand patient access.

 The economic question remained open, though: prior cost-effectiveness analyses evaluated reference denosumab against bisphosphonates, but none had assessed the biosimilar until a new cost-utility analysis took it on.

A Lifetime Markov Model From the Payer's Chair

The analysis modeled a hypothetical cohort of women with PMO at high fracture risk using an 8-health-state Markov model with a lifetime horizon and 6-month cycles, tracking patients from treatment initiation until death or age 99 years. The starting age of 72.3 years mirrored the mean age enrolled in the pivotal FREEDOM trial (

), which established reference denosumab's fracture-prevention efficacy. The model adopted a US payer perspective aligned with Medicare fee-for-service/Part B, counting only direct medical costs—drug acquisition, administration, disease monitoring, and fracture management—discounted at 3% annually.

Biosimilar denosumab was compared individually against alendronate, risedronate, ibandronate, and zoledronic acid; reference denosumab was excluded as a “dominated” comparator since the biosimilar was assumed to match its efficacy at a lower price. Because biosimilar denosumab's actual US price was not yet public at the time of modeling, the researchers estimated it at 80% of reference denosumab's cost, using Medicare pricing data and a 2022 Amgen biosimilar report. Treatment-effect estimates for hip, vertebral, wrist, and other osteoporotic fractures were drawn from published network meta-analyses.

ICERs Stayed Under $150,000, but Not Always Under $100,000

Biosimilar denosumab produced more QALYs than every bisphosphonate—0.043, 0.043, 0.042, and 0.030 additional QALYs per patient vs alendronate, risedronate, ibandronate, and zoledronic acid, respectively—at incremental costs of $4379, $4057, $4265, and $4390. The resulting incremental cost-effectiveness ratios (ICERs) were $101,017; $93,544; $100,515; and $144,995 per QALY gained, all of which fell under a willingness-to-pay threshold of $150,000 per QALY gained. Only the risedronate comparison cleared the more conservative $100,000 threshold outright; the alendronate and ibandronate comparisons missed it narrowly, and the zoledronic acid comparison missed it by the widest margin.

“As a lower-cost alternative to reference denosumab, biosimilar denosumab may enhance patient access to effective PMO treatment in the USA,” the researchers wrote.

A probabilistic sensitivity analysis of 1000 iterations reinforced that picture. At the $150,000 threshold, biosimilar denosumab was cost-effective in 100% of iterations against alendronate, risedronate, and ibandronate, but in only 55.4% of iterations against zoledronic acid. At the $100,000 threshold, it was cost-effective in 72.3% of iterations against risedronate, 29.9% against ibandronate, and 24.0% against alendronate, and not cost-effective against zoledronic acid.

Price and patient age were the 2 most influential drivers of the results. Dropping biosimilar denosumab's price to 40% of reference denosumab's cost pushed every ICER below $100,000 per QALY gained; at 20% of reference cost, the biosimilar dominated all 4 bisphosphonates—cheaper and more effective across the board. Starting age cut just as sharply: modeled ICERs ranged from roughly $164,000 to $215,000 per QALY gained at age 65 years but fell to $25,000 to $95,000 per QALY gained at age 85—the biosimilar's economic case strengthens in older, higher-risk patients and weakens in younger ones.

A Hypothetical Price, Built on Borrowed Data

The analysis carries meaningful caveats. Because biosimilar denosumab's US price was unknown at the time of modeling, the study's central estimate—a 20% discount to reference denosumab—was hypothetical, and the authors acknowledged that actual cost-effectiveness will depend on the biosimilar's real price. Jubbonti's June 2025 launch gives payers an actual contract price to test that assumption against as pricing data becomes available.

Other inputs relied on non-US data where domestic evidence was lacking, including a Swedish study for postfracture risk and multinational trials for AE rates, and the analysis excluded societal costs like productivity losses, consistent with its payer-only perspective.

For health plans weighing formulary strategy, biosimilar denosumab clears a reasonable value bar even before the price erosion typical of biosimilar markets sets in. Combined with denosumab's twice-yearly dosing and lower GI-related discontinuation, the economic case could support broader coverage for older, high-risk patients, where the model's ICERs were most favorable, while bisphosphonates may remain the more cost-effective first choice for younger postmenopausal women.

Flanigan J, Kane S, Mirzayeh Fashami F, et al. Cost-effectiveness of biosimilar denosumab versus bisphosphonates in postmenopausal osteoporosis. 

. 2026;10(4):733-748. doi:10.1007/s41669-026-00651-0

Jeremias S. Wyost and Jubbonti launch as first denosumab biosimilars in the US. 

. June 2, 2025. Accessed August 4, 2026. 

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

Biosimilar denosumab cleared a $150,000 per QALY cost-effectiveness threshold against bisphosphonates for high-risk PMO, but not always at $100,000.

Biosimilar Denosumab Shows Cost-Effectiveness Over Bisphosphonates in PMO

Long-term treatment with an eculizumab biosimilar (Elizaria; Generium) produced stable hematologic and safety outcomes in patients with atypical hemolytic uremic syndrome (aHUS), according to the results of a prospective, multicenter observational study published in 

A 50-patient study found sustained platelet recovery and low TMA rates through 52 weeks of biosimilar therapy, with a favorable safety profile. | Image credit: สัมฤทธิ์ ไกรยนุช - stock.adobe.com

“The objective of a multicenter, prospective, observational study of an eculizumab biosimilar (Elizaria) was to analyze the efficacy and safety of long-term complement inhibitor therapy in patients with atypical hemolytic uremic syndrome (aHUS),” wrote the researchers of the study.

aHUS is a rare, life-threatening form of thrombotic microangiopathy (TMA) driven by uncontrolled activation of the complement alternative pathway, leading to microvascular thrombosis, hemolytic anemia, and progressive kidney injury.

 Without treatment, the condition carries a high risk of end-stage kidney disease and death. Terminal complement inhibition with eculizumab has been standard of care for more than a decade, transforming aHUS from a frequently fatal diagnosis into a manageable chronic condition. However, the reference product's cost has limited access in many health systems, spurring development of biosimilars intended to expand access while preserving efficacy and safety.

Consistent Efficacy Across Age Groups and Treatment Histories

The observational study enrolled 50 patients with aHUS aged 1 to 55 years, 42% of whom were under age 18.

 Patients received the eculizumab biosimilar in routine clinical practice over 56 weeks. Nineteen patients (38%) had previously been treated with reference eculizumab before enrolling, while 31 (62%) were naive to complement inhibitor therapy.

By the end of the study, mean (SD) platelet counts rose by 39.48 (21.7) × 10

/L in treatment-naive patients and 33.61 (24.06) × 10

/L in treatment-experienced patients. Nearly all patients achieved normal platelet counts—100% of treatment-naive patients and 96% of treatment-experienced patients. Mean lactate dehydrogenase activity, a marker of hemolysis, remained essentially unchanged, from 253.84 (122.22) U/L at screening to 245.24 (93.52) U/L at the end of the study, indicating that hemolytic activity was already controlled and stayed controlled.

63 Unrelated Adverse Events, Low Immunogenicity Reported

Investigators reported 63 adverse events judged unrelated to the biosimilar during the safety assessment period. No details on serious adverse events or discontinuations attributable to the study drug were disclosed in the published abstract. The authors characterized the overall safety profile as favorable, with low immunogenicity observed over the treatment course, a notable finding given ongoing concerns among clinicians about antidrug antibody formation with long-term biologic switching in rare disease populations.

Freedom from TMA events was reported in 77.6% of patients at week 21 and 80% at week 52. The proportion of patients achieving a complete TMA response increased significantly over the study period, reaching 8% (

= .046). Renal function also improved for a subset of patients: 12% had an estimated glomerular filtration rate gain of at least 15 mL/min/1.73 m

The stability of platelet counts and TMA response rates across both treatment-naive and switch populations may support formulary strategies that favor biosimilar initiation or transition for eligible patients, provided ongoing pharmacovigilance continues to confirm low immunogenicity. As more eculizumab biosimilars gain global approval, comparative real-world evidence like this study will be important for utilization management decisions and prior authorization criteria in rare disease programs.

“Long-term complement inhibitor therapy with the eculizumab biosimilar in patients with aHUS has demonstrated a stable effect, a favorable safety profile, and low immunogenicity,” wrote the researchers. 

Kotenko O, Kozlovskaya N, Emirova K, et al. Long-term therapy with eculizumab biosimilar in patients with atypical haemolytic uraemic syndrome: outcomes of a prospective observational study. 

. Published online June 12, 2026. doi:10.1159/000552914

Campbell P. FDA approves first interchangeable biosimilar to eculizumab for PNH and aHUS. 

https://www.hcplive.com/view/fda-approves-first-interchangeable-biosimilar-to-eculizumab-for-pnh-and-ahus

A 50-patient study found sustained platelet recovery and low thrombotic microangiopathy rates through 52 weeks of biosimilar therapy, with favorable safety.

Eculizumab Biosimilar Shows Durable Benefit in Long-Term aHUS

Aflibercept 2 mg biosimilar SB15 (Afilivu; Samsung Bioepis) produced significant anatomical improvements and stable visual acuity across multiple retinal diseases, supporting its effectiveness and safety in both treatment-naïve and biosimilar-switching patient populations.¹

This large, multicenter, retrospective real-world study conducted in South Korea is published in 

Aflibercept biosimilar SB15 improved retinal anatomy while preserving vision in both treatment-naive and switching patients with nAMD, RVO, and DME. | Image Credit: Orawan - stock.adobe.com

Evaluating Biosimilars Across a Broad Real-World Retinal Population

Biosimilars have become an increasingly important lever for expanding access to anti–vascular endothelial growth factor (VEGF) therapy amid the substantial treatment burden of chronic intravitreal injections. The AURA Korea study, conducted across 3 South Korean tertiary centers, evaluated outcomes among 1083 eyes from 984 patients who received a total of 2762 injections of SB15 between March 2023 and February 2025. The cohort included 188 treatment-naïve eyes (17.4%) and 895 eyes switched from another anti-VEGF agent (82.6%), spanning neovascular age-related macular degeneration (nAMD, n = 611), retinal vein occlusion (RVO, n = 182), diabetic macular edema (DME, n = 173), and other retinal conditions (n = 117). 

Anatomical Gains Held Across Diagnoses, With Vision Preserved

Over a mean (SD) follow-up of 5.17 (2.76) months and 2.55 (1.09) injections per eye, central foveal thickness decreased significantly by −47.5 µm (95% CI, −55.2 to −39.8; 

 < .001), while best-corrected visual acuity (BCVA) remained stable (mean change, −0.003 

 = .572). Treatment-naïve eyes showed greater anatomical improvement than switching eyes (−93.9 µm vs −37.9 µm; 

Retinal fluid resolution was significant across all 3 major diagnostic groups: subretinal fluid in nAMD decreased from 51.2% to 29.6% (

< .001), intraretinal fluid in RVO fell from 92.9% to 76.4% (

 < .001), and intraretinal fluid in DME declined from 90.8% to 84.4% (

 = .002). Safety findings were reassuring, with only 1 case (0.09%) of rhegmatogenous retinal detachment and no episodes of intraocular inflammation or other serious adverse events reported.

These findings are broadly consistent with other real-world switching data in retinal disease. A United Kingdoom study of patients switched to high-dose aflibercept after treatment-refractory nAMD similarly found stable visual acuity alongside anatomical improvement, reinforcing that switching anti-VEGF regimens—whether to a biosimilar or a reformulated originator—can maintain disease control without compromising outcomes.

“Switching to aflibercept 8 mg in treatment-refractory nAMD eyes in a real-world setting was associated with increased treatment durability, modest anatomical improvements, stable BCVA, and a favorable short-term safety profile,” wrote the researchers of the UK study. “These early outcomes support the use of aflibercept 8 mg in eyes with high treatment burden and persistent disease activity within routine clinical practice. Importantly, no serious ocular adverse events were observed despite the higher injection volume compared to conventional anti-VEGF agents. Further prospective studies with larger sample sizes and longer follow-up are warranted to confirm the long-term efficacy, durability, and safety of aflibercept 8 mg.”

For payers and health systems, these findings offer real-world reassurance that switching established patients to the aflibercept biosimilar SB15 is unlikely to compromise anatomical or visual outcomes across the most common retinal indications, supporting formulary strategies that favor biosimilar adoption to reduce per-injection costs. The low serious adverse event rate further supports confidence in safety-driven step therapy or mandatory-switch policies, although plans should continue to monitor longer-term durability data, as follow-up in this cohort was limited to roughly 5 months.

“These findings support the real-world effectiveness and safety of SB15 (Afilivu) in both treatment-naïve and switching populations across diverse retinal diseases,” wrote the researchers of the study. 

Song JR, Jeon J, Baek SC, et al; International Retina Biosimilar Study Group (Inter BIOS Group). Aflibercept biosimilar use and real-world outcomes in various retinal diseases: the AURA Korea study. 

Musadiq M, Musadiq M, Latif F, et al. Early real-world outcomes of switching to 8 mg aflibercept for neovascular age-related macular degeneration in the United Kingdom. 

. 2025;15(6):903. doi:10.3390/life15060903

Aflibercept biosimilar SB15 improved retinal anatomy while preserving vision in both treatment-naïve and switching patients with nAMD, RVO, and DME.

Aflibercept Biosimilar SB15 Shows Real-World Efficacy Across Retinal Diseases

A multicenter retrospective study spanning nearly 5000 eyes across 5 tertiary eye-care centers in India has added substantial real-world weight to the case that biosimilar ranibizumab can serve as a viable, lower-cost alternative to the innovator drug for treating a range of vision-threatening retinal conditions.

Nearly 5000 eyes and nearly 21,000 injections show comparable vision, anatomical, and safety outcomes between Ranieyes and Lucentis/Accentrix. | Image credit: Viktor - stock.adobe.com

“Much of the available evidence is disease-specific, noncomparative, or limited by relatively short follow-up,” wrote the researchers of the study. “In addition, fewer multicenter real-world studies have evaluated a single ranibizumab biosimilar brand against innovator ranibizumab across heterogeneous retinal vascular diseases while simultaneously examining longitudinal outcomes, treatment burden, and safety. This gap provided the rationale for the present study.”

The study compared outcomes between biosimilar ranibizumab (Ranieyes; Lupin Pharmaceuticals) and innovator ranibizumab (Lucentis/Accentrix; Novartis) in 4997 eyes from 3577 patients treated between July 2022 and October 2025. The biosimilar arm included 2543 eyes (10,893 injections), while the innovator arm included 2454 eyes (10,136 injections). Patients were treated for neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), branch and central retinal vein occlusion (BRVO/CRVO), myopic choroidal neovascularization (mCNV), and an exploratory group receiving anti-VEGF therapy as a preoperative adjunct before vitreoretinal surgery.

Comparable Vision and Anatomical Outcomes

Across nearly all disease categories, both drugs produced a similar pattern: rapid improvement in best-corrected visual acuity (BCVA) and reduction in central subfield thickness within the first 3 months, followed by long-term stabilization through 24 months. In DME, BRVO, CRVO, and mCNV, the visual acuity trajectories of the 2 groups tracked closely together at every follow-up visit. The nAMD subgroup showed 1 statistically notable gap—a slightly better BCVA in the biosimilar group at 12 months—but the researchers noted the difference was small in magnitude and did not persist at 18 or 24 months, making it unlikely to reflect a true clinical distinction between the drugs.

The number of injections needed over the study period was nearly identical between groups for DME, nAMD, and CRVO. Small but statistically significant differences emerged in BRVO and mCNV, although the researchers cautioned that real-world retreatment decisions are shaped by cost, logistics, and physician judgment rather than a fixed protocol, so these gaps should not be overinterpreted.

Across more than 21,000 total injections, serious complications were rare in both arms. Endophthalmitis, the most feared injection-related complication, occurred in only 1 of 10,893 biosimilar injections vs 2 of 10,136 innovator injections—a difference with no statistical significance. Rates of retinal pigment epithelial tears, intraocular inflammation, and serious systemic vascular events such as myocardial infarction and stroke were also similar between groups, and the authors reported no new safety signal for the biosimilar.

The economic case is central to the study's relevance. At the participating Indian hospitals, innovator ranibizumab cost roughly $270 to $325 per injection compared with about $129 to $173 for the biosimilar—a discount that could meaningfully affect treatment continuity in settings where repeated injections over years strain patient budgets. Because retinal vascular diseases are chronic and relapsing, requiring long-term anti–vascular endothelial growth factor therapy, affordability directly affects whether patients keep up with the injection schedules needed to preserve vision.

This Indian cohort adds to a growing body of real-world data on ranibizumab biosimilars internationally. A related multicenter study in South Korea, the ROSE Korea study, evaluated 2 regulatory-approved biosimilars—Amelivu and LucenBS—and similarly found outcomes broadly comparable to reference ranibizumab, while noting that such biosimilars generally offer a 20% to 30% cost reduction compared with the originator product.

Together, these studies suggest that as more ranibizumab biosimilars clear regulatory bars around the world, clinicians are accumulating the kind of large-scale, real-world reassurance that tends to drive broader adoption—provided prescribers keep in mind that each biosimilar brand still needs its own body of evidence, since findings from one product don't automatically transfer to another.

“These findings should be interpreted as supportive observational comparative evidence rather than formal proof of equivalence,” wrote the researchers.

“Because this study evaluated a single biosimilar brand, the results should not be generalized to all ranibizumab biosimilars. Further adjusted, disease-specific multicenter comparative studies across different biosimilar brands are warranted.”

Chakraborty D, Sinha TK, Sinha S, et al. Real-world comparison of biosimilar ranibizumab (Ranieyes) and innovator ranibizumab (Lucentis/Accentrix) across multiple retinal vascular diseases (the BRIO study). 

Song JR, Park UC, Lee CS, et al. Real-world outcomes of ranibizumab biosimilars in various retinal diseases: a Korean multi-center experience-ROSE Korea Study. 

. 2026;16(1):4220. doi:10.1038/s41598-025-34325-4

Nearly 5000 eyes and nearly 21,000 injections show comparable vision, anatomical, and safety outcomes between biosimilar ranibizumab and the innovator drug.

Biosimilar Ranibizumab Performs on Par With Innovator Drug Across Retinal Diseases

While most patients who switched from originator natalizumab (Tysabri; Biogen) to the biosimilar (Tyruko; Polpharma Biologics) for 

 (RRMS) rated the 2 products as equivalent, a subset reported new adverse effects, and overall treatment satisfaction dropped after the switch, echoing a pattern seen across biosimilar classes: outcomes that look clean in blinded trials can shift once patients know which product they are receiving.

Real-world natalizumab biosimilar switching preserved relapsing-remitting MS outcomes but lowered treatment satisfaction, likely due to a nocebo effect. | Image Credit: AlexBlogoodf - stock.adobe.com

Patient Satisfaction Declined Despite Stable Clinical Outcomes After Biosimilar Switch

In the real-world cohort study published in 

, researchers at Amsterdam UMC followed 83 patients with RRMS who were switched from originator natalizumab to the first FDA-approved MS biosimilar as part of a hospitalwide, cost-driven conversion. Patients completed validated questionnaires and had serum drawn before and during biosimilar treatment, and all were aware of the brand switch.

Twelve patients (15%) reported experiencing more adverse effects with the biosimilar than with the originator, most commonly skin itching, fatigue, dizziness, headache, joint pain, and bowel issues. One patient developed a new skin rash that recurred with each biosimilar infusion and resolved only after switching back to the originator. 

Overall treatment satisfaction, measured with the Treatment Satisfaction Questionnaire for Medication, was significantly lower during biosimilar treatment (mean score [SD], 71.74 [22.4]) than with the originator (76.84 [17.6]; 

 = .02). No other patient-reported measures, including MS symptom impact, perceived effectiveness, adverse effect frequency, treatment convenience, or wearing-off symptoms, differed significantly between products. Similarly, no clinical relapses occurred after the switch.

Nocebo Effect May Explain Lower Satisfaction After Switch

The authors attributed the drop in satisfaction and uptick in reported adverse effects to a possible nocebo effect, a phenomenon in which negative expectations about a switched medication produce perceived harm unrelated to the drug's actual pharmacology. Because the study was not blinded and patients knew about the brand change, the design could not rule out this influence.

Real-world natalizumab biosimilar switching preserved relapsing-remitting MS outcomes but lowered treatment satisfaction, likely due to a nocebo effect.
