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

Skylar Jeremias

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

Articles

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. 

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

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.

Real-world evidence partially mitigated these concerns but remained limited in scope. Observational pediatric studies, largely from Europe and focused on single switches from reference products, generally reported maintained disease control and no new safety signals. However, sample sizes were small, follow-up was short, and some cohorts reported that up to one-quarter of patients switched back to the reference product or another biologic due to reduced effectiveness, injection discomfort, or perceived adverse effects.

Cost considerations strongly influenced institutional decisions, with biosimilars typically priced at 60% to 85% of reference biologics. Pediatric studies in inflammatory bowel disease and hematology settings suggested savings of approximately 10% to 30% after switching. The review emphasized, however, that direct drug savings must be weighed against indirect implementation costs, including staff time for education, changes to infusion or delivery systems, and additional monitoring. Equity issues related to variable outpatient insurance coverage were also noted.

Patient- and caregiver-centered factors featured prominently. Surveys and qualitative studies showed that many families had limited baseline knowledge of biosimilars and expressed anxiety about non-medical switching. Trust in clinicians and clear communication were critical to acceptance, and the review identified the potential for nocebo effects when expectations were negative. At the same time, some families expressed willingness to accept biosimilars to support broader health-system sustainability.

On the procedural side, the authors found wide variation in institutional approaches to interchangeability and substitution. Most pediatric settings avoided automatic pharmacist substitution and favored physician-led switching, particularly for children who were stable on reference biologics. Multidisciplinary governance, clear electronic prescribing differentiation between products, and robust pharmacovigilance systems were consistently recommended to ensure traceability and safety monitoring.

The review acknowledged several limitations. As a scoping review, it did not formally assess study quality or quantify effect sizes. The pediatric evidence base was heterogeneous, with many studies underpowered to detect rare safety events or small differences in effectiveness. Much of the real-world data originated outside the US, potentially limiting generalizability. In addition, perspectives from industry and payers were excluded, which may have omitted insights into market-level dynamics.

The report concluded that pediatric biosimilar adoption was constrained less by a single barrier than by intersecting evidence gaps, regulatory inconsistencies, and implementation challenges. The authors called for earlier and more robust pediatric studies during biosimilar development, sustained investment in pharmacovigilance and registries, and institution-specific frameworks that balance affordability with safety and trust for children and their caregivers.

1. Lau E, Koo A, Kang HB, Ames M, Matinnia C, Denburg A. Considerations for biosimilar adoption in pediatrics: a scoping review. 

. Published online December 1, 2025. December 22, 2025. doi:10.1007/s40290-025-00593-8

2. Hong D, Kesselheim AS, Sarpatwari A, Rome BN. Biosimilar uptake in the U.S.: patient and prescriber factors. 

. 2024;43(8):1159-1164. doi:10.1377/hlthaff.2023.01215

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

Evidence Gaps Continue to Shape Biosimilar Adoption in Pediatric Care

The biosimilar landscape experienced significant expansion in late 2025, marked by crucial regulatory progress in Europe across immunology and bone health, alongside major strategic agreements positioning companies for key launches in the high-value North American oncology market. Recent news demonstrated how companies strengthened their portfolios by securing positive opinions from the Committee for Medicinal Products for Human Use (CHMP), announcing launches for high-demand therapies, and forging new alliances.

Doctor with patient | Image credit: Suteren Studio - stock.adobe.com

European Regulatory Momentum in Autoimmune Diseases

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

Celltrion received a positive CHMP opinion for the autoinjector presentation of SteQeyma (ustekinumab biosimilar). SteQeyma, a biosimilar to Stelara, was developed for the treatment of people with plaque psoriasis, psoriatic arthritis, and Crohn disease. The positive opinion specifically covered the 45-mg and 90-mg solutions for injection via autoinjector. The availability of the autoinjector option aimed to improve convenience and enhance the individual patient experience by expanding administration options. Celltrion noted that the autoinjector utilized a simple two-step administration process, which included clear visual and audible indicators to help people easily identify the injection status. The autoinjector formulation was also citrate-free and featured special thin-wall needle technology intended to reduce injection pain. This new administration option joined the currently approved presentations of SteQeyma, including pre-filled syringes and vials for subcutaneous injection, as well as concentrate for intravenous infusion.

In a separate announcement, STADA Arzneimittel and Bio-Thera Solutions received a positive CHMP opinion recommending approval for their biosimilar candidate, Gotenfia (golimumab).

 Gotenfia, which references Simponi, was recommended for marketing authorization for people with several chronic inflammatory autoimmune diseases. These conditions included rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, and ulcerative colitis in adult patients. The positive recommendation also covered juvenile idiopathic arthritis in people aged 2 years and older. Gotenfia was developed by Bio-Thera, who retained responsibility for manufacturing and supply, while STADA secured the exclusive rights for commercialization across the European Union, the UK, Switzerland, and other selected countries.

Expanding Access Through New Launches in Bone Health and Ophthalmology

Biosimilar launches in Europe broadened therapeutic access in bone health and ophthalmology, areas where current treatment costs place a high burden on health care systems.

Accord Healthcare announced the launch of 2 denosumab biosimilars following the scheduled expiration of the reference medicine’s patent on November 27, 2025.

 These launches included Osvyrti, a biosimilar referencing Prolia, and Jubereq, a biosimilar referencing Xgeva. Both medicines received approval from the European Medicines Agency in September 2025, after trials demonstrated they were highly similar to their reference products. Osvyrti, available as a 60-mg prefilled syringe, was indicated for the treatment of people with osteoporosis and bone loss linked to hormone ablation in men with prostate cancer.

Jubereq, available as a 120-mg vial, was indicated for the prevention of skeletal-related events in adults with advanced malignancies involving bone. Accord Healthcare stated that these biosimilars possessed the potential to provide treatment alternatives that helped lessen cost as a barrier for people accessing proven therapies.

Meanwhile, Sandoz announced the European launch of Afqlir (aflibercept), providing an affordable treatment option for people with retinal diseases.

 Afqlir, approved by the European Commission in November 2024, matched the reference medicine, Eylea, in efficacy, safety, and pharmacokinetics. The biosimilar, available as a 2-mg vial kit and pre-filled syringe for intravitreal injection, was indicated for the same indications as Eylea in adult patients.

Aflibercept is considered a gold standard treatment for various neovascular retinal diseases, which are leading causes of vision loss. The launch of Afqlir aimed to bring a high-quality, affordable aflibercept option for European people that maintains and improves vision while supporting more sustainable care across the region.

Strategic Partnership Targets US Oncology Market

Formycon AG and Zydus Lifesciences Limited cemented a partnership focused on penetrating the lucrative North American oncology biosimilar market.

 The companies jointly announced a strategic collaboration for the exclusive licensing and supply of FYB206, a biosimilar of Keytruda (pembrolizumab), in the US and Canada. Under the agreement, Formycon committed to finalizing development, preparing and filing the regulatory dossier, and supplying the product. Zydus assumed responsibility for the commercialization of FYB206 in both the US and Canada.

Pembrolizumab is a humanized monoclonal antibody used to treat various tumors, and its reference product, Keytruda, was one of the world’s best-selling drugs in 2024. Formycon anticipated receiving primary endpoint data from the clinical development phase of FYB206 in the first quarter of 2026, leading to the eventual submission of a biologics license application to the FDA. Zydus noted that this venture marked its entry into the North American biosimilar market, beginning with an immunotherapy product.

Sandoz launches Afqlir (aflibercept) in Europe, providing affordable treatment option for patients with retinal diseases. News release. Sandoz. November 11, 2025. Accessed December 18, 2025. 

https://www.sandoz.com/sandoz-launches-afqlirr-aflibercept-europe-providing-affordable-treatment-option-patients-retinal/

Golimumab biosimilar Gotenfia from STADA and Bio-Thera receives positive CHMP opinion. News release. Bio-Thera Solutions. December 12, 2025. Accessed December 18, 2025. 

https://www.prnewswire.com/news-releases/golimumab-biosimilar-gotenfia-from-stada-and-bio-thera-receives-positive-chmp-opinion-302640091.html

Accord Healthcare announces launch of denosumab - second biosimilar in bone health. News release. Accord Healthcare. December 2, 2025. Accessed December 18, 2025. 

https://www.prnewswire.com/news-releases/accord-healthcare-announces-launch-of-denosumab---second-biosimilar-in-bone-health-302629590.html

Celltrion receives positive CHMP opinion for SteQeyma (ustekinumab biosimilar) autoinjector. News release. Celltrion. December 18, 2025. Accessed December 18, 2025. 

https://www.celltrion.com/en-us/company/media-center/press-release/4348

Formycon and Zydus partner for exclusive licensing and supply agreement of FYB206, a biosimilar to Keytruda (Pembrolizumab), in the U.S. and Canada. News release. Formycon. December 9, 2025. Accessed December 18, 2025. 

https://www.globenewswire.com/news-release/2025/12/09/3202239/0/en/Formycon-and-Zydus-partner-for-exclusive-licensing-and-supply-agreement-of-FYB206-a-biosimilar-to-Keytruda-Pembrolizumab-in-the-U-S-and-Canada.html

Biosimilar partnerships and EU approvals surge, enhancing access to innovative treatments in immunology, oncology, and bone health markets.

Biosimilar Market Momentum: EU Approvals, Strategic Launches, and Major US Partnerships 

The US biosimilar market continues to evolve rapidly, characterized by significant milestones in patient access and persistent challenges related to market acceptance and policy barriers. The following roundup details the key news items from 2025 that reflect the current state and future trajectory of biosimilar adoption, covering everything from landmark approvals and market competition struggles to major regulatory and political efforts aimed at enhancing affordability and sustainability.

Here are the most-read biosimilar news articles of 2025.

Explore the latest developments in the US biosimilar market, highlighting key approvals, challenges, and future trends shaping patient access in 2025.

5. From Amjevita to Zarxio: A Decade of US Biosimilar Approvals

Since the FDA granted its landmark decision to approve the first biosimilar, Sandoz’ filgrastim-sndz (Zarxio), on March 6, 2015, the US biosimilars market has grown substantially, accumulating 67 total approvals across 18 originator products over 10 years. This expansion has delivered significant cost savings, with generics and biosimilars collectively generating $12.4 billion in savings during 2023, bringing the total savings since 2015 to $36 billion.

A major focus of this decade was the adalimumab market, which saw the entry of 10 biosimilars beginning with Amgen’s Amjevita (adalimumab-auub) in January 2023. Despite this growth, biosimilars only account for about 23% of the overall biologics market, with uptake varying drastically across therapeutic areas; for instance, it is higher in oncology and lower in chronic conditions like rheumatology and gastroenterology. Major challenges hindering biosimilar adoption include regulatory barriers requiring extensive studies for approval and interchangeability, low market acceptance driven by payer controls and provider preferences, and high development costs, which can range from $100 million to $250 million.

Reference manufacturers have also utilized the patent legal system to stall competition, notably resulting in delayed launches for the adalimumab biosimilars. However, there is optimism for policy changes, including draft FDA guidance that might remove switching study requirements for interchangeability status, aligning the US more closely with European regulatory agencies.

4. Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

The launch of 10 adalimumab biosimilars, which began with Amgen's Amjevita in January 2023, created hope for robust competition; however, the sustainability of this market is now under threat. AbbVie’s Skyrizi (risankizumab-rzaa) surpassed the originator product, Humira (adalimumab), to become the company's top sales driver for the first time, according to AbbVie’s Q3 2024 financial report.

The shift is a consequence of "product hopping," a strategy used by drug companies to encourage demand to move from an innovator drug facing biosimilar competition to a newer, patented version from the same manufacturer. In Q3 2024, Skyrizi sales increased by 50.8% globally, while Humira’s worldwide revenues fell by 37.2%.

Although the combined market share for the 10 adalimumab biosimilars reached 22% by October 2024, experts noted that biosimilars are gaining share in a diminishing market, as the overall volume of adalimumab is shrinking due to the adoption of replacement products like Skyrizi. The practice of product hopping can hinder fair competition and allow originator companies to maintain near-monopolies. While the Affordable Prescriptions for Patients Act of 2023 was introduced in Congress to prohibit such practices, the bill currently remains stalled in the House.

3. President Trump Signs Executive Order to Bring Down Drug Prices

President Donald Trump signed an executive order to address escalating drug costs by promoting faster biosimilar development, increasing transparency, and imposing tougher regulations on pharmacy benefit managers (PBMs). The executive order highlighted the substantial cost-saving potential of biosimilars, which can cost up to 80% less than reference biologics. The order projected the potential to save up to $181 billion over the next 5 years, building on the $56 billion in savings biosimilars had already generated.

Among the 13 directive actions outlined, the order specifically mandates the FDA commissioner to submit a report detailing recommendations to accelerate the approval of generics and biosimilars.

The order directs HHS to propose regulations aimed at increasing employer health plan transparency regarding PBM compensation. The order also sought to improve upon the Inflation Reduction Act by requiring HHS to issue guidance to enhance transparency in Medicare drug price negotiations and prioritize high-cost drugs. Accelerating biosimilar approval and development is a bipartisan objective, reflected by numerous bills introduced in Congress.

2. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars

A report from the IQVIA Institute for Human Data Science identified a significant “biosimilar void,” revealing that 90% of the 118 biologics scheduled to lose exclusivity over the next decade currently lack biosimilars in development. This represents a vast missed opportunity, as the affected biologics account for $234 billion overall in sales that could be exposed to competition through 2034.

The next decade will see an average of 12 biologics lose exclusivity annually, which is more than double the rate of the preceding decade. Biosimilar development remains concentrated on high-sales products, particularly in immunology and oncology, leaving therapeutic areas such as neurology, diabetes, and hematology with limited competition. The primary reason for this void, particularly among lower-sales biologics, is the high development cost, which ranges from $100 million to $250 million, coupled with a low projected return on investment. This is exacerbated in the rare disease space, where 61% of patent expiries through 2034 are orphan indications.

Other deterrents include regulatory burdens, low market acceptance, and reimbursement challenges as PBMs and payers favor originators due to rebate incentives. The report emphasized that addressing these development and market challenges through regulatory streamlining, collaboration, and improving market conditions is crucial for realizing the full affordability benefits of biosimilars.

1. Welcome Wezlana: The First Stelara Biosimilar to Launch in the US

January 2025 marked a major milestone with the US launch of Amgen’s Wezlana (ustekinumab-auub), the first biosimilar referencing Stelara (ustekinumab), introducing a new category of lower-cost biologics for patients with conditions such as Crohn disease and plaque psoriasis. Wezlana’s approval was supported by phase 3 trial data confirming its comparable safety and efficacy profiles relative to the reference product.

Wezlana received an interchangeability designation, allowing it to be substituted for Stelara at the pharmacy level without requiring prior approval from a health care provider, which is intended to increase patient access and convenience. Amgen had previously settled with Johnson & Johnson, the parent company of the manufacturer of Stelara (Janssen), resulting in a delayed launch date of “no later than January 1, 2025.” Wezlana was the first of 7 ustekinumab biosimilars expected to launch in 2025.

However, following the experience in the adalimumab market, experts expressed concern regarding potential “product hopping” in the ustekinumab space, especially since Janssen, Stelara's manufacturer, also markets Tremfya (gusekumab), which could be used to shift patients away from the new biosimilar competition.

Top 5 Most-Read Biosimilar News of 2025

The gastroenterology biosimilar landscape is undergoing rapid transformation, dominated primarily by the introduction of ustekinumab biosimilars (referencing Stelara) and the ongoing dynamics of the adalimumab biosimilar market (referencing Humira). The following roundup highlights the top 5 news stories detailing these developments, focusing on regulatory milestones, market challenges, and real-world clinical outcomes for inflammatory bowel disease (IBD) and related gastrointestinal conditions.

5. High Acceptance Levels After Switching to an Adalimumab Biosimilar for IBD

Positive real-world data emerged regarding patient willingness and clinical outcomes following a switch to an adalimumab biosimilar. A French observational study focused on patients with IBD, which includes Crohn disease and ulcerative colitis, who were offered a switch from the reference adalimumab product. The study found "high acceptance levels" among patients with IBD who received education and personalized guidance regarding the switch.

Specifically, 92% of patients accepted the switch, and a notable 71% remained on a biosimilar after 12 months. Clinical outcomes were strong: 85% of switched patients remained in clinical remission at the 12-month mark, suggesting that the switch had no negative impact on disease control. The high cost of biologics, including adalimumab, makes these biosimilar alternatives crucial for treating the estimated 7 million people with IBD around the world.

While the majority reported a positive experience (66%), the most frequent reason for discontinuing the biosimilar was injection site pain (25%). Researchers concluded that most patients with IBD were receptive to switching to a biosimilar and achieved good outcomes, emphasizing that continuous patient education and addressing individual concerns are "crucial for improving overall satisfaction with biosimilars."

4. FDA Approves Starjemza as New Stelara Biosimilar

The momentum in the ustekinumab space continued with the FDA approval of Starjemza (ustekinumab-hmny) in May 2025, marking the eighth ustekinumab biosimilar to receive regulatory clearance. Starjemza, developed through a partnership between Hikma Pharmaceuticals and Bio-Thera Solutions, is approved for treating several rheumatic and gastrointestinal conditions.

The approval further enhances the treatment landscape for patients, following the approval of Steqeyma in late 2024. The FDA’s decision was based on data from 2 clinical studies, including a phase 3 trial in patients with moderate to severe plaque psoriasis, which confirmed that Starjemza maintained comparable efficacy, safety, and immunogenicity to the reference product, Stelara. At the time of this approval, 6 ustekinumab biosimilars were already available on the US market, some of which—like Wezlana—are available exclusively through private label distributors.

3. Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

In a significant market shift concerning biologics used to treat conditions like Crohn disease and ulcerative colitis, AbbVie’s Skyrizi (risankizumab-rzaa) officially surpassed Humira (reference adalimumab) as the company’s leading sales driver in the third quarter of 2024. The change can be attributed to the practice of "product hopping," where originator companies strategically shift patient demand from an innovator drug facing biosimilar competition (Humira) to a newer, patented product (Skyrizi or Rinvoq) that treats the same indications.

This market maneuver has complicated the sustainability of the US adalimumab biosimilar space. While 10 adalimumab biosimilars have launched since January 2023, the combined market shares only reached 22% by October 2024, a notable improvement from the 2% share after the first year. However, the growth of Skyrizi and Rinvoq has led to a "large drop in total adalimumab volume," effectively shrinking the overall market size, meaning biosimilars are gaining share in a diminishing pie.

Experts attending the GRx+Biosims conference emphasized that policy reforms, such as fair access fees and better formulary placement, are necessary to ensure a transparent and competitive market for biosimilars to thrive against product hopping practices.

2. 3 Ustekinumab Biosimilars Launch on US Market

The ustekinumab market heated up quickly following Wezlana's launch, as 3 additional biosimilars entered the US market in February 2025. These competitors—Pyzchiva (ustekinumab-ttwe) from Samsung Bioepis/Sandoz, Yesintek (ustekinumab-kfce) from Biocon Biologics, and Selarsdi (ustekinumab-aekn) from Teva/Alvotech—expand patient access to more affordable options referencing the blockbuster drug Stelara. Stelara generated $10.4 billion in sales in 2024 alone.

All 7 FDA-approved ustekinumab biosimilars are indicated for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Inflammatory bowel disease, encompassing Crohn disease and ulcerative colitis, is estimated to impact between 2.4 million and 3.1 million Americans. The Crohn's and Colitis Foundation's chief education, support, and advocacy officer commented that this influx of options represents a "meaningful advancement" for eligible patients with chronic disease. The competition is particularly important because Wezlana's initial access is restricted by its exclusive agreement with Nuvaila. Although Pyzchiva has been provisionally designated as interchangeable, it must wait for the lapse of Wezlana's one-year exclusivity for being the first interchangeable ustekinumab biosimilar before the full designation can be granted.

January 1, 2025, marked a significant moment for gastroenterology patients with the launch of the first ustekinumab biosimilar in the US: Amgen’s Wezlana (ustekinumab-auub). Ustekinumab products, which are interleukin (IL)-12 and IL-23 antagonists, are crucial for treating conditions like Crohn disease and ulcerative colitis, in addition to plaque psoriasis and psoriatic arthritis. The arrival of Wezlana, delayed from a projected 2023 launch due to a settlement with Johnson & Johnson, ushers in a new class of lower-cost biologics for Americans with these gastrointestinal and rheumatic conditions.

Wezlana was the first ustekinumab biosimilar to receive FDA approval and possesses an interchangeability designation. This designation is key for patient access and convenience, as it allows the biosimilar to be substituted for the reference product, Stelara, at the pharmacy level without requiring prior provider approval. However, the initial launch has been partially limited: the biosimilar is exclusively available through Nuvaila, Optum Rx's biosimilar procurement business. This launch is being closely watched to see if it follows the path of adalimumab biosimilars, especially concerning the risk of "product hopping," where the originator company might shift patients to a newer product, such as Tremfya (gusekumab), to limit the uptake of biosimilars. Wezlana’s approval was supported by a phase 3 trial confirming comparable safety and efficacy profiles to Stelara.

Explore this year's advancements in gastroenterology biosimilars, highlighting key FDA approvals and market dynamics impacting IBD treatment options.

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