Christina Mattina

Biosimilar uptake in ophthalmology is lagging well behind other therapy areas in Europe, and a 

 suggests that without coordinated action from clinicians, payers, and policy makers, the specialty could miss out on an estimated €747 million in savings over the next 5 years.

Why Europe’s eye clinics lag on biosimilars—and how education, guidance, and smarter tenders could unlock €747 million in savings. | Image credit: Dilshad - stock.adobe.com

The IQVIA Institute for Human Data Science published a case study in February 2026 examining barriers to biosimilar adoption in ophthalmology, with a focus on the recent European entry of aflibercept biosimilars. Funded by Sandoz, the report drew on 142 in-depth interviews conducted between late 2024 and early 2025 with ophthalmologists, retina specialists, hospital and retail pharmacists, payers, nurses, and patient advocacy group representatives across France, Germany, Italy, Spain, and the UK. The study sought to assess why uptake had stalled in a specialty where prior biosimilar experience was limited and what structural and educational interventions could change that trajectory.

A High-Burden Specialty With Limited Biosimilar History

Retinal diseases, including wet age-related macular degeneration (wAMD), diabetic macular edema, and retinal vein occlusion, imposed a substantial and growing burden on European health systems. In 2022, approximately 67 million people in Europe were affected by age-related macular degeneration—a figure expected to increase by 15% by 2050.

 The standard of care relied on frequent intravitreal anti–vascular endothelial growth factor injections, placing sustained demand on already-strained ophthalmology services facing clinician shortages, limited clinic infrastructure, and growing waitlists.

Biologics accounted for more than 40% of total pharmaceutical expenditure in the EU in 2023 and 2024, up from 28% in 2014. Biosimilars, despite generating €75 billion in cumulative list-price savings in Europe as of mid-2025, represented only about 5% of biologics spending. 

The entry of ranibizumab biosimilars in Europe beginning in 2022 offered the specialty its first real-world test of biosimilar adoption—and the results were instructive. Ranibizumab biosimilars reached only 40% penetration 6 quarters after launch, compared with 50% to 60% or more seen in other therapy areas over comparable periods. The report attributed this largely to the absence of a prefilled syringe (PFS) formulation for the biosimilar at launch—a critical shortcoming in a specialty where PFS had become the standard delivery format due to efficiency, reduced contamination risk, and ease of use in high-volume injection settings.

By contrast, 9 companies received European Commission approval for aflibercept biosimilars, with launches beginning in late 2025, and all were expected to offer PFS presentations.

Stakeholder confidence in biosimilars varied widely by country but was low overall. On a 1-to-7 scale, average biosimilar confidence scores in France, Germany, and Spain each came in at 2 or below. Italy registered a score of 3.5, while the UK led with an average of 5.5, a gap the report linked in part to earlier guidance from professional bodies such as the British and Eire Association of Medical Retina Specialists (BEAMS), which published a position statement in 2025 recommending first-line use of aflibercept and ranibizumab biosimilars for wAMD and calling for ring-fencing a portion of biosimilar savings for ophthalmology capacity reinvestment.

Across countries, cost-effectiveness and reliable supply emerged as the two primary enablers of adoption. As one retina specialist in the UK noted in an interview, “A big driving influence is the fact that the biosimilars are expected to be more cost-effective. The next enabler will be—I hope—that there will be a good supply chain, so we won't have an issue in terms of access to these treatments."

The report identified 3 structural barriers that cut across the 5 markets studied.

First, limited familiarity with biosimilars among ophthalmologists left many clinicians defaulting to reference products. Prescribing habits in the specialty tended to be conservative, given the precision and risk associated with intravitreal therapies. In the absence of targeted education, clinicians with little prior biosimilar exposure were unlikely to switch without clear evidence and institutional guidance.

Second, the poor experience with ranibizumab biosimilars shaped perceptions that could carry forward. Despite aflibercept biosimilars offering PFS formats, the feature most commonly cited as absent and most strongly linked to ranibizumab's limited uptake, residual skepticism from prior experience was expected to require active, product-specific communication to overcome it.

Third, fragmented decision-making across national, regional, and hospital levels delayed formulary access. Treatment guidelines frequently lagged behind market entry and lacked enforceability, leaving significant discretion to individual prescribers in a context where stakeholder confidence was already limited.

The report outlined 5 strategic enablers for improving biosimilar adoption. Targeted education campaigns—tailored not only to ophthalmologists but also to ophthalmic nurses, optometrists, and pharmacists—were identified as foundational. Patient advocacy groups were highlighted as especially effective dissemination partners, particularly in countries like Spain, where these organizations actively hosted workshops, webinars, and peer support groups.

Strengthening the real-world evidence base on biosimilar comparability, safety, and cost-effectiveness was identified as critical for hospital procurement teams and payers. Timely guideline updates coordinated through professional societies were also emphasized; the BEAMS position statement and National Health Service England's September 2025 treatment pathway recommendation, which designated aflibercept biosimilar as first-line alongside ranibizumab biosimilar for wAMD, were cited as models for proactive guidance ahead of market entry.

Reinvesting savings into ophthalmology services was presented as a mechanism both to address long-standing capacity bottlenecks and to create provider-level incentives for biosimilar adoption. Finally, well-designed tender-based procurement was noted as a lever for competitive pricing, with the report cautioning that single-winner tenders risked reducing supplier diversity and supply reliability and citing the UK's active multi-lot aflibercept biosimilar tender as an example of a more balanced approach.

The report estimated cumulative list-price savings from aflibercept biosimilars of €747 million between 2026 and 2031 across the 5 markets studied, with a range of €241 million to €1.4 billion depending on adoption rates and price dynamics. The authors noted that broader sustainability pressures extended well beyond ophthalmology: between 2024 and 2030, 69 biologics were anticipated to lose exclusivity in Europe, representing approximately €28 billion in pre-expiry value, yet only 29% of those molecules had a biosimilar currently in development.

The ophthalmology space, the authors argued, offered a concentrated test case for whether education, evidence, guideline reform, reinvestment, and procurement design could unlock benefits that had so far remained out of reach. "Overcoming barriers to biosimilar adoption in ophthalmology requires a multifaceted effort that spans education, evidence generation, guideline alignment, strategic reinvestment, and procurement reforms," they wrote.

Unlocking Biosimilar Potential: Ophthalmology Case Study

. February 5, 2026. Accessed March 5, 2026. 

https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/unlocking-biosimilar-potential-2026

Li JQ, Welchowski T, Schmid M, Mauschitz MM, Holz FG, Finger RP. Prevalence and incidence of age-related macular degeneration in Europe: a systematic review and meta-analysis. 

. 2020;104(8):1077-1084. doi:10.1136/bjophthalmol-2019-314422

Articles

A new analysis dives into why Europe’s eye clinics lag on biosimilars and how education, guidance, and smarter tenders could unlock €747 million in savings.

Clinician Confidence in Ophthalmology Biosimilars Remains Low Across Europe

Since the first launch in 2015, biosimilars have fundamentally reshaped the US health care system, generating over $56 billion in savings, according to the 

Biosimilars save billions, yet FDA streamlining, payer hurdles and Humira switchbacks expose a looming void in US biologic competition. | Image credit: alexkich - stock.adobe.com

Although biosimilars have generated billions in cumulative health care savings over the previous decade, new data suggest that achieving long-term market sustainability remained a complex objective. By early 2026, biosimilars accounted for approximately 23% of the total biologics market in the US. While the market demonstrated significant growth, stakeholders identified a "biosimilar void" that could result in $232 billion in missed savings over the next 10 years if current development and adoption trends do not accelerate.

The regulatory environment for biosimilars underwent a significant shift in late 2025. The FDA issued draft guidance that proposed the elimination of comparative efficacy studies (CES) for most biosimilar applications.

 This change was intended to streamline the approval process by focusing on analytical data rather than costly clinical trials. The FDA estimated that this shift could save manufacturers up to $100 million in development costs per product and reduce development timelines by as much as 50%.

Looking forward, the pipeline for these therapies remains active. Nearly 25 new biosimilars are expected to receive FDA approval between 2026 and 2027, targeting therapeutic areas such as oncology, immunology, and retina. Despite this activity, a substantial gap persists; while more than 110 biologics are set to lose patent protection over the next decade, only 10% of those products have biosimilars currently in development.

Physician Perspectives and Adoption Drivers

A Cardinal Health survey of 101 physician practices in late 2025 revealed high levels of clinical confidence alongside persistent operational concerns. Approximately 99% of participating providers reported they felt confident explaining biosimilars to their patients. The survey indicated that adoption was primarily driven by clinical data (56%) and payer requirements (50%).

However, physicians also identified significant points of hesitancy. The leading concern, cited by 53% of respondents, involved the nonmedical switching of a long-term, stable patient from a reference biologic to a biosimilar. Reimbursement complexities were also noted as a barrier by 34% of the surveyed practices. Furthermore, 94% of respondents stated that a stable reimbursement rate for medical benefit biosimilars was an important factor in their utilization decisions.

The Adalimumab Case Study and the "Switchback" Phenomenon

The launch of adalimumab biosimilars provided a critical real-world test for market disruption. Although biosimilar adoption increased significantly, research from Truveta through April 2025 identified a notable "switchback" trend. Data showed that 13.2% of patients who initially transitioned to an adalimumab biosimilar eventually reverted to the reference biologic, Humira.

This phenomenon was particularly prevalent among older adults and patients with rheumatoid arthritis or ankylosing spondylitis. Notably, nearly 40% of these switchbacks occurred within the first 30 days of treatment. Experts attributed this trend largely to the nocebo effect—a psychological phenomenon where a patient's negative perceptions or anxiety regarding a new medication led to perceived worsened clinical outcomes or adverse events.

Specialty Trends: Oncology and Gastroenterology

The impact of biosimilars varied by specialty. Oncology remained the most mature market, achieving an average 81% market share within 5 years of initial competition. In contrast, community gastroenterology practices faced increasing operational complexity. These practices managed the simultaneous launch of 3 different biosimilar classes: infliximab, adalimumab, and ustekinumab.

 For these providers, the primary challenges included navigating frequently changing payer formularies and managing the logistics of a growing inventory of similar but nonidentical products.

The report concluded that the long-term viability of the biosimilar market depended on aligning stakeholder incentives and stabilizing reimbursement models. To address the projected "biosimilar void," the authors suggested that proactive policy measures were necessary to ensure that the health care system could realize the billions of dollars in potential savings offered by these therapies. 

2026 biosimilars report: driving access and patient outcomes in physician practices. Cardinal Health. February 24, 2026. Accessed February 24, 2026. 

https://www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/biosimilars/biosimilars-report.html

Jeremias S. The biosimilar void: 90% of biologics coming off patent will lack biosimilars. The Center for Biosimilars

. February 5, 2025. Accessed February 24, 2026. 

https://www.centerforbiosimilars.com/view/the-biosimilar-void-90-of-biologics-coming-off-patent-will-lack-biosimilars

A closer look at new FDA guidance removing barriers to biosimilar development. The Center for Biosimilars. October 30, 2025. Accessed February 24, 2026. 

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

Jeremias S. Adalimumab double take: the unexpected return to reference Humira. The Center for Biosimilars. June 30, 2025. Accessed February 24, 2026. 

https://www.centerforbiosimilars.com/view/adalimumab-double-take-the-unexpected-return-to-reference-humira

Biosimilars save billions, but FDA’s new guidance, physician concerns, and Humira switchbacks reveal hurdles to a sustainable US market.

Cardinal Health Biosimilar Report: $56 Billion in Savings and the Road to Market Sustainability

Access to antibody-drug conjugates remains uneven in many low- and middle-income countries, leaving clinicians to balance evidence-based care with financial realities.

 In that context, new real-world data from India evaluated whether a trastuzumab emtansine biosimilar could deliver outcomes comparable to the reference product for patients with HER2-positive metastatic breast cancer.

Real-world data from India evaluated whether a trastuzumab emtansine biosimilar could deliver outcomes comparable to the reference product for patients with HER2-positive metastatic breast cancer. | Image credit: Bangkok Click Studio - stock.adobe.com

In a retrospective, single-center analysis 

, Chandrakanth and colleagues assessed the safety and effectiveness of Ujvira (ZRC-3256), a biosimilar to trastuzumab emtansine (T-DM1), in 51 patients treated at a tertiary oncology center in India. The reference product, Kadcyla, had previously demonstrated improved progression-free survival (PFS) and overall survival in phase 3 trials such as EMILIA and TH3RESA. However, high acquisition costs limited its availability in many resource-constrained settings, prompting interest in lower-cost biosimilar alternatives.

All patients in the current cohort had HER2-positive metastatic breast cancer and prior exposure to trastuzumab. Ujvira was administered intravenously at 3.6 mg/kg every 21 days until disease progression or unacceptable toxicity. The primary end point was PFS, estimated using the Kaplan-Meier method. Secondary end points included objective response rate (ORR), safety as graded by CTCAE version 5.0, and exploratory subgroup analyses based on clinical and biomarker characteristics.

The mean (SD) age of participants was 58.0 (8.4) years, and 49.0% were 60 years or older. Most patients were postmenopausal (92.2%) and had an Eastern Cooperative Oncology Group performance status of 1 (64.7%). Comorbidity burden was notable: 60.8% had hypertension, and 58.8% had type 2 diabetes. More than 40% had at least 3 metastatic sites at baseline. HR-positive disease was common, with estrogen receptor positivity in 70.6% and progesterone receptor positivity in 54.9%. Nearly three-quarters (74.5%) had HER2 immunohistochemistry 3+ tumors, and 23.5% were fluorescence in situ hybridization–positive.

Patients were heavily pretreated. All had received prior trastuzumab; 84.3% had prior taxane exposure, 62.7% anthracyclines, 39.2% lapatinib, and 19.6% pertuzumab. Forty patients (78.4%) received Ujvira in the second-line setting, and 11 (21.6%) in the third-line setting.

Median PFS for the overall cohort was 6.9 months (95% CI, 6.2-9.0). In second-line use, median PFS was 7.7 months (95% CI, 6.2-10.5), compared with 9.1 months (95% CI, 1.47-not estimable) in the third-line setting; the difference was not statistically significant (

Exploratory subgroup analyses showed numerical but not statistically significant differences across clinical characteristics. Patients with brain metastases had a median PFS of 6.3 months compared with 9.1 months in those without central nervous system involvement (

 = .2203). Patients with diabetes had a median PFS of 7.0 months vs 9.37 months among those without diabetes (

 = .2405). Progesterone receptor–positive tumors were associated with numerically longer PFS (9.37 vs 7.7 months), although this did not reach statistical significance.

Treatment was generally well tolerated. The most common adverse events of any grade were thrombocytopenia (33.3%), anemia (19.6%), and neutropenia (7.8%). Elevated transaminases occurred in 3.9% of patients and represented the only reported grade 3 or higher toxicity. Reduced left ventricular ejection fraction below 50% was observed in 3.9% of patients. Dose reductions were required in 15.7% of patients because of treatment-related toxicities. Median PFS was similar among those who required dose reductions and those who did not (6.8 vs 6.9 months; 

 = .25), suggesting that dose modification did not appear to compromise effectiveness.

When contextualized against registrational trials of the reference product, the observed median PFS was shorter than the 9.6 months reported in the EMILIA study. The authors attributed this difference to the real-world nature of the cohort, including substantial comorbidity burden and prior exposure to multiple HER2-directed therapies. They also noted alignment with other real-world studies of T-DM1 that reported median PFS of approximately 6 months.

The study had several limitations. Its retrospective, single-center design introduced the potential for selection and reporting bias. The sample size was modest, limiting statistical power for subgroup comparisons and increasing the risk of type II error. Overall survival data were immature at the time of analysis, precluding robust comparisons with global benchmarks. Additionally, 2 authors were affiliated with the biosimilar’s manufacturer, although they reported limited roles in study conceptualization and manuscript review.

Despite these constraints, the findings add to the growing body of real-world biosimilar evidence in oncology. For managed care stakeholders in resource-limited settings, the data suggest that trastuzumab emtansine biosimilars may provide clinically meaningful disease control with a safety profile consistent with prior experience, even among heavily pretreated and comorbid patient populations.

Montemurro F, Delaloge S, Barrios CH, et al. Trastuzumab emtansine (T-DM1) in patients with HER2-positive metastatic breast cancer and brain metastases: exploratory final analysis of cohort 1 from KAMILLA, a single-arm phase IIIb clinical trial. 

. 2020;31(10):1350-1358. doi:10.1016/j.annonc.2020.06.020

Chandrakanth MV, Agarwala V, Manna R, et al. Real-world evaluation of a trastuzumab emtansine biosimilar (Ujvira) in human epidermal growth factor receptor 2 (HER2)-positive metastatic breast cancer. 

. Published online February 16, 2026. doi:10.7759/cureus.103700


Real-world India data show trastuzumab emtansine biosimilars deliver meaningful PFS and manageable safety in heavily pretreated HER2+ metastatic breast cancer.

Biosimilar Trastuzumab Emtansine Shows Consistent PFS in HER2-Positive Breast Cancer

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

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

 (pertuzumab-dpzb) injection, making it the first biosimilar approved for Perjeta (pertuzumab). Poherdy was also with interchangeability.

 This approval, granted to the product developed by Shanghai Henlius Biotech and commercialized by Organon, signals the expansion of biosimilar competition into the HER2-positive breast cancer treatment landscape.

FDA approves Poherdy, the first interchangeable biosimilar for Perjeta, enhancing competition in HER2-positive breast cancer treatment. | image credit: gustavofrazao - stock.adobe.com

Rationale for Approval and Approved Indications

The FDA’s decision to approve Poherdy was based on a comprehensive review of scientific evidence demonstrating that the product is highly similar to Perjeta and possesses no clinically meaningful differences in terms of safety and effectiveness. The evidence package included a detailed analytical comparison utilizing an extensive battery of physicochemical tests and biological assays across multiple manufactured lots, confirming similarity in structural and functional features known to impact safety and efficacy.

Clinical data supporting the approval included results from a human pharmacokinetic (PK) similarity study in healthy adult participants, which confirmed similar exposure between Poherdy and Perjeta after a single intravenous infusion. Additionally, data from a study involving patients with early HER2-positive and HR-negative breast cancer in the neoadjuvant setting supported Poherdy's approval as an interchangeable biosimilar.

Poherdy is a HER2/neu receptor antagonist that targets subdomain II of HER2, working in concert with trastuzumab to augment antitumor activity. It was approved for all the same treatment indications currently approved for Perjeta in adults, including:

Use in combination with trastuzumab and docetaxel for HER2-positive metastatic breast cancer in adults who have not received prior anti-HER2 therapy or chemotherapy for metastatic disease

Use in combination with trastuzumab and chemotherapy as neoadjuvant treatment for adults with HER2-positive, locally advanced, inflammatory, or early-stage breast cancer (greater than 2 cm or node positive)

Use in combination with trastuzumab and chemotherapy as adjuvant treatment for adults with HER2-positive early breast cancer at high risk of recurrence.

Next Steps: Legal Battles and Market Dynamics

The approval of Poherdy thrusts its developers, Shanghai Henlius Biotech and Organon, into the familiar territory of patent litigation, mirroring patterns seen previously in the adalimumab, ustekinumab, and etanercept markets.

Genentech and Hoffman-La Roche, the originators of Perjeta, have already filed the first patent infringement case concerning the pertuzumab biosimilar against Shanghai Henlius Biotech and Organon.

 The complaint, filed in the US District Court of New Jersey, alleges that the proposed biosimilar could reasonably infringe on 24 patents related to Perjeta. Genentech is seeking multiple forms of relief, including judgments of infringement, preliminary and/or permanent injunctions, and damages. Such litigation frequently leads to delayed market launches and prolonged monopolies.

The broader oncology landscape is gearing up for a significant wave of biosimilar competition, with the market opportunity expected to reach approximately $25 billion by 2029.

 The success of new entrants like Poherdy will depend heavily on offering steep net price discounts to gain rapid payer and provider adoption, a strategy that drove successful uptake for earlier oncology biosimilars (referencing Herceptin, Rituximab, and Avastin).

Policy Ambiguity: Interchangeability and Draft Guidances

Poherdy's designation as the first interchangeable biosimilar for Perjeta carries significant policy weight, although its practical impact in oncology may be limited. Interchangeability allows for substitution at the pharmacy level without prescriber consultation, similar to generic drugs.

 However, laws regarding interchangeability have never restricted access to provider-administered biologics—which often includes many oncology treatments like Poherdy (an injection)—meaning patients receiving clinic-based therapies can already access biosimilars regardless of this status.

Meanwhile, policy surrounding biosimilar development and interchangeability remains in flux at the FDA level, with key draft guidances yet to be finalized.

 The FDA has released draft guidance suggesting that comparative efficacy studies may be waived for a biosimilar biologics license application if the product is analytically well-characterized, a move intended to trim development costs (estimated between $100 million and $300 million per program) and shorten timelines. 

Similarly, updated draft guidance on interchangeability proposes removing the requirement for expensive switching studies, citing emerging scientific consensus that switching risk is insignificant.

 These unfinalized guidances create potential confusion for manufacturers as they plan their subsequent launches. Furthermore, while federal officials have expressed strong political support for considering all biosimilars interchangeable, state laws requiring specific prescriptions or banning automatic substitution create ambiguity about the immediate practical effect of this designation across the country.

Remaining Challenges for Oncology Biosimilars

Despite the momentum generated by Poherdy's approval, the oncology biosimilar space faces several systemic challenges:

 A major long-term issue remains the "biosimilar void," where only about 10% of the biologics expected to lose patent protection between 2025 and 2034 have biosimilars in active development.

 This gap is driven by prolonged development timelines, manufacturing complexity, and limited return on investment for treatments targeting smaller patient populations.

 Even with lower list prices, the benefit of biosimilars may not reach patients due to prevailing rebate structures and reimbursement policies negotiated between pharmacy benefit managers (PBMs) and manufacturers.

 PBM policies often favor more expensive originator products, thereby inhibiting biosimilar uptake.

 Reference product manufacturers often deploy lifecycle management tactics, such as winning approval for new routes of administration or new indications, to protect exclusivity and limit the scope of biosimilar extrapolation on labels.

 The possibility of the US imposing tariffs on international pharmaceutical products and active pharmaceutical ingredients adds complexity, particularly since many biosimilars are developed by international companies.

The successful entry of Poherdy into the US market is a step forward for competition in oncology, putting pressure on reference product manufacturers like Roche.

 However, to realize the full potential of these treatments—including cost reductions and broader patient access—regulatory advancements must be paired with commercial reforms, litigation certainty, and stakeholder education to ensure long-term confidence in biosimilars.

1. FDA approves first interchangeable biosimilar to Perjeta to treat certain types of breast cancer. FDA. November 13, 2025. Accessed November 13, 2025. 

https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-first-interchangeable-biosimilar-perjeta-treat-certain-types-breast-cancer

2. Yadav P, Corridon C, Mathuria M. The next frontier: oncology biosimilars in 2025 and beyond. The Center for Biosimilars

. January 13, 2025. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/the-next-frontier-oncology-biosimilars-in-2025-and-beyond

3. Genentech files first pertuzumab BPCIA complaint against Shanghai Henlius and Organon. 

. August 18, 2025. Accessed November 18, 2025. 

https://www.jdsupra.com/legalnews/genentech-files-first-pertuzumab-bpcia-3305474/

4. Poore D. Breaking down biosimilar barriers: interchangeability. The Center for Biosimilars. November 14, 2024. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-interchangeability

5. Jeremias S. A closer look at new FDA guidance removing barriers to biosimilar development. The Center for Biosimilars. October 30, 2025. Accessed November 18, 2025. 

6. Jeremias S. FDA draft guidance removes switching study requirements for biosimilar interchangeability. The Center for Biosimilars. June 20, 2024. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/fda-draft-guidance-removes-switching-study-requirements-for-biosimilar-interchangeability

7. Jeremias S. The biosimilar void: 90% of biologics coming off patent will lack biosimilars. The Center for Biosimilars. February 5, 2025. Accessed November 18, 2025. 

8. Jeremias S. The age of adalimumab is upon us: how stakeholders can prepare. The Center for Biosimilars. June 28, 2023. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/the-age-of-adalimumab-is-upon-us-how-stakeholders-can-prepare

9. Jeremias S. The Trump administration’s drug price actions and why US prices are already sky-high. The Center for Biosimilars. May 17, 2025. Accessed November 18, 2025. 

https://www.centerforbiosimilars.com/view/the-trump-administration-s-drug-price-actions-and-why-us-prices-are-already-sky-high

FDA approves Poherdy, the first interchangeable biosimilar for pertuzumab (Perjeta), enhancing competition in HER2-positive breast cancer treatment.

FDA Approves Poherdy: First Interchangeable Biosimilar to Perjeta

Not all adalimumab biosimilars are created equal when it comes to formulation design, injection devices, and patient support services—differences that may affect comfort, adherence, and access for individuals using these therapies around the world, according to a new international analysis.

, compared adalimumab biosimilars and the originator Humira across 9 countries. The authors said the goal was to help prescribers navigate a growing number of products that are clinically comparable but differ in nonpharmacologic features that can shape patient experience.

Explore the diverse landscape of adalimumab biosimilars, focusing on formulation, devices, and patient support programs that enhance treatment experiences. | Image Credit: hamkin - stock.adobe.com

Patent Expirations Drive Rapid Market Expansion

Humira, a fully human monoclonal antibody that inhibits tumor necrosis factor (TNF)–α, was first approved by the FDA in 2002 for rheumatoid arthritis and later for Crohn disease and ulcerative colitis. Global patents for the product began expiring in 2018 in Europe and Australia and in 

, paving the way for what experts hoped would be a surge in biosimilar competition.

The research team gathered information from global medication registries and regulatory agencies, including the FDA, European Medicines Agency, and Health Canada, as well as authorities in Australia, India, Singapore, and the UK.

 Data were supplemented with responses from pharmaceutical manufacturers and expert insights from gastroenterologists in each participating country.

By late 2024, more than 20 adalimumab biosimilars had entered markets worldwide. The study examined 14 products in detail: 13 biosimilars and the originator Humira. Data collection concluded in September 2024, with analysis focusing on device characteristics, formulation type, and the breadth of available patient support systems.

While all products share comparable efficacy and safety with the originator, the authors noted that subtle distinctions—such as excipient composition, device usability, and availability of patient support—may meaningfully impact patient satisfaction and persistence on therapy.

In total, 29 adalimumab products were identified worldwide, though many were marketed only in limited regions or lacked publicly available information. Among the 14 analyzed in depth, the authors reported notable variation in device and formulation features.

All products were available as either prefilled syringes (PFS) or auto-injectable pens (AIPs), with AIPs incorporating retractable needles to reduce needlestick risk. Most devices used 29-gauge needles, although Amgevita and Cyltezo prefilled syringes used slightly larger 27-gauge needles.

Injection mechanisms also differed: some pens delivered the drug in 2 steps, while others required a third button-press step, which could affect usability for individuals with limited dexterity.

Concentration and excipient profiles varied across brands. Several newer biosimilars—such as Yuflyma, Hukyndra, and Cyltezo—offered high-concentration (100 mg/mL), citrate-free formulations that may reduce injection volume and site discomfort. Older products, including Humira and Hadlima, retained citrate in small amounts.

Shelf life and storage flexibility also distinguished products. Imraldi offered the longest refrigerated shelf life (42 months), while Yuflyma, Abrilada, Hukyndra, and Xelenka could be stored at room temperature for up to 30 days. Humira and several others lasted only 14 days outside refrigeration. All reviewed products were latex-free except for certain versions of Cyltezo and Amgevita.

Stronger Patient Support Programs in Australia, Canada, and the US

Patient support program (PSP) availability differed significantly between countries. Programs in Australia, Canada, and the United States were the most comprehensive, often providing 1-on-1 injection training, educational videos, help hotlines, and adherence reminders.

Some manufacturers also offered additional resources. In Australia, for example, Idacio patients could access online cognitive behavioral therapy modules, and Humira users were eligible for personalized health coaching calls covering nutrition or lifestyle goals. Amgevita and Hadlima offered both digital reminders and refill notifications, while all major products in Australia provided sharps containers and travel packs.

In contrast, PSPs in India, Japan, and Portugal were less standardized and sometimes limited to online informational portals or printed materials. The authors noted that these disparities may affect how confident and supported individuals feel when starting biologic therapy.

The investigators acknowledged that not all manufacturers responded to data requests, particularly those marketing products exclusively in India and other emerging markets. Additionally, the analysis focused on product attributes and support programs rather than clinical or adherence outcomes, limiting conclusions about how these features affect real-world use.

The study’s authors emphasized that although all adalimumab biosimilars are designed to be therapeutically equivalent, their practical differences matter. Formulation concentration, injection ease, storage requirements, and patient education resources can influence both provider preference and patient adherence.

“Adalimumab biosimilars have various strengths and weaknesses, and no single product is perfect for every patient,” the researchers wrote. “It’s important to choose a product that fits each patient’s individual needs and healthcare situation.”

New findings explore the adalimumab biosimilar landscape, focusing on formulation, devices, and patient support programs that enhance treatment experiences.

Christina Mattina

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