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

Skylar Jeremias

People living with moderate-to-severe rheumatoid arthritis (RA) may soon have access to a more affordable treatment option, as new data confirmed that biosimilar AVT05 performed comparably to the reference product (RP) golimumab (Simponi) across efficacy, safety, and immunogenicity measures over 1 year.

One-year trial shows AVT05 golimumab biosimilar matches Simponi in rheumatoid arthritis, including switching, with comparable safety and immunogenicity outcomes. | Image credit: Valentina - stock.adobe.com

, was conducted to establish biosimilarity between AVT05 and RP golimumab in support of regulatory submissions to both the FDA and the European Medicines Agency (EMA). Biologic therapies such as golimumab carry high costs that can limit patient access, and biosimilars represent a potential pathway to broader treatment availability without compromising clinical outcomes.

The multicenter, randomized, double-blind, parallel-group, active-controlled trial was conducted across 36 European sites between March 2023 and September 2024. Investigators enrolled 502 adults with active RA, randomizing participants 1:1 to receive either AVT05 (n = 251) or RP golimumab (n = 251), each administered as a 50 mg subcutaneous injection once every 4 weeks in combination with methotrexate.

Participants were adults aged 18 to 75 years with a diagnosis of active RA for at least 4 months prior to screening. Eligibility required a Clinical Disease Activity Index score greater than 10.1 at screening, at least 6 swollen and 6 tender joints, and C-reactive protein (CRP) levels above 1 mg/L. All participants had been taking methotrexate at a stable dose for at least 12 weeks prior to enrollment.

The study population was predominantly female (approximately 80%) and white (approximately 99%), with a mean age of roughly 55 years across both arms. While the groups were well balanced at baseline, the narrow racial and ethnic composition of the sample reflects the European site selection and may limit generalizability to broader patient populations.

At week 16, participants who met responder criteria, defined as a decrease in Disease Activity Score-28 for RA using CRP (DAS28-CRP) of more than 0.6 from baseline and a disease activity DAS28-CRP of 5.1 or lower, continued in the study. Responders originally assigned to the RP arm were re-randomized 1:1 to either continue RP or switch to AVT05, allowing investigators to assess the clinical impact of a real-world-like treatment transition.

The primary endpoint was change from baseline in DAS28-CRP at Week 16. The least squares mean change was −2.89 for the AVT05 group and −2.98 for the RP group, yielding a least squares mean difference of 0.09. The 95% confidence interval (−0.07 to 0.25) fell entirely within the prespecified EMA equivalence margin of −0.6 to 0.6, and the 90% confidence interval (−0.05 to 0.22) fell within the FDA margin of −0.6 to 0.54, supporting a finding of comparable efficacy. Two sensitivity analyses produced identical confidence intervals, reinforcing the robustness of the primary result.

Secondary endpoints, including American College of Rheumatology 20/50/70 response rates and changes in the Simplified Disease Activity Index and Clinical Disease Activity Index, were consistent with the primary finding through week 52. Notably, participants who switched from RP to AVT05 at week 16 maintained stable disease activity scores through the end of the study, with no clinically meaningful differences compared to those who remained on their original treatment.

The overall incidence of treatment-emergent adverse events (TEAEs) was comparable between arms through week 16, at 38.2% in the AVT05 group and 41.8% in the RP group. The most commonly reported TEAEs included urinary tract infection and, later in the study, upper respiratory tract infection and nasopharyngitis. 1 participant in the RP group died before Week 16 due to a metastatic neoplasm that was assessed as related to study treatment; no deaths occurred after week 16. No new safety signals emerged in either arm.

Immunogenicity profiles were also comparable. Through week 16, treatment-emergent binding anti-drug antibodies were detected in 54.1% of participants in the AVT05 group and 58.3% in the RP group. Neutralizing antibody rates were similarly parallel. Switching from RP to AVT05 did not appear to alter immunogenicity profiles.

The authors noted that the sensitivity of the anti-drug antibody assay resulted in nearly all participants testing positive, which made it difficult to evaluate the impact of immunogenicity on efficacy or pharmacokinetic outcomes. Additionally, the 52-week duration, while sufficient for regulatory purposes, may not capture rare long-term adverse events. Longer follow-up studies will be needed to further characterize AVT05's safety profile over time.

The study was funded by Alvotech Swiss AG, the manufacturer of AVT05, and all authors were employees or former employees of the company at the time the research was conducted.

Luque M, Zhelyazkova K, Vashishta L, et al. Efficacy and safety of biosimilar AVT05 versus reference product golimumab in combination with methotrexate in moderate-to-severe rheumatoid arthritis: 52-week results of a randomized, parallel-group, double-blind study. 

. 2026;40(135-149). doi:10.1007/s40259-025-00748-8

Articles

One-year trial shows AVT05 golimumab biosimilar matches Simponi in rheumatoid arthritis, including switching, with comparable safety and immunogenicity outcomes.

Golimumab Biosimilar Matches Reference Drug in Year-Long RA Trial

Patients with inflammatory rheumatic and musculoskeletal diseases who switched from reference etanercept to a biosimilar version maintained comparable treatment outcomes, 

according to a narrative literature review published in 

Real-world evidence shows switching between etanercept products and etanercept biosimilars preserves efficacy and safety, easing concerns and highlighting nocebo challenges. | Image credit: Phichaphat - stock.adobe.com

Researchers conducted the review in response to persistent barriers limiting biosimilar adoption worldwide, particularly prescriber and patient concerns about whether switching from a reference biologic to a biosimilar could compromise safety or efficacy.

 Despite cost-saving potential, biosimilar uptake has remained suboptimal in several countries, including Canada and the United States, where the reference etanercept price in 2019 was reported to be more than 3 times higher than in Germany. The nocebo effect, in which patients experience new or worsening symptoms driven by negative expectations rather than pharmacological changes, has been identified as one of the more difficult barriers to address.

To examine the current body of evidence, investigators searched PubMed in November 2024 using terms related to etanercept biosimilar switching. After removing duplicates and screening for relevance, the team identified 18 peer-reviewed original articles meeting inclusion criteria: 4 reporting data from controlled clinical trials and 14 from real-world studies. Articles were excluded if they involved healthy volunteers, did not specify the biosimilar used, or were congress abstracts only.

The 4 included phase 3, randomized, double-blind trials evaluated 3 biosimilars—SDZ-ETN (Erelzi), SB4 (Benepali), and LBEC0101 (Eucept)—across a combined switching population of 1091 patients. Enrolled patients carried diagnoses of either rheumatoid arthritis (RA) or plaque psoriasis (PsO).

In the EQUIRA trial, 376 patients with moderate-to-severe RA who switched from reference etanercept to SDZ-ETN at week 24 demonstrated Disease Activity Score in 28 joints with C-reactive protein and functional assessment score changes from baseline to week 48 that were comparable to those who remained on continuous SDZ-ETN. 

Similarly, the EGALITY trial, the only controlled trial to evaluate multiple switches, enrolled 531 patients with PsO who underwent up to 3 switches between reference etanercept and SDZ-ETN, with Psoriasis Area and Severity Index scores remaining similar across pooled continued and switched treatment groups through week 52. Trials evaluating SB4 and LBEC0101 in patients with RA produced consistent findings through 100 weeks of follow-up. No new or unexpected safety signals were reported in any of the 4 trials, and anti-drug antibody presence was infrequent and comparable between switchers and non-switchers.

The 14 real-world studies enrolled a combined 7174 patients, of whom 4044 switched between reference etanercept and a biosimilar. More than half of all switchers carried a diagnosis of RA, with the remainder having psoriatic arthritis, axial spondyloarthritis, ankylosing spondylitis, or PsO. Nine studies examined single switches to SB4, 2 evaluated multiple switches involving SB4 and SDZ-ETN, and 1 study each addressed SDZ-ETN, YLB113, and LBEC0101.

Across studies, switching did not meaningfully affect disease activity scores or patient-reported outcome measures. One-year retention rates in the COMPACT study following a switch to SDZ-ETN reached 91.2%, while rates among SB4 switchers ranged from 83.0% to 88.6% across studies. Two SB4 studies identified a potential nocebo effect in patients with RA, in which those who discontinued treatment showed statistically significant increases in subjective disease activity measures but minimal changes in objective inflammatory markers such as C-reactive protein and swollen joint counts. Patients with RA who had a longer duration on reference etanercept prior to switching demonstrated higher biosimilar withdrawal rates in these studies, though the observational designs precluded causal conclusions.

The authors acknowledged several limitations. The included studies varied substantially in design, patient characteristics, follow-up duration, and geographic setting, limiting direct cross-study comparisons. As a narrative rather than systematic review, the manual selection process introduced potential for selection bias. Additionally, data on multiple biosimilar switches, patient-reported outcomes following switching, and the prevalence of the nocebo effect across different patient populations remained limited, with the authors calling for further research in each of these areas.

The review was funded by Sandoz, and 2 authors were employees of Sandoz Limited at the time of publication. The remaining authors disclosed consulting fees, speaker honoraria, or other relationships with various pharmaceutical manufacturers.

1. 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. 

 2026;43(1):49-75. doi:10.1007/s12325-025-03367-5

2. Jeremias S. Biosimilars account for 23% market share, with wide uptake disparities across molecules. The Center for Biosimilars

. May 22, 2024. Accessed March 16, 2026. 

https://www.centerforbiosimilars.com/view/biosimilars-account-for-23-market-share-with-wide-uptake-disparities-across-molecules

3. Jeremias S. Nocebo effect is difficult to diagnose in patients switched to biosimilars. The Center for Biosimilars. March 17, 2020. Accessed March 16, 2026. 

https://www.centerforbiosimilars.com/view/nocebo-effect-is-difficult-to-diagnose-in-patients-switched-to-biosimilars

Real-world evidence shows switching between etanercept products and etanercept biosimilars preserves efficacy and safety, easing concerns and highlighting nocebo challenges.

Switching to Biosimilar Etanercept Shows No Impact on Efficacy, Safety Across 18 Trials

Despite over a decade of biosimilar insulin availability and growing pressure on health care systems to adopt cost-saving alternatives, a new scoping review revealed that stakeholders across the care continuum remain uncertain about switching.

Scoping review shows clinicians and patients still worry about biosimilar insulin switching, devices and safety—evidence gaps shape insulin product swaps. | Image credit: Syda Productions - stock.adobe.com

 the review aimed to systematically map and summarize existing literature on the perceptions and experiences of biosimilar insulin switches among health care professionals (HCPs), health service administrators (HSAs), and people with diabetes. The authors were motivated by the increasing prevalence of managed switch programs and the apparent lack of evidence guiding their implementation. In the UK alone, freedom of information requests had identified at least 13 regions that had already undertaken some form of biosimilar insulin switch program, with 6 more planning to do so.

Researchers searched 3 bibliographic databases (PubMed, Web of Science, and CINAHL Ultimate) and conducted supplementary gray literature searches of regulatory agency and patient advocacy group websites. Of 235 total records identified, 20 met inclusion criteria. Eligible articles included research studies (n = 8), reviews (n = 8), guidance documents (n = 3), and 1 opinion piece, published from January 2014 onward across countries, including the US, UK, Canada, Japan, Belgium, and India. No restrictions were placed on patient characteristics or health care setting.

Awareness of biosimilar principles was high among HCPs across the included studies, with pharmacists demonstrating the strongest knowledge base. However, 67% of surveyed HCPs reported a lack of practical switching experience. Concerns about safety and efficacy were elevated when switching established patients compared with initiating biosimilars in insulin-naive patients, and diabetologists expressed notably higher concern than specialists in other fields; fewer than 10% of gastroenterologists reported major concerns, compared with rates reaching 63% among nurses and up to 50% among pharmacists when asked about switching efficacy.

Barriers to prescribing included a perceived lack of long-term safety data, uncertainty about interchangeability, and concerns over differences in delivery devices. Several HCPs and guidance documents recommended against switching patients whose glycemic control was already satisfactory. Pharmacy-level substitution—switching without prescriber input—was considered a contested practice by many HCPs, who also raised concerns about the workload implications of managing device transitions. Notably, no studies documented the actual experiences of HCPs who had participated in a biosimilar insulin switch.

Only 3 research studies examined perspectives or experiences of people with diabetes, drawing from populations in the US, Canada, and Japan. A 2014 US study found that the majority of respondents (66%) expressed positive views about theoretically switching to a biosimilar insulin, with only 5% of people with type 1 diabetes indicating they would definitely not use one. Reasons for hesitancy included satisfaction with current therapy, perceived brand quality of the reference product, and prior negative experiences with generic drug switching.

A Japanese study found no meaningful change in treatment satisfaction, efficacy, or adverse events among patients with type 2 diabetes who switched from reference to biosimilar insulin glargine. A Canadian study examining a mandatory switch policy found that only 2.8% of patients subsequently returned to the reference product, though the authors noted that a strong financial incentive to remain on the biosimilar may have influenced that outcome. No studies examined patient perspectives specifically within publicly funded health care systems where cost is not a direct patient concern.

HSAs were primarily focused on administrative considerations, including formulary selection, legal responsibilities, and the need for structured transition plans. One Canadian study found no increase in healthcare resource utilization following a mandatory switch program. Financial themes ran throughout the literature: in publicly funded systems such as the UK's National Health Service, HCPs cited cost as the dominant prescribing consideration but noted that only modest price differences between products could serve as a disincentive.

The authors acknowledged several limitations. The body of literature was small, and most studies originated in higher-income countries, limiting applicability to low- and middle-income settings. Some earlier studies, published between 2014 and 2018, may not reflect current stakeholder attitudes, as biosimilar adoption has matured. Because this was a scoping review, no formal critical appraisal of included studies was conducted, restricting the authors' ability to assess evidence reliability.

The review concluded that high-quality, context-specific research is needed to meaningfully guide healthcare systems in implementing biosimilar insulin switch programs in ways that are acceptable to both clinicians and the people they treat.

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

Scoping review shows clinicians and patients still worry about biosimilar insulin switching, devices and safety—evidence gaps shape insulin product swaps.

Gaps in Knowledge Persist Around Biosimilar Insulin Switching, Review Finds

From corporate restructuring to pipeline setbacks and surging market penetration in Asia, recent developments across the biosimilar landscape reflect an industry simultaneously navigating opportunity and regulatory complexity.

Global biosimilar market shifts: Celltrion leads biosimilars in Asia, biosimilars in Europe expand, while Sandoz restructures and FDA hurdles loom. | Image credit: Planetz - stock.adobe.com

Sandoz Creates Unified Biosimilar Unit, Appoints New President

In a major organizational overhaul aimed at capitalizing on what company leaders described as a "golden decade" of opportunity, Sandoz Group AG announced the creation of a dedicated global biosimilar development, manufacturing, and supply unit, according to a press release published on the Sandoz website.

The company appointed industry veteran Armin Metzger as president of the new division and member of the executive committee. Metzger, who previously held senior roles at Ferring and Merck, is scheduled to officially join the Executive Committee on April 1, 2026.

The initiative was designed to capitalize on anticipated opportunities arising from the upcoming expirations of medical exclusivity, valued at more than USD 650 billion over the next decade. By consolidating all biosimilar activities, such as spanning development, manufacturing, and supply chain under a single executive, Sandoz is hoping to speed decision-making, deepen vertical integration, and tailor strategies to distinct market dynamics.

Concurrent leadership changes included the appointment of Claire D'Abreu-Hayling as president of generics development and Glenn Gerecke as president of generics manufacturing and supply, effectively separating the generics and biosimilars businesses under specialized leadership. Sandoz posted full-year 2025 revenue of $11.09 billion, with biosimilar sales growing 13% at constant currency to $3.29 billion, representing 30% of total revenue, underscoring why the company moved to sharpen its structural focus on the segment.

Outlook Therapeutics Evaluates Options After FDA Type A Meeting on Bevacizumab Candidate

In contrast to Sandoz's forward momentum, Outlook Therapeutics stated that it was still weighing its regulatory options for its bevacizumab ophthalmic candidate following a Type A meeting with the FDA, as reported by Pearce IP.

The Type A meeting was held to clarify the outstanding issue identified in the complete response letter (CRL), issued December 30, 2025, regarding substantial evidence of effectiveness for ONS-5010/LYTENAVA (bevacizumab-vikg)—and to discuss potential paths forward for regulatory approval. The biologics license application (BLA) had been submitted for the treatment of wet age-related macular degeneration (wet AMD).

Outlook Therapeutics stated it was evaluating available regulatory options to advance ONS-5010/LYTENAVA toward potential US approval, noting that the product demonstrated clinically meaningful and statistically significant improvements in visual acuity in the NORSE TWO randomized, double-masked, active-controlled phase 3 trial, which met its primary and key secondary end points.

The company noted that if approved, ONS-5010/LYTENAVA would be the first FDA-approved ophthalmic formulation of bevacizumab supported by standardized manufacturing, FDA-approved labeling, and robust pharmacovigilance. The product has already received marketing authorization in Europe and was commercially launched in Germany, Austria, and the United Kingdom for wet AMD treatment, providing some commercial foundation as the company navigated the US regulatory path.

Celltrion Biosimilars Achieve Dominant Shares Across Asian Markets

While others grappled with structural or regulatory challenges, Korean biopharmaceutical company Celltrion reported strong commercial gains across Southeast Asia and other key Asian markets, according to Korea BioMedical Review.

The company said it drove prescription growth in Malaysia, Singapore, Thailand, and Hong Kong through tender wins and localized sales strategies, with several key product lines achieving leading market shares.

Celltrion's flagship infliximab biosimilar, Remsima, held market shares of 93% in Singapore, 77% in Hong Kong, 73% in Thailand, and 65% in Malaysia as of the third quarter of 2025, according to IQVIA, a pharmaceutical market research firm. 

Performance extended beyond autoimmune disease. Herzuma (trastuzumab), a treatment for people with breast and gastric cancer, held prescription shares of 87% in Thailand, 57% in Hong Kong, and 51% in Malaysia as of Q3 2025, while Truxima (rituximab), a treatment for people with blood cancers, maintained leading prescription shares of 90% in Singapore and 79% in Thailand. 

Celltrion's adalimumab biosimilar, Yuflyma, was also gaining ground, surpassing its originator product to become the second-most prescribed treatment for people with autoimmune conditions in Singapore. Looking ahead, Celltrion's Thai subsidiary announced plans to launch 3 new biosimilars in 2026—ustekinumab, bevacizumab, and omalizumab—to build on its existing portfolio of 5 marketed products in the country.

Sandoz Group AG. Sandoz creates new global biosimilar development, manufacturing and supply unit, appoints industry veteran Armin Metzger to lead next phase of growth. Published March 10, 2026. Accessed March 10, 2026. 

https://www.sandoz.com/sandoz-creates-new-global-biosimilar-development-manufacturing-and-supply-unit-appoints-industry

Pearce IP. Outlook Therapeutics provides update regarding bevacizumab biosimilar after Type A FDA meeting. Published March 5, 2026. Accessed March 10, 2026. 

https://www.pearceip.law/2026/03/05/outlook-therapeutics-provides-update-regarding-bevacizumab-biosimilar-after-type-a-fda-meeting/

Lee H. Celltrion biosimilars secure leading share in key Asian countries. 

. Published March 9, 2026. Accessed March 10, 2026. 

https://www.koreabiomed.com/news/articleView.html?idxno=30850

Global biosimilar market shifts: Celltrion leads biosimilars in Asia, biosimilars in Europe expand, while Sandoz restructures and FDA hurdles loom.

Global Biosimilar Market Sees Structural Shifts, Regulatory Hurdles, and Pipeline Gains

Persons living with cancer, rheumatoid arthritis, or other conditions requiring costly biologic therapies may one day pay less for their medications—if a cascade of federal regulatory changes translates into meaningful market competition. 

Biosimilars make up just 5% of prescriptions in the US but accounted for 51% of total drug spending in 2024, and only about 10% of reference biologics that will lose patent protection in the next decade currently have a biosimilar in development. | Image credit: Tada Images - stock.adobe.com

On March 9, 2026, the FDA issued new draft guidance aimed at further reducing the time and expense of bringing biosimilars to market, the latest in a series of actions taken under the current administration to lower the cost of biologic drugs.

The draft guidance, titled "New and Revised Draft Q&As on Biosimilar Development and the BPCI Act (Revision 4)," recommends streamlining unnecessary clinical pharmacokinetic (PK) testing when scientifically justified. 

PK studies evaluate how the body processes a drug and have traditionally been required as part of demonstrating that a biosimilar behaves like its reference product. The FDA stated this change could save biosimilar developers up to 50% of their PK study costs, or approximately $20 million per program.

The March guidance also revises how developers may use international data. Specifically, it provided updated recommendations to biosimilar applicants seeking to use data from a comparator product approved outside the US as evidence that a proposed product is biosimilar to the US-licensed product—describing scenarios in which a biosimilar applicant may use such clinical data without conducting an additional 3-way PK study involving the proposed biosimilar, the US-licensed reference product, and the non–US-licensed comparator.

In a related action, the FDA withdrew its 2015 final guidance on demonstrating biosimilarity to a reference product, stating it no longer represents the agency's current thinking.

The March announcement builds on a prior FDA effort in October 2025, when FDA Commissioner Marty Makary, MD, MPH, announced draft guidance reducing certain unnecessary comparative efficacy studies (CES), which can require 1 to 3 years and cost $24 million.

That earlier guidance drew wide attention for proposing a significant shift in how biosimilarity is demonstrated. The FDA emphasized that current analytical technologies offer sufficiently sensitive tools to characterize highly purified therapeutic proteins and, in many cases, can detect minor differences more precisely than a clinical trial.

 Under that framework, a well-conducted comparative analytical assessment (CAA) is often more sensitive than a CES, whose outcomes may be affected by factors such as dose selection, patient population variability, or trial design.

Weighing Market Urgency With Cautious Optimism

The urgency behind these actions is grounded in a stark spending imbalance. Biosimilars make up just 5% of prescriptions in the US but accounted for 51% of total drug spending in 2024, and only about 10% of reference biologics that will lose patent protection in the next decade currently have a biosimilar in development.

Congress established the approval pathway for biosimilars in 2010 through the Biologics Price Competition and Innovation Act, and the FDA has since approved 82 biosimilars, providing additional treatment options for conditions such as cancer, rheumatoid arthritis, diabetes, Crohn disease, and osteoporosis—although that figure represents a small fraction of approved biologics overall.

Industry stakeholders and patient advocates largely welcomed the October and March guidance. The Biosimilars Forum described the October guidance as addressing the affordability crisis in prescription medicines, and Makary emphasized that regulatory barriers have prevented greater biosimilar entry into the US market and that expanding competition is essential to driving down biologic prices and improving patient access.

Still, analysts and health policy experts cautioned against reading the regulatory changes as a near-term solution to drug costs.

Taking the New Guidance With a Grain of Salt

Regulatory streamlining addresses only one of several layers of friction slowing biosimilar uptake in the US. Even with lower development costs and shortened timelines, significant structural barriers remain. Manufacturers have shown hesitation to invest in biosimilars for small patient populations where return on investment is limited, manufacturing complexity for advanced biologics continues to require specialized facilities and expertise, and even with streamlined guidance, bringing a biosimilar to market can take nearly a decade.

Patent protections pose a particularly stubborn challenge. A GlobalData health care analyst noted that branded biologics will still control the market through patents, which act as a bottleneck to market entry for biosimilars, meaning the guidance will not, on its own, improve patient access to biosimilars.

The guidance has also attracted pushback from organizations focused on biologic safety. The Alliance for Safe Biologic Medicines submitted comments to the FDA expressing strong concern over what it characterized as the "genericizing" of biosimilars, stating that the proposed shifts would be "scientifically inappropriate and potentially harmful to patient confidence" and urging the agency to regulate in a manner consistent with the recognition that biosimilars are not generics.

Without additional reforms—such as addressing rebate structures, patent thickets, prescriber incentives, biosimilar education gaps, and pharmacy benefit manager transparency—the US may not realize the full potential of biosimilar competition.

 The benefits of these regulatory reforms could take years to materialize, underscoring that policy change alone will not close the biosimilar access gap.

The FDA is accepting public comments on the March 9 draft guidance, and developers and payers alike are expected to weigh in before the guidance is finalized.

FDA takes further steps to streamline biosimilar development and make medicines more affordable. News release. FDA. March 9, 2026. Accessed March 9, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-takes-further-steps-streamline-biosimilar-development-and-make-medicines-more-affordable

Jeremias S. FDA guidance to remove one of the largest barriers to biosimilar development. 

. October 29, 2025. Accessed March 9, 2026. 

https://www.ajmc.com/view/fda-guidance-to-remove-one-of-the-largest-barriers-to-biosimilar-development

Jeremias S. A closer look at new FDA guidance removing barriers to biosimilar development. The Center for Biosimilars

. October 30, 2025. Accessed March 9, 2026. 

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

Jeremias S. The biosimilar void: 90% of biologics coming off patent will lack biosimilars. The Center for Biosimilars. February 5, 2025. Accessed March 9, 2026. 

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

The Center for Biosimilars. Biosimilar approvals. Updated December 22, 2025. Accessed March 9, 2026. 

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

Allen AK. FDA looks to simplify biosimilar development with new draft guidance. Clinical Trials Arena. October 30, 2025. Accessed March 9, 2026. 

https://www.clinicaltrialsarena.com/news/fda-biosimilar-approval-draft-guidance-2025

Worcester S. FDA aims to streamline biosimilar drug development. Medscape. November 21, 2025. Accessed March 9, 2026. 

https://www.medscape.com/viewarticle/fda-aims-streamline-biosimilar-drug-development-2025a1000whe

Biologics eat 51% of drug spending despite being 5% of prescriptions, but the FDA's new draft guidance hopes more competition can close that gap.

FDA Issues Draft Guidance Aimed at Cutting Expenses for Biosimilar PK Studies

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

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

The global biosimilar landscape continues to evolve as European regulators expand treatment options for patients with chronic conditions, while legal battles in the US highlight the ongoing tension between biosimilar manufacturers and originator companies over market entry.

European Regulators Recommend Approval for Fifth Teriparatide Biosimilar

On February 26, 2026, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending that a marketing authorization be granted for Zandoriah.

 Developed by CinnaGen, Zandoriah was designed as a biosimilar to the reference product Forsteo (teriparatide), which was produced by Eli Lilly.

Teriparatide is a recombinant form of parathyroid hormone (PTH). This agent serves as an anabolic, or bone-growing, treatment that activates osteoblasts to increase bone formation. The CHMP recommended Zandoriah for the treatment of postmenopausal women and men with osteoporosis who were at a high risk of fracture. Additionally, the recommendation covered patients with osteoporosis associated with sustained systemic glucocorticoid therapy.

Clinical data submitted to the committee demonstrated that Zandoriah possessed comparable quality, safety, and efficacy to its reference product. If the European Commission (EC) follows the recommendation, Zandoriah will become the fifth teriparatide biosimilar authorized in the European Union (EU), joining previously approved options such as Sondelbay and Terrosa. This marks the first biosimilar from CinnaGen to receive a positive CHMP opinion for the European market.

European Commission Grants Marketing Authorization for Gotenfia

Shortly before the recommendation for Zandoriah, the EC granted marketing authorization for Gotenfia (golimumab) on February 13, 2026.

 This biosimilar, which references Simponi, was developed through a partnership between Bio-Thera Solutions and STADA Arzneimittel AG. Gotenfia was approved for the treatment of patients with several chronic inflammatory autoimmune diseases, including rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and ulcerative colitis.

Gotenfia functions as a human monoclonal antibody that targets tumor necrosis factor alpha, a pro-inflammatory molecule. The authorization applied across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway. As the second golimumab biosimilar approved in the EU, Gotenfia was expected to increase market competition and lower unit costs for biological treatments.

STADA, which held exclusive commercialization rights in the EU and UK, noted that this was its 11th biosimilar authorization. Bio-Thera remained responsible for the development and manufacturing of the product. Launch preparations were reported to be underway to bring this once-monthly treatment option to healthcare providers and their patients in the coming months.

Genentech Initiates Patent Litigation Against Biocon Over Pertuzumab

While European markets expanded, the US saw new legal hurdles for biosimilar entry. On February 27, 2026, Genentech filed a formal complaint at the US International Trade Commission (ITC) alleging that Biocon’s importation of a pertuzumab biosimilar, BMAB 1500, violated Section 337 of the Tariff Act. Biocon’s biologics license application (BLA) referenced Perjeta (pertuzumab), a therapy used for patients with HER2-positive breast cancer.

Genentech contended that Biocon imported more than 17,800 pieces of the biosimilar from India in October 2025. The complaint characterized this activity as "stockpiling" commercial supplies before receiving approval from the FDA. Genentech argued that such conduct fell outside the patent infringement "safe harbor," which typically protects importation solely for the development of information for federal regulatory review.

The litigation involved 4 asserted patents covering the pharmaceutical compositions and manufacturing methods of the antibody. Genentech sought a limited exclusion order to block the importation of the product until the patents expired, with the latest expiration date set for September 2031. Unlike district court litigations, ITC investigations generally reach a final decision within 16 months and focus on excluding infringing products from the border rather than awarding monetary damages. This legal action followed a similar case involving another pertuzumab biosimilar, Poherdy, which was approved by the FDA in November 2025 and settled in early 2026. 

Generics and Biosimilars Initiative. EMA recommends approval for teriparatide biosimilar Zandoriah. Generics and Biosimilars Association. Published March 4, 2026. Accessed March 5, 2026. 

https://gabionline.net/biosimilars/news/ema-recommends-approval-for-teriparatide-biosimilar-zandoriah

Bio-Thera Solutions, Ltd., STADA, and Bio-Thera receive European marketing authorization for Gotenfia, a biosimilar to Simponi. Bio-Thera Solutions. News release. Published February 13, 2026. Accessed March 5, 2026. 

https://www.prnewswire.com/news-releases/stada-and-bio-thera-receive-european-marketing-authorization-for-gotenfia-a-biosimilar-to-simponi-302687571.html

Nock J, Wang S. ITC as a Biosimilar Battleground: Genentech Challenges Biocon's Pertuzumab Biosimilar. JD Supra. Published March 5, 2026. Accessed March 5, 2026. 

https://www.jdsupra.com/legalnews/itc-as-a-biosimilar-battleground-1228151/

CHMP backs a fifth teriparatide biosimilar as biosimilars in Europe grow, while US patent fights threaten new biologic competition.

Biosimilars Development Roundup: Expanding Global Options Amidst Rising US Legal Hurdles

For people with advanced hepatocellular carcinoma whose disease has progressed despite prior immunotherapy, treatment options have remained limited and largely empirical. New findings from the 

suggested that integrating stereotactic body radiotherapy (SBRT) with continued immune checkpoint inhibition and a bevacizumab biosimilar may offer a strategy to overcome resistance while maintaining an acceptable safety profile.

A phase 2 trial found that combining targeted radiotherapy with PD-1 blockade and a bevacizumab biosimilar generated meaningful responses in people with advanced liver cancer whose disease had progressed on prior immunotherapy. | Image credit: natali_mis - stock.adobe.com

The open-label, single-arm ReUNION-1 study, published in Nature Communications, evaluated SBRT followed by sintilimab (a PD-1 inhibitor) plus a bevacizumab biosimilar in people with unresectable hepatocellular carcinoma (HCC) whose disease had progressed after at least one prior anti–PD-1–based regimen. Immune checkpoint inhibitor resistance remains a substantial challenge in HCC, where objective response rates to monotherapy have historically ranged from 13% to 20%, and where second-line standards have largely been extrapolated from sorafenib-pretreated populations.

Between March 2022 and April 2024, investigators screened 25 patients and enrolled 21. All participants were included in the intention-to-treat analysis. The median age was 55 years, and 81.0% were men. All patients had Child-Pugh class A liver function and an Eastern Cooperative Oncology Group performance status of 0 or 1. Chronic hepatitis B virus infection was the predominant underlying liver disease (85.7%). Most patients (61.9%) had received one prior line of systemic therapy, and 71.5% had extrahepatic metastases. Nearly all had previously received a tyrosine kinase inhibitor plus a PD-1 inhibitor combination.

Patients underwent SBRT (median dose 8 Gy per fraction for 5 fractions) directed at a selected lesion, followed by sintilimab 200 mg and bevacizumab biosimilar 15 mg/kg every 3 weeks until disease progression or unacceptable toxicity. The primary end point was objective response rate (ORR) in nonirradiated lesions per RECIST v1.1 criteria.

At a median follow-up of 9.1 months, the ORR in nonirradiated lesions was 33.3%, with 7 of 21 patients achieving a confirmed partial response. Stable disease was observed in 7 additional patients, resulting in a disease control rate (DCR) of 66.7%. Notably, irradiated lesions demonstrated a 100% local-regional control rate, and 76.2% achieved an objective response within the treated field. Durable disease control lasting at least 6 months was observed among patients with partial response or prolonged stable disease.

Median progression-free survival (PFS) was 6.2 months (95% CI, 3.7-15.1), with 6- and 12-month PFS rates of 57.1% and 14.3%, respectively. The estimated median overall survival (OS) was 24.4 months (95% CI, 9.2 months–not reached). Eight deaths had occurred at data cutoff.

Treatment-related adverse events (TRAEs) of any grade occurred in 81.0% of patients. Grade 3 or higher TRAEs were reported in 33.3%, including decreased platelet count, neutropenia, and gastrointestinal hemorrhage. Two grade 4 gastrointestinal hemorrhages were managed with endoscopic intervention, and 1 patient experienced grade 3 anaphylaxis requiring discontinuation of sintilimab. No treatment-related deaths were reported, and 14.3% discontinued therapy due to serious TRAEs.

The study also incorporated serial proteomic and immune profiling analyses. Responders had lower baseline interferon-γ (IFN-γ) levels and higher IL-6 and TNF-α levels compared with nonresponders. Lower baseline IFN-γ levels were associated with longer PFS and OS; patients with low IFN-γ had a median OS of 24.4 months compared with 9.3 months in those with high IFN-γ (HR, 4.12; 95% CI, 1.36-12.46). SBRT was associated with increased circulating IL-6, IL-15, and CD70 levels and decreased VEGFA levels, suggesting immune modulation that may have contributed to renewed sensitivity to PD-1 blockade.

The investigators acknowledged several limitations, including the small sample size, single-arm design, and enrollment at a limited number of centers in China, where hepatitis B–related HCC predominates. The relatively short follow-up period and lack of a comparator arm limited definitive conclusions regarding survival benefit. In addition, prior treatment heterogeneity may have influenced outcomes.

For managed care stakeholders monitoring the evolving biosimilar landscape, the use of a bevacizumab biosimilar in combination with immunotherapy and radiotherapy demonstrated feasibility in a heavily pretreated population. Although confirmatory randomized trials are needed, the findings suggested that combining locoregional and systemic approaches may represent a viable strategy for people with HCC whose disease has progressed on prior PD-1–based therapy.

1. Tang J, Yang Y, Liu D, et al. Stereotactic body radiotherapy with sintilimab and bevacizumab biosimilar in anti-PD-1 refractory hepatocellular carcinoma: the ReUNION-1 phase 2 trial. 

. 2025;17(1):823. doi:10.1038/s41467-025-67528-4

2. Abou-Alfa GK, Lau G, Kudo M, et al. Tremelimumab plus durvalumab in unresectable hepatocellular carcinoma. 

. 2022;1(8):EVIDoa2100070. doi:10.1056/EVIDoa2100070

3. Qin S, Kudo M, Meyer T, et al. Tislelizumab vs Sorafenib as first-line treatment for unresectable hepatocellular carcinoma: a phase 3 randomized clinical trial. 

. 2023;9(12):1651-1659. doi:10.1001/jamaoncol.2023.4003

A phase 2 trial showed that combining targeted radiotherapy with PD-1 blockade and a bevacizumab biosimilar can elicit responses in advanced liver cancer.

Biosimilar-Backed Triplet Regimen Shows Feasibility in Heavily Pretreated Liver Cancer

More than €787 million was spent on omalizumab across 23 European countries in 2024 alone, underscoring the fiscal pressure associated with biologic treatment of severe allergic diseases.

 projected that the introduction of an omalizumab biosimilar could generate substantial savings for public payers over the next 5 years, with the potential to expand access to tens of thousands of additional patients.

Budget impact analysis finds omalizumab biosimilars in Europe could cut payer costs by €641M in 5 years, expanding access and driving major omalizumab savings. | Image credit: vadish - stock.adobe.com

Omalizumab, marketed as Xolair, is indicated for individuals with severe persistent allergic asthma, chronic spontaneous urticaria (CSU), and chronic rhinosinusitis with nasal polyps (CRSwNP). Although results from clinical trials have demonstrated reductions in exacerbations and improvements in quality of life, acquisition costs remain high. In the UK, annual treatment costs have ranged from £1664 to £26,624 depending on weight-based dosing.

 Across Europe, access has been constrained in some countries because of reimbursement restrictions and cost-effectiveness concerns.

To estimate the financial implications of biosimilar entry following patent expiry in September 2025, investigators developed a 5-year budget impact model from the payer perspective. The model compared a “world without biosimilars,” in which only originator omalizumab was available, with a “world with biosimilars,” in which a lower-cost biosimilar gradually captured market share. Twenty-three countries were included: Austria, Belgium, Bulgaria, Croatia, the Czech Republic, Finland, France, Germany, Greece, Hungary, Italy, Latvia, Lithuania, Luxembourg, Norway, Poland, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, and the UK. Countries were selected based on formulary listing, publicly available pricing, and IQVIA volume data.

Drug acquisition costs were derived from national list prices. The base-case analysis assumed that the biosimilar would enter the market at a 30% discount relative to the originator and that originator pricing would remain static—an assumption the authors noted likely underestimated real-world savings, as price erosion commonly occurs after biosimilar entry. Biosimilar uptake was modeled using adalimumab biosimilar adoption as a proxy, and omalizumab volume growth was extrapolated using historical compound annual growth rates between 2021 and 2024.

Budget impact analysis finds omalizumab biosimilars in Europe could cut payer costs by €641M in 5 years, expanding access and driving major omalizumab savings.