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

Skylar Jeremias

The FDA expanded an indication for a tocilizumab biosimilar to include cytokine release syndrome, Kashiv BioSciences and MS Pharma partnered on an omalizumab biosimilar for the Middle East and North Africa, and Lupin teamed with Sandoz on a ranibizumab biosimilar to improve global access to affordable biologics.

Discover the latest advancements in biosimilars, including tocilizumab's new indication, and partnerships for omalizumab and ranibizumab..

Tocilizumab Biosimilar Indication Expansion

 for the intravenous (IV) formulation of tocilizumab-anoh (Avtozma; Celltrion), a biosimilar to Actemra, to include treatment of cytokine release syndrome (CRS) in adults and children 2 years and older.

 This aligns Avtozma IV’s indications fully with the reference product, broadening therapeutic options for a potentially life-threatening complication of chimeric antigen T-cell therapy. CRS, caused by excessive release of proinflammatory cytokines like interleukin (IL)-6, can lead to severe inflammation, organ damage, and multi-organ failure. Tocilizumab-anoh, an IL-6 receptor antagonist, blocks IL-6 signaling to mitigate the inflammatory cascade while preserving the effects of immunotherapy. The FDA decision was supported by robust biosimilarity data, including a global phase 3 trial in rheumatoid arthritis, which also underpinned earlier approvals for multiple inflammatory conditions. Avtozma IV will be available in the US on August 31, 2025, following a patent settlement with Genentech, offering a cost-effective alternative that may reduce health care costs.

Kashiv BioSciences and MS Pharma have signed a 

 for ADL-018, Kashiv’s biosimilar candidate to Xolair (omalizumab), covering the Middle East and North Africa (MENA) region.

 Xolair generated about $4.5 billion in global sales and $60 million in MENA in 2024, according to IQVIA. Under the deal, Kashiv will handle product development, while MS Pharma will manage licensing, distribution, and commercialization, with the option for local manufacturing at its biologics facility in Saudi Arabia.

The companies emphasized their shared commitment to expanding access to biologic therapies and growing their specialty portfolios. MS Pharma aims to submit for regulatory approval in MENA in Q4 2025. Omalizumab is used to treat chronic urticaria, severe allergic asthma, chronic rhinosinusitis with nasal polyps, and immunoglobulin E–mediated food allergies. ADL-018 remains investigational and has not yet been approved or deemed biosimilar by any regulatory authority.

Lupin and Sandoz Partner on Ranibizumab Biosimilar

 with Sandoz to develop and commercialize a biosimilar version of ranibizumab, a treatment for retinal disorders such as age-related macular degeneration and diabetic macular edema.

 Under the arrangement, Lupin will oversee manufacturing and regulatory submissions, while Sandoz will manage commercialization in select global markets, with exclusive and semi-exclusive rights in those regions.

The partnership aims to improve patient access to affordable therapies for vision-threatening conditions. Lupin will focus on meeting stringent regulatory requirements during production and filing, and Sandoz will utilize its strong market presence to ensure effective distribution. The collaboration is expected to expand treatment availability in key regions and contribute to lowering health care costs associated with retinal disease management.

1. Serani S. FDA expands approval for tocilizumab biosimilar to treat CRS. Targeted Oncology

https://www.targetedonc.com/view/fda-expands-approval-for-tocilizumab-biosimilar-to-treat-crs

2. Levy S. Kashiv BioSciences, MS Pharma ink deal for Xolair biosimilar. Drug Store News. August 12, 2025. Accessed August 12, 2025. 

https://drugstorenews.com/kashiv-biosciences-ms-pharma-ink-deal-xolair-biosimilar

3. Chian M. Lupin Partners with Sandoz to develop and commercialize biosimilar ranibizumab for retinal disorders. Gene Online. August 12, 2025. Accessed August 12, 2025. 

https://www.geneonline.com/lupin-partners-with-sandoz-to-develop-and-commercialize-biosimilar-ranibizumab-for-retinal-disorders/

Articles

Discover the latest advancements in biosimilars, including tocilizumab's new indication, and partnerships for omalizumab and ranibizumab.

Biosimilar Business Recap: Updates on Tocilizumab, Omalizumab, and Ranibizumab Products

Japan’s slow uptake of therapeutic monoclonal antibody (mAb) biosimilars—despite more than a decade of regulatory approval—has led researchers to examine whether quality concerns are a factor.

 In a recent study, scientists analyzed the quality characteristics of biosimilar mAbs and their reference products approved in Japan, assessing multiple product lots to measure variation and lot-to-lot consistency.

 The findings aimed to inform clinically acceptable quality ranges and strengthen public confidence in biosimilars.

Researchers analyze the quality of monoclonal antibody biosimilars in Japan, revealing variations that impact adoption and public confidence in these therapies. | Image credit: Rawf8 - stock.adobe.com

Biosimilars are cost-effective alternatives to reference biologics that match their efficacy and safety but differ in cell lines and manufacturing processes. Japan’s Ministry for Health, Labour, and Welfare (MHLW) and the Pharmaceuticals and Medical Devices Agency (PMDA) introduced biosimilar guidelines in 2009, modeled on the European Union’s similarity concept.

 While 35 biosimilars have been approved since then, adoption of mAbs has lagged, with 2020 replacement rates at roughly 70% for rituximab, 40% for etanercept, and just 20% for infliximab—figures experts attribute partly to limited awareness of biosimilar quality and clinical evidence for certain indications.

The study examined reference products and biosimilars for infliximab, trastuzumab, rituximab, bevacizumab, and etanercept, purchased between 2019 and 2022. Key quality attributes measured included glycosylation profiles, charge heterogeneity, binding affinities to antigens and Fcγ receptors, high-molecular-weight species, and subvisible particles. Higher-order structures were also assessed. Similarity was evaluated against quality ranges defined by the reference product's standard deviation. Patient demographic information was not part of this product-focused characterization study.

The study confirmed that the degree of similarity in quality attributes varied for each biosimilar product when compared to its reference. Significant differences in overall glycan profiles were noted, particularly for infliximab, where different cell substrates influenced glycosylation. Some biosimilars (eg, specific infliximab, trastuzumab, rituximab, bevacizumab, and etanercept products) showed glycan content outside the reference product's quality range. Similarly, charge heterogeneity differed, with infliximab biosimilars exhibiting notable variations in basic variants. While lot-to-lot variation was present, no clear upward or downward drifts were observed among lots.

Regarding biological activities, no biosimilar products exhibited binding affinities to antigens outside the reference product's quality ranges. Differences in FcγRIIIa binding affinity correlated with glycosylation variations; for instance, certain infliximab and rituximab biosimilars had lower FcγRIIIa 158F affinity, while etanercept biosimilars showed higher affinity.

In terms of aggregation, some biosimilars had higher high-molecular-weight species content, but no products exceeded pharmacopoeial acceptance criteria for subvisible particles. Crucially, despite variations in glycan and charge profiles, all biosimilar products demonstrated similar higher-order structures to their corresponding reference products.

Researchers concluded that the observed quality differences, often consistent with prior regulatory review reports, were not considered to impact efficacy or safety at the time of approval. The absence of significant post-marketing adverse events for these products further suggests these observed ranges are clinically acceptable. The study underscores the importance of ongoing monitoring of quality attributes throughout a product's lifecycle to ensure continued safety and efficacy. This comprehensive post-approval analysis offers valuable information for healthcare providers, fostering a deeper understanding of biosimilar quality and supporting their continued integration into patient care.

1. Avhad VR, Patil SB. A comparison of US, Europe, Japan and India biosimilar regulation. 

. 2025;13(1):34-39. doi:10.22270/ijdra.v13i1.745

2. Shibata H, Harazono A, Kiyoshi M, Saito Y, Ishii-Watabe A. Characterization of biosimilar monoclonal antibodies and their reference products approved in Japan to reveal the quality characteristics in post‑approval phase. 

. 2025;39:645-667. doi:10.1007/s40259-025-00722-4

3. Biosimilars approved in Japan. Generics and Biosimilars Initiative (GaBI Online). Published March 7, 2014. Updated October 24, 2023. Accessed June 24, 2024. 

https://www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Japan

Researchers analyze the quality of monoclonal antibody biosimilars in Japan, revealing variations that impact adoption and public confidence in these therapies.

Japanese Study Provides Postapproval Insights Into Biosimilar Quality Attributes

Despite early price advantages and long-standing regulatory approval, biosimilar insulin glargine has yet to gain significant traction in the UK market.

 A comprehensive analysis of primary care prescribing data from 2020 to 2024 across all 4 nations of the UK revealed that originator insulin products, particularly Lantus (insulin glargine), continue to dominate prescriptions, raising questions about the effectiveness of market-based strategies alone in promoting biosimilar adoption.

Biosimilar insulin glargine struggles for market share in the UK, facing pricing challenges and prescriber inertia despite regulatory support and cost-saving potential. | Image credit: millaf - stock.adobe.com

, point to persistent barriers to biosimilar uptake and underscore the complexity of achieving cost savings in biologic prescribing through competition alone.

Since biosimilar insulin glargine first entered the UK market in 2014, there have been high hopes that these agents would drive down the cost of long-acting insulin therapy for patients with diabetes.

 Today, several biosimilar insulin glargine products are approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), including Abasaglar (biosimilar to Lantus), Semglee, and most recently, Insulin Glargine Medac.

 These biosimilars offer clinically comparable efficacy and safety to the originator product, Lantus, yet they continue to face resistance in widespread clinical adoption, only obtaining  24% market share in England, 5% in Northern Ireland, 24% in Scotland, and 11% in Wales in 2024, even after the MHRA declared all biosimilars as interchangeable with their reference products in 2022.

The present study, which reviewed prescribing patterns and pricing across England, Northern Ireland, Scotland, and Wales, found that Lantus consistently remained the most prescribed insulin glargine product throughout the study period.

 In fact, by 2024, Lantus was not only the market leader but also the least expensive option in all 4 nations—a reversal of expectations that further eroded incentives for biosimilar use. In England, for example, Lantus accounted for 66% of all insulin glargine prescriptions in 2020 and 65% in 2024, while biosimilars increased only slightly from 15% to 24% over the same period. Abasaglar was prescribed 6 times more often than Semglee, while use of generic descriptions declined by 63%.

Northern Ireland saw even less movement toward biosimilars. Lantus made up 90% of prescriptions across the 5-year span, and biosimilar usage barely nudged upward from 4% to 5%. In Scotland, total insulin glargine prescriptions declined by 13% from their 2020 peak, but Lantus maintained a 62% to 63% share. Although Semglee became available in mid-2023, biosimilar use only modestly increased from 20% to 24%. Wales showed a similar pattern, with Lantus holding 80% of the market by 2024 and biosimilar uptake climbing gradually from 7% to 11%.

A key factor dampening biosimilar growth was pricing. In mid-2021, Lantus underwent a series of price reductions that made it the least expensive insulin glargine product in every nation.

 By 2024, the actual price per pre-filled device in England had dropped to £6.83 for Lantus compared with £6.93 for Abasaglar.

 These price dynamics were similar in Scotland and Wales, even though only gross ingredient costs were available for those regions. Rather than allowing biosimilars to undercut the originator, Lantus’ manufacturer appears to have adjusted its pricing strategy to neutralize competitive threats and retain market share.

Despite support from the MHRA for biosimilar interchangeability, national prescribing guidelines from the British National Formulary do not permit automatic substitution, meaning that brand switching must be initiated by prescribers. This regulatory friction, combined with prescriber familiarity with Lantus and potentially limited awareness of the cost implications, may help explain why biosimilar adoption remains modest a decade after market entry.

These findings echo earlier concerns that the potential cost savings from biosimilars will remain unrealized without active measures to support their uptake. Although the UK continues to lead globally in biosimilar regulation and access, the case of insulin glargine demonstrates that achieving meaningful shifts in prescribing requires more than regulatory approval and competitive pricing. Addressing inertia in prescriber behavior, clarifying policy around switching, and better aligning economic incentives may be necessary steps to fully unlock the value of biosimilars in the UK health care system.

1. Agirrezabal I, Sánchez-Iriso E, Mandar K, Cabasés JM. Real-world budget impact of the adoption of insulin glargine biosimilars in primary care in England (2015–2018). 

. 2020.43(8):1767-1773. doi:10.2337/dc19-2395

2. Alsaif M, Blumer Z. Insulin glargine biosimilar prescribing and cost trends in the United Kingdom’s primary care from 2020 to 2024. 

. 2025;13(3):85. doi:10.3390/pharmacy13030085

3. Semglee summary of product characteristics. European Medicines Agency. Accessed July 5, 2025. 

https://www.ema.europa.eu/en/documents/product-information/semglee-epar-product-information_en.pdf

4. Abasaglar summary of product characteristics. European Medicines Agency. Accessed July 5, 2025. 

https://www.ema.europa.eu/en/documents/product-information/abasaglar-epar-product-information_en.pdf

5. Guidance on the licensing of biosimilar products. MHRA. February 27, 2025. Accessed July 5, 2025. 

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

6. Press release: Sanofi cuts U.S. list price of Lantus, its most-prescribed insulin, by 78% and caps out-of-pocket Lantus costs at $35 for all patients with commercial insurance. News release. Sanofi. March 16, 2023. Accessed July 5, 2025. 

http://sanofi.com/en/media-room/press-releases/2023/2023-03-16-20-06-43-2629188

Biosimilar insulin glargine struggles for market share in the UK, facing pricing challenges and prescriber inertia despite regulatory support and cost-saving potential.

Low Prices Fail to Boost Insulin Biosimilar Uptake in the UK

CT-P47, a biosimilar candidate to tocilizumab, has shown promising results in the treatment of rheumatoid arthritis (RA), according to findings from a phase 3 clinical trial conducted at 22 centers in Poland.

Over the course of a year, CT-P47 demonstrated comparable efficacy, safety, and immunogenicity to the reference product (Actemra/RoActemra), including among patients who transitioned from the originator biologic. The findings, 

, may strengthen payer and provider confidence in switching to biosimilars as a cost-effective alternative for RA care.

Tocilizumab’s Role and the Biosimilar Landscape

Tocilizumab, an interleukin-6 (IL-6) receptor inhibitor, has played a central role in RA management for over a decade. RA is a chronic autoimmune disease marked by inflammation and joint destruction, driven in part by elevated IL-6 activity.

The US and European markets for tocilizumab biosimilars are experiencing rapid growth. In the US, the FDA has approved several tocilizumab biosimilars, including Biogen's Tofidence (tocilizumab-bavi) in September 2023, Fresenius Kabi's Tyenne (tocilizumab-aazg) in March 2024, and most recently, Celltrion's CT-P47 (Avtozma; tocilizumab-anoh) in January 2025.

 Similarly, the European Commission has granted marketing authorization for multiple biosimilars, including Tyenne in November 2023, Tofidence in June 2024, and Avtozma in February 2025.

Despite the effectiveness of these biosimilars, the high cost of biologics like tocilizumab has limited access for some patients and driven interest in lower-cost biosimilar options.

Although biosimilars are increasingly entering the market, long-term data remain essential to validate their clinical equivalence. The European League Against Rheumatism (EULAR) has endorsed the use of biosimilars when supported by evidence of comparable efficacy and safety, but real-world data on switching remain limited. This trial aims to address that gap.

The multicenter, randomized, double-blind study enrolled adult patients (aged 18-75 years) with moderate to severe RA of at least 24 weeks’ duration, all of whom were on stable methotrexate therapy for at least 12 weeks prior to enrollment. Participants were randomized 1:1 to receive either CT-P47 or the reference product intravenously at a dose of 8 mg/kg every 4 weeks over the initial 20-week treatment phase.

At week 24, patients receiving CT-P47 continued treatment, while those on Actemra were rerandomized to either continue the reference product or switch to the biosimilar. All patients were then treated through week 48 and followed through week 52. Outcomes assessed included disease activity, radiographic progression, pharmacokinetics (PK), safety, and immunogenicity.

Among the 444 patients who completed the first treatment phase, 225 continued on CT-P47, 109 continued on Actemra, and 110 switched from Actemra to CT-P47. Efficacy, measured by the mean change from baseline in Disease Activity Score in 28 joints using erythrocyte sedimentation rate (DAS28-ESR), remained consistent through week 52 across all groups (CT-P47, −4.279; Actemra, −4.231; switch group, −4.376).

Radiographic progression, assessed using the modified total Sharp score, was minimal. More than 81% of patients in all groups showed no radiographic progression over the study period. Serum drug concentration levels remained stable, indicating similar PK profiles across treatment arms.

The incidence of antidrug antibodies was low (< 5%), and the safety profile was consistent with historical data for tocilizumab. No new safety concerns were identified in patients who switched to the biosimilar.

The results support CT-P47 as a viable biosimilar alternative for RA treatment and provide reassurance regarding the safety and efficacy of switching from the originator biologic. For clinicians, these findings add to the growing body of evidence supporting biosimilar use in rheumatology.

With rising biologic costs and growing RA prevalence, biosimilars such as CT-P47 may expand treatment access and relieve financial pressure on health systems. Broader uptake will depend on continued evidence generation, physician and patient education, and favorable reimbursement policies. Further real-world studies are needed to confirm these findings and support wider adoption.

1. Burmester G, Trefler J, Racewicz A, et al. Efficacy and safety of biosimilar CT-P47 versus reference tocilizumab: 1-year results of a randomised, active-controlled, double-blind, phase iii study in patients with rheumatoid arthritis. 

. 2025;45(8):551-563. doi:10.1007/s40261-025-01453-8

2. Biosimilar approvals. The Center for Biosimilars

. Updated August 5, 2025. Accessed August 5, 2025. 

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

CT-P47 emerges as a promising tocilizumab biosimilar, demonstrating comparable efficacy and safety in rheumatoid arthritis treatment, enhancing access and affordability.

Year-Long Phase 3 Study Confirms Tocilizumab Biosimilar Comparability With Actemra

The past month has seen significant developments in the biosimilar landscape, ranging from legislative proposals to combat market access barriers to new product approvals and ongoing challenges related to public and professional understanding. Here's a concise roundup of the key biosimilar news from July 2025.

Addressing Patent Thickets to Boost Access

A new report from the Association for Accessible Medicines (AAM) highlighted patent thickets as a major obstacle to biosimilar access, which drives up costs and delays affordable treatments.

 These "excessive webs of secondary patents" are filed by branded manufacturers to extend market exclusivity, leading to complex and costly litigation. US litigation involves a staggering number of asserted patents (11 to 65 per product), far exceeding other countries.

The AAM report proposed 3 legislative solutions: capping the number of asserted patents in biologic patent litigation, allowing biosimilar manufacturers freedom to settle litigation procompetitively, and providing a statutory safe harbor for carve-outs of patented methods of treating diseases. The authors argued that these changes will reduce litigation delays, limit patent abuse, and promote timely market entry, ultimately lowering health care costs and improving patient access.

Global Biosimilar Approvals Expand Treatment Options

Recent weeks have demonstrated global momentum in biosimilar regulatory advancements, with key approvals and positive opinions in the US, Europe, and Canada.

 The FDA accepted the biologics license application (BLA) for BAT2506, a proposed biosimilar to Simponi, intended for various autoimmune conditions.

In Europe, Alteogen received a positive opinion from the EMA for Eyluxvi (ALT-L9), a biosimilar to Eylea, for ophthalmic conditions like wet age-related macular degeneration. The European Commission also approved Denbrayce and Izamby, denosumab biosimilars referencing Xgeva and Prolia, respectively, for bone-related conditions and osteoporosis.

Canada also saw approvals for Aflivu and Yesafili, both biosimilars to Eylea. These approvals signify enhanced access to affordable, high-quality therapeutic options.

White Paper Offers Solutions to Avert a Biosimilar Market Void

After a previous report warned of a potential "biosimilar void," where 90% of biologics losing exclusivity in the next decade lack biosimilars in development, a new white paper from Samsung Bioepis proposes urgent policy reforms to ensure market sustainability, including:

Introducing free pricing at launch for biosimilars.

Implementing multi-winner tenders to diversify supply.

Linking biosimilar pricing to comprehensive health technology assessments.

Establishing minimum price boundaries to prevent excessive price erosion.

Promoting collaborative frameworks across Europe for harmonized policies. The report also highlights persistent skepticism among prescribers and patients, emphasizing the need for targeted education to build confidence.

The report warned that current pricing and reimbursement policies often undermine biosimilar sustainability. Mandated price cuts at launch and rigid reimbursement rules can distort competition and deter investment. Instead, the authors advocated for more flexible, market-based pricing models that allow biosimilars to compete on value rather than cost alone.

Medicare Price Negotiations May Slow Biosimilar Momentum

A report from Matrix Global Advisors suggested that government price negotiations under the Inflation Reduction Act may unintentionally hinder biosimilar development, potentially widening a "biosimilar void."

 Despite the IRA's goal to rein in high drug costs, the threat of negotiations may deter manufacturers from launching biosimilars, especially for high-sales biologics, risking billions in potential annual savings if biosimilar entry is delayed. The report advocated for fostering competitive markets rather than suppressing biosimilar entry through government pricing, stressing the need to address anticompetitive behaviors like patent thickets.

Insulin Biosimilar Gains in a Growing Market

The FDA approved Kirsty (insulin aspart-xjhz) as the first rapid-acting interchangeable biosimilar product to Novolog (insulin aspart).

 This is a crucial step towards enhancing access to more affordable insulin for millions of Americans with diabetes. The "interchangeable" designation allows Kirsty to be substituted for Novolog at the pharmacy without a new prescription in states where laws permit it, further streamlining patient access and driving competition. This approval follows Merilog (insulin-aspart-szjj), the first insulin aspart biosimilar, and two insulin glargine products.

Separately, a recent narrative review underscored persistent concerns among health care providers and patients regarding the efficacy, safety, and quality of biosimilar insulins compared with reference products.

 The review dissected the regulatory pathways in the European Union and the US, still ultimately confirming the safety and efficacy of insulin biosimilars. Researchers detailed the necessity of comparative analytical, functional, preclinical, and pivotal clinical pharmacology studies for approval.

Knowledge Gaps Hinder Biosimilar Adoption

Despite the growing presence of biosimilars, a recent analysis revealed significant knowledge gaps and uncertainties among both consumers and health care professionals (HCPs).

 A study using mock advertisements for a fictitious biosimilar found that overall comprehension of biosimilar information was suboptimal, with only 48.5% to 62.0% of consumers and 68.4% to 88.4% of HCPs accurately understanding core characteristics like comparable safety and efficacy.

The study noted that expanded definitions led to more positive attitudes and stronger prescribing intentions for HCPs, and both groups preferred more detailed definitions. These findings underscore an urgent need for clearer, more comprehensive educational initiatives to foster better understanding and adoption of biosimilars, which is vital for realizing their cost-saving benefits and expanding treatment access.

1. Jeremias S. Clearing the thicket: new report outlines legislative fixes to boost biosimilar access. The Center for Biosimilars

. July 29, 2025. Accessed July 31, 2025. 

https://www.centerforbiosimilars.com/view/clearing-the-thicket-new-report-outlines-legislative-fixes-to-boost-biosimilar-access

2. Jeremias S. New approvals expand access to biosimilars for ophthalmology, bone, and joint conditions. The Center for Biosimilars. July 28, 2025. Accessed July 31, 2025. 

https://www.centerforbiosimilars.com/view/new-approvals-expand-access-to-biosimilars-for-ophthalmology-bone-and-joint-conditions

3. Jeremias S. Medicare price negotiations will slow biosimilar momentum, widening market gap. The Center for Biosimilars. July 16, 2025. Accessed July 31, 2025. 

https://www.centerforbiosimilars.com/view/medicare-price-negotiations-will-slow-biosimilar-momentum-widening-market-gap

4. Jeremias S. White paper offers tips for sustaining biosimilar progress, avoiding a market void. The Center for Biosimilars. July 15, 2025. Accessed July 31, 2025. 

https://www.centerforbiosimilars.com/view/white-paper-offers-tips-for-sustaining-biosimilar-progress-avoiding-a-market-void

5. Jeremias S. FDA approves Kirsty as first interchangeable insulin aspart biosimilar. The Center for Biosimilars. July 15, 2025. Accessed July 31, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-kirsty-as-first-interchangeable-insulin-aspart-biosimilar

6. Jeremias S. Dispelling doubts: review affirms safety, efficacy of biosimilar insulins. The Center for Biosimilars. July 8, 2025. Accessed July 31, 2025. 

https://www.centerforbiosimilars.com/view/dispelling-doubts-review-affirms-safety-efficacy-of-biosimilar-insulins

7. Jeremias S. Consumers and providers face biosimilar knowledge hurdles. The Center for Biosimilars. July 7, 2025. Accessed July 31, 2025. 

https://www.centerforbiosimilars.com/view/consumers-and-providers-face-biosimilar-knowledge-hurdles

Explore the latest biosimilar developments, including legislative changes, new approvals, and challenges in understanding, shaping the future of affordable health care.

Biosimilars News Roundup: July 2025

The promise of biosimilars to revolutionize patient access and affordability in health care faces a formidable adversary: patent thickets. A recent white paper from the Association for Accessible Medicines (AAM) laid bare how complex patent landscapes and protracted litigation were significantly delaying the entry of more affordable biologic alternatives, ultimately impacting patients and straining the US health care system.

Patent Law. | Image Credit: WrightStudio - stock.adobe.com .jpeg

The report not only detailed these challenges but also outlined legislative solutions aimed at fostering a more competitive and sustainable biosimilar market.

The Costly Reality of Biologics and Patent Barriers

Biologic medicines have transformed the treatment of numerous diseases, offering life-changing therapies for many. However, their high cost remains a major concern. The AAM report highlighted that biologics accounted for more than half of all prescription drug spending, despite representing only a small percentage of total prescriptions.

Biosimilars were designed to address this imbalance, offering more affordable versions of these complex drugs. The report noted that prices typically dropped with each new biosimilar that entered the market, underscoring their potential for significant cost savings.

However, branded manufacturers often created "patent thickets,” which are essentially excessive webs of secondary patents filed as the original patents for a product neared expiry, often extending market exclusivity far past the intended date. Although some of these patents might have been genuinely innovative, many were not. The US Patent and Trademark Office was found to grant more secondary patents than its counterparts in other countries, contributing to this complex landscape.

“Patent thickets, and the prohibitively complex, expensive and risky patent litigations they enable, are hobbling biosimilar competition and delaying public access to these vital, safe and effective lower-cost medicines. For example, thickets, not allowed in Europe and other developed nations, directly contribute to the US paying more for drugs than other countries,” explained the authors.

The white paper revealed a striking difference in patent litigation practices between the US and other nations.

 In the US, branded companies asserted a staggering number of patents in biosimilar litigation—between 11 and 65 patents per product, far exceeding the numbers seen in countries like Canada and the UK. This led to incredibly expensive and time-consuming legal battles, often costing millions of dollars and stretching for years.

The intricate "patent dance" process, coupled with lengthy court proceedings and extensive discovery phases, exacerbated these delays (

The "patent dance" is a informal term referring to a structured, but optional, information exchange process outlined in the Biologics Price Competition and Innovation Act (BPCIA) of 2009 for biosimilar applicants and reference product sponsors to identify and potentially resolve patent disputes before a biosimilar enters the market. This process is designed to streamline and formalize patent litigation related to biosimilars, aiming to reduce the cost and time of bringing these products to market.

“Overburdened federal courts are poorly equipped to resolve these patent pile-ons quickly, inexpensively, or fairly. Biosimilar manufacturers are left with the difficult choice of spending years and millions of dollars to challenge hundreds—or even thousands—of patent claims in court or waiting out the patents until they expire. Neither choice helps patients,” the authors emphasized.

Furthermore, legislative proposals around patent settlements had inadvertently complicated matters, sometimes stifling procompetitive agreements and further delaying biosimilar launches.

“Even before biosimilar litigation commences, large patent estates thwart competition by requiring extensive freedom to operate challenges. Biosimilar companies must ‘clear the decks’ to compete with biologics without patent liability, and particularly when faced with large patent estates, must expend significant resources assessing such patents during development. In many cases, such patent landscaping analyses require time-consuming design around strategies and significant legal costs, ‘creating a moving target for its
biosimilar rivals,’” wrote the authors.

This means that patients continued to pay higher prices for branded biologics for longer than necessary, directly impacting their access to more affordable treatment options.

Paving the Way for a Sustainable Biosimilar Market

The AAM report didn't just identify problems; it proposed actionable solutions for Congress to consider. To accelerate biosimilar market entry and ensure long-term sustainability, the white paper suggested 3 key legislative changes.

First, Congress should cap the number of asserted patents in biologic patent litigation to a reasonable number. Legislation like HR 3269 (the ETHIC Act) and S 1041 (the Affordable Prescriptions for Patients Act) aimed to prevent brands from using excessive patent claims to block market entry.

Second, biosimilar manufacturers needed the freedom to settle time-consuming and expensive patent litigation in a procompetitive manner.

 The report advocated for reforms that encouraged, rather than restricted, such agreements, allowing for earlier market entry.

Finally, Congress should provide a statutory safe harbor for carve-outs of patented methods of treating diseases. Authors of the report claim that this could protect biosimilars when they excluded patented treatment methods from their labels, enabling faster access to lower-cost options without infringing patent rights.

In essence, these legislative changes aimed to reduce litigation delays, limit the abuse of patent rights, and promote timely biosimilar market entry. By enacting these reforms, the authors believe that Congress could significantly lower health care costs and improve patient access to essential biologic medicines, fostering a more robust and equitable health care system for all.

1. Patent thickets and litigation abuses hinder all biosimilars. AAM. July 8, 2025. Accessed July 28, 2025. 

https://accessiblemeds.org/resources/press-releases/patent-thickets-and-litigation-abuses-hinder-all-biosimilars/

2. Sampat BN, Shadlen KC. Secondary pharmaceutical patenting: a global perspective. 

. 2017;46(3):693-707. doi:10.1016/j.respol.2017.01.005

3. Jeremias S. Breaking down biosimilar barriers: the patent system. The Center for Biosimilars

. November 11, 2024. Accessed July 28, 2025. 

https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-the-patent-system

4. ETHIC Act, HR 3269, 119 Cong (2025). Accessed July 28, 2025. 

https://www.congress.gov/bill/119th-congress/house-bill/3269

5. Affordable Prescriptions for Patients Act, S 1041, 119 Cong (2025). Accessed July 28, 2025. 

https://www.congress.gov/bill/119th-congress/senate-bill/1041

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Recent weeks have demonstrated global momentum in the regulatory advancement of biosimilars, with key approvals and positive opinions emerging from the US, Europe, and Canada. These developments are poised to enhance access to affordable, high-quality therapeutic options for individuals with various complex conditions, including autoimmune disorders, bone diseases, and ophthalmic conditions, which holds substantial implications for managed health care systems.

Recent weeks have demonstrated global momentum in the regulatory advancement of biosimilars, with key approvals and positive opinions emerging from the US, Europe, and Canada. | Image credit: C Malambo:peopleimages.com - stock.adobe.com

The FDA accepted the biologics license application (BLA) for BAT2506, a proposed biosimilar to Simponi (golimumab).

 This biosimilar, developed by Bio-Thera Solutions, aims to treat several autoimmune conditions, including moderately to severely active rheumatoid arthritis, active psoriatic arthritis, active ankylosing spondylitis, and moderately to severely active ulcerative colitis in adults. The BLA, submitted by Bio-Thera’s US commercialization partner Accord BioPharma, also requested that BAT2506 be declared interchangeable with Simponi.

The application was supported by a comprehensive analytical, nonclinical, and clinical data package, which included a phase 3 study in patients with active psoriatic arthritis that demonstrated similar efficacy, safety, and immunogenicity compared with the reference product.

Europe has also experienced significant regulatory progress, particularly in the ophthalmic biosimilar space. Alteogen, a Republic of Korea–based biopharmaceutical company, received a positive opinion from the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) for Eyluxvi (ALT-L9) on July 24, 2025.

 Eyluxvi is a biosimilar to Eylea (aflibercept), which is widely used for conditions such as wet age-related macular degeneration (wet AMD) and diabetic retinopathy.

The recommendation followed a rigorous phase 3 trial involving 431 patients across 12 countries, which confirmed therapeutic equivalence to Eylea in terms of efficacy, safety, and immunogenicity. This positive CHMP opinion is a crucial step towards European Commission (EC) approval, which is anticipated within months, coinciding with Eylea’s substance patent expiration in 2025. The European market for aflibercept generated over €5 billion in annual sales before generic competition, presenting a significant opportunity for early entrants. Alteogen's intellectual property strategy, including patents for ALT-L9's prefilled syringe formulation and culture methods in the US and European Union, further solidifies its competitive edge.

Furthermore, the EC approved Denbrayce, a denosumab biosimilar referencing Xgeva.

 Denbrayce was approved for preventing skeletal-related events in adult patients with advanced malignancies involving the bone and in adult and skeletally mature adolescent patients with giant cell tumor of the bone. This regulatory decision followed a positive recommendation from the EMA CHMP. The EC also approved Izamby, the same denosumab biosimilar but with the same indications as Prolia: osteoporosis in postmenopausal women and in men at increased risk of fractures.

Canada has emerged as a key region for new biosimilar introductions, particularly in ophthalmology. Apotex announced that Health Canada had approved Aflivu (aflibercept), a biosimilar to Eylea.

 This marked Apotex’s first ophthalmic biosimilar and its fourth biosimilar overall since 2016, reflecting the company's commitment to expanding its biologics portfolio.

Like Eyluxvi, Aflivu is indicated for the treatment of wet AMD as well as macular edema secondary to central or branch retinal vein occlusion, diabetic macular edema, and myopic choroidal neovascularization. Physicians highlighted that a broader range of therapeutic options, including affordable alternatives like Aflivu, can empower them to tailor care to individual patient needs.

In a separate but related development, Biocon Biologics also received Health Canada approval for Yesafili (aflibercept 2 mg), another biosimilar to Eylea.

 Notably, Yesafili was the first biosimilar to Eylea to be approved by Health Canada. This approval was supported by comprehensive analytical, nonclinical, and clinical data demonstrating high similarity in quality, safety, and efficacy to Eylea. Yesafili was scheduled for a Canadian launch on July 4, 2025, and represents Biocon’s 10th biosimilar to be commercialized worldwide.

As patent expirations continue and regulatory pathways streamline, the biosimilars market is poised for sustained growth, enabling health care providers to offer high-quality care with potentially significant cost savings, ultimately benefiting patients and health care budgets alike.

1. Bio-Thera Solutions announces FDA accepts biologics license application for BAT2506, a proposed biosimilar to Simponi. News release. Bio-Thera Solutions. July 16, 2025. Accessed July 28, 2025. 

https://www.prnewswire.com/news-releases/bio-thera-solutions-announces-fda-accepts-biologics-license-application-for-bat2506-a-proposed-biosimilar-to-simponi-302506633.html

2. Doherty K. Denosumab biosimilar earns European approval in advanced malignancies involving the bone and giant cell tumors of the bone. 

https://www.onclive.com/view/denosumab-biosimilar-earns-european-approval-in-advanced-malignancies-involving-the-bone-and-giant-cell-tumors-of-the-bone

3. Hale V. Alteogen's strategic positioning in the biosimilars market with positive CHMP opinion for Eyluxvi (ALT-L9). AI Invest. July 28, 2025. Accessed July 28, 2025. 

https://www.ainvest.com/news/alteogen-strategic-positioning-biosimilars-market-positive-chmp-opinion-eyluxvi-alt-l9-2507/

4. Apotex receives Health Canada approval for Aflivu, a biosimilar to Eylea, available in pre-filled syringe and vial formats. News release. Apotex. July 2, 2025. Accessed July 28, 2025. 

Global regulatory advancements in biosimilars enhance access to affordable treatments for autoimmune disorders, bone diseases, and ophthalmic conditions.

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