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

Skylar Jeremias

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

Articles

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

Patent thickets hinder biosimilar access, driving up costs and delaying affordable treatments. Discover legislative solutions to enhance competition and patient care.

Clearing the Thicket: New Report Outlines Legislative Fixes to Boost Biosimilar Access

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. 

https://www.prnewswire.com/news-releases/apotex-receives-health-canada-approval-for-aflivu-a-biosimilar-to-eylea-available-in-pre-filled-syringe-and-vial-formats-302496912.html

5. Harp MD. Health Canada approves Biocon's Yesafili, biosimilar to Eylea. 

https://www.ophthalmologytimes.com/view/health-canada-approves-biocon-s-yesafili-biosimilar-to-eylea

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

New Approvals Expand Access to Biosimilars for Ophthalmology, Bone, and Joint Conditions

Explore the evolving biosimilars landscape with expert insights on development, regulation, and global health harmonization in this engaging podcast episode.

Follow the Science: Bridging the Biosimilar Gap With Dr Hillel Cohen

In this insightful podcast episode, host Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at the Association for Accessible Medicines (AAM), welcomes former Sandoz executive and biosimilar expert Hillel Cohen, PhD, to discuss the evolving world of biosimilars. The conversation covers the scientific and regulatory landscape, touching on the progress in streamlining biosimilar development, the importance of following scientific advancements, and the potential for harmonization in global health regulations.

This special vodcast series provided by The Center for Biosimilars

 was developed in partnership with the AAM and Biosimilars Council. Check out 

 of the series featuring a discussion between Giuseppe Randazzo and Craig Burton, former executive director of the Biosimilars Council and current senior vice president of government affairs and policy at Fresenius Kabi.



Jeremias S. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars. February 5, 2025. Accessed May 3, 2025. 

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

Podcasts

As clinicians in Australia search for alternatives following the loss of subsidized Avastin (reference bevacizumab), many have turned to Mvasi—an oncology-approved biosimilar—using it off-label to manage a wide range of sight-threatening retinal conditions. | Image Credit: Orawan - stock.adobe.com

As clinicians in Australia search for alternatives following the loss of subsidized Avastin (reference bevacizumab), many have turned to Mvasi—an oncology-approved biosimilar—using it off-label to manage a wide range of sight-threatening retinal conditions. Now, 

 from South Australia’s public hospitals suggest that this practice is not only widespread but also safe.

“While anti-VEGF [vascular endothelial growth factor] biosimilars approved for oncology may offer cost savings, their use in ophthalmology without dedicated trials raises ethical and safety concerns. Off‐label adoption without ophthalmic‐specific studies risks exposing patients to harm.… Healthcare providers must prioritise evidence‐based practice over cost incentives, advocating for research that confirms the suitability of these biosimilars for ophthalmic use, with patient safety as the primary consideration,” wrote the authors.

In a large retrospective review, researchers evaluated 6,230 intravitreal Mvasi (bevacizumab-awwb) injections administered to 1682 eyes between May 2022 and May 2024. The study found low rates of adverse events, with only 3 cases each of bacterial endophthalmitis and uveitis (0.05%), and no cases of retinal vasculitis—results comparable to those seen with reference bevacizumab.

The findings offer critical reassurance for ophthalmologists and health systems relying on biosimilars to fill the gap left by Avastin, which was discontinued from Australia’s Pharmaceutical Benefits Scheme (PBS) in 2021 due to commercial reasons. Mvasi, though not specifically approved for ocular use, has since become a go-to anti-VEGF therapy in public hospitals for conditions such as neovascular age-related macular degeneration and diabetic macular edema.

In response, researchers reviewed more than 6000 injections of Mvasi—a biosimilar to Avastin—administered across South Australia’s public hospital system between May 2022 and May 2024.

The retrospective review, published in a recent abstract, analyzed 6230 intravitreal MVASI injections administered in 1682 eyes. The study found that Mvasi had a strong safety profile, with sight-threatening complications occurring in less than 0.1% of cases. There were 3 reported cases of bacterial endophthalmitis (0.05%) and 3 of uveitis (0.05%), and no cases of retinal vasculitis.

“These complication rates are consistent with what we see with reference bevacizumab and other anti-VEGF agents,” the authors noted. “This supports Mvasi as a practical alternative for continued high-quality retinal care in Australia.”

The study population had a mean age of 69.8 years. The most frequent treatment indications were neovascular age-related macular degeneration (33.8% of injections), diabetic macular edema (26.2%), and retinal vein occlusions. On average, patients received 3.7 injections per eye.

Prior to this study, safety data for intravitreal Mvasi had been limited, as most research centered on its systemic use in oncology. The findings are especially timely given the global interest in expanding biosimilar use to curb drug costs while maintaining patient safety.

“Real-world data like this is critical, especially for off-label biosimilar use,” said one biosimilar market analyst. “It helps build clinician and regulatory confidence, particularly in therapeutic areas like ophthalmology where the margin for error is very small.”

The implications extend beyond Australia. In the US, while biosimilars for ranibizumab and aflibercept have entered the ophthalmology market, bevacizumab biosimilars such as Mvasi are not yet FDA approved for intravitreal use. Nevertheless, some physicians prescribe them off label due to affordability and access considerations.

The study highlights the importance of continued postmarket surveillance to detect rare complications and evaluate biosimilars in real-world clinical settings. As biosimilar adoption grows globally, especially in cost-sensitive markets, robust safety data will be crucial for integrating these products into routine care.

With mounting evidence, Mvasi could help fill the gap left by Avastin and ensure continued access to sight-saving treatments—particularly in public health systems where affordability and availability are paramount.

1. Wang H, Bahrami B, Huang S, et al. Safety of an intravitreal bevacizumab biosimilar (Mvasi). 

. 2025;53(5):523-528. doi:10.1111/ceo.14515

2. Ateeq A, Tahir MA, Cheema A, Darhi A, Tareen S. Intravitreal injection of bevacizumab in diabetic macular edema. 

. 2014;30(6):1383-1387. doi:10.12669/pjms.306.5738

Real-world data confirm Mvasi's safety as a cost-effective alternative to reference bevacizumab (Avastin) for treating retinal conditions.

Bevacizumab Biosimilar Fills Gap for Retinal Disease With Encouraging Safety Data

Patients with ankylosing spondylitis may be able to get the same benefits as Humira (adalimumab) at a lower cost by using the biosimilar IBI303, based on 

The retrospective analysis out of Shenzhen Luohu People’s Hospital in China adds to the growing body of real-world evidence showing that the adalimumab biosimilar IBI303 delivers comparable effectiveness to Humira while offering significant cost savings in the treatment of ankylosing spondylitis. | Image credit: peterschreiber.media - stock.adobe.com

Drawing on data from 106 patients treated between May 2020 and December 2023, the study highlights how biosimilars like IBI303 can ease financial pressure on patients and health care systems without sacrificing quality of care.

The retrospective analysis out of Shenzhen Luohu People’s Hospital in China adds to the growing body of real-world evidence showing that the adalimumab biosimilar IBI303 delivers comparable effectiveness to Humira while offering significant cost savings in the treatment of ankylosing spondylitis.

Ankylosing spondylitis is a chronic inflammatory disease that primarily targets the spine, often resulting in persistent pain and mobility issues. The condition affects an estimated 0.2% to 0.5% of the US population.

 Globally, its occurrence ranges from 0.4 to 14 new cases per 100,000 people each year. Symptoms typically begin early in adulthood, with the onset peaking in a person's 20s and 30s. A significant majority, around 80% of patients, experience symptoms by age 30 or younger, while only a small fraction (5%) will see symptoms emerge after age 45.

Adalimumab has been a mainstay in ankylosing spondylitis management, but the high cost of originator products such as Humira has posed major access challenges—especially in resource-constrained settings.

 Biosimilars offer a lower-cost alternative, but real-world data are essential to understanding their performance outside the controlled environment of clinical trials.

In this analysis, 38 patients received Humira and 68 received IBI303. The researchers looked at adalimumab retention rates at 52 weeks as the primary outcome. At 1 year, retention was higher in the IBI303 group (63%) than the Humira group (44%). IBI303 also showed stronger early retention at 24 weeks (82% vs 67%).

Safety outcomes were nearly identical. Just 2 patients in each group experienced mild infusion-related reactions, with no statistically significant differences between the arms.

Cost differences were notable. Median treatment costs were significantly lower for patients on IBI303 compared with those on Humira, both at 12 weeks ($762.20 vs $903.70; 

 = .042) and at 52 weeks ($2543.00 vs. $2982.30; 

 = .004). The data suggest IBI303 may be a more cost-effective option for long-term disease management.

According to the authors, IBI303 demonstrated not only comparable effectiveness and safety but also higher retention and lower overall cost—key considerations in chronic disease treatment.

Although this study was conducted in China, its implications are far-reaching. As the US health care system continues to wrestle with drug pricing and access, real-world data like these bolster the case for broader adoption of biosimilars. IBI303’s strong performance supports the notion that biosimilars aren’t just budget alternatives—they’re viable first-line options that can help expand access to care while controlling costs.

The study also provided insight into dosing, with data suggesting that a maintenance dose of 40 mg every 4 weeks may be sufficient for many patients, potentially offering further savings.

The authors concluded, “From a Chinese perspective, there is no difference in retention rate and safety between IBI303 and Humira in real-world use [in patients with ankylosing spondylitis], but because IBI303 has [a] lower price, it will lighten patients’ economic burden, and our drug exposure results can provide data support for tapering of biological therapy.”

1. Cheng X, Fu Z, Liu J, et al. Comparative real-world retention rate and safety of biosimilar IBI303 versus Humira in ankylosing spondylitis: a retrospective study. 

. 2025;104(26):e43010. doi:10.1097/MD.0000000000043010

2. Ankylosing spondylitis. Johns Hopkins Arthritis Center. Accessed July 17, 2025. 

https://www.hopkinsarthritis.org/arthritis-info/ankylosing-spondylitis/

Biosimilar IBI303 offers comparable effectiveness to Humira for ankylosing spondylitis, providing significant cost savings and improved patient retention rates.

Data Show Comparable Efficacy, Added Cost Benefit With Adalimumab Biosimilar vs Humira

Despite the recognized potential of biosimilars to expand patient access to critical biologic medicines and significantly reduce health care costs, their uptake in Latin American (LatAm) countries has remained notably slow.

 A recent manuscript, drawing on a comprehensive analysis involving key opinion leaders and industry representatives across Latin America and Europe, shed light on the multifaceted barriers hindering biosimilar adoption and proposed strategic initiatives to accelerate their use.

Biosimilars promise cost savings and improved patient access in Latin America, yet face significant regulatory and educational barriers hindering their uptake. | Image credit: Olsek - stock.adobe.com

, underscored the urgent need for harmonized regulatory processes, robust education, and coordinated regional efforts to unlock the full benefits of biosimilars for patients and health care systems in the region.

“The impact of high-cost biologics is felt greatly in the LatAm region, where most of the population depends on underfunded public health systems. Moreover, there are considerable differences in the epidemiology and burden of cancer among countries in this region that further impact on patient outcomes…. The development and implementation of a standardized and streamlined regulatory process for biosimilars across the LatAm region, including translation into daily practice in a timely manner, is crucial,” wrote the authors.

Health care expenditures in LatAm countries have been on a sharp upward trajectory, fueled by demographic shifts such as population growth and aging, alongside the increasing prevalence of chronic diseases like cancer. Biologic medicines, although vital, represent a disproportionately high share of drug budgets, creating significant access barriers for patients. Biosimilars offer a powerful solution by fostering price competition and enhancing affordability.

However, despite their proven benefits in regions like Europe and the US, their integration into LatAm health care systems has been sluggish, prompting this investigation into the underlying causes and potential remedies. According to a 2022 study, the LatAm biosimilar market had the potential to grow at a 33% rate annually to reach $3.9 billion by 2025.

To understand the complexities of biosimilar uptake in Latin America, researchers convened an online forum of 6 key opinion leaders from Brazil, Chile, Mexico, and the UK, encompassing expertise in pharmacology, hematology, oncology, and health economics.

 Two industry representatives from Latin America and Europe also participated, moderating discussions and providing crucial context. The group offered perspectives on the barriers impacting biosimilar acceptance in Latin America, drawing comparisons to European experiences.

Complementing these expert discussions, industry representatives from 12 LatAm countries completed a survey detailing their national biosimilar policies. The insights gathered from these discussions and survey results ultimately led to the identification of 6 key themes affecting biosimilar acceptance, which formed the core of the expert opinion.

Main Findings Highlight Critical Barriers

Biosimilars promise cost savings and improved patient access in Latin America, yet face significant regulatory and educational barriers hindering their uptake.