Christina Mattina

Doctors in China are seeing encouraging results with HLX02, a trastuzumab biosimilar that may help expand access to treatment for people with HER2-positive metastatic breast cancer (MBC).

 A new real-world study from Fudan University Shanghai Cancer Center found the drug worked as well and was just as safe as the originator, even for patients who switched mid-treatment.

HLX02 shows promise as a safe, effective trastuzumab biosimilar for HER2-positive metastatic breast cancer, enhancing treatment access and affordability. | Image Credit: shidlovski - stock.adobe.com

, analyzed outcomes for 124 women treated between April 2021 and October 2022. HLX02, launched in China in 2020 under the brand name Zercepac, is the first domestically manufactured trastuzumab biosimilar. Because the high cost of Herceptin (reference trastuzumab) has long limited treatment access,

 researchers set out to evaluate whether HLX02 could provide comparable outcomes in routine practice, and whether switching from originator to biosimilar raised any concerns.

Among the participants, 80 were treated with HLX02 from the start, while 44 switched from Herceptin after several months. The median age was 53 years, and more than 60% of patients were postmenopausal. Nearly half were estrogen receptor–positive, and more than one-third had 3 or more sites of metastasis.

Results showed that HLX02 delivered similar effectiveness in both groups: 57.5% of patients who started with HLX02 responded to treatment, compared with 54.5% of those who switched (

 = .751). Median progression-free survival (PFS) was 14.2 months across the full cohort, with no significant differences between groups. Instead, outcomes were more strongly influenced by factors such as brain metastases and the number of prior treatment lines.

Safety findings were also consistent across groups. More than 90% of patients experienced treatment-emergent adverse events, most of which were mild to moderate. Severe events occurred in 29% of patients, with anemia, liver enzyme elevations, leukopenia, and neutropenia among the most common. Infusion-related reactions and cardiotoxicity were rare, and no new safety signals emerged.

The authors emphasized that HLX02 performed on par with previous clinical trial results, reinforcing its role as a viable and cost-effective alternative to Herceptin. “Our findings support the use of HLX02 as a safe and effective treatment option for HER2-positive metastatic breast cancer,” they wrote, noting that the ability to switch safely between the originator and biosimilar could help reduce costs and expand access in resource-limited settings.

As with any retrospective single-center analysis, the study had limitations. The sample size was modest, and most patients received HLX02 alongside other antitumor drugs, complicating attribution of some adverse events. The results also may not be generalizable outside China. Still, the research adds meaningful evidence at a time when health systems are weighing substitution policies for oncology biologics.

For managed care decision-makers, the findings offer reassurance that transitioning patients from Herceptin to HLX02 is unlikely to compromise efficacy or safety. In countries where affordability remains a major barrier, biosimilars such as HLX02 may be key to making life-extending therapies more widely available.

1. Ye X, Wang L, Liu W, et al. Efficacy and safety of biosimilar trastuzumab (HLX02) in patients with HER2-positive advanced breast cancer: a retrospective real-world analysis. 

. Published online August 1, 2025. doi:10.3389/fonc.2025.1622854

2. Lammers P, Criscitiello C, Curigliano G, and Jacobs I. Barriers to the use of trastuzumab for HER2+ breast cancer and the potential impact of biosimilars: a physician survey in the United States and emerging markets. 

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HLX02 shows promise as a safe, effective trastuzumab biosimilar for HER2-positive metastatic breast cancer, enhancing treatment access and affordability.

Real-World Evidence Supports Biosimilar HLX02 in Metastatic Breast Cancer

Patients with inflammatory bowel disease (IBD) who transitioned from reference adalimumab (Humira) to the biosimilar Amgevita (adalimumab-atto) maintained stable disease control and generated substantial drug cost savings, according to a single-center 

 from Galway University Hospitals in Ireland.

Results showed no significant differences in objective disease activity or biomarkers before and after the switch. | Image credit: eddows - stock.adobe.com

Biologic therapies such as adalimumab account for a large portion of pharmaceutical expenditures, and biosimilars have been introduced as lower-cost alternatives with comparable efficacy and safety. In Ireland, national health authorities recommend nonmedical switching to biosimilars to improve affordability and expand access. Despite these policy shifts, concerns remain that a “

”—in which patients anticipate worse outcomes due to their negative perceptions about a drug

—could undermine confidence in biosimilars. Researchers sought to explore these clinical, psychological, and economic dynamics during a structured switch to Amgevita.

Seventy-one individuals with IBD were initially recruited, of whom 64 were included in the final analysis. Participants ranged in age from 18 to 67 years, with an average disease duration of 12 years and mean Humira use of nearly 4 years. Most participants had Crohn disease (78%), while others had ulcerative colitis (17%) or indeterminate colitis (5%). Clinical status was measured with standard indices, including the Harvey–Bradshaw Index and partial Mayo score, as well as fecal calprotectin and C-reactive protein. Patient-reported outcomes included the Inflammatory Bowel Disease Control Questionnaire (IBDCQ) and EQ-5D-5L quality-of-life scale, and psychosocial variables were assessed with validated health anxiety and medication belief instruments.

Results showed no significant differences in objective disease activity or biomarkers before and after the switch. Patient-reported symptoms measured by the IBDCQ improved slightly, from 13.3 before switching to 12.5 afterward (

 = .043), though this change was small and of uncertain clinical importance. Quality-of-life measures did not meaningfully change.

Adverse events were reported by 25% of participants, with headaches, joint pain, nausea, fatigue, and injection site reactions among the most common. Importantly, statistical analysis indicated that health anxiety was a strong predictor of adverse event reporting, with each 1-point increase in health anxiety score raising the likelihood of an event by 21% (

 = .0079). Only 2 patients reverted to Humira because of intolerance.

Cost analysis revealed meaningful financial benefits. Switching reduced drug expenditures by €143,958 over 8 weeks for the cohort, amounting to an estimated €864,000 in annual savings. Even after accounting for switching clinic costs (€133 per patient) and unscheduled care needs, net savings averaged €2091 per patient over 2 months.

The authors noted that the structured switching clinic was resource intensive but effective in minimizing uncertainty and ensuring patients received adequate support. They suggested that scaling such clinics could further reduce per-patient costs and improve uptake.

Study limitations included its single-center design, short follow-up period, and open-label structure, which prevented a definitive distinction between true adverse effects and nocebo responses. The lack of blinded comparators and the potential influence of the COVID-19 pandemic on response rates were also acknowledged.

Still, the results reinforce international evidence supporting biosimilar adalimumab as a safe and effective alternative to the reference product. “With biosimilar switching, prescribers may expect some patients to develop new side effects, particularly those with high levels of health anxiety,” the authors wrote.

Overall, the study demonstrated that a nonmedical switch to Amgevita preserved disease control and quality of life while delivering significant cost savings, highlighting the importance of patient education and structured implementation to address psychological factors and optimize outcomes.

1. Rabbitt L, Keogh Á, Duane L, et al. A single-centre analysis of a biosimilar switching programme for adalimumab in inflammatory bowel disease. 

. 2025;91(9):2628-2635. doi:10.1002/bcp.70086

2. Jeremias S. 13 strategies to avoid the nocebo effect during biosimilar switching. The Center for Biosimilars

. December 18, 2024. Accessed September 8, 2025. 

https://www.centerforbiosimilars.com/view/13-strategies-to-avoid-the-nocebo-effect-during-biosimilar-switching

A study reveals that switching from Humira to Amgevita for IBD maintains disease control and offers significant cost savings.

Switch to Biosimilar Adalimumab Found Safe and Cost-Saving for Patients With IBD

August 2025 proved to be another dynamic month for the biosimilar landscape, characterized by significant financial milestones, new product launches, reinforcing clinical data, and ongoing battles over market access. These developments underscore the growing impact of biosimilars on health care affordability and treatment options, even as persistent challenges continue to shape their adoption.

August 2025 highlights significant advancements in biosimilars, showcasing financial successes, new product launches, and ongoing challenges in market access.

, showcasing a remarkable financial turnaround.

 The Iceland-based biotech company swung from a $153.5 million net loss in the first half of 2024 to a 

 for the same period in 2025. This success was largely fueled by a 

more than 200% year-on-year increase in product revenues

, reaching $204.7 million, and marking the company's first-ever quarterly positive cash flow from operations. 

Key drivers included the strong commercial performance of its high-concentration adalimumab biosimilar, Simlandi (marketed as Hukyndra in Europe), and its ustekinumab biosimilar, Selarsdi (Uzpruvo in Europe). 

Selarsdi, which gained interchangeable status from the FDA in April 2025, achieved more than 20% of the overall Stelara market share in the US by July 2025. Alvotech is also advancing its pipeline, with biologics license applications for proposed denosumab and aflibercept biosimilars accepted by the FDA, and its aflibercept biosimilar, Mynzepli, recently secured European approval.

Accord BioPharma commercially launched Imuldosa

, its biosimilar to Stelara, approved for various indications including plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis.

 Accord BioPharma priced Imuldosa at the 

 among branded ustekinumab biosimilars and offered a $0 co-payment program for eligible patients, aiming to expand access to cost-effective biologic therapies.

Clinical Data Reinforce Biosimilar Equivalence and Safety

Several studies published in August bolstered the scientific evidence for biosimilars. A 

year-long phase 3 clinical trial in Poland

, to the reference product Actemra/RoActemra for rheumatoid arthritis (RA).

comparable efficacy, safety, and immunogenicity

, even for patients who switched from the originator biologic, with consistent disease activity scores and no new safety concerns identified. This adds to the growing confidence in biosimilars for RA management, alongside other FDA-approved tocilizumab biosimilars like Tofidence and Tyenne.

equivalence of denosumab biosimilar LY01011 to the reference product Xgeva

 for treating bone metastases in solid tumors.

 LY01011 demonstrated similar efficacy in reducing bone metabolism biomarkers, comparable safety profiles, and a lack of unexpected adverse reactions across 850 patients. This evidence supports the use of denosumab biosimilars, such as Wyost/Jubbonti, which were approved in the US in March 2024. Long-term safety data also emerged for Sandoz’s biosimilar filgrastim. 

10-year prospective follow-up of 244 healthy stem cell donors

 who received Zarzio (marketed as Filgrastim Hexal in Germany) 

 for hematopoietic stem and progenitor cell mobilization.

 While most donors experienced adverse events during initial mobilization, serious adverse events documented over the decade were not deemed related to the biosimilar filgrastim, and donors maintained superior physical health scores. This study reinforces the established safety profile of filgrastim biosimilars, including Zarxio (filgrastim-sndz), which was the first FDA-approved biosimilar in the US in 2015.

 found comparable outcomes between etanercept biosimilars (Brenzys or Erelzi) and the originator, Enbrel

, for patients with rheumatoid arthritis.

 The analysis revealed no significant differences in time to first remission or sustained remission rates, aligning with findings from randomized controlled trials and European registry data. This highlights the clinical interchangeability of these products, in stark contrast to the 

delayed market entry of etanercept biosimilars in the US due to ongoing patent litigation

Battles Over Market Entry and Access Innovation

The ongoing challenge of patent disputes continues to affect biosimilar market entry. Genentech and Hoffman-La Roche initiated the 

first patent infringement case (BPCIA complaint) concerning a pertuzumab biosimilar

, filing against Shanghai Henlius Biotech and Organon.

 The complaint alleges infringement of 24 patents related to Genentech’s originator, Perjeta, following a pattern of litigation that has previously delayed market launches for other biosimilars.

However, innovative strategies are emerging to enhance access. 

MedImpact Holdings announced plans to provide access to an unbranded ustekinumab-aekn biosimilar

. This unbranded interchangeable biosimilar to Stelara is anticipated to be available at a significantly lower cost, aiming to bypass traditional supply chain costs, enhance price transparency, and reduce reliance on rebates, thus offering a more affordable treatment option for patients.

Despite the clear benefits, challenges in biosimilar adoption persisted. A comprehensive analysis of primary care prescribing data from 2020 to 2024 revealed that 

low prices failed to boost insulin glargine biosimilar uptake

 Even after the MHRA declared all biosimilars interchangeable with their reference products in 2022, originator Lantus continued to dominate prescriptions and, by 2024, became the least expensive option in all 4 UK nations. 

Biosimilars like Abasaglar and Semglee achieved only modest market shares (eg, 24% in England and Scotland, 5% in Northern Ireland, 11% in Wales). Key barriers identified include Lantus's price reductions, prescriber inertia, and national prescribing guidelines that require prescribers to initiate brand switching.

1. Jeremias S. Alvotech reports record-breaking first half of 2025 amid strong biosimilar sales. The Center for Biosimilars

. August 27, 2025. Accessed September 2, 2025. 

https://www.centerforbiosimilars.com/view/alvotech-reports-record-breaking-first-half-of-2025-amid-strong-biosimilar-sales

2. Jeremias S. Litigation, launch, and lower costs: 3 big moves in the US biosimilar space. The Center for Biosimilars. August 19, 2025. Accessed September 2, 2025. 

https://www.centerforbiosimilars.com/view/litigation-launch-and-lower-costs-3-big-moves-in-the-us-biosimilar-space

3. Jeremias S. Year-long phase 3 study confirms tocilizumab biosimilar comparability with Actemra. The Center for Biosimilars. August 6, 2025. Accessed September 2, 2025. 

https://www.centerforbiosimilars.com/view/year-long-phase-3-study-confirms-tocilizumab-biosimilar-comparability-with-actemra

4. Santoro C. Denosumab biosimilar LY01011 shows equivalence to reference product for bone metastases. The Center for Biosimilars. August 14, 2025. Accessed September 2, 2025. 

https://www.centerforbiosimilars.com/view/denosumab-biosimilar-ly01011-shows-equivalence-to-reference-product-for-bone-metastases

5. Jeremias S. Ten years of data support the safety of biosimilar filgrastim for donor mobilization. The Center for Biosimilars. August 22, 2025. Accessed September 2, 2025. 

https://www.centerforbiosimilars.com/view/ten-years-of-data-support-safety-of-biosimilar-filgrastim-for-donor-mobilization

6. Jeremias S. Canadian RWE shows comparable outcomes between etanercept biosimilars, originator. The Center for Biosimilars. August 26, 2025. Accessed September 2, 2025. 

https://www.centerforbiosimilars.com/view/canadian-rwe-show-comparable-outcomes-between-etanercept-biosimilars-originator

7. Jeremias S. Low prices fail to boost insulin biosimilar uptake in the UK. The Center for Biosimilars. August 11, 2025. Accessed September 2, 2025. 

https://www.centerforbiosimilars.com/view/low-prices-fail-to-boost-insulin-biosimilar-uptake-in-the-uk

August 2025 brought significant advancements in biosimilars, including financial successes, new product launches, and research on ongoing challenges in market access.

Biosimilars News Roundup: August 2025

As the US continues to wait for etanercept biosimilars to be allowed entrance into the market,

 a new Canadian analysis using real-world evidence (RWE) found no meaningful differences in remission outcomes between individuals with rheumatoid arthritis (RA) initiating etanercept biosimilars and those starting the reference product.

As the US continues to wait for etanercept biosimilars to be allowed entrance into the market, a new Canadian analysis using real-world evidence (RWE) found no meaningful differences in remission outcomes between patients treated with etanercept biosimilars vs the reference product. | Image credit: ungvar - adobe.stock.com

, evaluated 150 adults with RA from 4 Canadian prospective cohorts who initiated etanercept therapy between January 2015 and May 2022. Participants were etanercept naive at baseline, and 65.3% (n = 98) received a biosimilar (Brenzys or Erelzi), while 34.7% (n = 52) received the originator (Enbrel).

The overall cohort was predominantly female (76.0%) and largely White (82.2%). The mean age at etanercept initiation was 56.8 years, with individuals in the biosimilar group diagnosed at a younger age than those in the originator group (mean, 47.7 vs 54.2 years). The mean RA duration was longer among biosimilar initiators (9.3 years vs 5.1 years). Obesity (body mass index ≥ 30) was reported in 41.4% of participants, and 16.0% were current smokers. Most individuals (72.7%) initiated therapy after 2017, reflecting the 2016 approval of the first etanercept biosimilar in Canada.

Among the 125 participants with active disease at baseline, the median time to first remission was 8.7 months (95% CI, 5.2-12.1) for biosimilar users and 14.5 months (95% CI, 4.7-18.6) for originator users. However, the difference was not statistically significant (log-rank 

 = .51). Multivariate Cox regression showed no clear difference in time to first remission (adjusted HR, 1.52; 95% CI, 0.68-3.39).

Sustained remission, defined as at least 2 consecutive visits in remission within 12 months, was achieved by 19.5% of biosimilar initiators and 21.0% of originator initiators. Adjusted analyses showed no significant difference (adjusted OR, 1.14; 95% CI, 0.29-4.87). The only baseline factor associated with increased likelihood of remission was hydroxychloroquine use (adjusted HR, 1.96; 95% CI, 1.01-4.73).

The findings mirror results from randomized controlled trials and European registry data, which have consistently shown comparable outcomes between etanercept biosimilars and the originator. Observational studies in the UK and Catalonia also reported similar remission rates, reinforcing the clinical interchangeability of biosimilars.

Biosimilars are increasingly important to managed care systems due to their potential to expand access and reduce costs, with some estimates predicting that biosimilars could generate $180 billion by 2028.

 In Canada, biologics accounted for 27.3% of public drug expenditures in 2018 despite representing less than 2% of claims.

 Policy makers have responded by implementing biosimilar adoption initiatives, contributing to greater RWE for these products.

By contrast, in the US, etanercept biosimilars have faced delayed market entry.

 Although the FDA approved Erelzi (Sandoz) in 2016 and Eticovo (Samsung Bioepis) in 2019, patent litigation with Amgen has kept them off the US market. Enbrel, first approved in 1998, continues to face limited biosimilar competition, highlighting a key barrier to affordability in the US health care system.

The authors of the present analysis concluded, “Biosimilars present an opportunity to expand treatment options for RA patients while mitigating healthcare costs. Our study contributes to the growing body of evidence supporting the equivalence of biosimilars and bio-originators.”


1. Herman B. Amgen wins Enbrel drug patent appeal. Axios. July 2, 2020. Accessed August 25, 2025. 

https://www.axios.com/2020/07/02/amgen-enbrel-drug-patent-appeal

2. Birck MG, Boivin J, Yan L, et al. Disease remission and sustained remission after etanercept biosimilar or originator initiation in rheumatoid arthritis: an interim real-world analysis. 

 2025;27:150. doi:10.1186/s13075-025-03607-7

3. Joszt L. Biosimilars can create huge savings, but interchangeability needs to be reviewed. 

. April 10, 2023. Accessed December 17, 2024. 

www.ajmc.com/view/biosimilars-can-create-huge-savings-but-interchangeability-needs-to-be-reviewed

4. Lexchin J, Law MR. Policies on the use of biosimilars in Canada: developments over the past 5 years. 

. 2022;194(15):E556-E560. doi:10.1503/cmaj.211599

5. Jeremias S. Given public concerns, Canadian policy makers should be cautious when making new biosimilar policies. The Center for Biosimilars

. May 5, 2022. Accessed August 25, 2025. 

https://www.centerforbiosimilars.com/view/given-public-concerns-canadian-policy-makers-should-be-cautious-when-making-new-biosimilar-policies

Canadian study reveals no significant differences in remission outcomes between etanercept biosimilars and the originator, Enbrel, for rheumatoid arthritis patients.

Canadian RWE Shows Comparable Outcomes Between Etanercept Biosimilars, Originator

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

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

Biosimilars face a potential void as biologics lose exclusivity, prompting urgent calls for policy reform and enhanced education to ensure market sustainability. | Image credit: FUTURESEND - stock.adobe.com

Introducing free pricing at launch when reference medicines are available, allowing biosimilars to compete on fair market terms without arbitrary initial price restrictions.

Decoupling price erosion mechanisms such as mandatory discounts or clawbacks that disproportionately impact biosimilars, thus protecting their market value and incentivizing manufacturers to participate.

Enhancing Procurement and Tendering Processes

Implementing multi-winner tenders with contract volume shares to diversify supply sources and foster healthy competition over the product lifecycle.

Designing tender frameworks that consider additional value criteria such as device convenience and supply robustness, encouraging manufacturers to innovate and invest.

Aligning Pricing and Reimbursement Policies with Value

Linking biosimilar pricing decisions to comprehensive health technology assessments (HTAs) that reflect their true value, particularly in markets where reference biologics lack prior HTA evaluations.

Exempting biosimilars from strict cost-containment measures like automatic price cuts or rebates during their lifecycle, thus providing stability and incentivizing sustained manufacturing interest.

Fostering Policy and Market Environment Adaptability

Establishing minimum price boundaries that shield biosimilars from excessive price erosion, ensuring adequate margins for manufacturers.

Promoting collaborative frameworks across Europe for harmonized policies that value biosimilars appropriately, reduce fragmentation, and provide long-term market clarity.

Biosimilars have delivered substantial cost savings and broadened patient access across Europe. However, stakeholders now face the growing risk of a “biosimilar void”—a scenario in which 90% of the biologics losing exclusivity in the next 10 years lack biosimilars in development.

 called for urgent policy reform and industry collaboration to protect the long-term sustainability of the biosimilar market.

Despite their proven efficacy and safety, biosimilars continue to face skepticism among both prescribers and patients. According to the paper, in Spain, limited adoption has been linked to physicians’ reluctance to switch patients from reference biologics.

 Additionally, in France, patient hesitation—often influenced by the nocebo effect—stems from poor understanding of biosimilars.

To address these barriers, the report recommended targeted education and awareness initiatives led by trusted medical authorities. Enhancing understanding of biosimilars’ clinical value can help build confidence and support informed decision-making.

“Biosimilars are not one-size-fits-all, and establishing a sustainable framework for biosimilars requires a nuanced understanding of their heterogeneous applications across clinical settings. It is vital to tailor key solutions that address the unique challenges faced by different product types, prescribing patterns, and patient and disease characteristics. It is also important to consider the future viability of the market when reshaping policies, as the market needs clear signals of long-term sustainability to encourage continued investments in the biosimilar pipeline,” said Adam Levysohn, vice president and head of commercial strategy Europe, at Samsung Bioepis.

Rethinking Pricing and Market Entry Policies

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.

Reforming health technology assessment (HTA) processes was another priority. Streamlining approval pathways and harmonizing timelines across the European Union could accelerate access and support fair competition. Germany’s approach—exempting biosimilars from certain HTA steps—has been cited as a successful example, leading to faster market entry and stronger uptake.

Biosimilars face a potential void as biologics lose exclusivity, prompting urgent calls for policy reform and enhanced education to ensure market sustainability.

Christina Mattina

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