Christina Mattina

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

Articles

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.

Investment in monitoring infrastructure will also be key. Real-world data on biosimilar use can inform tailored outreach efforts and support updated clinical guidelines, developed in partnership with medical societies and patient advocacy groups. These strategies are essential for shifting perceptions and encouraging greater adoption.

Ensuring Supply Resilience Through Pipeline Expansion

Supply shortages remain a persistent threat, particularly in oncology and other high-need areas. To mitigate this risk, the white paper urges proactive investment in developing biosimilars for biologics nearing patent expiry. Expanding the pipeline ensures that multiple alternatives enter the market, reducing reliance on single-source manufacturers.

A competitive marketplace not only promotes price stability but also enhances resilience during global disruptions. Encouraging multiple manufacturers to participate in the same therapeutic area strengthens supply security and improves patient access.

While biosimilars are often viewed through the lens of cost containment, they also present opportunities for innovation. The industry can differentiate products by improving environmental sustainability, enhancing patient convenience, and incorporating new technologies.

These next-generation biosimilars—offering features such as easier administration or better packaging—can add value for patients and providers alike. Highlighting these advantages may help attract investment and secure supportive policies from payers and regulators.

To avoid a biosimilar market collapse, coordinated action is needed. Industry and policymakers must work together to revise pricing structures, modernize regulatory frameworks, and foster robust pipeline development. As the white paper noted, “A biosimilar market with multiple marketed alternatives could play a significant role in increasing supply security and reducing shortages.”

By addressing these structural challenges now, European countries can preserve the economic and clinical benefits of biosimilars, ensuring long-term sustainability for health systems and better outcomes for patients.

Lavysohn commented, “It is important for healthcare systems to recognize that biosimilars are not merely a cost-saving tool for organizations. Policies should take a patient-centric approach, positioning biosimilars as part of the solution to expand access, improve patient outcomes, ensure supply continuity, and strengthen system resilience.”

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

. February 5, 2025. Accessed July 14, 2025. 

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

2. Solving the biosimilar void in Europe: empowering the patients through sustainable access. 

https://www.samsungbioepis.com/en/etc/gadown.do?filename=Solving_the_Biosimilar_whitepaper_2025.pdf

3. Samsung Bioepis’ European whitepaper proposes solutions to bridge policy gaps that hinder healthy market competition and timely access to biosimilar medicines. News release. Samsung Bioepis. July 14, 2025. Accessed July 14, 2025. 

https://www.businesswire.com/news/home/20250710186470/en/Samsung-Bioepis-European-Whitepaper-Proposes-Solutions-to-Bridge-Policy-Gaps-that-Hinder-Healthy-Market-Competition-and-Timely-Access-to-Biosimilar-Medicines

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

White Paper Offers Tips for Sustaining Biosimilar Progress, Avoiding a Market Void

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic.

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, welcomes the advent of biosimilars in multiple myeloma treatment, particularly a potential biosimilar for daratumumab, as a means to reduce costs and increase market competition. However, she foresees significant challenges, especially if an intravenous (IV) biosimilar becomes available before a subcutaneous version.

The FDA approved Celltrion's investigational new drug application for CT-P44, a daratumumab biosimilar, enabling a global phase 3 trial.

 Researchers will evaluate CT-P44's pharmacokinetics, efficacy, and safety against daratumumab in 486 patients with refractory or relapsed multiple myeloma.


Sandahl notes that the original IV daratumumab infusions can take 8 to 10 hours, creating considerable scheduling difficulties. She explains that even with current patient volumes and nursing shortages, switching just a few patients from subcutaneous back to IV has proven challenging for infusion centers.


While acknowledging the clear cost containment benefits of biosimilars, she emphasizes that the cost difference would need to be substantial to justify moving patients from the more convenient and less chair-time-intensive subcutaneous formulation back to an IV one. She questions how centers managed this logistical burden universally before the subcutaneous option became available, highlighting a potential conflict between cost savings and current clinical practice efficiency.

This transcript was lightly edited for clarity.

: Please discuss the potential impact of biosimilars on the treatment paradigm of multiple myeloma. How might the growing availability of biosimilars influence prescribing patterns, cost management, and the role pharmacists play in integrating them into practice?

As a pharmacist, I welcome biosimilars and generic medications, anything we can do to reduce costs and increase competition. I think one thing that I've thought about is a biosimilar for daratumumab because that's probably the first one we would see, based on when things were approved. I'm curious what the adoption of that would look like because you'd see a biosimilar most likely for the IV formulation sooner than you would with the subcutaneous, and that's a huge difference in chair time. The cost difference would have to be pretty substantial for people to say, "Hey, we're putting everyone on the daratumumab biosimilar and abandoning the subcutaneous Darzalex."

I think it'd be an interesting change in practice because the way our things stood, the first infusion for IV daratumumab can take 8 to 10 hours, and scheduling that can be really challenging. We've had a few patients in the last couple of months who have needed to be switched from subcutaneous to IV for some reason or another, and even just finding them a space in the infusion center to get those first couple infusions has been a huge challenge. Where I've gone back, I'm like, "Gosh, how did we do this for everyone before we had subcutaneous? How did we make this work before because now we can't seem to?"

Some of that is an increase in patient volumes and differences in nursing shortages that maybe we didn't have 5 to 6 years ago. I think from a cost containment standpoint, biosimilars would be great but then when we look at like clinical practice and how that fits with current practice, going from subcutaneous back to IV would be a challenge.

FDA approves global phase 3 trial for Celltrion’s daratumumab biosimilar. Pearce IP. December 27, 2024. Accessed July 14, 2025. 

https://www.pearceip.law/2024/12/27/fda-approves-global-phase-3-trial-for-celltrions-daratumumab-biosimilar/

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, supports biosimilars for cost savings but foresees challenges adopting an intravenous daratumumab biosimilar, preferring the more convenient subcutaneous option.

Balancing Cost Savings With Clinical Practice for Multiple Myeloma Biosimilars: Tyler Sandahl, PharmD

Alvotech and Advanz Pharma have announced a positive Committee for Medicinal Products for Human Use (CHMP) opinion for their aflibercept biosimilar, AVT06, aiming for European approval. Concurrently, Amneal Pharmaceuticals shared positive clinical trial results for Kashiv BioSciences' omalizumab biosimilar, ADL-018, targeting the US market, while Bio-Thera Solutions and SteinCares have partnered to bring a dupilumab biosimilar to Latin America.

Alvotech and Advanz Pharma announced that the European Medicines Agency's CHMP has issued a positive opinion, recommending approval for AVT06, a proposed biosimilar to Eylea (aflibercept, 2 mg).

 The decision brings the companies closer to marketing the biosimilar in the European Economic Area for various eye conditions, including wet age-related macular degeneration and diabetic macular edema. Alvotech is responsible for development and supply, while Advanz Pharma handles registration and commercialization in Europe.

“CHMP’s positive opinion takes us a step closer to being able to market our proposed biosimilar in Europe, which is excellent news for patients and their caregivers,” commented Joseph McClellan, chief scientific officer of Alvotech. The recommendation follows positive results from a 2024 clinical study confirming AVT06's therapeutic equivalence to Eylea, a drug with global sales of approximately $9 billion in 2024.

AVT06 is a recombinant fusion protein designed to bind vascular endothelial growth factors, thereby inhibiting abnormal blood vessel growth and vascular permeability, which are key mechanisms in the progression of various eye disorders. Alvotech is also developing AVT29, a biosimilar candidate for Eylea HD (aflibercept, 8 mg), and Advanz Pharma holds the distribution rights for both biosimilar candidates in the same European territories. The European Commission will make the final decision on European approval for AVT06.

Amneal Shares Results for Omalizumab Biosimilar

Amneal Pharmaceuticals has announced positive topline results from a pivotal clinical trial for ADL-018, a proposed biosimilar to reference omalizumab (Xolair), developed by Kashiv BioSciences.

 The study, involving patients with chronic idiopathic or spontaneous urticaria, successfully met its primary and secondary end points, demonstrating therapeutic equivalence and comparable safety between ADL-018 and reference omalizumab. This represents a crucial step toward making an omalizumab biosimilar available in the US.

Amneal anticipates submitting a biologics license application to the FDA in Q4 2025 and holds exclusive US commercialization rights. With Xolair's US annual sales reaching approximately $3.9 billion, ADL-018 is poised to be a significant addition to Amneal's biosimilar portfolio, enhancing access to this vital treatment.

Omalizumab is a humanized monoclonal antibody targeting free IgE indicated for various allergic conditions, including severe allergic asthma, chronic rhinosinusitis with nasal polyps, food allergies, and chronic spontaneous urticaria. Expanded access to omalizumab could significantly benefit patients and health care systems by offering a more affordable treatment alternative for these conditions.

Bio-Thera and SteinCares Join Forces on Dupilumab

Bio-Thera Solutions and SteinCares have forged a new agreement to commercialize a proposed dupilumab biosimilar across Latin America. This marks their fourth collaboration, underscoring a shared commitment to enhancing access to affordable, high-quality therapies in the region. Bio-Thera will handle product development and supply, while SteinCares will manage registration and commercialization throughout Latin America.

Mitchell Waserstein, CEO of SteinCares, emphasized that the partnership reinforces their position as a leading biosimilar platform in the region, aiming to make advanced therapies more accessible and affordable. Given dupilumab's status as 1 of the top 5 medicines globally by annual sales, this biosimilar represents a significant milestone for SteinCares' expansion, potentially aiding in the treatment of chronic inflammatory conditions in both adults and children.

1. European Medicines Agency recommends market approval of AVT06, Alvotech’s proposed biosimilar to Eylea (aflibercept). Press release. Alvotech; June 23, 2025. Accessed June 26, 2025. 

https://www.globenewswire.com/news-release/2025/06/23/3103152/0/en/European-Medicines-Agency-Recommends-Market-Approval-of-AVT06-Alvotech-s-Proposed-Biosimilar-to-Eylea-aflibercept.html

2. Amneal highlights positive topline results from confirmatory clinical study of biosimilar candidate to Xolair (omalizumab), developed by Kashiv BioSciences. Press release. Amneal Pharmaceuticals; June 25, 2025. Accessed June 26, 2025. 

https://www.globenewswire.com/news-release/2025/06/25/3105002/0/en/Amneal-Highlights-Positive-Topline-Results-from-Confirmatory-Clinical-Study-of-Biosimilar-Candidate-to-XOLAIR-R-omalizumab-Developed-by-Kashiv-BioSciences.html

3. Bio-Thera Solutions and SteinCares expand partnership to commercialize biosimilars for treatment of inflammatory diseases across Latin America. Press release. Bio-Thera Solutions; June 25, 2025. Accessed June 26, 2025. 

https://www.prnewswire.com/news-releases/bio-thera-solutions-and-steincares-expand-partnership-to-commercialize-biosimilars-for-treatment-of-inflammatory-diseases-across-latin-america-302490693.html

Regulators and manufacturers advance biosimilars for aflibercept, omalizumab, and dupilumab, enhancing access to treatment in Europe and Latin America.

Eye on Pharma: CHMP Aflibercept Decision; Omalizumab Results; Dupilumab Biosimilar Deal

Infliximab biosimilar initiation among pediatric patients with inflammatory bowel disease (IBD) rose gradually from 1% in 2018 to nearly 42% in 2023, with no consistent differences by age, race, or ethnicity and notable regional variation, according to a retrospective study.

, incorporated data from the ImproveCareNow (ICN) Network, a multicenter pediatric IBD quality improvement collaborative.

Pediatric IBD is becoming increasingly common, with an incidence of about 10 cases per 100,000 children in the US and Canada and a rising trend | Image credit: Art_Photo - stock.adobe.com

Pediatric IBD is becoming increasingly common, with an incidence of about 10 cases per 100,000 children in the US and Canada and a rising trend.

 In the US alone, IBD prevalence ranges from 100 to 200 per 100,000 children—amounting to an estimated 70,000 affected children—meaning that most pediatricians are likely to encounter and care for patients with IBD in their practice.

Access to FDA-approved treatments for pediatric IBD remains limited, as tumor necrosis factor-α inhibitors are currently the only class of medications approved for use in children with Crohn disease and ulcerative colitis, despite the availability of multiple therapeutic options for adults.

 Additionally, a 2018 survey by the Crohn’s and Colitis Foundation found that pediatric IBD providers were less comfortable prescribing biosimilars than their adult-care counterparts, likely due to the limited experience with biosimilars in children and the scarcity of pediatric-specific safety and efficacy data.

Although infliximab biosimilars offer a promising opportunity to reduce drug costs and expand treatment access, their uptake in pediatric populations has been slow, in part because of provider hesitancy, limited pediatric-specific efficacy and safety data, and regulatory and educational barriers.

 This retrospective cohort study was conducted to assess patterns in the initiation of infliximab biosimilars among a large pediatric IBD cohort and to determine whether differences in use existed by age, race, ethnicity, or geographic region.

Researchers prospectively collected data from 2016 to 2023 within the ICN Network to evaluate patterns in the initiation of infliximab originator and biosimilars among children and young adults with IBD, using statistical tests to assess differences by age, race, ethnicity, IBD phenotype, region, and year, while excluding patients with prior infliximab use, incomplete data, or enrollment at centers with limited infliximab prescribing.

“A notable strength is that data in the ICN Network registry are collected prospectively by clinicians. The ICN Network represents one of the largest pediatric IBD registries in existence and includes both large academic medical centers as well as small hospital-based and private practices, truly reflective of the real-world nature of pediatric IBD care,” the authors wrote.

Out of 26,256 pediatric IBD patients in the ICN registry, 4602 patients from 73 US-based centers met the study criteria and were included in the analysis. The study population was 45% female, with a median age of infliximab initiation of 13.7 years. Most patients had Crohn disease (70%). Between 2016 and 2023, 3807 patients began treatment with the infliximab originator, while 795 patients started on a biosimilar. No meaningful clinical differences were observed between the 2 groups.

Despite the introduction of infliximab biosimilars in late 2016, their uptake was initially minimal—rising from just 1% of infliximab initiations in 2018 to nearly 42% by 2023. Infliximab-dyyb (Inflectra; Celltrion) was the most commonly used biosimilar. While biosimilar use was generally consistent across age groups, a statistically significant difference was observed in 2020, likely due to the small number of children under age 6 initiating therapy that year. Similarly, 2020 was the only year with a significant difference in biosimilar use by race, with higher usage among patients categorized as “other.” No consistent differences in biosimilar use by ethnicity were observed. However, regional variation was evident, with the Midwest, West, and Southwest regions consistently initiating biosimilars at higher rates than the Northeast and Southeast from 2020 onward.

Cumulatively, just 17.3% of patients initiating infliximab from 2016 to 2023 were started on a biosimilar, reflecting a gradual but uneven adoption. The number of ICN centers using biosimilars increased significantly—from just 1 center in 2016 to 59 centers (88.1%) by 2023. The percentage of centers with very low biosimilar use (fewer than 10% of patients) steadily declined, while the number of centers with moderate (25%-69%) or high (70%-100%) biosimilar adoption grew notably. By 2023, more than half of centers had at least 25% of infliximab initiators starting on a biosimilar, highlighting a clear trend toward broader, though still variable, uptake.

This study had several limitations, including potential biases stemming from differences in how ICN centers consented patients and recorded infliximab product use, which may have led to underreporting—particularly for biosimilars like infliximab-axxq that were not explicitly tracked in the registry. The accuracy of the real-world data could not be independently verified, and missing race (8%) and ethnicity (4.6%) data may have affected analyses of disparities. Additionally, insurance type was recorded only at diagnosis, not at the time of infliximab initiation, limiting the ability to assess its influence on biosimilar use.

1. Maltz RM, Saeed SA, Adler J. infliximab biosimilar utilization in a large pediatric learning health system. 

. 2025;12(5):656. doi:10.3390/children12050656

2. Rosen MJ, Dhawan A, Saeed SA. Inflammatory bowel disease in children and adolescents. 

2015;169(11):1053-1060. doi:10.1001/jamapediatrics.2015.1982

3. Malter L, Jain A, Cohen BL, et al. Identifying IBD providers' knowledge gaps using a prospective web-based survey. 

. 2020;26(9):1445-1450. doi:10.1093/ibd/izaa032

Pediatric infliximab biosimilar use has risen significantly, reflecting evolving treatment patterns in inflammatory bowel disease (IBD) among children and young adults.

Increasing Biosimilar Use Reflects Changing Practice in Pediatric IBD Care

The latest IQVIA Institute for Human Data Science report highlighted a crucial challenge for the biosimilar industry: bridging the knowledge gaps among health care professionals (HCPs) to unlock the full potential of these cost-efficient alternatives.

 This came as the industry continued its robust trajectory, driving significant cost savings and expanding patient access to critical biologic therapies. While the industry keeps growing fast, helping more patients access important biologic therapies and saving billions in health care costs (with Europe on track to save €56 billion by July 2024),

 there's still a noticeable gap in awareness.

Osteoporosis is a chronic condition chracterized by weakened bones that affects 1 in 2 women and 1 in 5 men aged 50 years and older. | Image credit: eddows - stock.adobe.com

“In 2023, IQVIA Institute published a report highlighting the importance of physician perspectives on biosimilars for their optimal utilization. This viewpoint continues to remain relevant, particularly as biosimilars enter new disease areas, including ones that involve complex interactions with a broad set of healthcare professionals. In such cases, different physician groups within a disease area may have varied experience with biosimilars. Ensuring that all groups are comfortable with and have knowledge about biosimilars is crucial to continue to gain the benefits from these biosimilars,” wrote Murray Aitken, executive director of the IQVIA Institute for Human Data Science, in the report’s introduction.

One area that illustrates this awareness gap is osteoporosis, a chronic condition that affects 1 in 2 women and 1 in 5 men 50 years and older.

 Biosimilars have already shown that they can save money and help more people get the treatment they need, with a 2024 report showing that they have contributed to 6.9 billion more patient treatment days across the European Union since their introduction.

 With many more biosimilars expected to launch across different conditions in the next 6 years, there’s a real opportunity to expand their impact. But as the new IQVIA report pointed out, that hinges on making health care providers more familiar—and comfortable—with using them.

Managing osteoporosis involves a range of providers, from general practitioners to specialists like rheumatologists and endocrinologists, making coordination and shared knowledge essential. In a survey of 266 European health care professionals, 73% agreed that biosimilars offer similar safety, efficacy, and cost benefits. Still, there was a clear disconnect: general practitioners (GPs) and traumatologists were much less likely to be involved in prescribing biosimilars, and only 5% of GPs showed strong awareness of what’s currently available, let alone what’s in the pipeline. It’s a sharp reminder that without broader HCP engagement, even the best biosimilar can fall short of its potential.

For the biosimilar industry, these findings could represent a call to action. While the potential for substantial savings is estimated at over €998 million in osteoporosis care alone between 2025 and 2030, the success of biosimilars in this space could hinge on overcoming these awareness deficits. The report emphasized that a lack of experience among certain HCPs, particularly those in primary care who often served as the initial point of contact for osteoporosis patients, directly impeded optimal biosimilar uptake.

The path forward, as outlined by the IQVIA Institute, involved a multipronged strategy. This included proactive sharing of best practices across health care systems, timely updates to clinical guidelines that explicitly incorporated biosimilar usage, and dedicated HCP education initiatives. Furthermore, supportive policy frameworks that incentivized biosimilar prescribing and streamlined their integration into formularies were essential.

As new biosimilars continued to gain regulatory approval and enter the market, the industry's success increasingly depended on its ability to cultivate a well-informed and confident prescriber base. The insights from this osteoporosis-focused report served as a powerful reminder that while the science and economics of biosimilars were compelling, the human element—specifically, HCP awareness and comfort—remained the critical differentiator for realizing their full market potential.

The authors concluded that “biosimilar sustainability continues to be a crucial part of ensuring optimal patient care in a healthcare system. Biosimilar markets need to ensure that appropriate incentives exist for all stakeholders to participate, thereby allowing the healthcare system to reap the benefits of biosimilar entry.”

1. Unlocking biosimilar potential: learnings from an osteoporosis case study of complex patient pathways. IQVIA Institute for Human Data Science. May 29, 2025. Accessed June 7, 2025. 

https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/unlocking-biosimilar-potential-2025

2. The impact of biosimilar competition in Europe 2024. IQVIA. January 24, 2025. Accessed June 7, 2025. 

https://www.iqvia.com/library/white-papers/the-impact-of-biosimilar-competition-in-europe-2024

3. Non-pharmacological management of osteoporosis: a consensus of the Belgian Bone Club. 

 2011;22(11):2769-2788. doi:10.1007/s00198-011-1545-x

The biosimilar industry faces awareness challenges among health care professionals (HCPs), which must be addressed to increase cost savings and patient access to treatments.

Boosting Biosimilar Use in Osteoporosis: Why HCP Education Matters

The US pharmaceutical market has witnessed the launch of the first denosumab biosimilars, Wyost (denosumab-bbdz) and Jubbonti (denosumab-bbdz), marking a significant development for patients and health care systems.

 These products are now available for use across all indications of their reference medicines, Xgeva (denosumab) and Prolia (denosumab), respectively.

These biosimilars were originally approved in March 2024 and were also approved with interchangeability, meaning that they can be substituted in place of their respective reference agents (Wyost to Xgeva; Jubbonti to Prolia) at the pharmacy level without waiting for a physician to approve the switch.

Denosumab is a critical therapeutic agent used to manage conditions such as osteoporosis and cancer-related skeletal events. Osteoporosis, a condition characterized by weakened bones, affects more than 10 million US adults 50 years or older, with many more at risk.

 Bone metastases, where cancer cells spread to the bone, impact approximately 330,000 individuals in the US, often leading to painful skeletal-related events and fractures.

Keren Haruvi, president of Sandoz’ North America division, commented on the significance of this launch. "Denosumab is a vital medicine for conditions such as osteoporosis and cancer-related skeletal events. Providing an additional high-quality, cost-effective treatment option helps improve access and affordability for US patients," he stated.

The availability of these biosimilars is anticipated to introduce increased competition within the denosumab market, which could contribute to greater affordability for patients and health care payers. Both Wyost and Jubbonti are designed to have the same dosage form, route of administration, dosing regimen, and presentation as their reference medicines. Additionally, these new biosimilars will launch with an established Q code, which is expected to facilitate reimbursement processes.

Organizations focused on patient advocacy have welcomed the development. Claire Gill, CEO of the Bone Health and Osteoporosis Foundation, noted the potential positive impact. "Bone loss and cancer-related skeletal complications can have a profound impact on patients’ lives, but access to effective treatments has often been impacted by cost. With the introduction of new biosimilar options, patients now have access to more treatments they need and deserve," Gill said.

Support resources for patients prescribed Wyost and Jubbonti, including reimbursement and financial assistance programs, are also being provided. The entry of these interchangeable denosumab biosimilars into the US market signifies the potential for wider availability of more affordable treatment options for patients requiring denosumab therapy.

1. Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients. Sandoz. June 2, 2025. Accessed June 2, 2025. 

https://www.sandoz.com/sandoz-launches-first-and-only-interchangeable-denosumab-biosimilars-us-providing-new-affordable/

2. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars

https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar

3. Osteoporosis: from the FDA Office of Women's Health. FDA. Updated May 13, 2024. Accessed June 2, 2025. 

https://www.fda.gov/consumers/womens-health-topics/osteoporosis

4. Bone metastasis. Moffitt Cancer Center. Accessed June 2, 2025. 

https://www.moffitt.org/cancers/bone-metastasis/

Denosumab biosimilars Wyost and Jubbonti launch in the US, enhancing access to affordable treatments for osteoporosis and cancer-related skeletal events.

Wyost and Jubbonti Launch as First Denosumab Biosimilars in the US

Robert F. Kennedy Jr. confirmed as HHS Secretary, despite vaccine skepticism and controversial health views.

His confirmation faced scrutiny over financial ties to vaccine litigation and shifting abortion stances.

Kennedy's agenda includes promoting healthier foods, tackling pollution, and addressing chronic disease causes.

Concerns arose over his lack of clear plans for Medicare and Medicaid funding structures.

His tenure is expected to bring significant changes to health policy, closely watched by both political parties.

, the US Senate made Robert F. Kennedy Jr the nation’s top health official as secretary of HHS.

 The vote comes after intense confirmation hearings and tense committee votes in which it appeared some Republicans were struggling with the choice, but the majority party has now thrown their support behind the longtime vaccine skeptic, critic of processed foods, and initiator of the Make America Healthy Again agenda.

The lone Republican holdout was Sen Mitch McConnell (R, Kentucky), a polio survivor who has taken issue with Kennedy’s decades of opposition to vaccines. McConnell has also voted against confirming some other nominees in the new administration, including Tulsi Gabbard as director of national intelligence and Pete Hegseth to lead the Department of Defense.

President Donald Trump’s initial announcement of Kennedy as his pick to lead HHS was met with both 

 Proponents are enthusiastic about his pledges to promote healthier foods, tackle pollution, address root causes of chronic disease, and ban prescription drug ads. Mainstream public health voices, however, have raised concerns about his long history of false statements about vaccines and touting of raw milk and unproven COVID-19 “cures.”

After a rocky path to confirmation, the Senate on Thursday made Robert F. Kennedy Jr the nation’s top health official as secretary of HHS. | Image credit: Lila Patel - stock.adobe.com

The path to Kennedy’s confirmation was rocky, with Democrats drawing attention to his 

, which included stakes in lawsuits against vaccine makers including Merck.

 He resigned from his nonprofit, Children’s Health Defense, which is known for its antivaccine efforts, and during the confirmation hearings agreed to 

 in fees from litigation against Merck over the human papillomavirus vaccine.

, Kennedy maintained that he is not antivaccine, but rather calling for greater transparency around the safety and effectiveness of vaccines.

 Still, he pushed back on widely accepted meta-analyses that show the safety of vaccines and instead cited papers with 

 purporting to show associations between vaccines and neurodevelopmental disorders.

After a rocky path to confirmation, the Senate on Thursday made Robert F. Kennedy Jr the nation’s top health official as secretary of HHS. | Image credit: Magic Art - stock.adobe.com

 during his hearings also garnered criticism.

 He acknowledged not yet having a specific plan for aligning Medicare and Medicaid funding structures, and at times appeared to 

, including making the incorrect statement that Medicaid is “fully paid for by the federal government.”

 He also painted a picture of Medicaid as having premiums and deductibles that are too high; premiums and deductibles are 

 although enrollees report barriers to accessing care, such as 

Both Democrats and Republicans took issue with Kennedy’s shifting stances on abortion, which were rehashed throughout the confirmation hearings.

 Democratic senators brought up that as recently as March 2024, he had said he supported a woman’s right to choose abortion “throughout the pregnancy,” and accused him of ceding his beliefs for political gain. Meanwhile, some conservatives including former Vice President Mike Pence aimed to 

 but Republican senators largely did not press the issue during the hearings. When questioned about abortion by Democrats, Kennedy 

: “I agree with President Trump that every abortion is a tragedy. I agree with him we cannot be a moral nation if we have 1.2 million abortions a year. I agree with him that the states should control abortion.”

During the hearings, Sen Bill Cassidy (R, Louisiana) asked Kennedy tough questions about his history of vaccine skepticism and embrace of flawed science claiming links between vaccination and autism.

 Cassidy, a physician, admitted that he was grappling with whether to advance Kennedy’s nomination, but ultimately decided to 

 to the full Senate vote, stating, “With the serious commitments I’ve received from the administration and the opportunity to make progress on the issues we agree on, like healthy foods and a pro-American agenda, I will vote yes.”

Now, with Kennedy officially confirmed to head HHS, he will be handed a portfolio of thorny issues ranging from compliance with 

 to overseeing the administration’s policies on 

 and more. His tenure as HHS secretary portends a status quo shakeup that will be closely watched by both sides of the aisle.

US Senate 2025-02-13. C-Span. Accessed February 13, 2025. 

https://www.c-span.org/event/us-senate/us-senate/430935

Joszt L. Support and skepticism emerge as reactions to Robert F. Kennedy Jr’s HHS nomination. 

. November 15, 2024. Accessed February 13, 2025. 

https://www.ajmc.com/view/support-and-skepticism-emerge-as-reactions-to-robert-f-kennedy-jr-s-hhs-nomination

The Senate voted 52-48 to confirm Robert F. Kennedy Jr as secretary of HHS, setting up the vaccine skeptic to carry out major changes in pursuit of his Make America Healthy Again agenda.