Maggie L. Shaw

A 10-year prospective follow-up of 244 healthy stem cell donors found no new safety concerns with Sandoz’s filgrastim biosimilar, reinforcing its long-term safety for donor mobilization. | Image credit: sola_sola - stock.adobe.com

A 10-year prospective surveillance study of healthy stem cell donors who received the Sandoz biosimilar filgrastim (Zarzio, marketed as Filgrastim Hexal in Germany) for hematopoietic stem and progenitor cell (HSPC) mobilization reported no evidence of long-term safety concerns, providing reassurance for the continued use of granulocyte colony-stimulating factors (G-CSFs) in donor mobilization.

) study enrolled 244 adult, healthy, unrelated stem cell donors from the Deutsche Stammzellspenderdatei registry at 2 German centers. Participants received at least 1 dose of Sandoz’s filgrastim biosimilar, Zarzio, administered subcutaneously for up to 5 days to mobilize stem cells for collection by leukapheresis. Median donor age was 34 years (mean [SD], 35.8 [9.8] years; range, 19-60 years), and approximately three-fourths of participants were male. Median body mass index was 26.9 kg/m², placing the cohort in the overweight category.

Follow-up included structured assessments of physical and mental health, self-reported outcomes via the SF-12 questionnaire, and adverse event (AE) reporting at baseline, 1, 6, and 12 months after apheresis, and annually for 10 years.

Nearly all donors (95%) reported at least 1 AE during the initial mobilization period, with bone pain being the most common. After this period, a total of 564 AEs were documented, with median onset occurring about 4 years after mobilization (3.86 years for women and 4.02 years for men).

The majority of AEs were musculoskeletal or connective tissue disorders (n = 134) and infections or infestations (n = 130). Other categories included gastrointestinal (n = 29), endocrine (n = 18), and vascular disorders (n = 16). A total of 98 serious AEs were reported in 56 donors, but none were deemed related to biosimilar filgrastim.

Age and sex differences emerged: younger donors had significantly lower AE rates compared with older donors (rate ratio, 0.64; 95% CI, 0.43–0.95; 

 = .026). Female donors experienced higher annual AE rates than male donors (0.40 vs 0.21 AEs/year; rate ratio, 1.87; 95% CI, 1.32–2.64; 

Twelve women reported 13 pregnancies following donation, resulting in 14 live births. Pregnancy-related AEs—such as gestational diabetes, cervical incompetence, and gestational hypertension—occurred only once each, with no clustering or suspected relationship to prior biosimilar filgrastim exposure. No miscarriages, congenital anomalies, or neonatal complications were reported.

SF-12 assessments indicated that donors maintained superior average physical health scores compared with the general German population, even after 10 years (53.0 [6.9] vs 43.1 [6.9]; 

 < .0001). Mental health scores remained comparable to population averages. Neither long-term declines in health nor increased incidence of malignancies were observed. Importantly, the COVID-19 pandemic did not appear to affect donor well-being during follow-up.

Sandoz, the developer of Zarzio, funded the study. Authors concluded that the findings confirm the established safety profile of filgrastim biosimilars and provide critical long-term reassurance for donor safety in the context of allogeneic transplantation.

“No new or excessive adverse events were identified during a 10-year follow-up of mobilized stem cell donors and therefore reassure about the overall safety of stem cell mobilization with G-CSF in healthy volunteers,” wrote the investigators.

The results bolster confidence in biosimilar filgrastim products as safe, cost-effective alternatives to reference filgrastim for HSPC mobilization, supporting their continued integration into transplantation practice and managed care formularies.

A Brief History of Zarzio/Zarxio in the EU and US

Sandoz’s filgrastim biosimilar was first approved in Europe in 2009 under the brand name Zarzio.

 Approval was based on phase 3 confirmatory clinical data—the most sensitive population being patients with breast cancer undergoing myelosuppressive chemotherapy—and regulatory extrapolation of other indications such as stem cell mobilization and chronic neutropenia. Over the subsequent decade, real-world evidence, including the MONITOR-GCSF study (

) across 12 European countries (n = 1447), supported Zarzio’s efficacy and safety in oncology treatments.

In the US, Sandoz’s biosimilar (filgrastim-sndz, branded as Zarxio) became the first FDA-approved biosimilar on March 6, 2015, under the Biologics Price Competition and Innovation Act pathway.

 Its approval was grounded in a robust "totality of evidence," which included structural/functional characterization, nonclinical and clinical comparability, and the PIONEER trial data (

) showing equivalent reductions in severe neutropenia durations vs the reference product.

 The product launched in the US in September 2015 and offered patient support through Sandoz One Source.

Zarxio’s transatlantic approval signified a major biosimilar milestone, leveraging its extensive EU track record (>7.5 million patient-days of exposure) to facilitate FDA acceptance.


1. Heyn J, Bräuninger S, Becker P, et al. Healthy volunteer stem cell donors followed up 10 years after stimulation with biosimilar filgrastim. 

 2025;65(8):1418-1426. doi:10.1111/trf.18317

2. Davio K. A decade of biosimilar filgrastim experience highlights the scientific basis for extrapolation, study says. The Center for Biosimilars

. September 17, 2019. Accessed August 21, 2025. 

https://www.centerforbiosimilars.com/view/a-decade-of-biosimilar-filgrastim-experience-highlights-the-scientific-basis-for-extrapolation-study-says

3. Jeremias S. From Amjevita to Zarxio: a decade of US biosimilar approvals. The Center for Biosimilars. March 6, 2025. Accessed August 21, 2025. 

https://www.centerforbiosimilars.com/view/from-amjevita-to-zarxio-a-decade-of-us-biosimilar-approvals

4. FDA approves first biosimilar Zarxio (filgrastim-sndz) from Sandoz. News release. Sandoz. March 6, 2015. Accessed August 21, 2025. 

https://www.novartis.com/news/media-releases/fda-approves-first-biosimilar-zarxiotm-filgrastim-sndz-from-sandoz

Articles

A 10-year prospective follow-up of 244 healthy stem cell donors found no new safety concerns with Sandoz’s filgrastim biosimilar, reinforcing its long-term safety for donor mobilization.

Ten Years of Data Support Safety of Biosimilar Filgrastim for Donor Mobilization

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

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

Tocilizumab Biosimilar Indication Expansion

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

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

Kashiv BioSciences and MS Pharma have signed a 

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

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

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

Lupin and Sandoz Partner on Ranibizumab Biosimilar

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Low Prices Fail to Boost Insulin Biosimilar Uptake in the UK

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

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

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

Tocilizumab’s Role and the Biosimilar Landscape

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

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

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

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

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

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

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

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

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

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

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

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

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

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

2. Biosimilar approvals. The Center for Biosimilars

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

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

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

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

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

The analysis revealed a fragmented and inconsistent landscape for biosimilars across Latin America. Lack of harmonized regulatory processes was a significant challenge identified. Unlike the more uniform approach seen in Europe, LatAm countries often have unique and sometimes nonstandardized regulatory pathways, leading to delays in approval or, in some cases, the approval of "intended copy biologics" (ICBs) that do not meet rigorous international biosimilarity standards. For instance, the rituximab ICB Kikuzubam in Mexico was withdrawn due to higher-than-expected serious adverse effects, undermining trust in biosimilars.

Beyond regulatory hurdles, the study highlighted a scarcity of policies to actively incentivize biosimilar use. While some public health tenders in Chile favored biosimilars, a widespread lack of national policies and incentives for prescribers, particularly in the private sector, limited uptake.

This contrasts sharply with Europe, where initiatives like Ireland's "best-value biologic" program, offering enhanced prescriber payments, dramatically increased biosimilar market share and generated estimated cost savings of €22.7 million. Furthermore, confusion surrounding terminology like 

, coupled with a lack of specific naming policies for biosimilars, contributed to misinformation among health care professionals (HCPs) and patients. This absence of clear national guidelines often left clinicians and patients to make individual decisions about switching.

Implications for the Biosimilar Industry and US Health Care

For the biosimilar industry, the study underscored the immense, yet largely untapped, market potential in Latin America, estimated to reach $3.9 billion by 2025. However, realizing this potential demands a proactive approach to advocating for policy reforms and investing in comprehensive stakeholder education.

For US health care, the challenges in the LatAm region serve as a reminder of the foundational importance of clear, harmonized regulatory pathways and robust educational efforts in fostering biosimilar trust and uptake. The FDA's recent clarification on biosimilar interchangeability, affirming confidence in all approved biosimilars, directly addresses some of the informational barriers identified in Latin America, demonstrating how regulatory clarity can empower prescribers.

Ultimately, the study reinforced that although biosimilars offer a powerful tool for health care sustainability, their full benefit can only be realized through concerted efforts that address regulatory consistency, stakeholder education, and strategic incentive programs that prioritize both affordability and patient confidence.

The authors concluded, “We can envision a future scenario for the position of biosimilars in [Latin America] based on what is currently taking place in Europe…. It is crucial to continue discussing and considering these future developments throughout [Latin America], especially as an increasing number of biologic reference drugs lose their patents and become targets for biosimilar development.”

1. Feijó Azevedo V, Mysler E, Aceituno Álvarez A, et al. Recommendations for the regulation of biosimilars and their implementation in Latin America. 

. 2014;3(3):143-148. doi:10.5639/gabij.2014.0303.032

2. Schaffel R, Cornes P, Espinoza MA, et al. The potential role of biosimilars in healthcare sustainability in Latin America. 

. 2025;25(6):633-647. doi:10.1080/14712598.2025.2507173

3. Teran E, Gomez H, Hannois D, et al. Streamlining breast cancer and colorectal cancer biosimilar regulations to improve treatment access in Latin America: an expert panel perspective. 

. 2022;23(7):e348–e358. doi:10.1016/S1470-2045(22)00121-8

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

Slow Biosimilar Uptake in Latin America Signals Missed Opportunities for Patient Access, Cost Savings

The FDA has announced a significant advancement in diabetes care with the approval of Kirsty (insulin aspart-xjhz), marking it as the first rapid-acting interchangeable biosimilar product to Novolog (insulin aspart).

 This pivotal approval is a crucial step toward enhancing access to more affordable insulin options for the over 8.4 million Americans who depend on insulin therapy to manage their condition.

The approval also makes Kirsty the second insulin aspart biosimilar to receive FDA clearance. It follows Merilog (insulin-aspart-szjj), approved in February 2025, the first biosimilar to reference Novolog.

 Merilog was the third overall insulin biosimilar approved, after 2 insulin glargine products: Semglee (insulin glargine-yfgn) and Rezvoglar (insulin glargine-aglr).

Upon launch, Kirsty will be available as a 3-mL single-patient-use prefilled pen and a 10-mL multiple-dose vial.

 It is indicated to improve glycemic control in both adult and pediatric patients with diabetes. Similar to Novolog, Kirsty can be administered subcutaneously into the abdomen, buttocks, thighs, or upper arms, typically within 5 to 10 minutes before a meal.

The 10-mL vial can also be used for continuous subcutaneous infusion or intravenously. Dosing must be individualized, and the medication should not be used during hypoglycemia or in patients with hypersensitivity to insulin aspart products. Serious adverse effects include hypoglycemia, severe allergic reactions, and hypokalemia. Common adverse effects may include injection site reactions, rash, lipodystrophy, weight gain, and swelling in the hands and feet.

What’s the Deal With Interchangeability?

The designation of "interchangeable biosimilar" is particularly significant for patient access and market dynamics. The added benefit of an interchangeable biosimilar is that it may be substituted for the reference product (Novolog) at the pharmacy without the need for a new prescription, depending on state laws.

 This capability is expected to streamline patient access and further drive competition.

The high cost of reference insulin products has long been a critical issue in the US, which has over 37 million people diagnosed with diabetes.

 This financial burden often forces patients to skip or ration their insulin treatments to save money. A 

 study highlighted this challenge, finding that 1 in 5 US adults under 65 years with diabetes who use insulin rationed their supply due to cost.

 Notably, nearly 71% of adults reporting insulin rationing for financial reasons were under 65 years, making them ineligible for the out-of-pocket cost limits established by the Inflation Reduction Act.

The FDA's ongoing approval of additional insulin biosimilars, especially interchangeable ones, underscores its commitment to fostering a competitive marketplace for insulin products.

Increasing access to safe, effective, and high-quality medications at potentially lower price points remains an ongoing priority for the FDA. In a statement touting the approval of Miralog, Sarah Yim, MD, director of the Office of Therapeutic Biologics and Biosimilars, further emphasized that "having a biosimilar option for their rapid-acting insulin injection can truly make a difference, as biosimilar products have the potential to increase access to these life-saving medications."

The availability of biosimilar and interchangeable insulin products is expected to provide more treatment options, potentially lowering costs, and ultimately enabling greater access for more patients.

1. FDA approves first interchangeable biosimilar insulin product to Novolog (insulin aspart). News release. FDA. July 15, 2025. Accessed July 15, 2025. 

https://content.govdelivery.com/accounts/USFDA/bulletins/3e995f3

2. American Diabetes Association announces support for INSULIN Act at Senate press conference. News release. ADA. June 22, 2022. Accessed July 15, 2025. 

https://diabetes.org/newsroom/american-diabetes-association-announces-support-for-insulin-act-at-senate-press-conference

3. Jeremias S. FDA approves first insulin aspart biosimilar. The Center for Biosimilars

. February 17, 2025. Accessed July 15, 2025. 

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

4. Fang M, Selvin E. Cost-related insulin rationing in US adults younger than 65 years with diabetes. 

. 2023;329(19):1700-1702. doi:10.1001/jama.2023.5747

The FDA has approved Kirsty, the first interchangeable insulin aspart biosimilar, enhancing access to affordable diabetes care for millions.

FDA Approves Kirsty as First Interchangeable Insulin Aspart Biosimilar

The US biosimilar market recently saw the introduction of 2 pairs of denosumab biosimilars from Fresenius Kabi and Celltrion USA, significantly expanding treatment options for individuals living with bone-related conditions.

The pairs of denosumab competitors follow the launches of Sandoz’ Wyost and Jubbonti (denosumab-bbdz for both), which launched in March 2025. | Image credit: SoftSheep - stock.adobe.com


 the commercial availability of Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). Conexxence is a biosimilar referencing Prolia (denosumab), and Bomyntra is a biosimilar referencing Xgeva (denosumab). The biosimilars 

 from the FDA for all indications of their respective reference products in March 2024.

Conexxence is indicated for various adult patient populations at high risk for fractures.

 This includes individuals with osteoporosis, people undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy. It is available in a 60-mg/mL single-use prefilled syringe. Fresenius Kabi noted that Conexxence carries a black box warning and is part of a Risk Evaluation and Mitigation Strategy program designed to inform prescribers and patients about the risk of severe hypocalcemia in individuals with advanced chronic kidney disease, including those on dialysis. The biosimilar is contraindicated in patients with hypocalcemia, during pregnancy, and in cases of known hypersensitivity to denosumab products.

Bomyntra is approved for the prevention of skeletal-related events in patients with multiple myeloma and in individuals with bone metastases from solid tumors. It is also indicated for the treatment of hypercalcemia of malignancy that is refractory to bisphosphonate therapy and for the treatment of adults and skeletally mature adolescents with giant cell tumor of the bone that is unresectable or where surgical resection is likely to result in severe morbidity. Bomyntra is available in a 120-mg/1.7-mL vial and a 120-mg/1.7-mL single-use prefilled syringe. It is contraindicated in patients with hypocalcemia and those with known hypersensitivity to denosumab products.

Sang Jin Pak, PhD, president of Fresenius Kabi Biopharma, expressed the company’s commitment to consistent biosimilar launches, stating, “Access to high-quality biological medicines creates the opportunity to provide more affordable therapies to patients and as our biosimilar portfolio expands, we will be able to provide access for even more patients.” Earlier this year, Fresenius Kabi reached a global settlement with Amgen regarding its denosumab biosimilars.

 the commercial availability of its denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo). Stoboclo references Prolia (denosumab), while Osenvelt references Xgeva (denosumab).

Stoboclo is available as a 60-mg/mL injection. It is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, and to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture. Additionally, it is indicated to increase bone mass in men at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Osenvelt, available as a 120-mg/1.7-mL (70 mg/mL) injection, is indicated to prevent skeletal-related events in patients with multiple myeloma and in individuals with bone metastases from solid tumors. It is also approved to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

Thomas Nusbickel, chief commercial officer at Celltrion USA, highlighted the significance of the launches, stating, "We are proud to introduce our denosumab biosimilars to the U.S. market, offering patients and professionals a valuable alternative treatment option." Celltrion also reached a global settlement with Amgen concerning its denosumab biosimilars. To support patients, Celltrion offers comprehensive patient support programs, including the Celltrion Connect patient support program and the Celltrion Cares co-pay assistance program, with options for uninsured patients to potentially receive treatment at no cost.

The pairs of denosumab competitors follow the launches of Sandoz’ Wyost and Jubbonti (denosumab-bbdz for both), which launched in March 2025, nearly a year after they became the first denosumab biosimilars to be greenlit by the FDA.

The US biosimilar market expands with new denosumab options, enhancing treatment for patients with osteoporosis and bone-related metastases.