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

Skylar Jeremias

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

Articles

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

Government price negotiations for certain products under the Inflation Reduction Act (IRA) that aimed to rein in high drug costs may have had unintended consequences for biosimilar development, according to a new report from Matrix Global Advisors (MGA).

Government price negotiations under the Inflation Reduction Act may hinder biosimilar development, impacting drug costs and patient access to affordable therapies. | Image credit: japhoto - stock.adobe.com

The report comes after a separate IQVIA Institute for Human Data Science report claimed that the globe could face what the report called a “biosimilar void.”

 Essentially, 90% of the biologics scheduled to lose exclusivity in the next decade, valued at $234 billion, do not currently have biosimilars in development, showcasing a large, missed opportunity for developers.

Although the negotiated prices don’t go into effect until 2026, the first 10 products chosen for the program have been announced.

 Only products that were not at risk of having biosimilars enter the market in the next few years were supposed to be eligible for Medicare price negotiation. However, the initial list includes Stelara (ustekinumab) and Enbrel (etanercept). Several biosimilars for Stelara are currently on the market, and 2 biosimilars for Enbrel (etanercept) have been approved by the FDA, with potential launches scheduled for 2029.

“Almost all the Medicare negotiated drugs have a generic or biosimilar equivalent in the pipeline, which in turn have a significantly lower cost,” said John Murphy III, president and CEO of the Association for Accessible Medicines, in a statement on the report.

 “The Medicare drug price negotiation program artificially extends the lifecycle of the brand version, resulting in higher costs for seniors.

The MGA analysis quantified the real-world implications not only on the cost of medicines but also on the long-term negative impact on future development of generics and biosimilars, which will result in fewer competitors and more delayed competition. The better option is the proven success of reducing drug prices through generic and biosimilar competition.”

The analysis revealed that the threat of price negotiations might deter manufacturers from launching biosimilars, especially for high-sales biologics.

 A 2024 Samsung Bioepis report indicated that after entering the market, biosimilars typically achieved a 53% market share with an average 53% decline in sales price relative to the reference biologic over 5 years.

 However, given the risks and costs involved, the MGA report estimated that for each biologic with $3.5 billion in annual sales, potentially $1.9 billion in annual savings could be lost if biosimilar entry was delayed due to government negotiations.

“In the current environment, the threat of government intervention appears to be chilling the incentives for biosimilar manufacturers to enter and compete effectively in the market,” noted the report. Unlike generics, biosimilars require steep investment, and future revenues often remain uncertain. That long timeline and financial risk, combined with government pricing uncertainty, appeared to be making some manufacturers think twice before investing.

Long-term Implications for Access and Cost

The report highlighted that these delays could impact patient access to affordable biologic therapies. Biosimilars serve as a crucial mechanism to lower treatment costs for complex conditions such as rheumatoid arthritis and certain cancers. Yet, the hesitancy among manufacturers resulting from the policy environment could blunt this potential.

According to Samsung Bioepis’ report, biosimilars continued to reduce prices by 24% to 76%, depending on therapeutic areas, but the “chilling effect” posed a threat to widespread continued price declines and broader market penetration in the future.

 “The reluctance of firms to develop biosimilars due to the risk of government price negotiations will hinder the full realization of biosimilar cost savings,” the present report stressed.

Recommendations to Address the Biosimilar Gap

To mitigate the detrimental effects of the so-called “biosimilar void,” the report offered several policy recommendations. Foremost among these was re-evaluating the use of price negotiations as a tool for controlling drug costs, emphasizing the importance of fostering competitive markets instead of suppressing biosimilar market entry.

Experts suggested that policy efforts should focus on reducing anticompetitive behaviors, including patent thickets that delay biosimilar approvals. The authors highlighted that patent thickets can impede biosimilar entry, and addressing these barriers could unlock significant savings and increase biosimilar availability.

Additionally, the report called for improved market transparency and targeted incentives for biosimilar manufacturers. “Creating a more predictable and supportive environment for biosimilar development could significantly narrow the current void," the authors wrote.

While policies aimed at reducing drug costs are vital, the report cautioned that aggressive government price negotiations might inadvertently stifle biosimilar development, ultimately undermining efforts to make biologic therapies more affordable. Moving forward, policymakers were encouraged to balance cost containment measures with strategies designed to promote biosimilar competition, ensuring equitable access to these complex therapies for patients and health systems alike.

1. Brill A, Robinson C. Long-term effects of Medicare price negotiations on drug competition. Matrix Global Advisors. July 14, 2025. Accessed July 15, 2025. 

https://accessiblemeds.org/wp-content/uploads/2025/07/Matrix_Global_Advisors_Long-Term_Effects_of_Medicare_Drug_Price_Negotiations.pdf

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

. February 5, 2025. Accessed July 15, 2025. 

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

3. Jeremias S. Stelara and Enbrel chosen for IRA price negotiation. The Center for Biosimilars. August 29, 2023. Accessed July 15, 2025. 

https://www.centerforbiosimilars.com/view/stelara-and-enbrel-chosen-for-ira-price-negotiation

4. Jeremias S. More ustekinumab biosimilars join US market share fight. The Center for Biosimilars. March 13, 2023. Accessed July 15, 2025. 

https://www.centerforbiosimilars.com/view/more-ustekinumab-biosimilars-join-us-market-share-fight

5. Biosimilar approvals. The Center for Biosimilars. Updated July 1, 2025. Accessed July 15, 2025. 

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

6. Medicare drug price negotiation has chilling effect on generic and biosimilar medicines development and availability. News release. Association for Accessible Medicines. July 15, 2025. Accessed July 15, 2025. 

https://accessiblemeds.org/resources/press-releases/medicare-drug-price-negotiation-has-chilling-effect-on-generic-and-biosimilar-medicines-development-and-availability

7. Santoro C. Samsung Bioepis reports 2024 biosimilar market growth trends. 

. October 15, 2024. Accessed July 15, 2025. 

https://www.ajmc.com/view/samsung-bioepis-reports-2024-biosimilar-market-growth-trends

Government price negotiations under the Inflation Reduction Act may hinder biosimilar development, impacting drug costs and patient access to affordable therapies.

Medicare Price Negotiations Will Slow Biosimilar Momentum, Widening Market Gap

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

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. 

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

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.

Now that Xgeva and Prolia have 3 competitors each, the market is starting to stack up, with 

 (denosumab-dssb for both), which were developed by Samsung Bioepis are waiting in the wings to launch next.

“By providing quality-proven biosimilars, we are helping to address a critical healthcare need and reduce the burden of skeletal fractures that impact patients’ quality of life,” Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, commented.

1. Fresenius expands biosimilars portfolio with the launch of denosumab biosimilars in the U.S. News release. Fresenius Kabi. July 1, 2025. Accessed July 9, 2025. 

https://www.businesswire.com/news/home/20250701511446/en/Fresenius-Expands-Biosimilars-Portfolio-With-The-Launch-of-Denosumab-Biosimilars-in-the-U.S

2. Celltrion USA announces U.S. launch of denosumab biosimilars, Stoboclo and Osenvelt (denosumab-bmwo). News release. Celltrion USA. July 7, 2025. Accessed July 9, 2025. 

https://www.prnewswire.com/news-releases/celltrion-usa-announces-us-launch-of-denosumab-biosimilars-stoboclo-and-osenvelt-denosumab-bmwo-302499495.html

3. Santoro C. FDA approves another pair of denosumab biosimilars, Conexxence and Bomyntra. The Center for Biosimilars

. March 27, 2025. Accessed July 9, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-another-pair-of-denosumab-biosimilars-conexxence-and-bomyntra

4. Jeremias S. FDA approves third pair of denosumab biosimilars. The Center for Biosimilars. March 4, 2025. Accessed July 9, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-third-pair-of-denosumab-biosimilars

5. Jeremias S. Wyost and Jubbonti launch as first denosumab biosimilars in the US. The Center for Biosimilars. June 2, 2025. Accessed July 9, 2025. 

https://www.centerforbiosimilars.com/view/wyost-and-jubbonti-launch-as-first-denosumab-biosimilars-in-the-us

6. Jeremias S. FDA, EMA approve second pair of denosumab biosimilars. The Center for Biosimilars. February 17, 2025. Accessed July 9, 2025. 

https://www.centerforbiosimilars.com/view/fda-ema-approve-second-pair-of-denosumab-biosimilars

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

Two More Pairs of Denosumab Biosimilars Enter US Market

Despite the growing presence of biosimilar insulins in the market, a new narrative review underscored persistent concerns among health care providers and patients regarding their efficacy, safety, and quality compared with reference products.

Image credit: 86008201-644px - stock.adobe.com

, dissected the rigorous regulatory pathways in the European Union (EU) and the US, ultimately confirming the safety of insulin biosimilars and confirming that people with diabetes and prescribers should be able to use approved biosimilars without concerns.

Authors of the review highlighted that although 6 biosimilar insulins were approved in the EU and 4 in the US, their commercial success had been limited, largely attributed to lingering skepticism.

 To address these concerns and provide a definitive answer on the comparability of biosimilar insulins, the narrative review examined the regulatory framework and pivotal studies supporting the registration of these products in the EU and US.

The study emphasized the multifaceted approach taken by regulatory bodies. It detailed the necessity of:

Comparative analytical and functional studies:

 These confirmed the primary, secondary, and higher-order structures of the biosimilar, along with post-translational modifications, ensuring molecular similarity.

 These investigated receptor binding and activation in cell models, assessing how biosimilar insulins induced their effects. For insulin, this included affinity to insulin receptors and studies on metabolic activity in cell cultures.

Pivotal clinical pharmacology studies using the euglycemic glucose clamp technique:

 This was the cornerstone of biosimilar insulin approval. In a double-blind, crossover design, a single subcutaneous dose of the biosimilar and reference insulin was administered, and blood glucose levels were meticulously "clamped" at a predefined level using a variable glucose infusion. The glucose infusion rate profile directly reflected the insulin's pharmacodynamic effect, while frequent blood samples established the pharmacokinetic profile. This highly sensitive method was preferred, as it could detect subtle differences that larger clinical efficacy studies might miss.

 Although not always strictly required for approval due to the sensitivity of clamp studies, these trials provided additional data on clinical safety, efficacy (eg, HbA1c), and immunogenicity.

The authors noted that both the European Medicines Agency (EMA) and FDA shared identical acceptance criteria for pharmacokinetic endpoints, with EMA having stricter criteria for pharmacodynamic endpoints. It also pointed out that whereas initial approvals involved multiple clamp studies, more recent approvals had relied on a single pivotal automated clamp study, consistently confirming biosimilarity.

The review was prompted by the low adoption of biosimilar insulins, despite their potential to reduce costs.

 Ongoing hesitation from prescribers and patients revealed a clear gap in understanding around the rigorous approval process for these biologics.

 By explaining the scientific standards behind biosimilar regulation, the review aimed to dispel misconceptions and build trust.

According to the researchers, their findings carry important implications for the biosimilar market and the US health care system. By confirming that biosimilar insulins are just as safe and effective as their reference products, the review supports increased uptake, which could help expand market share. Broader use may also lead to price competition, resulting in lower insulin costs and improved access for patients.

The review reinforced how evolving FDA guidance on interchangeability could make pharmacy-level substitution more feasible, improving convenience and access for patients.

“A clear regulatory framework ensures the efficacy and safety of biosimilar insulins in Europe and the US (and many other countries not considered in this review). This regulatory framework is based on scientific evidence that the demonstration of similar physico‐chemical properties and biological activity in preclinical studies and of pharmacological bioequivalence in glucose clamp studies is sufficient to make sure that the minor differences in the formulations between biosimilar and reference insulins are not of clinical relevance,” the authors concluded.

1. Heise T, DeVries JH. Biosimilar insulins: Narrative review of the regulatory framework and registration studies. 

2. Heinemann L, Davies M, Home P, Forst T, Vilsboll T, Schnell O. Understanding biosimilar insulins – development, manufacturing, and clinical trials. 

3. White J, Wagner A, Patel H. The impact of biosimilar insulins on the diabetes landscape. 

A recent review confirms the safety and efficacy of biosimilar insulins, addressing concerns and promoting their adoption for diabetes treatment.

Dispelling Doubts: Review Affirms Safety, Efficacy of Biosimilar Insulins

Despite the growing presence of biosimilar prescription drugs in the US health care market, a recent analysis revealed significant knowledge gaps and uncertainties among both consumers and health care professionals (HCPs).

 This widespread lack of understanding could hinder the full potential of biosimilars, which are poised to expand access to life-saving medications and potentially lower health care costs across the nation. The findings underscored an urgent need for clearer, more comprehensive educational initiatives to foster better understanding and adoption of these crucial therapeutic options.

The authors said their findings underscore an urgent need for clearer, more comprehensive educational initiatives to foster better understanding and adoption of these crucial therapeutic options. | Image credit: Alena - stock.adobe.com

The abbreviated approval pathway for biosimilars is rigorous, allowing for more affordable treatment options and increased patient access to crucial medications for conditions like chronic skin diseases, arthritis, and cancer. However, prior research had consistently shown a lack of familiarity and understanding of biosimilars among both patients and prescribers. Misconceptions around their efficacy, safety, and interchangeability had created hesitancy in their adoption.

With the FDA having issued draft guidance in 2020 on promotional labeling and advertising for biosimilars, particularly concerning disclosure statements, the present study aimed to experimentally test how different forms of disclosure impacted understanding and perceptions.

 The goal was to identify effective communication strategies that could inform and educate both groups in a neutral manner, dispelling misconceptions without unduly influencing perceptions.

The study employed an experimental design involving 379 consumers and 368 HCPs (primary care providers with prescribing authority) recruited via an online panel. Participants were randomized into one of seven biosimilar disclosure conditions or a control group.

Each condition presented a mock advertisement for "Kesterin," a fictitious biosimilar for rheumatoid arthritis. Disclosures varied by: identifying the product as a biosimilar; the comprehensiveness of the definition provided (ranging from basic to expanded details on safety, efficacy, source, dosage, and administration); and whether a specific reference product ("Mytrozen") was named. Consumer disclosures used lay language, while HCP disclosures used medical terminology. Researchers assessed the impact of these disclosures on participants' comprehension, perceptions of benefit and risk, attitudes, intentions (to use or prescribe), and preferences.

Significant knowledge gaps about biosimilars persist among consumers and healthcare professionals, hindering their adoption and potential benefits in health care.

Skylar Jeremias

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