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

Skylar Jeremias

In 2025, European, Asian, and African biosimilar markets saw major developments as Celltrion announced updates for several biosimilars in development, STADA Arzneimittel saw progress for its denosumab biosimilars, and Polpharma Biologics partnered with MS Pharma to commercialize 3 biosimilars in emerging markets.

Major advancements in biosimilars emerge in Europe and Middle East and North Africa (MENA) region, enhancing patient access and affordability in critical therapeutic areas.

Celltrion Updates on Omalizumab, Secukinumab, and Daratumumab

Celltrion announced several milestones at the 2025 European Academy of Dermatology and Venereology (EADV) Congress, underscoring its growing dermatology and immunology portfolio. Omlyclo, the first and only omalizumab biosimilar approved in Europe, will launch in Norway, with further rollouts across the region. The company also presented global Phase III results for Omlyclo in chronic spontaneous urticaria, allergic asthma, and chronic rhinosinusitis with nasal polyps, showing comparable efficacy and safety to the reference product during both treatment and observation periods. Experts emphasized the biosimilar’s significance in expanding patient access and improving quality of life for those with immuno-dermatologic conditions.

In addition, Celltrion highlighted positive early-stage results for CT-P55, a proposed secukinumab biosimilar, which demonstrated similarity in efficacy and safety in healthy subjects. With Omlyclo, Celltrion’s dermatology portfolio now includes 5 products: infliximab, adalimumab, ustekinumab, and omalizumab biosimilars.

Separately, Celltrion received European Medicines Agency approval to begin a phase 3 trial of CT-P44, a biosimilar candidate referencing daratumumab and hyaluronidase (Darzalex Faspro), in relapsed or refractory multiple myeloma. The randomized, 2-year trial will evaluate efficacy and safety in combination with lenalidomide and dexamethasone.

CHMP Opinion for STADA Denosumab Biosimilars

The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of STADA Arzneimittel’s denosumab biosimilar candidates Kefdensis and Zvogra, referencing Amgen’s Prolia and Xgeva, respectively.

 The recommendations cover all indications of the reference products, including osteoporosis and fracture prevention for Kefdensis and skeletal-related event prevention in oncology and treatment of giant cell tumor of bone for Zvogra. If approved by the European Commission, the products would mark STADA’s tenth approved biosimilar in Europe, complementing its teriparatide, bevacizumab, epoetin, adalimumab, tocilizumab, ustekinumab, aflibercept, and ranibizumab biosimilars.

Denosumab biosimilar entry is anticipated following the European Union exclusivity expiry in late 2025, with the market valued at approximately €1 billion. Increased competition is expected to expand access and reduce overall treatment costs. Ian Henshaw, STADA’s global specialty head, stated that the CHMP opinion “marks a significant milestone in broadening access to a blockbuster biologic medicine for bone conditions affecting millions of people in Europe.”

The denosumab biosimilars, also known as AVT03, were developed and manufactured by Alvotech, which partnered with STADA for commercialization in Europe, Central Asia, and the Middle East. Specialty, including biosimilars, was STADA’s fastest-growing segment in the first half of 2025, with revenues rising 18% to €486 million.

Polpharma Biologics and MS Pharma Partner for MENA Region

Polpharma Biologics has entered into licensing agreements with MS Pharma for the commercialization of 3 biosimilar candidates—vedolizumab (PB016), ocrelizumab (PB018), and guselkumab (PB019)—across the Middle East and North Africa (MENA) region.

 Under the deal, MS Pharma will handle registration, marketing, and distribution, while Polpharma Biologics will oversee development, manufacturing, and supply. Fill-and-finish activities will be localized to MS Pharma’s new biologics facility in Saudi Arabia.

The biosimilars target high-need therapeutic areas: vedolizumab for ulcerative colitis and Crohn disease, ocrelizumab for multiple sclerosis, and guselkumab for moderate to severe plaque psoriasis and psoriatic arthritis. According to the companies, these partnerships are expected to broaden access to affordable biologics in gastroenterology, neurology, and dermatology.

“Expanding our biosimilar portfolio in high-need therapeutic areas…is a strategic priority,” said MS Pharma CEO Kalle Känd, noting the collaboration reinforces the company’s regional leadership. Konstantin Matentzoglu, Supervisory Board Member of Polpharma Biologics, added that MS Pharma’s “deep regional expertise and strong commercial network” make it an ideal partner to improve patient access.

The agreement builds on an established relationship between the companies and supports efforts to strengthen biologics manufacturing capacity and health care sustainability in the MENA region.

1. Celltrion announces commercial availability of Omlyclo across Europe at EADV 2025. News release. Celltrion. September 18, 2025. Accessed September 23, 2025. 

https://www.businesswire.com/news/home/20250903480207/en/Celltrion-Announces-Commercial-Availability-of-Omlyclo-Across-Europe-at-EADV-2025

2. Kim J-h. Celltrion gets EMA nod for phase 3 trial of Darzalex biosimilar. Korea Biomedical Review. September 1, 2025. Accessed September 22, 2025. 

https://www.koreabiomed.com/news/articleView.html

3. STADA further builds its bone-health and oncology offering with positive CHMP opinion on denosumab biosimilars. News release. STADA Arzneimittel. September 19, 2025. Accessed September 22, 2025. 

https://www.stada.com/blog/posts/2025/september/stada-further-builds-its-bone-health-and-oncology-offering-with-positive-chmp-opinion-on-denosumab-biosimilars

4. Polpharma Biologics and MS Pharma sign licensing agreements for proposed vedolizumab (PB016), ocrelizumab (PB018) and guselkumab (PB019) biosimilars. News release. Polpharma Biologics. September 2, 2025. Accessed September 22, 2025. 

https://www.biospace.com/press-releases/polpharma-biologics-and-ms-pharma-sign-licensing-agreements-for-proposed-vedolizumab-pb016-ocrelizumab-pb018-and-guselkumab-pb019-biosimilars

Articles

Eye on Pharma: Europe and MENA Region See Expanding Biosimilar Pipelines

Biosimilars generated $20.2 billion in savings in 2024 alone, contributing to a total of $56.2 billion in savings since the first biosimilar entered the US market, according to a recent report by the Association for Accessible Medicines (AAM).

Biosimilars and generics drive significant health care savings, yet a concerning lack of biosimilar development for biologics set to lose exclusivity in the next 10 years threatens future access and affordability.| Image credit: Suriya - stock.adobe.com

The analysis titled the "U.S. Generic & Biosimilar Medicines Savings Report" also indicated that generic and biosimilar medicines collectively saved the US health care system a remarkable $467 billion in 2024, contributing to a total of nearly $3.4 trillion in savings over the preceding decade.

The report provided a special focus on the biosimilars market, celebrating a decade of progress since the first FDA approval. As of July 2025, the FDA had approved 84 biosimilars for 21 reference products, with 67 of these medicines now available to people. The increased affordability of biologic drugs due to biosimilar competition had also led to increased patient access, with people receiving an estimated 460 million more days of therapy than they would have without a biosimilar option. A recent analysis found that a second-to-market biosimilar entering within 3 years of the first could nearly double the pressure on average sales prices, accelerating price erosion for all treatments.

Despite these successes, a "biosimilar void" was identified as a significant concern.

 The report explained that while 118 biologics were expected to lose patent exclusivity over the next decade, only 12 molecules currently had biosimilars in development. This meant that 90% of the biologics losing exclusivity in the coming years lacked a biosimilar in the pipeline, representing a potential $234 billion opportunity that was not being pursued. This was a stark contrast to the European Union, where a 2023 analysis found that 73% of high-sales biologics had a biosimilar in the pipeline, compared to only 23% in the US at the time.

The report attributed the slow adoption of biosimilars to a complex web of systemic barriers, including issues with pricing, reimbursement, and patent challenges. For instance, it was noted that while 25 first-to-market biosimilars were designated as interchangeable, adoption was still slower than anticipated due to reference biologic rebate barriers.

“Closing the biosimilar void in the U.S. will take more than incremental change. It requires coordinated action across an entire ecosystem of stakeholders – manufacturers, providers, payers, and policymakers – to confront perverse, profit-driven incentives, normalize swift biosimilar adoption, and establish clear, predictable pathways to robust biosimilar competition,” wrote Giuseppe Randazzo, interim executive director of AAM’s Biosimilars Council. "I urge policymakers to wake up! Biosimilars have already provided more life-saving treatments to more patients, but additional savings and access are possible. This future is within reach if we take the bold steps needed to fill the biosimilar void."

The report also mentioned that the Inflation Reduction Act (IRA) was instituting a price control process for brand drugs before generic and biosimilar competition had a chance to begin, potentially preempting the proven savings that competition could provide. A specific example was the biologic drug Stelara (reference ustekinumab), which was selected for negotiation under the IRA, but months later, a biosimilar version launched with a price more than 80% less than the brand. As of July 2025, 9 biosimilar products were on the market for Stelara, with prices as much as 90% less than the original list price. This case was presented as an example of how competition could achieve greater price reductions than government negotiation.

The report detailed that generics comprised roughly 90% of all prescriptions filled in the US in 2024, yet accounted for only 12% of total prescription drug spending. This disparity underscored the role of generics in providing cost-effective care. It was noted that since 2019, the amount spent on all generic sales in the US had decreased by $6.4 billion, even as the volume of prescriptions increased and new generic products were launched.

For example, the number of generic oral solids prescribed increased from approximately 167 billion in 2015 to around 197 billion in 2024, a 15% increase. Additionally, the average out-of-pocket cost for a generic prescription was $6.95 in 2024, a stark contrast to the nearly 5 times higher average of $28.69 for a brand-name drug. For people who were uninsured, brand-name drug costs increased by about 50% to $130.18 per prescription since 2019, while generic costs dropped by approximately $2.45, or 6%, during the same period.

While the generics market demonstrated consistent savings, the report also pointed to a concerning trend of price deflation. The analysis found that generic prices were launching and bottoming out at lower rates compared to 3 decades ago. Around 30 years ago, generic prices tended to stabilize at approximately 34% of the brand product's list price, but in the last decade, that percentage continued to fall to 22%. The report suggested this deflation could lead to unsustainable market conditions for generic manufacturers and potentially impact patient access.

The report also detailed that the Generic Drug User Fee Program (GDUFA), created in 2012, had a goal of accelerating the review and approval of generic applications. Prior to the program, the FDA had a backlog of more than 2,500 generic drug applications, with review times averaging 31 months. As a result of GDUFA, from 2017 to 2021, the FDA approved more than 3000 generic drugs, which helped ensure quicker patient access to these medications. However, the report concluded that additional actions from stakeholders, including manufacturers, providers, payers, and policymakers, were needed to normalize biosimilar adoption and establish predictable pathways for competition in order to fully realize the potential of these medicines.

John Murphy III, president and CEO of AAM, summarized in his introductory letter, “While the U.S. generic market is clearly in peril, solutions are not far out of reach. Policymakers must streamline FDA processes, curb patent abuse, stop [pharmacy benefit managers] and Medicare policies from denying patient access, and rollback harmful federal policies – including IRA price controls. The time to act in the best interest of America’s patients is now!”

1. 2025 U.S. generic & biosimilar medicines savings report. September 3, 2025. Accessed September 22, 2025. 

https://accessiblemeds.org/resources/reports/2025-savings-report/

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

. February 5, 2025. Accessed September 22, 2025. 

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

Biosimilars and generics drive significant health care savings, yet a concerning lack of biosimilar development for biologics set to lose exclusivity in the next 10 years threatens future access and affordability.

Biosimilars Drive Savings and Access, Yet Looming Development Gap Threatens Future

Although Australia has one of the highest global rates of rheumatoid arthritis (RA), with an estimated 2000 cases per 100,000 people, the country has been an early adopter of biosimilars to help reduce costs and expand patient access to biologic therapies.

A new nationwide real-world study published in 

 assessed whether the availability of the etanercept biosimilar Brenzys, listed on Australia’s Pharmaceutical Benefits Scheme (PBS) in 2017, influenced treatment persistence among people living with severe RA.

Australia's adoption of etanercept biosimilars enhances access to rheumatoid arthritis treatments, maintaining treatment persistence and patient care quality. | Image credit: Manual - stock.adobe.com

Reference etanercept, marketed as Enbrel, has been a cornerstone biologic disease-modifying antirheumatic drug (bDMARD) for patients with severe RA since 2003. With the biosimilar Brenzys introduced in 2017, policymakers and clinicians sought evidence on whether integrating a biosimilar into practice would affect long-term treatment effectiveness, as measured by treatment persistence. Clinical trials had already established biosimilar efficacy and safety, but their short duration and selective populations limited insights into real-world use.

“Concerns have been raised among clinicians about whether biosimilars perform as well as originators outside of trial settings,” study authors noted. “Our study provides reassuring evidence that biosimilar entry has not negatively affected treatment continuity in routine care.”

Researchers conducted a retrospective cohort study using national PBS claims data linked to the National Death Index. Adults aged 18 years and older who initiated etanercept for severe RA between April 2013 and March 2022 were included. Participants were stratified into:

 (2013-2016): 4461 individuals who started etanercept before biosimilar entry

 (2018-2022): 5773 individuals who began therapy after the biosimilar was listed

The analysis excluded those using the 25 mg/mL formulation, as no biosimilar existed for that strength. Approximately 40% of contemporary cohort patients were estimated to have received the biosimilar.

Baseline characteristics showed the contemporary cohort was slightly older (mean age, 59.0 years vs 55.9 years) and had a higher proportion of men (27.8% vs 24.7%). Both groups had high comorbidity scores, reflecting the burden of chronic disease in this population. Most patients received conventional synthetic DMARDs (csDMARDs) prior to etanercept initiation, although this was somewhat lower in the contemporary group (85.8% vs 90.4%).

Treatment persistence was similar across groups:

 10.0 months (95% CI, 9.7-10.6) in the contemporary cohort vs 10.6 months (95% CI, 10.0-11.4) in the historical cohort (

 46.3% in the contemporary group vs 47.7% in the historical group

 1.00 (95% CI, 0.96-1.05), showing no significant differences in discontinuation risk

Subgroup analyses of older adults (≥ 65 years) and biologic-naïve individuals mirrored the main findings. For biologic-naïve patients, median persistence was slightly longer (11.7-12.7 months) but again showed no meaningful difference between cohorts.

Drug utilization after discontinuation was also consistent between groups. Nearly half of patients transitioned to another bDMARD, most often adalimumab, and about 19% reinitiated etanercept within 6 months.

This investigation is notable as the first population-level analysis in Australia using national claims data to evaluate real-world treatment persistence with etanercept before and after biosimilar entry. The large sample size of more than 10,000 patients strengthens the reliability of results.

However, several limitations were acknowledged. PBS data do not capture brand names, preventing direct comparisons between originator and biosimilar users. Thus, the contemporary cohort included a mix of both products. Additionally, the claims database lacked clinical measures of disease activity, laboratory markers, or reasons for treatment discontinuation, limiting insights into patient-level decision-making. Evolving treatment guidelines over time could also have influenced prescribing patterns.

These findings suggest that biosimilar entry has not disrupted treatment continuity among people living with severe RA in Australia. “Rather than adversely impacting patient care, biosimilar availability supports broader access to effective therapies at a reduced cost,” the authors concluded. They emphasized that future work should focus on brand-specific comparisons and safety outcomes to inform clinical and policy decisions.

The Australian experience offers timely reassurance for health care systems worldwide considering strategies to expand biosimilar adoption. Real-world data show that the introduction of the etanercept biosimilar has maintained stable treatment persistence.

1. Yiu CH, Ianni BD, Day RO, Raubenheimer J, Lu CY. Treatment persistence in rheumatoid arthritis before and after etanercept biosimilar introduction: a nationwide Australian real-world study. 

. 2025;39:369-381. doi:10.1007/s40290-025-00577-8

2. Treatment persistence in rheumatoid arthritis before and after etanercept biosimilar introduction: a nationwide Australian real-world study. 2025;39(5):369-381. doi:10.1007/s40290-025-00577-8

Australia's adoption of etanercept biosimilars enhances access to rheumatoid arthritis treatments, maintaining treatment persistence and patient care quality.

Stable Treatment Persistence in RA After Etanercept Biosimilar Introduction in Australia

Recent months have seen major developments in the international rollout of aflibercept biosimilars, with regulatory approvals, reimbursement milestones, and litigation settlements clearing the path for broader global access to affordable treatments for vision-threatening retinal diseases.

Recent approvals and settlements enhance global access to aflibercept biosimilars, improving treatment options for retinal diseases, like age-related macular degeneration and diabetic retinopathy. | Image credit: eevl - stock.adobe.com

United States: Sandoz Settlement Clears Path for Enzeevu

Sandoz announced a settlement with Regeneron Pharmaceuticals resolving all outstanding patent disputes over its aflibercept biosimilar, Enzeevu (aflibercept-abzv).

 Patent infringement proceedings, initially filed in 2024 under the Biologics Price Competition and Innovation Act, centered on as many as 46 patents covering the reference product, Eylea (aflibercept), some of which extend to 2040. Under the terms of the settlement, Sandoz is permitted to launch Enzeevu in the US in the fourth quarter of 2026, or earlier under certain circumstances.

Enzeevu received FDA approval in August 2024 with indications for neovascular age-related macular degeneration (nAMD). The product was also provisionally determined to be interchangeable with Eylea, although full interchangeability status remains subject to exclusivity protections. By aligning legal resolution with regulatory approval, Sandoz is positioned to strengthen its ophthalmology biosimilars portfolio and expand patient access to cost-saving alternatives in the US.

Europe: Alteogen Secures EC Approval for Eyluxvi

In Europe, the European Commission (EC) granted marketing authorization to Alteogen for Eyluxvi (ALT-L9), a biosimilar to Eylea.

 The decision followed a positive opinion issued by the Committee for Medicinal Products for Human Use in July 2025.

Eyluxvi is now approved across the European Union for multiple ophthalmic conditions, including nAMD, diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (branch or central), and myopic choroidal neovascularization. The approval was supported by results of a phase 3 clinical trial conducted in 12 countries between 2022 and 2024. The study, involving 431 patients with nAMD, confirmed therapeutic equivalence between Eyluxvi and Eylea, demonstrating similar safety and efficacy.

For Alteogen, Eyluxvi represents its second biosimilar approval, following its trastuzumab biosimilar launched in China, and the company’s first ophthalmology biosimilar developed through fully independent research and development and global clinical trials. Alteogen leadership emphasized that the approval marks a significant milestone in both regulatory experience and commitment to improving patient access to ophthalmic therapies in Europe and beyond.

The news comes as STADA Arzneimittel announced its aflibercept biosimilar Afiveg received EC marketing authorization the same week.

Canada: Biocon Biologics Gains Ontario Reimbursement for Yesafili

In Canada, Biocon Biologics announced that its aflibercept biosimilar, Yesafili, has been added to the Ontario Drug Benefit Formulary.

 Ontario, Canada’s largest province, will now publicly fund Yesafili for the treatment of nAMD, DME, macular edema secondary to central or branch retinal vein occlusion, and myopic choroidal neovascularization.

Yesafili was the first aflibercept biosimilar approved by Health Canada, supported by a phase 3 study in patients with DME confirming no clinically meaningful differences from Eylea in efficacy, safety, or immunogenicity.

With retinal diseases such as wAMD affecting over 2 million Canadians, public reimbursement is expected to significantly reduce barriers to access while alleviating financial pressure on the health care system. Company leadership emphasized that the listing represents Biocon’s seventh biosimilar launch in Canada and underscores its role in building a sustainable biosimilars ecosystem across the country.

1. Sandoz reaches agreement with Regeneron, resolving all patent litigation related to its US aflibercept biosimilar. News release. Sandoz. September 9, 2025. Accessed September 19, 2025. 

https://www.sandoz.com/sandoz-reaches-agreement-with-regeneron-resolving-all-patent-litigation-related-to-its-us-aflibercept-biosimilar/

2. Alteogen receives European Commission approval for aflibercept biosimilar, Eyluxvi (ALT-L9). News release. Alteogen. September 17, 2025. Accessed September 19, 2025. 

https://www.yourcentralvalley.com/business/press-releases/cision/20250917CN75735/alteogen-receives-european-commission-approval-for-aflibercept-biosimilar-eyluxvi-alt-l9/

3. Jeremias S. EC approves new biosimilars for bone and eye conditions. The Center for Biosimilars

. September 19, 2025. Accessed September 19, 2025. 

https://www.centerforbiosimilars.com/view/ec-approves-new-biosimilars-for-bone-and-eye-conditions

4. Biocon Biologics' Yesafili (aflibercept) now publicly funded in Ontario, Canada for the advanced treatment of patients with retinal diseases. News release. Biocon Biologics. September 18, 2025. Accessed September 19, 2025. 

https://finance.yahoo.com/news/biocon-biologics-yesafili-aflibercept-now-131100372.html

Recent approvals and settlements enhance global access to aflibercept biosimilars, improving treatment options for age-related macular degeneration and diabetic retinopathy.

Global Aflibercept Biosimilar Progress Signals Rising Access for Retinal Disease Care

The European Commission (EC) has recently granted marketing authorizations for several new biosimilar medications, expanding treatment options for patients with a range of conditions from osteoporosis and cancer-related bone disease to serious retinal disorders. The approvals include 2 denosumab biosimilars from Organon and its licensing partner Shanghai Henlius Biotech and an aflibercept biosimilar from STADA Arzneimittel.

The European Commission approves new biosimilars for osteoporosis and eye conditions, enhancing treatment options and patient access across Europe. | Image credit: Andrzej - stock.adobe.com

Denosumab Biosimilars to Enhance Bone Care

Bildyos (denosumab) and Bilprevda (denosumab)

, developed by Shanghai Henlius Biotech and Organon.

 These drugs are biosimilars to the reference products Prolia (denosumab) and Xgeva (denosumab), respectively, and are approved for all of the reference products' indications.

 in postmenopausal women and men at increased risk for fracture. It is also approved for treating bone loss associated with hormone ablation in men with prostate cancer and for bone loss linked to long-term systemic glucocorticoid therapy in high-risk adult patients.

 in adults with advanced malignancies involving bone. Additionally, it is approved to treat adults and skeletally mature adolescents with giant cell tumors of bone where surgical resection is not feasible or would likely result in severe morbidity.

The approval was based on a comprehensive data package demonstrating that the biosimilars are highly similar to their reference medicines in terms of structure, efficacy, safety, and immunogenicity. Nico Van Hoecke, head of international commercial at Organon, stated that the approvals mark a "pivotal moment in expanding access to essential bone care treatments for millions of Europeans" and may help support the sustainability of Europe's health care systems. The EC approvals for these treatments follow recent authorizations in the US. The partnership between the 2 companies dates back to a 2022 agreement granting Organon exclusive global commercialization rights, excluding China.

These biosimilars were also recently approved by the FDA for the same indications earlier this month.

STADA Gains Approval for Aflibercept Biosimilar

Adding to the recent wave of biosimilar approvals, Germany-based company STADA Arzneimittel announced that the EC granted marketing authorization for 

, a biosimilar to the reference product Eylea (aflibercept).

 Afiveg is approved as a 40 mg/mL solution for injection in both prefilled syringes and vials.

Afiveg is indicated for the treatment of multiple retinal diseases, including neovascular (wet) age-related macular degeneration. This marks STADA’s second approved biosimilar in the ophthalmology space, following Ximluci (ranibizumab), and its eighth approved biosimilar in Europe overall. STADA plans to launch Afiveg in Germany during the fourth quarter of 2025, coinciding with the expected loss of market exclusivity for its reference product, Eylea.

Ian Henshaw, STADA’s global specialty head, commented on the approval, stating, "We look forward to building on the credibility in the specialty ophthalmology sector we have built with biosimilar ranibizumab to expand patient access to aflibercept." The approval comes as STADA's specialty business segment reports strong growth, with biosimilars being a significant driver of its 18% revenue increase in the first half of 2025.

1. European Commission (EC) approves Henlius and Organon’s Bildyos (denosumab) and Bilprevda (denosumab), biosimilars to Prolia (denosumab) and Xgeva (denosumab), respectively. News release. Organon. September 19, 2025. Accessed September 19, 2025. 

https://www.organon.com/news/european-commission-ec-approves-henlius-and-organons-bildyos-denosumab-and-bilprevda-denosumab-biosimilars-to-prolia-denosumab-and-xgeva-denosumab-respectively/

2. STADA expands specialty biosimilars portfolio through European approval for Afiveg (aflibercept). News release. STADA Arzneimittel. September 16, 2025. Accessed September 19, 2025. 

https://www.stada.com/blog/posts/2025/september/stada-expands-specialty-biosimilars-portfolio-through-european-approval-for-afiveg-aflibercept

3. Jeremias S. FDA greenlights fifth pair of denosumab biosimilars: Bildyos and Bilprevda. The Center for Biosimilars

. September 2, 2025. Accessed September 19, 2025. 

https://www.centerforbiosimilars.com/view/fda-greenlights-fifth-pair-of-denosumab-biosimilars-bildyos-and-bilprevda

The European Commission (EC) approves new biosimilars for osteoporosis and eye conditions, enhancing treatment options and patient access across Europe.

EC Approves New Biosimilars for Bone and Eye Conditions

The FDA has approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), the sixth pair of denosumab biosimilars to receive the green light from the agency.

 The approvals, granted to Biocon Biologics, will provide more affordable treatment options for people with osteoporosis and cancer-related bone conditions.

The FDA has approved Bosaya and Aukelso, expanding affordable denosumab biosimilars for osteoporosis and bone-related cancers, enhancing treatment options. | Image Credit: wladimir1804 - stock.adobe.com

Bosaya is a biosimilar to the reference product Prolia, and Aukelso is a biosimilar to Xgeva. The FDA also granted a provisional interchangeability designation for both biosimilars. Clinical data demonstrated that both products had comparable quality, safety, and efficacy to their reference products.

Shreehas Tambe, CEO and managing director of Biocon Biologics, stated that the approvals were a significant milestone. "With Bosaya, we are proud to offer a more affordable treatment option for patients with osteoporosis, and with Aukelso, we are further expanding our oncology care portfolio," he said.

Bosaya was approved for treating postmenopausal women with osteoporosis at high risk for fracture and to increase bone mass in men with osteoporosis at high risk for fracture. It was also indicated for people with glucocorticoid-induced osteoporosis and for increasing bone mass in certain individuals receiving hormone ablation therapy for nonmetastatic prostate or breast cancer. Like its reference product, Bosaya carries a boxed warning for severe hypocalcemia in patients with advanced chronic kidney disease (CKD).

Aukelso was approved to prevent skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors. It was also indicated to treat adults and skeletally mature adolescents with a giant cell tumor of bone and to treat hypercalcemia of malignancy that is refractory to bisphosphonate therapy. Key warnings include the risk of hypersensitivity reactions, severe symptomatic hypocalcemia, and osteonecrosis of the jaw (ONJ).

Denosumab is a human monoclonal antibody that works by targeting RANKL, a protein essential for the formation and survival of osteoclasts, which are the cells responsible for bone resorption. By inhibiting RANKL, denosumab reduces bone breakdown and increases bone mass and strength. In 2024, US sales for denosumab products totaled nearly $5 billion.

The approval of Bosaya and Aukelso followed a series of denosumab biosimilar approvals over the past year and a half, intensifying competition in the market for bone health treatments.

Previous denosumab biosimilar approvals included:

 (denosumab-bddz) from Sandoz were the first biosimilars approved, referencing Xgeva and Prolia, respectively.

 They were also granted interchangeability and launched in the US in June 2025.

 (referencing Xgeva) from Samsung Bioepis (denosumab-dssb) gained approval with an interchangeability designation.

 (referencing Xgeva) from Celltrion (denosumab-bmwo) were approved and launched in the US in July 2025.

 (referencing Xgeva) from Fresenius Kabi (denosumab-bnht) were approved for all indications of their reference products and became commercially available on July 1, 2025.

 (referencing Xgeva) from Shanghai Henlius Biotech and Organon (denosumab-nxxp) received approval, marking the fifth pair cleared by the FDA.

1. Biocon Biologics receives U.S. Food and Drug Administration approval for Bosaya and Aukelso, denosumab biosimilars. News release. Biocon Biologics. September 17, 2025. Accessed September 18, 2025. 

https://www.prnewswire.com/news-releases/biocon-biologics-receives-us-food-and-drug-administration-approval-for-bosaya-and-aukelso-denosumab-biosimilars-302559101.html

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

. March 5, 2024. Accessed September 2, 2025. 

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

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

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

4. Jeremias S. Two more pairs of denosumab biosimilars enter US market. The Center for Biosimilars. July 9, 2025. Accessed September 2, 2025.  

https://www.centerforbiosimilars.com/view/two-more-pairs-of-denosumab-biosimilars-enter-us-market

5. Santoro C. FDA approves another pair of denosumab biosimilars, Conexxence and Bomyntra. The Center for Biosimilars. March 27, 2025. Accessed September 2, 2025. 

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

6. Jeremias S. FDA greenlights fifth pair of denosumab biosimilars: Bildyos and Bilprevda. The Center for Biosimilars. September 2, 2025. Accessed September 18, 2025. 

The FDA has approved Bosaya and Aukelso, expanding affordable denosumab biosimilars for osteoporosis and bone-related cancers and enhancing treatment options.

FDA Approves Biocon Biologics' Denosumab Biosimilars: Bosaya and Aukelso 

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Real-World Evidence Supports Biosimilar HLX02 in Metastatic Breast Cancer

The economic impact of biosimilars on the Australian health care system is now clearer, with data revealing their role in reducing market expenditure and driving price competition, a finding detailed in a new study published

Biosimilars significantly reduce healthcare costs in Australia, enhancing access to biologics while driving price competition in the pharmaceutical market. | Image credit: Zerophoto - stock.adobe.com

Researchers conducted the analysis to address a critical challenge facing health care payers: balancing the rapid growth in indications and costs of biologic medicines with finite health budgets. The researchers recognized that once patents for reference products expire, the introduction of biosimilar medicines is a key strategy to provide continued patient access to necessary treatments while ensuring the long-term affordability of funding schemes.

Monoclonal antibodies (mAbs) and Fc-fusion proteins, often referred to as biologics, have revolutionized the treatment of previously difficult-to-treat chronic inflammatory diseases and cancers.

 Since the late 1990s, when the first mAb, rituximab, was launched, these medicines have come to dominate the global pharmaceutical market. The global market for biologics was valued at an estimated $320 billion in 2020, representing 40% of the total pharmaceutical market in Europe.

 In Australia, this trend is mirrored, with mAbs accounting for a quarter of the total expenditure on the national Pharmaceutical Benefits Scheme (PBS) in 2022.

 Given the significant and growing expenditure on these medicines, there is a clear need to understand how the introduction of less expensive biosimilar alternatives impacts the market.

The primary objective of the present study was to describe the specific impact of biosimilars on the volume and cost of biologics within the Australian market. To achieve this, the research team extracted Australian sales data for selected biologic medicines with at least one biosimilar available for a minimum of 12 months. The data, spanning a decade from 2010 to 2020, was sourced from IQVIA-MIDAS. The researchers measured expenditure in US dollars and volume in standardized units (SUs). They calculated the differences in expenditure, volume, and average SU price for both the reference product and the total market for the 12-month periods before and after biosimilar market entry.

A key finding was the substantial reduction in total expenditure for biologic reference products. Just 12 months after a biosimilar entered the market, the expenditure for the reference product was reduced by 

. This occurred in a market that experienced only a minimal increase in overall use, demonstrating that the savings were primarily driven by price reduction rather than a change in market size.

The price competition was also evident in the per-unit cost. The average price of a standardized unit for reference products decreased by 

. Furthermore, the study confirmed that the price of biosimilar standardized units was as much as 

 than the price of their reference products. By 2020, the cumulative effect of these introductions was clear: biosimilars had grown to account for 

The study also identified differences in market share uptake depending on the timing of the biosimilar’s introduction. Earlier introductions, such as etanercept and infliximab, had a lower short-term market share (2.0% and 1.8%, respectively) compared with more recent introductions like rituximab (21.8%) and trastuzumab (9.3%). This suggests that policy changes and increased clinician confidence over time may have accelerated the adoption of newer biosimilars.

While the study in question did not focus on patient-level data, other research has shown that the acceptance and use of biosimilars are influenced by a variety of factors related to the people receiving the care. A separate study on patients with inflammatory arthritis and inflammatory bowel disease revealed that most people (95%) obtained their medication information from specialists.

However, only a small percentage (4.6%) of respondents in that study reported using a biosimilar, and a significant majority (66.9%) were unsure if biosimilars were even available in Australia. This highlights the ongoing need for patient education and communication from health care providers. The most frequent factor that would influence a person to switch from a reference product to a biosimilar was a specialist’s recommendation.

The study's focus on sales data meant it did not capture patient-level experiences or prescribing habits, which are influenced by factors like policies, incentives, and knowledge among healthcare providers and people receiving care. These limitations may help explain why, despite documented cost savings, Australia's biosimilar uptake has lagged behind that of European markets.

The authors noted the significance of the results for policymakers. "Our data confirms that biosimilar introduction is a powerful tool for reducing market expenditure and driving down the price of reference products. This suggests that targeted policy initiatives can create the potential for greater medicines access for people across Australia by improving the financial sustainability of the healthcare system."

The demonstrated cost savings and increased market penetration indicate that biosimilars are not only viable alternatives but are also essential for maintaining accessible and affordable health care.

1. Hillen JB, Stanford T, Ward M, et al. Medicines policy in action: the impact on volume and cost of biologic medicines after biosimilar introduction. 

. 2025;50:101173. doi:10.1016/j.vhri.2025.101173

2. Ingrasciotta Y, Cutroneo PM, Marcianò I, et al. Safety of biologics, including biosimilars: perspectives on current status and future direction. 

. 2018; 41:1013-1022. doi:10.1007/s40264-018-0684-9

3. Spotlight on biosimilars. IQVIA. 2021. Accessed September 8, 2025. 

https://www.iqvia.com/insights/the-iqvia-institute/reports-and-publications/reports/spotlight-on-biosimilars

Biosimilars significantly reduce health care costs in Australia, enhancing access to biologics while driving price competition in the pharmaceutical market.