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

Skylar Jeremias

In 2025, policy efforts intensely focused on reducing biosimilar barriers and promoting affordability worldwide, highlighted by a US bipartisan bill protecting skinny labeling to shield biosimilar manufacturers from costly patent litigation and a presidential executive order that emphasized biosimilars as the "clear answer" to sky-high US drug costs.

Here are the most-read biosimilar policy articles from 2025.

5. The Trump Administration’s Drug Price Actions and Why US Prices Are Already Sky-High

This article explores the complex factors contributing to the high cost of prescription drugs in the US, providing context for the Trump administration's second executive order aimed at lowering drug prices. The administration claimed the order would reduce current prescription drug prices by 59% by aiming to establish "most-favored nation" pricing, which they stated could reduce costs between 30% and 80%. Unlike many countries with price control policies, the US allows pharmaceutical companies to set and change their list prices freely. The resulting US prescription drug prices are nearly 3 times higher than in 33 Organisation for Economic Co-operation and Development countries, with brand-name innovator medications costing four times more. The US drug pricing crisis is rooted in high development costs, profit incentives, and the lack of comprehensive price control measures.

The article also noted that the administration signaled potential tariffs on pharmaceuticals, which could impact imported generics, biosimilars, and active pharmaceutical ingredients.

4. BioRationality: What’s Wrong With the Indian CDSCO Biosimilar Guidelines?

This piece submitted recommendations to the Indian Central Drugs Standard Control Organisation (CDSCO) regarding the revision of its 2016 "Guidelines on Similar Biologics." The report argues that rationality must prevail for biosimilars to flourish, advocating for extensive revisions to align the guidelines with current scientific understanding and the requirements of Stringent Regulatory Authorities (SRA). Author Sarfaraz K. Niazi, PhD, proposed removing requirements for preclinical studies, including pharmacodynamic and toxicological assessments in animals, because biological drugs do not necessarily show toxicity in animals and animal models often lack the necessary receptor binding. 

The recommendations also called for the removal of requirements for multiple-dose comparative pharmacokinetic studies, noting that animal testing cannot reveal differences in protein products. Furthermore, the article argued that the requirement for "confirmatory phase 3 clinical efficacy studies" is often unnecessary and incorrect terminology for biosimilars, suggesting India adopt the UK’s position that such trials may not be needed if scientifically justified.

3. President Trump Signs Executive Order to Bring Down Drug Prices

President Donald Trump signed an executive order directing leaders of HHS, CMS, and the Office of Management and Budget to develop meaningful actions to address high drug costs for Americans. The order emphasized that safe, effective, and lower-cost biosimilars are the clear answer to skyrocketing prescription drug costs. It highlighted the potential for biosimilars to generate substantial savings—$56 billion already, with the potential for $181 billion more in the next 5 years. 

The order included 13 directive actions, such as instructing the FDA commissioner to issue a report with recommendations to accelerate the approval of generics and biosimilars. It also mandated that HHS evaluate and propose regulations to prevent Medicare payment policies from incentivizing the use of costlier hospital-based drug administration over physician offices and directed the Secretary of Labor to propose regulations to increase employer health plan transparency into pharmacy benefit manager (PBM) compensation. The Biosimilars Forum applauded the administration for taking decisive action to support biosimilars and streamline their development based on science rather than bureaucracy. 

2. Cost-Efficiency in Action: Denmark's Transition to Biosimilar Adalimumab 

An observational cohort study confirmed the economic feasibility of biosimilar adoption following Denmark's nationwide mandatory switch from originator Humira (adalimumab) to biosimilar adalimumab. The study, utilizing the Danish DANBIO registry, found that the switch did not increase total health care costs over a 9-month period. Hospital costs, which accounted for approximately 90% of total health care costs, remained similar or even decreased after the transition for biosimilar switchers. 

Specific analysis showed that health care costs decreased by 15% for patients with psoriatic arthritis and axial spondyloarthritis who switched to the GP2017 biosimilar. These findings were reassuring to the authors, as concerns had been raised about potential additional costs associated with increased health care utilization for patient education and monitoring during the transition.

1. Senators Introduce Bipartisan Legislation to Protect Skinny Labeling

In a major policy move to close out the previous year, 4 senators introduced a new bipartisan bill (S 5573), also known as the Skinny Labels, Big Savings Act, designed to accelerate the rollout of biosimilars and generic drugs. "Skinny labeling" is a strategy allowing follow-on drug manufacturers to seek approval only for specific indications of a branded drug, thereby avoiding "new-use" patents that often extend the originator's exclusivity. 

The legislation would amend federal patent infringement law to protect biosimilar and generic drug manufacturers from costly patent litigation when they obtain skinny-label FDA approvals. The bill explicitly allows manufacturers to submit, market, and describe their skinny-labeled drug as a generic or therapeutic equivalent to the originator. 

Proponents of the bill argued it is imperative for US patients, as it helps to "level the playing field" against the originator pharmaceutical companies' use of endless patent litigation. The estimated savings to Medicare from skinny-label biosimilars between 2015 and 2020 amounted to approximately $1.5 billion, and future savings are anticipated, especially with the expected market entry of adalimumab biosimilars using this strategy.

The bill was reintroduced in the House in December 2025 and is awaiting committee review.

Articles

In 2025, the latest biosimilar policy developments included bipartisan efforts to enhance affordability and reduce barriers in the pharmaceutical landscape.

First Natalizumab Biosimilar Tyruko Launches, Expanding Access in Multiple Sclerosis

The final months of 2025 delivered a mix of significant victories and temporary setbacks for biosimilar developers in the global regulatory landscape, marked by multiple European approvals for biosimilars targeting blockbuster autoimmune and bone health treatments, while a manufacturing concern delayed a key entry into the competitive US market.

DNA syringe | Image credit: natali_mis - stock.adobe.com

Denosumab Biosimilars Flood European Economic Area Market

The European Economic Area (EEA) saw multiple approvals for biosimilars referencing Prolia and Xgeva (denosumab), opening the door to increased patient access and sustainable health care budgets.

Alvotech announced that the European Commission (EC) had approved AVT03 as a biosimilar to Prolia and Xgeva.

 Denosumab is an established treatment widely used for managing osteoporosis and preventing skeletal-related events in people with certain cancers. The EC decision underscored Alvotech’s continuing progress across its biosimilar portfolio and highlighted its role as a partner to health systems across Europe. This approval demonstrated the strength of the company’s end-to-end platform and ability to deliver high-quality biosimilars to patients across Europe.

AVT03 was approved in 2 presentations: a 60 mg/mL single-use pre-filled syringe biosimilar to Prolia, intended for the treatment of osteoporosis and bone loss, and a 70 mg/mL single-use vial biosimilar to Xgeva, for preventing skeletal-related events in adults with advanced malignancies involving bone. The approval was based on a totality of evidence, including confirmatory clinical studies demonstrating equivalent efficacy and pharmacokinetics and comparable immunogenicity and safety to the reference product. The European denosumab market was valued at approximately US$1.2 billion across all indications, based on originator sales in the 12 months leading up to the second quarter of 2025.

Alvotech planned to commercialize AVT03 in partnerships with Dr. Reddy’s and STADA in the EEA, Switzerland, and the UK. STADA planned to market the product as Kefdensis (biosimilar to Prolia) and Zvogra (biosimilar to Xgeva), while Dr. Reddy’s intended to market it as Acvybra and Xbonzy, respectively.

In parallel, Teva Pharmaceutical Industries also received EC marketing authorizations for its 2 denosumab biosimilar candidates: Ponlimsi (biosimilar to Prolia) and Degevma (biosimilar to Xgeva).

 The approvals followed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) earlier in the year. Ponlimsi (60 mg/1 mL pre-filled syringe) was indicated for treating osteoporosis in postmenopausal women and men who are at increased risk of fractures, as well as for treating bone loss associated with hormone ablation in men with prostate cancer or in adults on long-term systemic glucocorticoid treatment. Degevma (120 mg/1.7 mL solution in a vial) was indicated for preventing bone complications in adults with advanced cancer involving bone and for treating adults and skeletally mature adolescents with giant cell tumor of bone. Teva emphasized that these product launches provided additional treatment options for healthcare systems throughout Europe, aligning with the company's Pivot to Growth strategy.

Golimumab Biosimilar Approved in Europe, Faces US Delay

Alvotech celebrated further regulatory success in Europe with its golimumab candidate, but simultaneously reported a key delay in the US regulatory pathway for the same product.

Alvotech and Advanz Pharma announced the EC granted marketing authorizations for Gobivaz (golimumab), a biosimilar to Simponi, for use across the EEA.

 This approval allowed for the treatment of various immune-mediated diseases in adults, including axial spondyloarthritis, rheumatoid arthritis, ulcerative colitis, and psoriatic arthritis. Significantly, Gobivaz also received authorization for treating juvenile idiopathic arthritis in children aged 2 years and older when used in combination with methotrexate. Alvotech provided the commercial supply and development of Gobivaz, while Advanz Pharma held the exclusive commercialization rights for the UK and the EEA.

Just weeks earlier, however, Alvotech announced that the FDA issued a complete response letter (CRL) for the biologics license application for its golimumab biosimilar candidate, AVT05.

 The CRL cited specific deficiencies that needed satisfactory resolution; these deficiencies had been conveyed following the FDA’s pre-license inspection of Alvotech’s Reykjavik manufacturing facility, which concluded in July 2025.

The facility remained approved to manufacture and continued supplying the currently commercialized products. Despite expressing disappointment in receiving the CRL, the company expected to resolve the outstanding issues. Following this regulatory action, Alvotech adjusted its 2025 total revenue outlook downward to $570 million to $600 million, primarily due to expected continuation of investments related to resolving the facility issues and a temporary slowdown in production. At the time of the announcement, the sources noted that no biosimilar to Simponi had received FDA approval.

1. Alvotech announces approval of AVT03, a biosimilar to Prolia and Xgeva (denosumab) in the European Economic Area. Alvotech. News release. November 24, 2025. Accessed December 16, 2025. 

https://www.globenewswire.com/news-release/2025/11/24/3193284/0/en/Alvotech-Announces-Approval-of-AVT03-a-Biosimilar-to-Prolia-and-Xgeva-denosumab-in-the-European-Economic-Area.html

2. Teva receives European Commission approvals for Ponlimsi (denosumab) biosimilar to Prolia and Degevma (denosumab) biosimilar to Xgeva. Teva Pharmaceutical Industries. News release. November 25, 2025. Accessed December 16, 2025. 

https://www.globenewswire.com/news-release/2025/11/25/3194303/0/en/Teva-receives-European-Commission-approvals-for-PONLIMSI-denosumab-Biosimilar-to-Prolia-and-DEGEVMA-denosumab-Biosimilar-to-Xgeva.html

3. Alvotech and Advanz announce EC approval for Gobivaz biosimilar. Pharmaceutical Technology. November 21, 2025. Accessed December 16, 2025. 

https://www.pharmaceutical-technology.com/news/alvotech-advanz-ec-approval

4. Alvotech provides update on the status of U.S. biologics license application for AVT05. Alvotech. News release. November 2, 2025. Accessed December 16, 2025. 

https://www.globenewswire.com/news-release/2025/11/02/3178815/0/en/alvotech-provides-update-on-the-status-of-u-s-biologics-license-application-for-avt05.html

Biosimilar developers achieve key European approvals for denosumab and golimumab, enhancing patient access while facing US market entry delays.

Denosumab, Golimumab Biosimilars Clear Major Regulatory Milestones in Europe, as US Hurdles Remain

Rising cancer drug costs have pushed payers to search for practical ways to stretch limited budgets, and new modeling data indicate that a broad shift to biosimilar bevacizumab could give Medicare considerably more room to treat older adults with metastatic colorectal cancer (mCRC) and metastatic non-squamous non–small cell lung cancer (mNSCLC) without compromising care.

Biosimilar bevacizumab offers significant cost savings for Medicare, enhancing treatment access for metastatic colorectal and lung cancer patients without increasing spending. | Image credit: japhoto - stock.adobe.com

, assessed whether converting people from the reference bevacizumab product to several FDA-approved biosimilars could improve cost-efficiency in first-line treatment. Investigators conducted the analysis to quantify both direct savings and the number of additional individuals whose therapy could be funded using those savings on a budget-neutral basis—an increasingly relevant question as Medicare continues to spend heavily on biologics for solid tumors.

Researchers developed a simulation model rooted in a Medicare payer perspective, focusing exclusively on drug acquisition costs rather than clinical outcomes. Because biosimilars are expected to match their reference biologic in safety and efficacy, the analysis centered on pricing differences across bevacizumab-bvzr, bevacizumab-awwb, bevacizumab-adcd, and bevacizumab-maly. Costs were derived from 2024 average sales price (ASP) data, using Medicare’s reimbursement markups for originator and biosimilar products.

To estimate the number of beneficiaries likely to receive treatment, the model incorporated Medicare enrollment data, SEER incidence rates among adults aged 65 years and older, and published estimates describing the proportion of individuals who begin systemic therapy. This approach produced an estimated 6,579 people with mCRC and 3,843 people with mNSCLC who would receive bevacizumab-based regimens in an average year.

Modeled treatment reflected guideline-concordant regimens. People with mCRC were assigned bevacizumab-containing FOLFOX for initiation and maintenance. Those with mNSCLC were modeled on bevacizumab with paclitaxel plus carboplatin during induction, followed by bevacizumab alone in the maintenance phase. Dosing and vial counts were calculated using average weight and body surface area from prior research, aligning drug utilization with typical patient characteristics in the Medicare population.

Across both cancers, conversion to bevacizumab-bvzr generated the strongest cost-efficiency profile. In mCRC, switching produced per-patient per-month (PPPM) savings of $4,205, reflecting a 68% reduction relative to originator-based care. When applied to the full modeled population, monthly savings reached $27.7 million. Using these savings, Medicare could fund 13,887 additional patient-months of bevacizumab-bvzr plus FOLFOX on a budget-neutral basis. The “number needed to convert” (NNC) was 47, meaning that converting 47 individuals to the biosimilar would free enough funds to treat 100 more.

Savings were even greater for people with mNSCLC, given the higher baseline cost of originator bevacizumab in lung cancer regimens. Here, PPPM savings totaled $8,410, and full cohort monthly savings reached $32.3 million—a 70% reduction compared with the reference product. These savings could support 8,959 additional patient-months of bevacizumab-bvzr–based therapy. The NNC was 43, the lowest of all biosimilars evaluated.

Alternative biosimilars did produce savings, but to a smaller degree. Bevacizumab-awwb generated meaningful reductions—with PPPM savings of $3,876 in mCRC and $7,752 in mNSCLC—while bevacizumab-adcd offered minimal savings in both conditions.

The authors noted several limitations. The study assumed steady patient counts across the year, although treatment initiation and discontinuation vary in real-world practice. ASP values change quarterly, which may shift relative cost-efficiency over time. The analysis also relied on national averages for weight-based dosing, which may not reflect local population characteristics. Finally, because the model excluded administration or site-of-care costs, total spending differences may differ in real-world scenarios.

Even with these constraints, the findings highlight the potential for biosimilars to extend access to oncology biologics within fixed budgets—an issue of growing importance as Medicare’s oncology expenditures continue to rise. For bevacizumab, the model suggests that bevacizumab-bvzr may offer the most cost-efficient option among available biosimilars, allowing payers to treat more people with cancer without increasing overall spending.

Roth JA, Kratochvil D, Dorman S, Bernauer M. Cost-efficiency and expanded access modeling of conversion to biosimilar bevacizumab in metastatic colorectal and non-squamous non-small cell lung cancer in Medicare. 

. 2025;28(1):378-386. doi:10.1080/13696998.2025.2474884

Biosimilar bevacizumab offers significant cost savings for Medicare, enhancing treatment access for metastatic colorectal and lung cancer patients without increasing spending.

Medicare Modeling Shows Major Savings With Biosimilar Bevacizumab Use

Efforts to expand access to vision-saving therapies for people with diabetic eye disease increasingly depend on the availability of lower-cost biologic alternatives, and new comparative data add clarity to how one aflibercept biosimilar performs in routine clinical practice. A recently published retrospective analysis evaluated whether the aflibercept biosimilar QL1207 offered similar outcomes to reference aflibercept for individuals with diabetic macular edema (DME), a leading cause of vision impairment among people with diabetes.

eye doctor | Image credit: Coetzee:peopleimages.com - stock.adobe.com

The study was conducted to address a longstanding gap in real-world data. Although QL1207 was approved by China’s National Medical Products Administration in late 2023 based on structural and functional similarity to reference aflibercept, published comparative clinical information in DME populations remained limited. 

Given the high cost of originator anti-VEGF therapy and the chronic, injection-intensive nature of DME management, the investigators sought to determine whether the biosimilar performed comparably in anatomical and functional outcomes, macular perfusion metrics, injection burden, and safety.

The analysis included anonymized clinical data from 80 adults (80 eyes) with nonproliferative diabetic retinopathy and DME who were seen at a single ophthalmology department between June 2023 and April 2024. Participants were treatment-naïve and met diagnostic criteria outlined in the American Academy of Ophthalmology’s 2019 clinical guidelines. Individuals were excluded if they had other retinal diseases, a history of ocular procedures, proliferative disease, significant media opacity, or a hemoglobin A1c greater than 7%.

Demographic characteristics were balanced across treatment groups. The reference aflibercept group included 40 people (20 men and 20 women) with a mean age of 48.6 years. The QL1207 group included 40 people (19 men and 21 women) with a mean age of 46.7 years. Baseline HbA1c levels were similar, and no clinically meaningful differences emerged during the 12-month follow-up period.

All participants received 3 monthly loading doses followed by a pro re nata retreatment approach. Retreatment criteria included central retinal thickness (CRT) greater than 280 µm or a decrease of 5 or more Early Treatment Diabetic Retinopathy Study letters. Best-corrected visual acuity (BCVA), optical coherence tomography measures, and optical coherence tomography angiography parameters—including foveal avascular zone (FAZ) area and superficial and deep vascular density (SVD and DVD)—were collected at baseline and during follow-up. The investigators also recorded injection frequency and adverse events.

The study found no statistically significant differences between groups in BCVA or CRT at baseline or at 1, 3, 6, or 12 months. Both groups demonstrated significant improvement in BCVA relative to their own pretreatment values, as well as substantial reductions in CRT (

 < .05 for all within-group comparisons). At 12 months, mean CRT decreased from 447.1 µm to 280.4 µm in the reference group and from 441.0 µm to 290.3 µm in the QL1207 group. Injection burden was also similar, with mean injection counts of 3.58 in the reference group and 3.40 in the biosimilar group (

Macular microvascular outcomes also aligned closely across groups. FAZ area decreased significantly within each group, while both SVD and DVD increased, indicating improved or stabilized macular perfusion. None of these parameters differed significantly between groups at baseline or month 12.

Safety outcomes were consistent with the known safety profile of intravitreal anti-VEGF therapy. Mild events—including transient intraocular pressure elevations, corneal epithelial damage, and subconjunctival hemorrhage—occurred infrequently and at similar rates in both groups. No individuals experienced endophthalmitis, glaucoma, vitreous hemorrhage, cataract progression, or systemic cardiovascular or cerebrovascular events during the follow-up period.

The authors noted several limitations, including the retrospective design, relatively small sample size, nonrandomized treatment assignment, and 12-month follow-up period. In addition, while statistically significant changes in OCT angiography parameters were documented, their clinical significance remains uncertain. Longer, prospective, randomized studies will be needed to validate long-term comparability between QL1207 and reference aflibercept in DME.

Even with these limitations, the findings contribute to growing real-world evidence showing that aflibercept biosimilars may offer an effective and potentially more affordable option for individuals living with DME. As biosimilar adoption grows globally, studies like this may help inform formulary decisions and support broader access to sight-preserving therapy.

Zhai G, Liu N, Wang S, Zhang X. Comparative efficacy of intravitreal aflibercept biosimilar QL1207 versus reference aflibercept in the treatment of diabetic macular edema. 

. 2025:12:1662735. doi:10.3389/fmed.2025.1662735

Biosimilar QL1207 Demonstrates Equivalent Efficacy and Safety in DME

Widening interest in biosimilar adoption has renewed discussion in Switzerland about how closely priced follow-on agents compare with emerging extended-interval anti-VEGF options. A new cost-minimization analysis offers insight into this question by quantifying how ranibizumab biosimilars stack up financially against their reference product and against both doses of aflibercept for neovascular age-related macular degeneration (nAMD) and diabetic macular edema (DME).

Explore the cost-effectiveness of ranibizumab biosimilars versus aflibercept in treating AMD and DME, revealing significant savings and treatment implications. | Image credit: Syda Productions - stock.adobe.com

As Swiss payers continue to evaluate ways to control spending for chronic retinal diseases, biosimilars represent a potential mechanism for reducing direct health care costs without compromising clinical outcomes. Anti–vascular endothelial growth factor (VEGF) therapy remains the standard of care for both nAMD and DME, with treatment costs largely driven by medication pricing and injection frequency. With multiple ranibizumab biosimilars now marketed in Switzerland, the study aimed to clarify how much these agents reduce overall expenditures relative to reference ranibizumab and how their total 2-year costs compare with the more recently introduced higher-dose aflibercept 8 mg.

The model assessed unilateral treatment using real-world Swiss price data and injection frequencies derived from randomized trials. It assumed equivalent clinical outcomes across all evaluated therapies, which included aflibercept 2 mg, aflibercept 8 mg, faricimab, reference ranibizumab, and three ranibizumab biosimilars. The analysis was conducted from the health care payer perspective.

Across both disease areas, ranibizumab biosimilars generated meaningful cost savings relative to their reference product. In nAMD, the biosimilars’ 2-year total costs ranged from CHF 16,243 ($20,200) to CHF 17,618 ($21,900)—representing savings of approximately CHF 800 to CHF 2,200 per individual when compared with reference ranibizumab (CHF 18,424; $22,950). Similar results were seen in DME, where biosimilar costs ranged from CHF 18,187 ($22,600) to CHF 19,596 ($24,400), compared with CHF 20,637 ($25,700) for the reference product. These findings reflect the direct impact of lower acquisition costs, as injection frequencies for reference and biosimilar ranibizumab were assumed to be equivalent.

However, when biosimilars were compared with aflibercept products, the picture shifted. Aflibercept 2 mg carried higher overall 2-year costs than the biosimilars for both nAMD and DME, largely due to higher injection frequency. In nAMD, aflibercept 2 mg costs CHF 15,632 ($19,480)—slightly lower than the biosimilars but still higher than aflibercept 8 mg. In DME, the biosimilars were costlier than aflibercept 2 mg, which totaled CHF 15,243 ($18,990), with the difference driven by dosing intervals derived from clinical trial protocols.

Aflibercept 8 mg, designed to extend treatment intervals to as long as 16 weeks in some individuals, was consistently the lowest-cost therapy across both conditions. Its 2-year total cost was CHF 11,814 ($14,700) in nAMD and CHF 11,242 ($14,010) in DME—substantially lower than all ranibizumab products, including biosimilars. These savings stemmed from reduced injection frequency rather than drug price.

The study authors also performed break-even analyses to estimate how much biosimilar ranibizumab prices or injection frequencies would need to change to match the costs of aflibercept 8 mg. In nAMD, biosimilars would require price reductions of 55% to 59%. In DME, reductions of 76% to 79% would be needed. Similar patterns were observed for injection frequency: biosimilars would require 36% to 46% fewer injections in nAMD and up to 58% fewer in DME.

These findings highlight a central tension in the Swiss retina market. While biosimilars offer immediate, predictable price reductions compared with reference ranibizumab, the introduction of extended-interval therapies—particularly aflibercept 8 mg—shifts the cost landscape by reducing service utilization rather than drug unit cost. For conditions that require long-term maintenance therapy, fewer injections translate directly into reduced administration and visit costs.

The study had several limitations. Injection frequencies were based on clinical trials rather than real-world data, which may change as clinicians gain experience with newer products. The model assumed equivalent clinical outcomes among all agents, did not incorporate safety or adherence considerations, and used a 2-year horizon that may not reflect longer-term treatment patterns.

Even with these limitations, the analysis underscores that ranibizumab biosimilars meaningfully reduce costs relative to their reference product and offer a lower-cost alternative to aflibercept 2 mg, depending on disease area. However, the cost advantages of biosimilars are insufficient to offset the significantly reduced injection burden associated with aflibercept 8 mg, which remains the lowest-cost overall option in this model.

For Swiss health care payers and clinicians balancing immediate price savings against long-term resource use, these findings provide useful context for formulary decisions and treatment planning as biosimilar competition expands and extended-interval options continue to enter the market.

Explore the cost-effectiveness of ranibizumab biosimilars versus aflibercept in treating AMD and DME, revealing significant savings and treatment implications.

Swiss Analysis Shows Biosimilars Cut Costs but Longer-Interval Options Lead Savings

November 2025 marked a period of significant activity in the biosimilar market, characterized by multiple FDA approvals and crucial policy discussions concerning market access and regulatory modernization. Key themes included the expansion of competition in oncology and bone health, global efforts toward regulatory harmonization, and intense scrutiny of US market barriers.

The month saw major advancements in product approvals and interchangeability designations, particularly for denosumab and pertuzumab biosimilars.

The FDA approved multiple denosumab biosimilars throughout the fall, bolstering competition in therapies used for postmenopausal osteoporosis (referencing Prolia) and prevention of skeletal-related events in cancer (referencing Xgeva).

 This momentum included the formal granting of interchangeability (IC) designations to 2 pairs of products in late October: Fresenius Kabi's Conexxence and Bomyntra, and Celltrion’s Stobocclo and Osenvelt (denosumab-bmwo). Interchangeability status allows pharmacists to substitute these products for their reference biologics without prescriber approval, subject to state laws.

Further expanding the oncology pipeline, the FDA approved Poherdy (pertuzumab-dpzb) injection on November 18, making it the first interchangeable biosimilar for Perjeta (pertuzumab).

 Developed by Shanghai Henlius Biotech and commercialized by Organon, Poherdy is approved for all the same indications as Perjeta, including use in combination with trastuzumab and chemotherapy for HER2-positive metastatic, locally advanced, or early-stage breast cancer. The approval was based on evidence demonstrating that Poherdy is highly similar to Perjeta with no clinically meaningful differences. Despite this regulatory success, the product immediately faced patent litigation, as the originator manufacturers filed a complaint alleging infringement on 24 patents.

Global Biosimilars Week Focuses on Access

The sixth annual Global Biosimilars Week (November 3 to 7, 2025) included a webinar, "Aligning Biosimilar Access Policy With Global Health Priorities," which explored how biosimilars can help meet the UN’s Sustainable Development Goals for Health by 2030.

Lisa Hedman of the World Health Organization (WHO) noted that progress toward the WHO target of 80% biosimilar availability is uneven across regions, with public sector availability ranging from 38% to 68%. Julie Maréchal-Jamil of Medicines for Europe highlighted that regulatory convergence initiatives are key drivers for access, stressing the need for a global regulators roadmap toward tailored clinical development. She cautioned that the asynchronous adoption of new regulatory standards might force developers to maintain extended timelines or develop separate programs for different jurisdictions. Separately, in Mexico, where biosimilars are called biocomparables, current local rules still require clinical trials to demonstrate efficacy and safety, determined case-by-case by the New Molecules Committee.

Policy Updates: Regulatory Reform and Economic Impact

Policy discussions in November centered on bridging the gap between regulatory reforms and real-world market uptake.

In the podcast episode "All Things Biosimilars: How Streamlined CES Rules Could Shift the Market," Giuseppe Randazzo and Alex Keeton of the Association of Accessible Medicines (AAM) analyzed the FDA’s draft guidance on comparative efficacy studies (CES) and interchangeability.

 The guidance seeks to streamline development by reducing or eliminating the need for large, costly CES, instead recognizing the scientific value of advanced analytical tools and pharmacokinetic data. This regulatory evolution could save manufacturers years of development time and an estimated $100 million to $300 million per program. 

The hosts noted that while this shift supports competition, Congressional action is still needed to resolve policy gaps, particularly regarding the continuing existence of the interchangeable designation and restrictive state-level substitution laws. They also brought attention to the "biosimilar void," highlighting that over 100 biologics are nearing patent expiration without biosimilars in active development.

The general consensus across policy articles was that changing FDA interchangeability standards, while necessary, is likely insufficient to optimize US biosimilar competition.

 Additional steps needed include amending state pharmacist substitution laws, addressing strategies by payers and pharmacy benefit managers that inhibit competition (such as rebate walls), and enhancing education to build confidence among clinicians and patients.

Rounding out the month's news, an economic analysis underscored the tangible financial benefits of biosimilar uptake.

 A budget impact analysis evaluated the potential financial implications of adopting biosimilar denosumab within a US health plan, projecting substantial cost savings for payers. In a base case scenario, the model projected a 5-year net savings of over $38.6 million. 

Furthermore, the study modeled how reinvesting those savings could expand patient access, predicting that using savings to treat patients previously receiving zoledronic acid could allow for the treatment of nearly 1,000 additional patients over 5 years, thereby preventing 28.2 additional skeletal-related events. These findings suggest that biosimilar denosumab offers a pathway to reduce the total cost of care in oncology while potentially improving patient access to essential supportive therapy.

1. Jeremias S. FDA quietly approves denosumab biosimilars, issues interchangeability for others. The Center for Biosimilars

https://www.centerforbiosimilars.com/view/fda-quietly-approves-denosumab-biosimilars-issues-interchangeability-for-others

2. Jeremias S. FDA approves Poherdy: the first interchangeable biosimilar to Perjeta. The Center for Biosimilars. November 18, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-poherdy-first-interchangeable-biosimilar-to-perjeta

3. Jeremias S. Webinar: aligning biosimilar access policy with global health priorities. The Center for Biosimilars. November 14, 2025. 

https://www.centerforbiosimilars.com/view/webinar-aligning-biosimilar-access-policy-with-global-health-priorities

4. Jeremias S, Randazzo G, Keeton A. All things biosimilars: how streamlined CES rules could shift the market. The Center for Biosimilars. November 30, 2025. 

https://www.centerforbiosimilars.com/view/all-things-biosimilars-how-streamlined-ces-rules-could-shift-the-market

5. Rome BN, Bhaskar A, Kesselheim AS. Biosimilar interchangeability and substitution in the US: what comes next? The Center for Biosimilars. November 27, 2025. 

https://www.centerforbiosimilars.com/view/biosimilar-interchangeability-and-substitution-in-the-us-what-comes-next-

6. Jeremias S. Economic analysis supports the formulary shift to biosimilar denosumab. The Center for Biosimilars. November 26, 2025. 

https://www.centerforbiosimilars.com/view/economic-analysis-supports-formulary-shift-to-biosimilar-denosumab

November 2025 highlights FDA approvals for denosumab and pertuzumab biosimilars, enhancing competition and access in oncology and bone health markets.

Biosimilars News Roundup: Approvals Surge Amid Policy Changes

All things biosimilars

In the special video podcast episode, produced in partnership with the Association for Accessible Medicines (AAM), co-hosts Giuseppe Randazzo, senior vice president of sciences and regulatory affairs at AAM, and Alex Keeton, the new executive director of AAM's Biosimilars Council, break down one of the most consequential policy shifts in the biosimilar landscape in years: the FDA’s new draft guidance on comparative efficacy studies (CES) and interchangeability. 

Keeton opened the discussion by outlining how the agency’s updated scientific framework aims to streamline biosimilar development by reducing, and in many cases eliminating, the need for large, costly comparative efficacy studies. Instead, the FDA is formally recognizing that advanced analytical tools and pharmacokinetic data are often more sensitive and scientifically meaningful than clinical efficacy trials—an evolution that could save manufacturers years of development time and as much as $100 million to $300 million per program.

Randazzo emphasized the potential impact on access, noting that lower development costs can help expand competition and deliver more affordable biologic alternatives to patients. The hosts highlighted growing political momentum behind biosimilars following a recent press conference in which federal officials framed the guidance as a shift from bureaucracy to science. However, they also pointed to persistent policy gaps, including state-level substitution restrictions and the continued statutory existence of the interchangeable designation—an issue the hosts argued now requires Congressional action to align the law with current FDA science.

The conversation also addressed the “biosimilar void,” a term describing more than 100 biologics that are approaching patent expiration with no biosimilars in active development. Randazzo noted that reducing clinical trial requirements alone will not close this gap; challenges such as manufacturing complexity, market incentives, and payer-side barriers continue to slow progress.

Keeton and Randazzo closed by previewing a future episode dedicated entirely to payer dynamics, reinforcing that regulatory reform is only one piece of the broader effort to make biosimilars more accessible and sustainable across the US health care system.

To learn more about the FDA draft guidance regarding clinical efficacy studies for biosimilars and interchangeability, 

To read more about G's discussion with Sarah Yim, MD, from the FDA from the recent 2025 GRx+Biosims conference, 

To read more on Yim's perspectives on biosimilar policy harmonization, 

Podcasts

In this special video episode of Not So Different, co-hosts Giuseppe Randazzo and Alex Keeton from the Association of Accessible Medicines tackle the FDA's recent draft guidance on comparative efficacy studies (CES) and interchangeability for biosimilars, addressing some of the confusion around the new announcement and remaining action items for the agency.

All Things Biosimilars: How Streamlined CES Rules Could Shift the Market

In 2009, Congress created a regulatory pathway for biosimilars to encourage competition and address rising spending on biologic drugs. One barrier to adopting biosimilars in the US is that the FDA has traditionally required additional testing for biosimilars to be deemed interchangeable with the original biologic. This analysis reviews the history and current status of biosimilar regulation in the US, concluding that changing the FDA’s interchangeability standards—as proposed by some policy makers—is a potentially useful but likely insufficient step to improve biosimilar competition in the US. Other policy options include more state laws allowing pharmacists to automatically substitute biosimilars, addressing strategies by payers and pharmacy benefit managers that inhibit biosimilar competition, and implementing more widespread education of clinicians and patients to build confidence about biosimilars. Other policies to ensure the affordability of biologic drugs include expanding Medicare’s price negotiation to cover biologics with or without biosimilar competition.

Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US. | Image credit: MohamadFaizal - stock.adobe.com

Congress created an expedited approval pathway for biosimilar drugs to compete and lower costs of biologic medications, but biosimilar use has been characterized by slow uptake.

Changing the FDA biosimilar interchangeability standards is a necessary but likely insufficient step to improve biosimilar competition in the US.