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

Skylar Jeremias

The US biosimilar market continues to evolve rapidly, characterized by significant milestones in patient access and persistent challenges related to market acceptance and policy barriers. The following roundup details the key news items from 2025 that reflect the current state and future trajectory of biosimilar adoption, covering everything from landmark approvals and market competition struggles to major regulatory and political efforts aimed at enhancing affordability and sustainability.

Here are the most-read biosimilar news articles of 2025.

Explore the latest developments in the US biosimilar market, highlighting key approvals, challenges, and future trends shaping patient access in 2025.

5. From Amjevita to Zarxio: A Decade of US Biosimilar Approvals

Since the FDA granted its landmark decision to approve the first biosimilar, Sandoz’ filgrastim-sndz (Zarxio), on March 6, 2015, the US biosimilars market has grown substantially, accumulating 67 total approvals across 18 originator products over 10 years. This expansion has delivered significant cost savings, with generics and biosimilars collectively generating $12.4 billion in savings during 2023, bringing the total savings since 2015 to $36 billion.

A major focus of this decade was the adalimumab market, which saw the entry of 10 biosimilars beginning with Amgen’s Amjevita (adalimumab-auub) in January 2023. Despite this growth, biosimilars only account for about 23% of the overall biologics market, with uptake varying drastically across therapeutic areas; for instance, it is higher in oncology and lower in chronic conditions like rheumatology and gastroenterology. Major challenges hindering biosimilar adoption include regulatory barriers requiring extensive studies for approval and interchangeability, low market acceptance driven by payer controls and provider preferences, and high development costs, which can range from $100 million to $250 million.

Reference manufacturers have also utilized the patent legal system to stall competition, notably resulting in delayed launches for the adalimumab biosimilars. However, there is optimism for policy changes, including draft FDA guidance that might remove switching study requirements for interchangeability status, aligning the US more closely with European regulatory agencies.

4. Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

The launch of 10 adalimumab biosimilars, which began with Amgen's Amjevita in January 2023, created hope for robust competition; however, the sustainability of this market is now under threat. AbbVie’s Skyrizi (risankizumab-rzaa) surpassed the originator product, Humira (adalimumab), to become the company's top sales driver for the first time, according to AbbVie’s Q3 2024 financial report.

The shift is a consequence of "product hopping," a strategy used by drug companies to encourage demand to move from an innovator drug facing biosimilar competition to a newer, patented version from the same manufacturer. In Q3 2024, Skyrizi sales increased by 50.8% globally, while Humira’s worldwide revenues fell by 37.2%.

Although the combined market share for the 10 adalimumab biosimilars reached 22% by October 2024, experts noted that biosimilars are gaining share in a diminishing market, as the overall volume of adalimumab is shrinking due to the adoption of replacement products like Skyrizi. The practice of product hopping can hinder fair competition and allow originator companies to maintain near-monopolies. While the Affordable Prescriptions for Patients Act of 2023 was introduced in Congress to prohibit such practices, the bill currently remains stalled in the House.

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

President Donald Trump signed an executive order to address escalating drug costs by promoting faster biosimilar development, increasing transparency, and imposing tougher regulations on pharmacy benefit managers (PBMs). The executive order highlighted the substantial cost-saving potential of biosimilars, which can cost up to 80% less than reference biologics. The order projected the potential to save up to $181 billion over the next 5 years, building on the $56 billion in savings biosimilars had already generated.

Among the 13 directive actions outlined, the order specifically mandates the FDA commissioner to submit a report detailing recommendations to accelerate the approval of generics and biosimilars.

The order directs HHS to propose regulations aimed at increasing employer health plan transparency regarding PBM compensation. The order also sought to improve upon the Inflation Reduction Act by requiring HHS to issue guidance to enhance transparency in Medicare drug price negotiations and prioritize high-cost drugs. Accelerating biosimilar approval and development is a bipartisan objective, reflected by numerous bills introduced in Congress.

2. The Biosimilar Void: 90% of Biologics Coming Off Patent Will Lack Biosimilars

A report from the IQVIA Institute for Human Data Science identified a significant “biosimilar void,” revealing that 90% of the 118 biologics scheduled to lose exclusivity over the next decade currently lack biosimilars in development. This represents a vast missed opportunity, as the affected biologics account for $234 billion overall in sales that could be exposed to competition through 2034.

The next decade will see an average of 12 biologics lose exclusivity annually, which is more than double the rate of the preceding decade. Biosimilar development remains concentrated on high-sales products, particularly in immunology and oncology, leaving therapeutic areas such as neurology, diabetes, and hematology with limited competition. The primary reason for this void, particularly among lower-sales biologics, is the high development cost, which ranges from $100 million to $250 million, coupled with a low projected return on investment. This is exacerbated in the rare disease space, where 61% of patent expiries through 2034 are orphan indications.

Other deterrents include regulatory burdens, low market acceptance, and reimbursement challenges as PBMs and payers favor originators due to rebate incentives. The report emphasized that addressing these development and market challenges through regulatory streamlining, collaboration, and improving market conditions is crucial for realizing the full affordability benefits of biosimilars.

1. Welcome Wezlana: The First Stelara Biosimilar to Launch in the US

January 2025 marked a major milestone with the US launch of Amgen’s Wezlana (ustekinumab-auub), the first biosimilar referencing Stelara (ustekinumab), introducing a new category of lower-cost biologics for patients with conditions such as Crohn disease and plaque psoriasis. Wezlana’s approval was supported by phase 3 trial data confirming its comparable safety and efficacy profiles relative to the reference product.

Wezlana received an interchangeability designation, allowing it to be substituted for Stelara at the pharmacy level without requiring prior approval from a health care provider, which is intended to increase patient access and convenience. Amgen had previously settled with Johnson & Johnson, the parent company of the manufacturer of Stelara (Janssen), resulting in a delayed launch date of “no later than January 1, 2025.” Wezlana was the first of 7 ustekinumab biosimilars expected to launch in 2025.

However, following the experience in the adalimumab market, experts expressed concern regarding potential “product hopping” in the ustekinumab space, especially since Janssen, Stelara's manufacturer, also markets Tremfya (gusekumab), which could be used to shift patients away from the new biosimilar competition.

Articles

Top 5 Most-Read Biosimilar News of 2025

The gastroenterology biosimilar landscape is undergoing rapid transformation, dominated primarily by the introduction of ustekinumab biosimilars (referencing Stelara) and the ongoing dynamics of the adalimumab biosimilar market (referencing Humira). The following roundup highlights the top 5 news stories detailing these developments, focusing on regulatory milestones, market challenges, and real-world clinical outcomes for inflammatory bowel disease (IBD) and related gastrointestinal conditions.

5. High Acceptance Levels After Switching to an Adalimumab Biosimilar for IBD

Positive real-world data emerged regarding patient willingness and clinical outcomes following a switch to an adalimumab biosimilar. A French observational study focused on patients with IBD, which includes Crohn disease and ulcerative colitis, who were offered a switch from the reference adalimumab product. The study found "high acceptance levels" among patients with IBD who received education and personalized guidance regarding the switch.

Specifically, 92% of patients accepted the switch, and a notable 71% remained on a biosimilar after 12 months. Clinical outcomes were strong: 85% of switched patients remained in clinical remission at the 12-month mark, suggesting that the switch had no negative impact on disease control. The high cost of biologics, including adalimumab, makes these biosimilar alternatives crucial for treating the estimated 7 million people with IBD around the world.

While the majority reported a positive experience (66%), the most frequent reason for discontinuing the biosimilar was injection site pain (25%). Researchers concluded that most patients with IBD were receptive to switching to a biosimilar and achieved good outcomes, emphasizing that continuous patient education and addressing individual concerns are "crucial for improving overall satisfaction with biosimilars."

4. FDA Approves Starjemza as New Stelara Biosimilar

The momentum in the ustekinumab space continued with the FDA approval of Starjemza (ustekinumab-hmny) in May 2025, marking the eighth ustekinumab biosimilar to receive regulatory clearance. Starjemza, developed through a partnership between Hikma Pharmaceuticals and Bio-Thera Solutions, is approved for treating several rheumatic and gastrointestinal conditions.

The approval further enhances the treatment landscape for patients, following the approval of Steqeyma in late 2024. The FDA’s decision was based on data from 2 clinical studies, including a phase 3 trial in patients with moderate to severe plaque psoriasis, which confirmed that Starjemza maintained comparable efficacy, safety, and immunogenicity to the reference product, Stelara. At the time of this approval, 6 ustekinumab biosimilars were already available on the US market, some of which—like Wezlana—are available exclusively through private label distributors.

3. Skyrizi Overtakes Humira: “Product Hopping” Leaves Biosimilar Market in Limbo

In a significant market shift concerning biologics used to treat conditions like Crohn disease and ulcerative colitis, AbbVie’s Skyrizi (risankizumab-rzaa) officially surpassed Humira (reference adalimumab) as the company’s leading sales driver in the third quarter of 2024. The change can be attributed to the practice of "product hopping," where originator companies strategically shift patient demand from an innovator drug facing biosimilar competition (Humira) to a newer, patented product (Skyrizi or Rinvoq) that treats the same indications.

This market maneuver has complicated the sustainability of the US adalimumab biosimilar space. While 10 adalimumab biosimilars have launched since January 2023, the combined market shares only reached 22% by October 2024, a notable improvement from the 2% share after the first year. However, the growth of Skyrizi and Rinvoq has led to a "large drop in total adalimumab volume," effectively shrinking the overall market size, meaning biosimilars are gaining share in a diminishing pie.

Experts attending the GRx+Biosims conference emphasized that policy reforms, such as fair access fees and better formulary placement, are necessary to ensure a transparent and competitive market for biosimilars to thrive against product hopping practices.

2. 3 Ustekinumab Biosimilars Launch on US Market

The ustekinumab market heated up quickly following Wezlana's launch, as 3 additional biosimilars entered the US market in February 2025. These competitors—Pyzchiva (ustekinumab-ttwe) from Samsung Bioepis/Sandoz, Yesintek (ustekinumab-kfce) from Biocon Biologics, and Selarsdi (ustekinumab-aekn) from Teva/Alvotech—expand patient access to more affordable options referencing the blockbuster drug Stelara. Stelara generated $10.4 billion in sales in 2024 alone.

All 7 FDA-approved ustekinumab biosimilars are indicated for the treatment of plaque psoriasis, psoriatic arthritis, Crohn disease, and ulcerative colitis. Inflammatory bowel disease, encompassing Crohn disease and ulcerative colitis, is estimated to impact between 2.4 million and 3.1 million Americans. The Crohn's and Colitis Foundation's chief education, support, and advocacy officer commented that this influx of options represents a "meaningful advancement" for eligible patients with chronic disease. The competition is particularly important because Wezlana's initial access is restricted by its exclusive agreement with Nuvaila. Although Pyzchiva has been provisionally designated as interchangeable, it must wait for the lapse of Wezlana's one-year exclusivity for being the first interchangeable ustekinumab biosimilar before the full designation can be granted.

January 1, 2025, marked a significant moment for gastroenterology patients with the launch of the first ustekinumab biosimilar in the US: Amgen’s Wezlana (ustekinumab-auub). Ustekinumab products, which are interleukin (IL)-12 and IL-23 antagonists, are crucial for treating conditions like Crohn disease and ulcerative colitis, in addition to plaque psoriasis and psoriatic arthritis. The arrival of Wezlana, delayed from a projected 2023 launch due to a settlement with Johnson & Johnson, ushers in a new class of lower-cost biologics for Americans with these gastrointestinal and rheumatic conditions.

Wezlana was the first ustekinumab biosimilar to receive FDA approval and possesses an interchangeability designation. This designation is key for patient access and convenience, as it allows the biosimilar to be substituted for the reference product, Stelara, at the pharmacy level without requiring prior provider approval. However, the initial launch has been partially limited: the biosimilar is exclusively available through Nuvaila, Optum Rx's biosimilar procurement business. This launch is being closely watched to see if it follows the path of adalimumab biosimilars, especially concerning the risk of "product hopping," where the originator company might shift patients to a newer product, such as Tremfya (gusekumab), to limit the uptake of biosimilars. Wezlana’s approval was supported by a phase 3 trial confirming comparable safety and efficacy profiles to Stelara.

Explore this year's advancements in gastroenterology biosimilars, highlighting key FDA approvals and market dynamics impacting IBD treatment options.

BioRationality: Entering a New Era of Affordable Biosimilar Development

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.

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.

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.

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

Skylar Jeremias

Top 5 Most-Read Biosimilar News of 2025

Top 5 Most-Read Gastroenterology Articles of 2025

Top 5 Most-Read Ophthalmology Articles of 2025

Top 5 Most-Read Bone Health Articles of 2025

BioRationality: Entering a New Era of Affordable Biosimilar Development

Top 5 Most-Read Policy Articles of 2025

Top 5 Most-Read Regulatory Articles of 2025

First Natalizumab Biosimilar Tyruko Launches, Expanding Access in Multiple Sclerosis

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

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