Giuliana Grossi

A systematic review and economic model commissioned by the National Institute for Health and Care Excellence (NICE) and published in 

 found no randomized trials evaluating natalizumab (Tysabri; Biogen) or its biosimilar, natalizumab-sztn (Tyruko; Sandoz), specifically in patients with highly active relapsing-remitting multiple sclerosis (HARRMS).

 The assessment was designed to evaluate these treatments within their marketing authorizations for HARRMS after at least 1 disease-modifying therapy (DMT).

A study found no direct trial evidence for natalizumab or its biosimilar in highly active relapsing-remitting MS and found limited cost-effectiveness vs most alternatives. | Image credit: Sweeann - stock.adobe.com

“Multiple sclerosis is an immune-mediated inflammatory disease, causing long-term disability in young adults,” wrote the researchers of the study. “Most cases begin as relapsing–remitting multiple sclerosis. Some people have a form of relapsing–remitting multiple sclerosis known as highly active relapsing–remitting multiple sclerosis, defined as multiple sclerosis with unchanged or increased disease activity despite prior treatment with at least one disease-modifying therapy.”

HARRMS is broadly defined as relapsing-remitting MS (RRMS) with ongoing disease activity despite treatment with at least 1 DMT. The review noted that the lack of a consensus definition for HARRMS makes it difficult to consistently identify and treat this population. Investigators from the Bristol Technology Assessment Group at the University of Bristol searched MEDLINE, EMBASE, and trial registries through April 2024 and identified 42 studies encompassing 22,409 participants. Most studies enrolled a general RRMS population, while only 2 studies specifically enrolled patients with HARRMS. Four studies evaluated natalizumab or its biosimilar, but none reported HARRMS-specific outcomes for either natalizumab product.

Indirect Comparisons Suggest Similar Efficacy to Comparators

Using network meta-analysis, the authors found no evidence of a difference between natalizumab and its biosimilar in relapse rate (rate ratio, 0.65; 95% credible interval [CrI], 0.34-1.26), gadolinium-enhancing lesions (HR, 1.29; 95% CrI, 0.69-2.37), T2-weighted lesions (HR, 1.07; 95% CrI, 0.73-1.57), any adverse events (HR, 1.06; 95% CrI, 0.77-1.46), or treatment discontinuation (HR, 0.48; 95% CrI, 0.13-1.76) in the general RRMS population.

The HARRMS evidence base was limited to 6 studies covering fingolimod, ocrelizumab, alemtuzumab, cladribine, interferon beta, and autologous hematopoietic stem cell treatment. All interventions except interferon beta-1a reduced relapse risk versus placebo. The analysis also incorporated natalizumab based on a study population considered close to, but not fully meeting, the HARRMS definition. Because of the limited and indirect evidence, the authors emphasized uncertainty about whether treatment effects observed in broader RRMS populations can be extrapolated to HARRMS.

Economic Model Finds Natalizumab Costlier Without a Clear QALY Advantage

To assess cost-effectiveness, the team built a discrete event simulation model using UK MS registry data and willingness-to-pay thresholds of £20,000 and £30,000 per quality-adjusted life-year (QALY), equivalent to approximately $27,000 and $41,000 per QALY, respectively, based on the August 27, 2026, exchange rate. The economic analysis used the UK thresholds; the dollar amounts are provided here for US readers.

With the exception of ocrelizumab, all comparators had greater net benefit than intravenous natalizumab, intravenous natalizumab biosimilar, and subcutaneous natalizumab at the £20,000-to-£30,000/QALY thresholds. The natalizumab products also had close to a 0% probability of having the highest net benefit. Costs were generally higher with natalizumab than with other treatments, while 95% CrIs for QALYs completely overlapped, indicating no evidence of a difference in QALYs. The biosimilar had lower costs and lower QALYs than intravenous originator natalizumab, but the 95% CrIs overlapped.

Compared with ocrelizumab, however, intravenous natalizumab had lower costs and higher QALYs, meaning the model did not favor ocrelizumab over natalizumab on cost-effectiveness. Across the broader comparison, interferon beta-1b and several glatiramer acetate and interferon-based regimens had the greatest modeled net monetary benefit at the £20,000-to-£30,000/QALY thresholds.

A value-of-information analysis found that uncertainty surrounding treatment effects—including network meta-analysis estimates for annualized relapse rate, confirmed disability progression, serious adverse events, and treatment discontinuation—had the greatest impact on the results, although costs, utilities, and MS registry inputs also contributed substantial uncertainty.

The authors concluded that additional trials enrolling patients who meet HARRMS criteria are needed to determine whether natalizumab and its biosimilar perform as expected in this population, rather than relying primarily on extrapolation from broader RRMS trials.

The analysis was limited by the absence of randomized trials directly evaluating natalizumab or its biosimilar in patients meeting the HARRMS criteria, according to the researchers. Much of the evidence was therefore drawn from broader RRMS populations or studies involving populations considered similar to HARRMS, requiring indirect comparisons and extrapolation. The economic model also relied on assumptions about treatment effects, disease progression, costs, utilities, and registry data, contributing to uncertainty around the cost-effectiveness estimates. The authors identified treatment-effect estimates as the largest source of decision uncertainty.

The findings arrive as NICE's companion guidance recommends natalizumab (originator or biosimilar) for rapidly evolving severe RRMS—a narrower subgroup of HARRMS—rather than endorsing use across the full highly active population, with pricing negotiated through a confidential national commercial arrangement.

Overall, the assessment found no direct clinical evidence establishing the comparative effectiveness of natalizumab or its biosimilar specifically in HARRMS.

 Although natalizumab had lower modeled costs and higher QALYs than ocrelizumab, most other comparators had greater net benefit at willingness-to-pay thresholds of approximately $27,000 to $41,000 per QALY. The findings underscore the need for trials specifically enrolling patients with highly active disease to determine whether treatment effects observed in broader RRMS populations can be reliably extrapolated to HARRMS.

“The economic model found that natalizumab and natalizumab biosimilar were not cost-effective compared to any of the included comparators in highly active relapsing-remitting multiple sclerosis, with similar quality-adjusted life-years but higher costs, with the only exception being ocrelizumab,” wrote the researchers. 

Manzano CL, Sadek A, Cooper C, et al. Natalizumab and Tyruko (natalizumab biosimilar) for treating highly active relapsing-remitting multiple sclerosis after at least one disease-modifying therapy: a systematic review and economic model. 

. 2026;30(60):1-290. doi:10.3310/GJHT1811

Natalizumab (originator and biosimilar) for treating highly active relapsing–remitting multiple sclerosis after disease-modifying therapy. National Institute for Health and Care Excellence. Last reviewed January 28, 2026. Accessed August 27, 2026. 

Articles

A study found no direct trial evidence for natalizumab or its biosimilar in MS and found limited cost-effectiveness vs most alternatives.

Natalizumab Biosimilar Shows Limited Cost-Effectiveness in MS

An abbreviated biologics license application (ABLA) pathway modeled on the 1984 Hatch-Waxman Act—one that would grant new biosimilars class-level interchangeability with their reference products immediately upon licensure—is needed to revive a stalled US biosimilar market, according to a recent study published in 

Therapeutic Innovation & Regulatory Science

The authors frame the proposal against a backdrop of rising biologic spending. Prescription drug expenditures reached $806 billion in 2024, with biologics accounting for 49.6% of that total. Specialty drug spending, driven largely by biologics, grew at an annual rate of 23.5% and now makes up 71% of Medicare Part D spending. Yet competition remains scarce: 81% of biologic products, or 216 drugs, had only a single manufacturer in 2022, and just 12 biosimilars were in development for the 118 biologics expected to lose patent protection over the next decade.

A researcher reviews biosimilar drug pricing data alongside FDA regulatory guidance documents. | Image credit: @TStudious_AdobeStock.jpeg

Hatch-Waxman's Lesson for Biosimilar Competition

The authors trace the model to the small molecule generics market before 1984, when only 2 of 13 top drugs saw generic entry between 1976 and 1982 because manufacturers faced the same clinical trial costs as brand-name developers. Hatch-Waxman tied market entry to bioequivalence rather than new clinical studies, transforming the market: generics now account for 91% of dispensed prescriptions, and the FDA estimated $18.9 billion in savings the following year from 2022 generic approvals alone.

By contrast, the 2009 Biologics Price Competition and Innovation Act required biosimilar developers to prove interchangeability through additional "switching studies" beyond biosimilarity data, driving development costs as high as $300 million over 9 years, the authors noted, citing McKinsey estimates. In the years since, the FDA has approved 81 biosimilars, but only 21 have achieved interchangeability, and uptake has lagged further behind state substitution laws and payer formulary decisions that shape which products reach patients.

"The need for a more competitive biosimilars marketplace is clear," the study authors wrote.

How an Abbreviated Biologics Pathway Would Work

The authors called on Congress to establish an ABLA pathway that grants class-level interchangeability and directs the FDA to create a review office independent of the new drugs program. The pathway would need mechanisms to determine program eligibility, adjudicate any "residual uncertainty" about biosimilarity, and decide what additional evidence, if any, is required to resolve it, while statutorily emphasizing the minimum evidence necessary for bioequivalence.

"The small number of interchangeable products and high entry barriers has doomed the biosimilar market to repeating the early history of generic markets," the study authors wrote.

The proposal follows recent FDA action in the same direction. In an October 29, 2025, announcement, the agency said it would generally no longer recommend switching studies for interchangeability determinations, noting that the requirement has slowed development and created public confusion about biosimilar safety.

Congress has 2 competing bills pending: the Biosimilar Red Tape Elimination Act, which would grant immediate interchangeability upon licensure for new biosimilars, and the Expedited Access to Biosimilars Act, which would keep pharmacokinetic study requirements but eliminate blanket pharmacodynamic and immunogenicity testing unless warranted.

The Limits of an Abbreviated Biosimilar Pathway

The authors acknowledged that an ABLA pathway would not fit every product. As with generics, some biosimilar candidates would likely encounter distinct barriers to a streamlined route, summarized below.

Patent challenges, payment policy, and manufacturing infrastructure would remain obstacles even under an ABLA pathway, the authors wrote, but they maintain that for most biosimilar products, the pathway would attract more entrants and help keep older biologics affordable for patients.

1. Miller BJ, Woodcock J. The future of biologics: lessons from Hatch-Waxman. 

. 2026;60:925-928. doi:10.1007/s43441-026-00961-9

2. US Food and Drug Administration. FDA moves to accelerate biosimilar development and lower drug costs. News release. October 29, 2025. Accessed August 19, 2026. 

https://www.fda.gov/news-events/press-announcements/fda-moves-accelerate-biosimilar-development-and-lower-drug-costs

An editorial modeled on Hatch-Waxman proposes an abbreviated FDA pathway granting biosimilars class-level interchangeability to spur competition.

Abbreviated Biologics Pathway Could Revive Biosimilar Competition

 of rituximab biosimilars vs the originator biologic in antineutrophil cytoplasmic antibody–associated vasculitis (AAV) found no significant differences in remission rates, relapse rates, or serious adverse events, supporting continued use of biosimilars as mandates expand across this rare disease space.

Real-world data found no significant differences in 6-month outcomes between rituximab biosimilars and the originator in AAV. | Image Credit: MQ-Illustrations - stock.adobe.com

Rituximab is the only FDA- and Health Canada–approved biologic for severe AAV, and Health Canada, like the FDA, does not require biosimilar manufacturers to demonstrate clinical equivalence across every approved indication before approval, only comparable structure and function to the reference product. That gap, often referred to as indication extrapolation, has fueled clinician hesitancy about nonmedical switching, a pattern 

 among rheumatologists prescribing biosimilars for inflammatory arthritis.

 Because AAV has distinct disease mechanisms and adverse event patterns compared with the rheumatoid arthritis and lymphoma populations in which most rituximab biosimilar trials were conducted, the current study authors argued that dedicated AAV-specific data were needed.

Because no randomized trials of rituximab biosimilars have been conducted in patients with AAV, the investigators noted that real-world evidence is likely to remain the primary basis for comparative decision-making in this population. Consequently, they conducted a multicenter cohort study published in 

drew on data from 207 adults with granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) across 9 Canadian centers. 

Similar 6-Month Remission Rates Seen With Biosimilar Rituximab

Among the 132 participants starting rituximab induction, 96% of originator recipients and 90% of biosimilar recipients achieved remission at 6 months (difference, 6%; 95% CI, −4% to 15%), a gap that was not statistically significant. An exploratory analysis at 3 months, however, showed a wider and statistically significant gap: 94% of originator recipients were in remission compared with 79% of biosimilar recipients (difference, 15%; 95% CI, 2%-26%). After adjusting for an age imbalance between groups, biosimilar recipients had lower odds of 3-month remission, though this difference did not persist at 6 months in either the primary or sensitivity analyses.

The most commonly used biosimilar was rituximab-pvvr (89%), followed by CT-P10 (rituximab-abbs) and GP2013. Notably, patients starting biosimilar induction received payer authorization faster, with a median wait of 3 days compared with 12 days for the originator. This pattern echoes 

 that biosimilar adoption is accelerating, with electronic medical record defaults and formulary preferences shifting prescribing behavior.

Biosimilar Switching Maintained Remission Without New Safety Signals

The maintenance and switch subgroups showed no early warning signs.

 All participants who started rituximab maintenance therapy, whether on originator or biosimilar, were in remission at 6 months. Similarly, all 16 participants who underwent an originator-to-biosimilar switch, 94% of them for payer-mandated reasons, remained in remission with no relapses at a mean follow-up of about 6 months. Similar results were 

 with biosimilar switching in other rheumatologic conditions, as studies of infliximab and adalimumab biosimilar switches found it to be generally well tolerated, with treatment effectiveness maintained.

 Serious adverse events (SAEs) occurred in 6% to 19% of subgroups, with no significant differences in SAE or serious infection rates between originator and biosimilar recipients. The biosimilar induction and switch groups had numerically higher SAE and infection point estimates. The authors, however, attributed this largely to older age in the biosimilar induction group and longer cumulative B-cell depletion exposure in the switch group, rather than to the biosimilar itself. COVID-19, which overlapped temporally with the study period, also accounted for a meaningful share of serious infections.

These findings arrive as biosimilar rituximab uptake continues to expand across rheumatologic and hematologic indications in both Canada and the US, driven largely by cost pressures rather than new clinical equivalence data, underscoring the continued importance of real-world post-marketing surveillance in indications that fall outside pivotal biosimilar trials.

Study Limitations Do Not Undermine Findings

The authors acknowledged their study’s limitations, one being that differences in the selection of originator and biosimilar participants could lead to bias. In addition, the small sizes of the maintenance subgroups limited power to conduct meaningful comparisons between groups while accounting for differences in baseline characteristics.

“In conclusion, we did not observe signiﬁcant differences in 6-month induction outcomes between the rituximab originator or biosimilars in GPA and MPA,” the authors wrote. “Although 24-month follow-up will optimally evaluate relapses during maintenance, these real-world data support continued biosimilar rituximab use in AAV and should reassure patients, providers, and policymakers.”

Mendel A, Barra L, Behlouli H, et al. Biosimilar rituximab in ANCA-associated vasculitis compared to the originator: a multicenter cohort study. 

. 2026;8(8):e90119. doi:10.1002/acr2.90119

Joszt L. US rheumatologists reluctant to switch to biosimilars for patients doing well on a reference product. 

. November 16, 2020. Accessed August 14, 2026. 

https://www.ajmc.com/view/us-rheumatologists-reluctant-to-switch-to-biosimilars-for-patients-doing-well-on-a-reference-product

Joszt L. Driving biosimilar uptake in rheumatology, biosimilar-to-biosimilar switching: ACR abstracts. 

. November 26, 2020. Accessed August 14, 2026. 

https://www.ajmc.com/view/driving-biosimilar-uptake-in-rheumatology-biosimilar-to-biosimilar-switching-acr-abstracts

Joszt L. Switching among infliximab biosimilars effective and well tolerated, research finds. 

. June 24, 2022. Accessed August 14, 2026. 

https://www.ajmc.com/view/switching-among-infliximab-biosimilars-effective-and-well-tolerated-research-finds

Rituximab biosimilars showed no significant 6-month differences vs the originator in antineutrophil cytoplasmic antibody–associated vasculitis (AAV).

Rituximab Biosimilars Show Comparable 6-Month Outcomes in AAV

Adalimumab biosimilars maintained favorable efficacy and safety after patients with psoriasis or hidradenitis suppurativa (HS) switched from the originator, according to a retrospective single-center study conducted in Riyadh, Saudi Arabia.

, add region-specific evidence to a literature that remains limited outside Europe and North America.

Adalimumab biosimilars maintained favorable efficacy and safety after patients with psoriasis or HS switched from the originator. | Image credit: Soni's - stock.adobe.com

Investigators reviewed electronic medical records from King Abdulaziz Medical City and King Abdullah Specialized Children's Hospital, identifying 57 pediatric and adult patients who had been treated with originator adalimumab (Humira; AbbVie) before switching to the biosimilar Amgevita between 2016 and 2022. The switch followed a hospital-wide policy change driven primarily by cost considerations rather than clinical concerns. 

Most patients (93%) were adults, just over half were women (50.9%), and more than a third (35.1%) had obesity. Plaque psoriasis was the most common diagnosis (72.5% of the psoriasis subgroup), whereas 35.3% of patients had psoriatic arthritis; 6 patients (10.5%) had HS.

Every patient with HS maintained clinical improvement after switching to the biosimilar, including one patient who had shown suboptimal adherence to the originator. Responses among patients with psoriasis were more mixed, with 68.6% responding favorably, 19.6% showing no improvement, and 11.8% experiencing worsening after the switch. The authors noted this divergence may reflect underlying differences in disease mechanism or individual variation in treatment response rather than a biosimilar-specific effect.

Two variables were significantly associated with biosimilar response: absence of obesity (

 = .012) and prior clinical improvement on the originator (

 = .022). Obesity has previously been linked to a roughly 60% higher likelihood of anti-tumor necrosis factor treatment failure across inflammatory diseases, a finding the authors cited as consistent with their own results.

Adverse events were infrequent overall, occurring in 1 patient with HS (16.7%) and 4 patients with psoriasis (7.8%) after the switch, most commonly bone pain and joint stiffness. One case of grade 2/4 biosimilar-associated hepatitis led to treatment discontinuation, a finding the authors flagged as unusual given that hepatitis has been rarely reported with adalimumab biosimilars in the published literature. 

Despite these events, the difference in adverse event rates between originator and biosimilar exposure was not statistically significant (

 = 1.000), supporting a comparable safety profile.

How These Findings Compare With Other Switching Studies

The Saudi results contrast with some European data on nonmedical switching. A Danish nationwide study of patients with psoriasis who underwent a mandatory switch from originator to biosimilar adalimumab 

 that lack of efficacy was the leading reason for treatment discontinuation, though most patients maintained disease control.

 That study similarly found that patients who had previously done well on the originator were more likely to sustain response after switching, a pattern mirrored in the Saudi cohort.

The authors also pointed to differing outcomes reported in Italian and Spanish HS cohorts, where switching was associated with greater loss of effectiveness, underscoring that biosimilar switching outcomes may vary by population and setting.

The study's authors described their data as an early step toward closing a regional evidence gap, noting that adalimumab biosimilar use among Saudi dermatologists has been sparsely documented until now. 

They called for larger, multicenter, longitudinal studies to confirm long-term immunogenicity and safety since the single-center design and modest sample size, particularly within the HS subgroup, limit how broadly these findings can be generalized.

Najjar RH, Alrashid SO, Almahfouz RF, Alzahrani HT, Aleissa MY, Hakami AR. Safety and efficacy of adalimumab biosimilar in psoriasis and hidradenitis suppurativa: a clinical experience. 

. 2026;47(11):1196-1201. doi:10.15537/1658-3175.8808

Loft N, Egeberg A, Rasmussen MK, et al. Outcomes following a mandatory nonmedical switch from adalimumab originator to adalimumab biosimilars in patients with psoriasis. 

. 2021;157(6):676-683. doi:10.1001/jamadermatol.2021.0221

Saudi real-world study finds adalimumab biosimilar switching preserves efficacy and safety, with full response in patients with HS.

Adalimumab Biosimilar Sustains Efficacy After Switch in Saudi Cohort

As biosimilar development continues to expand across biologic therapies, analytical characterization plays a critical role in demonstrating that monoclonal antibody (mAb) biosimilars are highly similar to their reference products, according to a new review published in 

Analytical characterization supports monoclonal antibody biosimilar approvals and may reduce clinical testing needs, researchers found. | Image Credit: lexiconimages - stock.adobe.com

Analytical Methods Support mAb Biosimilar Comparability

The review examined analytical methods used to support successful mAb biosimilar applications and approvals in the US and European Union (EU). As of December 2024, the FDA had 

 63 biosimilars, including 43 mAb biosimilars, whereas the European Medicines Agency 

 more than 90 biosimilars, including 54 mAb biosimilars.

Using publicly available regulatory documents, the authors identified the quality attributes and analytical approaches used in successful mAb biosimilar applications.

 The review evaluated regulatory submissions for approved mAb biosimilars, examining critical quality attributes, including primary structure, higher-order structure, purity, impurities, charge variants, glycosylation patterns, and biological activity. 

The analysis included the 43 FDA-approved mAb biosimilars representing 11 reference products and 54 EU-approved mAb biosimilars representing 12 reference products; adalimumab (Humira) had the greatest number of approved biosimilars in both regions.

Across these approvals, analytical characterization was central to demonstrating similarity between biosimilars and their reference products. The authors noted that applicants commonly relied on multiple complementary analytical methods to evaluate the same quality attributes, allowing for a more comprehensive assessment of potential differences between products.

The review also highlighted how continued advancements in analytical technologies have strengthened biosimilar development by improving the ability to detect and evaluate molecular differences. The researchers noted that these improvements have supported greater confidence in regulatory decision-making and may help streamline biosimilar development by reducing reliance on extensive clinical efficacy studies when robust analytical and pharmacokinetic or pharmacodynamic data are available.

The researchers emphasized that the findings reinforce the importance of analytical evidence in supporting confidence among clinicians, patients, regulators, and other health care stakeholders as biosimilars continue entering the market.

Biosimilars may provide opportunities to improve access to biologic therapies while reducing costs associated with high-priced biologic medicines. However, broader adoption depends in part on understanding the rigorous scientific processes used to demonstrate that approved biosimilars maintain comparable quality, safety, and efficacy to their reference products, they noted.

For managed care organizations, evidence supporting biosimilar comparability may help inform formulary decisions, utilization management strategies, and efforts to increase the use of cost-effective biologic alternatives. The authors emphasized that analytical assessments are an important component of the approval framework, as they help determine whether identified differences between products could have meaningful effects on clinical performance.

Future Considerations for Biosimilar Development

As increasingly complex biologic therapies enter development, continued advances in analytical technologies will remain important for evaluating biosimilarity. Consequently, the researchers highlighted the need for continued refinement and standardization of analytical approaches to support efficient biosimilar development and regulatory review. 

The expanding availability of mAb biosimilars across therapeutic areas, including oncology and immune-mediated diseases, further underscores the importance of robust comparative analytical assessments. Because of this, the authors noted that their review findings on analytical comparability strategies used in successful biosimilar applications may help guide future development efforts.

“Robust comparative analytical assessment data…has become the foundation of biosimilar development and can be leveraged to reduce the need for extensive, costly, and time-consuming clinical efficacy studies,” the authors concluded. “Greater alignment on the [product quality attributes] to be included in comparative analytical assessment and appropriate test methods can further improve efficiency and encourage new biosimilar development.”

Aithal R, Majedi OM, McCarthy D, Atouf F, Peckham N. Review of quality attributes and analytical methods used for comparative analytical assessment of monoclonal antibodies as part of successful biosimilar approvals in the United States and European Union. 

. 2026;40(4):713-732. doi:10.1007/s40259-026-00786-w

Biosimilar product information. FDA. Updated August 4, 2026. Accessed August 6, 2026. 

https://www.fda.gov/drugs/biosimilars/biosimilar-product-information

Biosimilar medicines: overview. European Medicines Agency. Accessed August 6, 2026. 

https://www.ema.europa.eu/en/human-regulatory-overview/biosimilar-medicines-overview

Analytical characterization supports monoclonal antibody biosimilar approvals and may reduce clinical testing needs, researchers found.

Analytical Characterization Supports Confidence in Monoclonal Antibody Biosimilars

In the span of 8 days this July, lawmakers introduced a new biosimilar bill, advanced 2 others out of committee in both chambers, and left a longer list of related proposals unmoved for months.

US capitol | Image credit: W.Scott McGill - stock.adobe.com

A Bill Introduced, Marked Up, and Advanced Inside a Week

Representative Nick Langworthy (R, New York) and Representative Kim Schrier, MD (D, Washington), introduced the Expedited Access to Biosimilars Act (HR 9661) on July 15, 2026.

 The measure would codify that comparative clinical efficacy and pharmacodynamic studies are not the default expectation for biosimilar licensure, preserve the FDA's authority to require such studies when scientifically warranted, and require the agency to notify sponsors early if additional studies would be needed. Schrier, a pediatrician who lives with type 1 diabetes, framed the bill around insulin costs, saying she had "seen firsthand how skyrocketing insulin prices have threatened access" to lifesaving medication.

Five days later, the House Committee on Energy and Commerce folded HR 9661 into a 29-bill markup, reporting it unanimously along with the Biosimilar Red Tape Elimination Act (HR 5526).

 On July 22, the Senate Committee on Health, Education, Labor, and Pensions (HELP) approved the Senate companion, S 1414, by a vote of 22-0 as amended.

"Comparative efficacy studies are rarely necessary to demonstrate biosimilarity," said Alex Keeton, executive director of the Biosimilars Council, after the Senate vote.

Senator Ashley Moody (R, Florida) introduced the newest measure, S 5059, on July 21, a bill to amend the Public Health Service Act to streamline the review of biosimilar biological products.

 It drew 3 cosponsors and was referred to the HELP committee, where it has seen no further action.

The Biosimilar Red Tape Elimination Act has been reintroduced across 3 consecutive Congresses. Senator Mike Lee (R, Utah) introduced the current Senate version, S 1954, in June 2025, with Senators Ben Ray Luján (D, New Mexico), Rand Paul (R, Kentucky), and Maggie Hassan (D, New Hampshire). It would deem FDA-licensed biosimilars interchangeable with their reference products, eliminating the switching studies the US uniquely requires. The bill cleared the HELP committee in June 2026.

 The House version, introduced by Representative August Pfluger (R, Texas) and Representative Greg Landsman (D, Ohio) in September 2025, sat in Energy and Commerce for 10 months before this week's markup.

"Legacy regulations can often outlive their usefulness," said John Murphy III, president and CEO of the Association for Accessible Medicines.

The STOP GAMES Act (HR 8908), introduced in May 2026 by Representative Eric Sorensen (D, Illinois) and Representative Stephanie Bice (R, Oklahoma), would direct the FDA to weigh specific factors for spotting delay-tactic citizen petitions and refer them to the Federal Trade Commission.

 Earlier versions stalled in 3 Congresses. It appeared on the July markup agenda, though committee records still listed it as referred.

The Biosimilar Inspection Modernization Act (S 3510), introduced in December 2025 by Senators Ted Budd (R, North Carolina) and Hassan, would expand remote regulatory assessments, convene a public meeting on mutual recognition agreements, and require an FDA strategic plan on domestic inspections.

 Julie Reed, executive director of the Biosimilars Forum, said the bill would bring biosimilar reviews "consistency with other drug classes under FDA review."

Regulatory reform covers only part of the pipeline. Testifying before the House Committee on Ways and Means Subcommittee on Health in April 2025, Aaron S. Kesselheim, MD, JD, MPH, urged lawmakers to advance laws "making it harder for manufacturers to build large thickets of biologic patents," restricting pharmacy benefit manager rebate practices that favor higher-cost originators, and changing CMS rules to permit common billing codes for biologics and biosimilars.

Craig Burton, then executive director of the Biosimilars Council, told the same panel that inaction carried consequences, calling it "a crisis that will impact real people," and pointed to the roughly 860,000 Medicare beneficiaries with diabetes who could benefit. The HELP committee advanced the INSULIN Act of 2026 by 17-5 that same day, though no pending bill directly ties insulin affordability to biosimilar competition.

Reimbursement design remains unaddressed. Sonia T. Oskouei, PharmD, vice president of biosimilars and specialty at Sandoz, argues that the average sales price model and Medicare Part B incentives undercut long-term investment while maintaining that "the biosimilar void is not permanent."

 A Matrix Global Advisors analysis found that price negotiation under the Inflation Reduction Act may deter biosimilar entry for high-revenue biologics, estimating that delayed competition for one biologic with $3.5 billion in annual sales could forfeit $1.9 billion yearly.

A Samsung Bioepis white paper has termed this gap the "biosimilar void," noting that only 12 of the 118 biologics projected to lose patent exclusivity between 2025 and 2034 currently have biosimilars in development.

 With several of these measures now moving through both chambers at once, Congress has an opening to close that gap and let biosimilars deliver the savings and access patients have been waiting for.

Congressmembers Langworthy and Schrier introduce a bipartisan bill to lower prescription drug costs by expanding access to biosimilars. News release. Office of Representative Nick Langworthy; July 15, 2026. Accessed July 23, 2026. 

https://langworthy.house.gov/media/press-releases/expedited-access-to-biosimilars-act

Chairman Guthrie announces full committee markup of 29 bills. News release. House Committee on Energy and Commerce; July 2026. Accessed July 23, 2026. 

https://energycommerce.house.gov/news/markups

AAM and the Biosimilars Council praise House action on biosimilar bills. 

. July 22, 2026. Accessed July 23, 2026. 

https://chaindrugreview.com/aam-biosimilars-council-praise-house-action-on-biosimilar-bills/

Chairman Cassidy advances legislation improving families' access to quality, affordable health care. News release. US Senate Committee on Health, Education, Labor and Pensions; July 22, 2026. Accessed July 23, 2026. 

https://www.help.senate.gov/rep/newsroom/press/chairman-cassidy-advances-legislation-improving-families-access-to-quality-affordable-health-care

The Biosimilars Council and AAM applaud the Senate markup and committee passage of the Expedited Access to Biosimilars Act. 

. July 23, 2026. Accessed July 23, 2026. 

https://chaindrugreview.com/the-biosimilars-council-and-aam-applaud-senate-markup-and-committee-passage-of-the-expedited-access-to-biosimilars-act/

A bill to amend the Public Health Service Act to streamline the review of biosimilar biological products, S 5059, 119th Cong (2026). Accessed July 23, 2026. 

https://www.congress.gov/bill/119th-congress/senate-bill/5059

AAM applauds momentum as two bills move through the Senate HELP Committee. News release. Association for Accessible Medicines; June 17, 2026. Accessed July 23, 2026. 

https://accessiblemeds.org/resources/press-releases/aam-applauds-momentum-two-bills-move-through-senate-help-committee/

Biosimilar Red Tape Elimination Act, HR 5526, 119th Cong (2025). Accessed July 23, 2026. 

https://www.congress.gov/bill/119th-congress/house-bill/5526

STOP GAMES Act of 2026, HR 8908, 119th Cong (2026). Accessed July 23, 2026. 

https://www.congress.gov/bill/119th-congress/house-bill/8908

Biosimilar Inspection Modernization Act of 2025, S 3510, 119th Cong (2025). Accessed July 23, 2026. 

https://www.congress.gov/bill/119th-congress/senate-bill/3510

Senators Budd and Hassan introduce a bipartisan bill to lower prescription drug prices for American families. News release. Office of Senator Ted Budd; December 17, 2025. Accessed July 23, 2026. 

Jeremias S. Experts pressure Congress to remove roadblocks for biosimilars. The Center for Biosimilars

. April 12, 2025. Accessed July 23, 2026. 

https://www.centerforbiosimilars.com/view/experts-pressure-congress-to-remove-roadblocks-for-biosimilars

Santoro C. Addressing patent abuse, reimbursement models key to sustainable biosimilar market. The Center for Biosimilars. April 25, 2025. Accessed July 23, 2026. 

https://www.centerforbiosimilars.com/view/addressing-patent-abuse-reimbursement-models-key-to-sustainable-biosimilar-market

Jeremias S. Medicare price negotiations will slow biosimilar momentum, widening market gap. The Center for Biosimilars. July 16, 2025. Accessed July 23, 2026. 

https://www.centerforbiosimilars.com/view/medicare-price-negotiations-will-slow-biosimilar-momentum-widening-market-gap

Jeremias S. White paper offers tips for sustaining biosimilar progress, avoiding a market void. The Center for Biosimilars. July 15, 2025. Accessed July 23, 2026. 

https://www.centerforbiosimilars.com/view/white-paper-offers-tips-for-sustaining-biosimilar-progress-avoiding-a-market-void

Congress fast-tracks biosimilar bills to cut drug and insulin costs, while patent, rebate, and reimbursement roadblocks still stall competition.

Biosimilar Bills Gain Steam in Congress, But Key Reforms Still Wait

Patients with moderate to severe Crohn disease in Spain could experience improved outcomes and lower treatment costs when biosimilar ustekinumab is used as a first-line therapy rather than reserved for later lines, according to a cost-effectiveness analysis 

Early use of ustekinumab biosimilars in Spain shows cost-effective Crohn disease care, boosting QALYs and cutting NHS spend—insights for Europe. |Image credit: mi_viri - stock.adobe.com

Crohn disease imposes a considerable economic burden on national health systems, with annual costs per patient in Spain reported to range from €11,000 to €18,000—differences driven largely by pharmacological expenses rather than other direct health care costs.

 offered important context for why this economic question matters at the bedside.

 Reviewers noted that despite ustekinumab's established efficacy in moderate to severe Crohn disease, its high acquisition cost had historically confined it to later lines of therapy, typically after patients experienced treatment failure on 1 or more antitumor necrosis factor agents. The availability of biosimilar versions, the review argued, carries the potential to shift that calculus—reducing financial barriers and enabling earlier use in the treatment algorithm, where evidence increasingly supports more aggressive initial intervention. Biosimilar ustekinumab candidates have demonstrated comparable efficacy, safety, pharmacokinetics, and immunogenicity to the reference product in studies conducted to date, though the review noted that real-world data specific to Crohn disease remain limited.

As biologic therapies have become the cornerstone of moderate to severe disease management, appropriate sequencing has grown more consequential both clinically and financially.

 The 2024 ECCO guidelines positioned ustekinumab as a first-line induction and maintenance option for moderate to severe Crohn disease, but until recently, the high acquisition cost of reference ustekinumab limited its appeal as an early-line choice in Spain. The entry of biosimilar ustekinumab (bsUST) into the Spanish market in mid-2024, at an assumed 30% price reduction vs the reference product, prompted investigators to formally evaluate whether repositioning bsUST to the front of treatment sequences would be cost-effective from the perspective of Spain's National Healthcare System (NHS).

Markov Model Evaluated Seven Biosimilar-Inclusive Treatment Sequences

Investigators developed a Markov model with 2-week cycles and a lifetime horizon to compare 7 treatment sequences in adults with moderate to severe Crohn disease. Health states included active disease, response, remission, surgery, and death. Funnel states simulated induction periods, and patients who lost response transitioned to the next treatment line after a 3-month delay to reflect real-world clinical practice. Surgery was considered only after 4 pharmacological lines had been exhausted.

The sequences incorporated biosimilar adalimumab (bsADA), biosimilar intravenous infliximab (bsIFX), bsUST, risankizumab, upadacitinib, and vedolizumab. Sequence 1—bsADA followed by bsUST, upadacitinib, risankizumab, and surgery—served as the reference comparator because it carried the lowest total lifetime cost at €157,224 per patient.

Patient characteristics were drawn from the UNITI-2 trial (NCT01369329) population and validated against Spanish real-world data from the ENEIDA registry. The modeled cohort had a mean age of 39.2 years, was 46.7% women, and had a mean weight of 73.4 kg. Clinical efficacy data were sourced from a published network meta-analysis, with maintenance efficacy for biologic-experienced patients drawn from pivotal trials. A willingness-to-pay (WTP) threshold of €27,000 per quality-adjusted life year (QALY), a benchmark commonly referenced in Spain, was used to assess cost-effectiveness.

Early use of ustekinumab biosimilars in Spain shows cost-effective Crohn disease care, boosting QALYs and cutting NHS spend—insights for Europe.

Giuliana Grossi

Natalizumab Biosimilar Shows Limited Cost-Effectiveness in MS

Abbreviated Biologics Pathway Could Revive Biosimilar Competition

Rituximab Biosimilars Show Comparable 6-Month Outcomes in AAV

Adalimumab Biosimilar Sustains Efficacy After Switch in Saudi Cohort

Analytical Characterization Supports Confidence in Monoclonal Antibody Biosimilars

Biosimilar Bills Gain Steam in Congress, But Key Reforms Still Wait

Positioning Biosimilar Ustekinumab Early Reduces Burden on Spain's National Health System

No Efficacy Loss After Multiple Ustekinumab Biosimilar Switches in Psoriasis

Global Biosimilar Market Sees Structural Shifts, Regulatory Hurdles, and Pipeline Gains

Biosimilars Development Roundup: Expanding Global Options Amidst Rising US Legal Hurdles