Julia Bonavitacola

The promise of biosimilars to revolutionize patient access and affordability in health care faces a formidable adversary: patent thickets. A recent white paper from the Association for Accessible Medicines (AAM) laid bare how complex patent landscapes and protracted litigation were significantly delaying the entry of more affordable biologic alternatives, ultimately impacting patients and straining the US health care system.

Patent Law. | Image Credit: WrightStudio - stock.adobe.com .jpeg

The report not only detailed these challenges but also outlined legislative solutions aimed at fostering a more competitive and sustainable biosimilar market.

The Costly Reality of Biologics and Patent Barriers

Biologic medicines have transformed the treatment of numerous diseases, offering life-changing therapies for many. However, their high cost remains a major concern. The AAM report highlighted that biologics accounted for more than half of all prescription drug spending, despite representing only a small percentage of total prescriptions.

Biosimilars were designed to address this imbalance, offering more affordable versions of these complex drugs. The report noted that prices typically dropped with each new biosimilar that entered the market, underscoring their potential for significant cost savings.

However, branded manufacturers often created "patent thickets,” which are essentially excessive webs of secondary patents filed as the original patents for a product neared expiry, often extending market exclusivity far past the intended date. Although some of these patents might have been genuinely innovative, many were not. The US Patent and Trademark Office was found to grant more secondary patents than its counterparts in other countries, contributing to this complex landscape.

“Patent thickets, and the prohibitively complex, expensive and risky patent litigations they enable, are hobbling biosimilar competition and delaying public access to these vital, safe and effective lower-cost medicines. For example, thickets, not allowed in Europe and other developed nations, directly contribute to the US paying more for drugs than other countries,” explained the authors.

The white paper revealed a striking difference in patent litigation practices between the US and other nations.

 In the US, branded companies asserted a staggering number of patents in biosimilar litigation—between 11 and 65 patents per product, far exceeding the numbers seen in countries like Canada and the UK. This led to incredibly expensive and time-consuming legal battles, often costing millions of dollars and stretching for years.

The intricate "patent dance" process, coupled with lengthy court proceedings and extensive discovery phases, exacerbated these delays (

The "patent dance" is a informal term referring to a structured, but optional, information exchange process outlined in the Biologics Price Competition and Innovation Act (BPCIA) of 2009 for biosimilar applicants and reference product sponsors to identify and potentially resolve patent disputes before a biosimilar enters the market. This process is designed to streamline and formalize patent litigation related to biosimilars, aiming to reduce the cost and time of bringing these products to market.

“Overburdened federal courts are poorly equipped to resolve these patent pile-ons quickly, inexpensively, or fairly. Biosimilar manufacturers are left with the difficult choice of spending years and millions of dollars to challenge hundreds—or even thousands—of patent claims in court or waiting out the patents until they expire. Neither choice helps patients,” the authors emphasized.

Furthermore, legislative proposals around patent settlements had inadvertently complicated matters, sometimes stifling procompetitive agreements and further delaying biosimilar launches.

“Even before biosimilar litigation commences, large patent estates thwart competition by requiring extensive freedom to operate challenges. Biosimilar companies must ‘clear the decks’ to compete with biologics without patent liability, and particularly when faced with large patent estates, must expend significant resources assessing such patents during development. In many cases, such patent landscaping analyses require time-consuming design around strategies and significant legal costs, ‘creating a moving target for its
biosimilar rivals,’” wrote the authors.

This means that patients continued to pay higher prices for branded biologics for longer than necessary, directly impacting their access to more affordable treatment options.

Paving the Way for a Sustainable Biosimilar Market

The AAM report didn't just identify problems; it proposed actionable solutions for Congress to consider. To accelerate biosimilar market entry and ensure long-term sustainability, the white paper suggested 3 key legislative changes.

First, Congress should cap the number of asserted patents in biologic patent litigation to a reasonable number. Legislation like HR 3269 (the ETHIC Act) and S 1041 (the Affordable Prescriptions for Patients Act) aimed to prevent brands from using excessive patent claims to block market entry.

Second, biosimilar manufacturers needed the freedom to settle time-consuming and expensive patent litigation in a procompetitive manner.

 The report advocated for reforms that encouraged, rather than restricted, such agreements, allowing for earlier market entry.

Finally, Congress should provide a statutory safe harbor for carve-outs of patented methods of treating diseases. Authors of the report claim that this could protect biosimilars when they excluded patented treatment methods from their labels, enabling faster access to lower-cost options without infringing patent rights.

In essence, these legislative changes aimed to reduce litigation delays, limit the abuse of patent rights, and promote timely biosimilar market entry. By enacting these reforms, the authors believe that Congress could significantly lower health care costs and improve patient access to essential biologic medicines, fostering a more robust and equitable health care system for all.

1. Patent thickets and litigation abuses hinder all biosimilars. AAM. July 8, 2025. Accessed July 28, 2025. 

https://accessiblemeds.org/resources/press-releases/patent-thickets-and-litigation-abuses-hinder-all-biosimilars/

2. Sampat BN, Shadlen KC. Secondary pharmaceutical patenting: a global perspective. 

. 2017;46(3):693-707. doi:10.1016/j.respol.2017.01.005

3. Jeremias S. Breaking down biosimilar barriers: the patent system. The Center for Biosimilars

. November 11, 2024. Accessed July 28, 2025. 

https://www.centerforbiosimilars.com/view/breaking-down-biosimilar-barriers-the-patent-system

4. ETHIC Act, HR 3269, 119 Cong (2025). Accessed July 28, 2025. 

https://www.congress.gov/bill/119th-congress/house-bill/3269

5. Affordable Prescriptions for Patients Act, S 1041, 119 Cong (2025). Accessed July 28, 2025. 

https://www.congress.gov/bill/119th-congress/senate-bill/1041

Articles

Patent thickets hinder biosimilar access, driving up costs and delaying affordable treatments. Discover legislative solutions to enhance competition and patient care.

Clearing the Thicket: New Report Outlines Legislative Fixes to Boost Biosimilar Access

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

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

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

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

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

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

Comparative analytical and functional studies:

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

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

Pivotal clinical pharmacology studies using the euglycemic glucose clamp technique:

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

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

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

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

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

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

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

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

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

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

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

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

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

Dispelling Doubts: Review Affirms Safety, Efficacy of Biosimilar Insulins

The launch of adalimumab biosimilars in the United States in 2023 marked a pivotal moment for health care cost savings and patient access, promising to disrupt the long-standing dominance of the originator biologic, Humira.

However, a recent analysis from Truveta, spanning data through April 2025 unveils a concerning trend: more than 13% of patients who initially switched to an adalimumab biosimilar ultimately reverted to the reference drug.

While the Truveta findings hint at patient dissatisfaction or adverse events, they leave crucial questions unanswered: Are the biosimilars themselves to blame? | Image Credit: Maksym - stock.adobe.com

While the Truveta findings hint at patient dissatisfaction or adverse events, they leave a crucial question unanswered: Are the biosimilars themselves to blame? Delving into these critical missing pieces can offer a more comprehensive understanding of the evolving adalimumab biosimilar landscape and the true implications of patient switching patterns.

The research analyzed switching patterns from bio-originator Humira to its biosimilars, finding a significant increase in biosimilar adoption, particularly peaking in April 2024 due to a major formulary change by CVS Health.

 Although biosimilar switching rates remained elevated compared to 2023, the study revealed that a notable proportion of patients—13.2% of those who initially switched—subsequently returned to reference drug Humira.

This "switching back" phenomenon was more prevalent among specific patient demographics: older adults (aged ≥ 65 years), women, and individuals with rheumatoid arthritis or ankylosing spondylitis. A key finding was the rapid nature of these switchbacks, with nearly 40% occurring within 30 days of initiating a biosimilar. Truveta researchers suggested potential early dissatisfaction, adverse events, or patient resistance and uncertainty regarding the new medication. Rural patients also showed higher rates of early switchbacks compared with urban patients.

The study highlighted that although biosimilar uptake is growing, sustained use faces challenges. Patient perceptions, clinical uncertainty, and factors like pharmacy stock or complex health conditions in older adults may contribute to patients reverting to the originator. Understanding these real-world experiences is crucial for promoting broader and more sustained biosimilar adoption, despite clinical trials showing no meaningful differences in safety or efficacy between biosimilars and the originator.

At first glance, the analysis provides a stark insight into the switching patterns of patients receiving adalimumab treatments but there is a significant lack of investigation into the possible reasons behind patients switching back. Although there are mentions of patient perceptions and adverse events after switching to a biosimilar, there is missing context for whether the biosimilars themselves are to blame for patients’ choosing to switch back to Humira. Without this context, it could be implied that biosimilars fail for more than 10% of patients who switch to them, calling into question the safety and efficacy of switching to biosimilars generally.

Overall, a major factor that can cause a patient to switch back from a biosimilar to the reference agent is the nocebo effect, a phenomenon where a patients’ negative opinions about a drug lead to perceived worsened clinical outcomes or adverse events.

Many studies, several of which concern switching between Humira and an adalimumab biosimilar,

 have looked at reference product to biosimilar switching and have found the nocebo effect to be the main cause for patients who switched back, suggesting that switching between biologic products of the same molecule is safe despite some patients still choosing to go back to Humira. Additionally, these studies are often conducted with patients undergoing multiple switches back and forth between products, which is an FDA data requirement to obtain interchangeability status.

Interchangeability is a regulatory designation that allows for pharmacies to exchange a reference product with an approved biosimilar version without waiting for a provider to approve the change first.

 The policy is intended to give patients easier access to their medications and provide pharmacies with better flexibility to deal with supply chain issues and drug shortages. Of the 10 adalimumab biosimilars currently on the market, 8 have interchangeability designations (Cyltezo, Hadlima, Hyrimoz, Simlandi, Yuflyma, Abrilada, Hulio, and Amjevita).

In addition, all states, as well as Puerto Rico, have individual laws regarding interchangeability, most of which concern requirements for patient and/or provider notification that a switch has occurred.

 Currently, 44 states either do not require patients to be notified or require patients to be notified but do not require them to give their consent for the switch, creating a breeding ground for the nocebo effect to occur in chronic patient populations who are typically unaware of what a biosimilar even is. These patients may also have taken many years and treatment failures to settle on a medication that works for them, and a new brand name or injector device could be jarring and anxiety-inducing.

Private labeling has also become popular in the ustekinumab space, another market in which a large number of biosimilars launched within the same year. | Image credit: New Africa - stock.adobe.com

Although Truveta did not look into how interchangeability played into their results,

 it could be worth investigating as the FDA and other governmental bodies consider whether the US should continue to allow interchangeability policy or to follow in the footsteps of the European Union and UK, where regulatory agencies have declared all biosimilars interchangeable.

Additionally, although Truveta did point out that CVS announced that its pharmacy benefit manager Caremark chose to prioritize adalimumab biosimilars on formulary over Humira as a big reason for growing adalimumab biosimilar adoption,

 it left out the several other PBMs that followed suit, overlooking the full extent of how the industry has been bolstering adalimumab biosimilars for success. Notably, the report omitted information on how PBMs Express Scripts, Optum Rx, Prime Therapeutics, Smith Rx, as well as private label pharmacies such as CarePartners Specialty Pharmacy and the Mark Cuban Cost Plus Drug Company have all chosen at least 1 adalimumab biosimilar to embrace.

 In fact, private labeling has also become popular in the ustekinumab space, another market in which a large number of biosimilars launched within the same year.

Sustaining the Biosimilar Momentum: Addressing Perceptions and Policy

The Truveta analysis, although shedding light on the increasing uptake of adalimumab biosimilars, underscores the intricate challenges of maintaining patient adherence. The seemingly high rate of patients reverting to originator Humira, particularly those experiencing early switchbacks, could, at first glance, cast a shadow on biosimilar efficacy and safety.

 However, a deeper dive into the market dynamics reveals that these switchbacks are often less about inherent biosimilar failure and more about the powerful influence of patient perception and the nuances of policy implementation.

Ultimately, the real-world data on adalimumab switchbacks serves as a vital call to action.

 To truly unlock the full potential of biosimilars in the US health care system, stakeholders must move beyond simply encouraging the initial switch. A concerted effort is needed to educate both patients and providers about the robust science underpinning biosimilar safety and interchangeability, actively mitigating the nocebo effect through transparent communication.

Furthermore, ongoing evaluation of interchangeability policies, potentially aligning with the broader European approach of universal biosimilar interchangeability, could further streamline access and build sustained patient confidence. By addressing these challenges, the US adalimumab biosimilar market might be able to fulfill its promise of delivering high-quality, affordable care to the masses.

1. Jeremias S. US welcomes first adalimumab biosimilar, Amjevita. The Center for Biosimilars

. January 31, 2023. Accessed June 29, 2025. 

https://www.centerforbiosimilars.com/view/us-welcomes-first-adalimumab-biosimilar-amjevita

2. Truveta Research. Biosimilar use is on the rise – but 1 in 8 patients return to Humira. Truveta Research. June 23, 2025. Accessed June 29, 2025. 

https://www.truveta.com/blog/research/research-insights/biosimilar-use-humira/

3. CVS to remove Humira from some reimbursement lists in favor of biosimilar options. The Center for Biosimilars. January 6, 2024. Accessed June 29, 2025 . 

https://www.centerforbiosimilars.com/view/cvs-to-remove-humira-from-some-reimbursement-lists-in-favor-of-biosimilar-options

4. Jeremias S. 13 strategies to avoid the nocebo effect during biosimilar switching. The Center for Biosimilars. December 18, 2024. Accessed June 29, 2025. 

https://www.centerforbiosimilars.com/view/13-strategies-to-avoid-the-nocebo-effect-during-biosimilar-switching

5. Jeremias S. Etanercept biosimilar switch shows stable outcomes and disease control in RA. The Center for Biosimilars. May 13, 2025. Accessed June 29, 2025. 

https://www.centerforbiosimilars.com/view/etanercept-biosimilar-switch-shows-stable-outcomes-and-disease-control-in-ra

6. Ferreri D. Switching from Avastin to bevacizumab-bvzr in CRC, NSCLC can reduce Medicare costs. The Center for Biosimilars. May 10, 2025. Accessed June 29, 2025. 

https://www.centerforbiosimilars.com/view/switching-from-avastin-to-bevacizumab-bvzr-in-crc-nsclc-can-reduce-medicare-costs

7. Ferreri D. High acceptance levels after switching to an adalimumab biosimilar for IBD. The Center for Biosimilars. June 14, 2025. Accessed June 29, 2025. 

https://www.centerforbiosimilars.com/view/high-acceptance-levels-after-switching-to-an-adalimumab-biosimilar-for-ibd

8. Jeremias S. New data support Hulio as an interchangeable adalimumab option. The Center for Biosimilars. June 16, 2025. Accessed June 29, 2025. 

https://www.centerforbiosimilars.com/view/new-data-supports-hulio-as-an-interchangeable-adalimumab-option

9. Considerations in demonstrating interchangeability with a reference product. FDA. May 2019. Accessed June 29, 2025. 

https://www.fda.gov/media/124907/download

10. Interchangeable biological products. FDA. Accessed June 29, 2025. 

https://www.fda.gov/media/151094/download

11. Jeremias S. Happy Birthday adalimumab biosimilars: reflecting on the first year of US competition. The Center for Biosimilars. January 31, 2024. Accessed June 29, 2025. 

https://www.centerforbiosimilars.com/view/happy-birthday-adalimumab-biosimilars-reflecting-on-the-first-year-of-us-competition

12. Biosimilar interchangeability laws by state. Cardinal Health. Updated January 2024. Accessed June 29, 2025. 

https://www.cardinalhealth.com/en/product-solutions/pharmaceutical-products/biosimilars/state-regulations-for-biosimilar.html

13. Mazzoni D, Vener C, Mazzocco K, Monzani D, Pravettoni G. The psychological risks associated with the non-medical switch from biologics to biosimilars. 

14. Biosimilar medicines can be interchanged. EMA. September 19, 2022. Accessed June 29, 2025. 

https://www.ema.europa.eu/en/news/biosimilar-medicines-can-be-interchanged

15. Guidance on the licensing of biosimilar products. UK MHRA. Accessed June 29, 2025. 

https://www.gov.uk/government/publications/guidance-on-the-licensing-of-biosimilar-products/guidance-on-the-licensing-of-biosimilar-products

16. Jeremias S. The Age of adalimumab is upon us: how stakeholders can prepare. The Center for Biosimilars. June 28, 2023. Accessed June 29, 2025. 

https://www.centerforbiosimilars.com/view/the-age-of-adalimumab-is-upon-us-how-stakeholders-can-prepare

17. Jeremias S. Welcome Wezlana: the first Stelara biosimilar to launch in the US. The Center for Biosimilars. January 31, 2025. Accessed June 29, 2025. 

https://www.centerforbiosimilars.com/view/welcome-wezlana-the-first-stelara-biosimilar-to-launch-in-the-us

18. Jeremias S. Eye on pharma: interchangeability, private labels, and patent settlements for biosimilars. The Center for Biosimilars. May 9, 2025. Accessed June 29, 2025. 

https://www.centerforbiosimilars.com/view/eye-on-pharma-interchangeability-private-labels-and-patent-settlements-for-biosimilars

19. Jeremias S. European data confirm real-world benefits of adalimumab biosimilars. June 11, 2025. Accessed June 29, 2025. 

https://www.centerforbiosimilars.com/view/european-data-confirms-real-world-benefits-of-adalimumab-biosimilars

About 13% of patients who switch from Humira to an adalimumab biosimilar switch back to the originator, according to research from Truveta. However, the presented data may not tell the full story.

Adalimumab Double Take: The Unexpected Return to Reference Humira

Switching from reference infliximab to biosimilars (infliximab-abda and infliximab-dyyb) for rheumatic diseases may lead to treatment delays and a higher risk of disease flares, particularly when the switch is mandated by insurance. | Image Credit: nick - stock.adobe.com

Infliximab biosimilars (infliximab-abda and infliximab-dyyb) may delay treatment after patients switch from the reference product, suggesting a possible risk factor for flaring/loss of disease control, according to a study published in the 

Clinicians often treat rheumatic diseases like ankylosing spondylitis, psoriatic arthritis, rheumatoid arthritis, and uveitis, with the anti-tumor necrosis factor agent, infliximab. Over the past few years, the FDA approved 4 infliximab biosimilars. The FDA approved the first biosimilar, infliximab-dyyb, in April 2016, and they approved infliximab-abda in May 2017.

 A few months later, the FDA approved infliximab-qbtx in December 2017, and it approved infliximab-axxq in December 2019.

Under the Biologics Price Competition and Innovation Act, a biosimilar product becomes interchangeable when it meets additional requirements that may produce the same clinical result as the reference product in any given patient, and pharmacists may substitute it for the reference product without prescriber input.

 Currently, researchers have not gathered any interchangeable related data for infliximab.

Researchers conducted a retrospective analysis of data to evaluate the level of disease control after nonmedical switches from reference infliximab to biosimilars in patients with rheumatic disease. A total of 48 patients met the inclusion criteria, the majority were White women on reference infliximab products with a mean age of 59 years and a psoriatic arthritis diagnosis.

Several patients who remained on reference infliximab used a concomitant disease-modifying antirheumatic drug (DMARD), with methotrexate (55.2%) being the most common. Patients who switched to the biosimilar product also included some who used a concomitant DMARD, with methotrexate (63.2%) being the most common.

Primary insurance coverage varied between the 2 groups; commercial and Medicare coverage split almost evenly for patients in the infliximab reference group. Commercial and Medicaid serve as the primary coverages for the biosimilar group.

Researchers observed 60.4% of patients on the reference infliximab and 39.6% who switched to the biosimilar; 42.1% flared after switching to the biosimilar. All patients taking the biosimilar used infliximab-dyyb, and insurance mandated 89.5% to switch. Almost half of all patients (42.1%) experienced flares/loss of disease control after switching products. Most of the patients who experienced flares no longer use the biosimilar product (75%).

Two patients who flared after switching to a biosimilar (25%) experienced a delay in treatment because they attempted to receive prior authorization for reference infliximab. There were 75% of patients who reported the flare/loss of disease control within the first 4 months following the switch.

Overall, pharmacists play an important role in the multidisciplinary team approach to manage chronic inflammatory diseases. Pharmacists play an important role in the substitution of biosimilars and patient education surrounding their use.

 The role of pharmacists in this space will only continue to grow as more biosimilars gain FDA-approved interchangeability status. Researchers need future studies that directly compare the rate of flares/loss of disease control in rheumatology patients who remain on the reference product with patients who switch to a biosimilar.

The study design limited the results because of the small sample size and a single health network that included a primarily White population. Researchers expressed that they should label the study a pilot because it needs more data to draw meaningful conclusions. Ultimately, this may have indicated more flares than clinicians found relevant. Lastly, the health network’s formulary does not include every available infliximab biosimilar, which limits the findings of the study only to infliximab-abda and infliximab-dyyb.

“Pharmacists should follow patients who switch to biosimilar closely during the transition period, to provide education on biosimilars and to monitor for signs of flares/loss of disease control,” study authors concluded.

1. Jankowska M, Dessureault K, MacDougall J, Sowers M, Merchand M, Kennedy AG. Impact of nonmedical switches from reference infliximab to biosimilars on disease control within a rheumatology practice. 

. Published online December 21, 2024. doi:10.1177/87551225241308475

2. Biosimilar approvals. The Center for Biosimilars

. January 7, 2025. Accessed June 4, 2025. 

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

3. Halpern L. As biosimilar substitutions become more common, education and patient counseling are paramount. 

https://www.pharmacytimes.com/view/as-biosimilar-substitutions-become-more-common-education-and-patient-counseling-are-paramount

Switching from reference infliximab to biosimilars (infliximab-abda and infliximab-dyyb) for rheumatic diseases may lead to treatment delays and a higher risk of disease flares, particularly when the switch is mandated by insurance.

Julia Bonavitacola

Clearing the Thicket: New Report Outlines Legislative Fixes to Boost Biosimilar Access

Dispelling Doubts: Review Affirms Safety, Efficacy of Biosimilar Insulins

Adalimumab Double Take: The Unexpected Return to Reference Humira

Infliximab Biosimilar Switch Due to Flare Risk: Monitoring Patients Is Crucial for Pharmacists