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

Articles

The FDA has approved Celltrion's Eydenzelt, a new aflibercept biosimilar, enhancing treatment options for retinal diseases in the US.

FDA Approves Celltrion Aflibercept Biosimilar: Eydenzelt

A recent study confirms the stability of XSB-001 biosimilar for retinal diseases under realistic clinical handling conditions.

Real-World Stability Confirmed for Biosimilar Ximluci in Prefilled Syringes

A review of the safety of biosimilar DMARDs during pregnancy reveals critical evidence gaps and the need for informed clinical guidance.

Review Identifies Gaps in Evidence on Biosimilar DMARD Use During Pregnancy

The latest advancements in global biosimilar access include new treatments, strategic partnerships, and competitive market entries enhancing patient care.

Global Biosimilars Market Sees Gains in Access and Pipeline Expansion 

AVT06, a promising biosimilar to aflibercept (Eylea), shows comparable efficacy and safety for treating neovascular age-related macular degeneration (AMD), enhancing patient access.

Proposed Aflibercept Biosimilar Shows Comparable Safety, Efficacy in Phase 3 AMD Trial

Sarfaraz K. Niazi, PhD, is an adjunct professor of biopharmaceutical sciences at the University of Illinois and the University of Houston, and founder of biosimilars companies Karyo Biologics and Adello Biologics. He also founded the biosimilar advisory company PharmSci.

In a position paper submitted to the FDA Commissioner at his request, I have detailed the changes that are needed in the Biologics Price Competition and Innovation Act (BPCIA) to enable faster entry of affordable biosimilars.

| Image Credit: ArtemisDiana - stock.adobe.com

I believe the most creative proposal, based on legal analysis is how the FDA need not entertain any legislative changes or modifications to BPCIA to change all policies related to biosimilars. The Secretary of HHS is granted this authority, but it has been legally challenged in the past by stakeholders who oppose the expansion of biosimilars. In my comparative global analysis, I am teaching the FDA Commissioner how to create guidelines that will not be subject to legal challenges. Here are the changes I am proposing:

Make clinical efficacy studies nonmandatory, leaving the onus of proving that they are not necessary on the filer. However, where it is obvious, prevent developers from conducting such studies to avoid human abuse.

Remove the need for clinical pharmacology studies, pharmacokinetic, and pharmacodynamic if intravenous (IV) administration of the product is not required or where non-IV administration with instant absorption is possible.

Analytical similarity testing is divided into 2 parts: the first is molecular similarity, which does not require multiple lots of reference products; the second is matching the release specification rather than conducting a side-by-side analytical similarity assessment. This will also allow the use of legacy limits that do not require comparison.

Allow the US Pharmacopeia to create product release specifications (PRS) instead of a monograph and provide validated test methods, thereby eliminating the need to secure multiple lots of the reference product.

Products with identical formulation, whether current or prior (due to intellectual property issues), should be required.

No unmatched degradation product is allowed; it must be removed by chromatography—no scientific justification allowed.

Post-translation attributes must match in identity and quantity within a 10% tolerance.

The prescribing information will be the same as the reference product information, modified as needed, without any changes to the formulation.

All biosimilars should be interchangeable unless the prescribers suggest otherwise.

Biosimilars will be allowed a Drug Master File to allow developers to secure drug substance just like it is done for the active pharmaceutical ingredient. However, the drug product qualification must be met with a complete dossier.

The FDA is expected to take an active role in addressing double-patenting, following the recent withdrawal by the US Patent and Trademark Office.

Injection of biosimilars will require point-of-use filtration to reduce the risk of aggregates causing immunogenicity.

No consultation with stakeholders to avoid conflict of interest; only scientific opinions will be sought, and that too, not from organizations with an agenda.

No consultation with associations of biosimilar developers, as these are based on non-scientific views. In my opinion, drug distribution and other issues, such as pharmacy benefit managers, are not related to the FDA agenda.

351(k) applications will be treated as fast-track, with a token applied for faster approval; the maximum limit of approval from the filing date is no more than 6 months.

All these changes can be brought by introducing guidelines, regardless of the details or requirements listed in the BPCIA. The correct language of these guidelines is also provided in the detailed paper I have submitted to the US FDA Commissioner. I anticipate meeting him soon.

BioRationality: How the FDA Can Bypass Congress to Change Biosimilar Guidance

Cameron Santoro is an associate editor for The Center for Biosimilars

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic.

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, welcomes the advent of biosimilars in multiple myeloma treatment, particularly a potential biosimilar for daratumumab, as a means to reduce costs and increase market competition. However, she foresees significant challenges, especially if an intravenous (IV) biosimilar becomes available before a subcutaneous version.

The FDA approved Celltrion's investigational new drug application for CT-P44, a daratumumab biosimilar, enabling a global phase 3 trial.

 Researchers will evaluate CT-P44's pharmacokinetics, efficacy, and safety against daratumumab in 486 patients with refractory or relapsed multiple myeloma.


Sandahl notes that the original IV daratumumab infusions can take 8 to 10 hours, creating considerable scheduling difficulties. She explains that even with current patient volumes and nursing shortages, switching just a few patients from subcutaneous back to IV has proven challenging for infusion centers.


While acknowledging the clear cost containment benefits of biosimilars, she emphasizes that the cost difference would need to be substantial to justify moving patients from the more convenient and less chair-time-intensive subcutaneous formulation back to an IV one. She questions how centers managed this logistical burden universally before the subcutaneous option became available, highlighting a potential conflict between cost savings and current clinical practice efficiency.

This transcript was lightly edited for clarity.

: Please discuss the potential impact of biosimilars on the treatment paradigm of multiple myeloma. How might the growing availability of biosimilars influence prescribing patterns, cost management, and the role pharmacists play in integrating them into practice?

As a pharmacist, I welcome biosimilars and generic medications, anything we can do to reduce costs and increase competition. I think one thing that I've thought about is a biosimilar for daratumumab because that's probably the first one we would see, based on when things were approved. I'm curious what the adoption of that would look like because you'd see a biosimilar most likely for the IV formulation sooner than you would with the subcutaneous, and that's a huge difference in chair time. The cost difference would have to be pretty substantial for people to say, "Hey, we're putting everyone on the daratumumab biosimilar and abandoning the subcutaneous Darzalex."

I think it'd be an interesting change in practice because the way our things stood, the first infusion for IV daratumumab can take 8 to 10 hours, and scheduling that can be really challenging. We've had a few patients in the last couple of months who have needed to be switched from subcutaneous to IV for some reason or another, and even just finding them a space in the infusion center to get those first couple infusions has been a huge challenge. Where I've gone back, I'm like, "Gosh, how did we do this for everyone before we had subcutaneous? How did we make this work before because now we can't seem to?"

Some of that is an increase in patient volumes and differences in nursing shortages that maybe we didn't have 5 to 6 years ago. I think from a cost containment standpoint, biosimilars would be great but then when we look at like clinical practice and how that fits with current practice, going from subcutaneous back to IV would be a challenge.

FDA approves global phase 3 trial for Celltrion’s daratumumab biosimilar. Pearce IP. December 27, 2024. Accessed July 14, 2025. 

https://www.pearceip.law/2024/12/27/fda-approves-global-phase-3-trial-for-celltrions-daratumumab-biosimilar/

Tyler Sandahl, PharmD, a clinical pharmacist at Mayo Clinic, supports biosimilars for cost savings but foresees challenges adopting an intravenous daratumumab biosimilar, preferring the more convenient subcutaneous option.

Balancing Cost Savings With Clinical Practice for Multiple Myeloma Biosimilars: Tyler Sandahl, PharmD

Aislinn Antrim serves as Managing Editor at Pharmacy Times.

Biosimilar adoption in inpatient settings has increased, offering financial benefits without compromising patient care, especially in oncology and supportive care.

From 2019 to 2024, biosimilars accounted for 24.4% of inpatient encounters, with significant growth in supportive care and oncology.

The study found a mean 35% reduction in wholesale acquisition costs for biosimilars compared to reference products, highlighting cost-saving potential.

Pharmacies can lead efforts to increase biosimilar use by collaborating with providers, educating stakeholders, and streamlining formularies for cost-effective prescribing.

This article was originally published by 

A comprehensive analysis of inpatient biologic and biosimilar use over 6 years reveals significant growth in biosimilar adoption, highlighting a valuable financial opportunity for pharmacy departments and health systems. The study, presented at the American Society of Health-System Pharmacists 2025 Pharmacy Futures meeting, emphasizes how expanding biosimilar utilization in the inpatient setting, especially in oncology and supportive care, can help reduce drug acquisition costs without compromising patient care.

Biologics have transformed the management of numerous acute and chronic conditions, including cancer, autoimmune diseases, and supportive care for chemotherapy. Their biosimilar counterparts offer highly similar therapeutic effects at reduced costs, a key factor for outpatient reimbursement.

However, inpatient biologic administration differs in reimbursement models, as there is typically no separate payment for individual drugs during hospital stays. This makes optimizing purchase prices crucial to managing inpatient drug budgets. Pharmacy leadership and health system executives must collaborate with clinical providers to identify where biosimilars can be leveraged to maximize cost savings without affecting clinical outcomes.

The study examined inpatient biologic use from 2019 through 2024, analyzing deidentified data from Trisus Medication Compare, representing national real-world data, and institutional data from Prisma Health. Researchers focused on inpatient encounters where patients received either reference biologics or biosimilars for 9 key agents: filgrastim, pegfilgrastim, infliximab, rituximab, bevacizumab, trastuzumab, tocilizumab, epoetin alfa, and insulin glargine.

The primary goal was to characterize overall and annual trends in biosimilar vs reference product dispensations. Secondary analyses explored variations by specialty areas, including oncology, supportive care, immunology, ophthalmology, and endocrinology; geographic location; and differences in wholesale acquisition costs (WAC) between reference and biosimilar products.

Key Findings: Steady Biosimilar Growth With Specialty Variations

The data set included 909,969 inpatient encounters from 458 health care entities. Approximately 75.6% involved reference biologics, whereas biosimilars accounted for 24.4%. The population was predominantly adult (97.3%), with an average age of 62 years, primarily treated in urban (89.4%) and nonacademic centers (63.3%).

Across most product categories, biosimilar use steadily increased from 2019 through 2024, except for ranibizumab, which showed limited biosimilar adoption. Insulin glargine represented the largest sample, with 723,170 dispensations, starting at 12.1% biosimilar use and rising to an expected 29.4% by 2024.

Supportive care drugs saw particularly high biosimilar adoption rates: filgrastim (84.8%), epoetin alfa (76.2%), and pegfilgrastim (52.6%). Rituximab, widely used for acute and chronic indications, showed biosimilar use in 59.3% of real-world encounters and 66.8% in institutional data.

Among oncology biologics, trastuzumab biosimilars accounted for 65.7% of inpatient use (although the sample size was small at 119 encounters), whereas bevacizumab biosimilar use was lower at 35.8% (329 encounters). Infliximab biosimilar adoption was notable—53.4% overall, increasing to 79.6% in 2024 real-world data, and 67% in institutional records. Tocilizumab biosimilars, newly introduced in 2024, had the lowest uptake, making up just 15.5% of dispensations.

By specialty, biosimilar utilization was highest in supportive care (77.8%) and oncology (57.9%) settings, underscoring areas where substitution could deliver the most impact.

Financial Impact: Significant Cost Savings Potential

The wholesale acquisition cost comparison revealed a mean 35% reduction in 2024 for biosimilars vs reference products. The largest cost differentials were observed with filgrastim 480 mcg (-55%), epoetin alfa (-51%), and pegfilgrastim (-48%). These savings highlight the potential for inpatient biosimilar adoption to meaningfully reduce health system drug expenditures.

This study demonstrates that inpatient biosimilar adoption is increasing nationally and within health systems like Prisma Health, especially in oncology and supportive care specialties. Despite this progress, opportunities remain to further increase biosimilar use to optimize drug procurement costs.

Pharmacies are well positioned to lead these efforts by collaborating with providers to identify areas ripe for biosimilar substitution, educate stakeholders about clinical equivalency, and streamline formularies to support cost-effective prescribing. With biologics representing a substantial portion of inpatient drug budgets, expanding biosimilar adoption can support sustainable health care delivery while maintaining quality patient care.

1. Mccoy JW. Real-world inpatient use of reference versus biosimilar products. Presented at: American Society of Health-System Pharmacists 2025 Pharmacy Futures. Charlotte, NC; June 10, 2025.

2. Biosimilar and Interchangeable Biologics: More Treatment Choices. FDA. Updated August 17, 2023. Accessed June 10, 2025. 

https://www.fda.gov/consumers/consumer-updates/biosimilar-and-interchangeable-biologics-more-treatment-choices

Inpatient Biosimilar Use Grows, Offering Cost-Saving Opportunities for Health Systems

Here are the top 5 biosimilar articles for the week of July 7, 2025.

: Long-term data from the SAME study confirm that 

 is safe and effective for patients with inflammatory bowel disease (IBD).

 persist among consumers and health care professionals, hindering their adoption and potential benefits in health care.

, including FDA approvals, patient switching trends, and real-world efficacy insights.

 demonstrated comparable efficacy and safety for paroxysmal nocturnal hemoglobinuria (PNH) to its reference drug, showing similar outcomes across diverse patient groups.

 switch back to the originator, according to research from Truveta. However, the presented data may not tell the full story.

To read all of these articles and more, visit 

Videos

The Top 5 Biosimilar Articles for the Week of July 7

The US biosimilar market recently saw the introduction of 2 pairs of denosumab biosimilars from Fresenius Kabi and Celltrion USA, significantly expanding treatment options for individuals living with bone-related conditions.

The pairs of denosumab competitors follow the launches of Sandoz’ Wyost and Jubbonti (denosumab-bbdz for both), which launched in March 2025. | Image credit: SoftSheep - stock.adobe.com


 the commercial availability of Conexxence (denosumab-bnht) and Bomyntra (denosumab-bnht). Conexxence is a biosimilar referencing Prolia (denosumab), and Bomyntra is a biosimilar referencing Xgeva (denosumab). The biosimilars 

 from the FDA for all indications of their respective reference products in March 2024.

Conexxence is indicated for various adult patient populations at high risk for fractures.

 This includes individuals with osteoporosis, people undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy. It is available in a 60-mg/mL single-use prefilled syringe. Fresenius Kabi noted that Conexxence carries a black box warning and is part of a Risk Evaluation and Mitigation Strategy program designed to inform prescribers and patients about the risk of severe hypocalcemia in individuals with advanced chronic kidney disease, including those on dialysis. The biosimilar is contraindicated in patients with hypocalcemia, during pregnancy, and in cases of known hypersensitivity to denosumab products.

Bomyntra is approved for the prevention of skeletal-related events in patients with multiple myeloma and in individuals with bone metastases from solid tumors. It is also indicated for the treatment of hypercalcemia of malignancy that is refractory to bisphosphonate therapy and for the treatment of adults and skeletally mature adolescents with giant cell tumor of the bone that is unresectable or where surgical resection is likely to result in severe morbidity. Bomyntra is available in a 120-mg/1.7-mL vial and a 120-mg/1.7-mL single-use prefilled syringe. It is contraindicated in patients with hypocalcemia and those with known hypersensitivity to denosumab products.

Sang Jin Pak, PhD, president of Fresenius Kabi Biopharma, expressed the company’s commitment to consistent biosimilar launches, stating, “Access to high-quality biological medicines creates the opportunity to provide more affordable therapies to patients and as our biosimilar portfolio expands, we will be able to provide access for even more patients.” Earlier this year, Fresenius Kabi reached a global settlement with Amgen regarding its denosumab biosimilars.

 the commercial availability of its denosumab biosimilars, Stoboclo (denosumab-bmwo) and Osenvelt (denosumab-bmwo). Stoboclo references Prolia (denosumab), while Osenvelt references Xgeva (denosumab).

Stoboclo is available as a 60-mg/mL injection. It is approved to treat postmenopausal women with osteoporosis at high risk for fracture, to increase bone mass in men with osteoporosis at high risk for fracture, and to treat glucocorticoid-induced osteoporosis in men and women at high risk for fracture. Additionally, it is indicated to increase bone mass in men at high risk for fracture who are receiving androgen deprivation therapy for nonmetastatic prostate cancer and to increase bone mass in women at high risk for fracture receiving adjuvant aromatase inhibitor therapy for breast cancer.

Osenvelt, available as a 120-mg/1.7-mL (70 mg/mL) injection, is indicated to prevent skeletal-related events in patients with multiple myeloma and in individuals with bone metastases from solid tumors. It is also approved to treat adults and skeletally mature adolescents with giant cell tumor of bone that is unresectable or where surgical resection is likely to result in severe morbidity and to treat hypercalcemia of malignancy refractory to bisphosphonate therapy.

Thomas Nusbickel, chief commercial officer at Celltrion USA, highlighted the significance of the launches, stating, "We are proud to introduce our denosumab biosimilars to the U.S. market, offering patients and professionals a valuable alternative treatment option." Celltrion also reached a global settlement with Amgen concerning its denosumab biosimilars. To support patients, Celltrion offers comprehensive patient support programs, including the Celltrion Connect patient support program and the Celltrion Cares co-pay assistance program, with options for uninsured patients to potentially receive treatment at no cost.

The pairs of denosumab competitors follow the launches of Sandoz’ Wyost and Jubbonti (denosumab-bbdz for both), which launched in March 2025, nearly a year after they became the first denosumab biosimilars to be greenlit by the FDA.

Now that Xgeva and Prolia have 3 competitors each, the market is starting to stack up, with 

 (denosumab-dssb for both), which were developed by Samsung Bioepis are waiting in the wings to launch next.

“By providing quality-proven biosimilars, we are helping to address a critical healthcare need and reduce the burden of skeletal fractures that impact patients’ quality of life,” Byoungin Jung, vice president and regulatory affairs team leader at Samsung Bioepis, commented.

1. Fresenius expands biosimilars portfolio with the launch of denosumab biosimilars in the U.S. News release. Fresenius Kabi. July 1, 2025. Accessed July 9, 2025. 

https://www.businesswire.com/news/home/20250701511446/en/Fresenius-Expands-Biosimilars-Portfolio-With-The-Launch-of-Denosumab-Biosimilars-in-the-U.S

2. Celltrion USA announces U.S. launch of denosumab biosimilars, Stoboclo and Osenvelt (denosumab-bmwo). News release. Celltrion USA. July 7, 2025. Accessed July 9, 2025. 

https://www.prnewswire.com/news-releases/celltrion-usa-announces-us-launch-of-denosumab-biosimilars-stoboclo-and-osenvelt-denosumab-bmwo-302499495.html

3. Santoro C. FDA approves another pair of denosumab biosimilars, Conexxence and Bomyntra. The Center for Biosimilars

. March 27, 2025. Accessed July 9, 2025. 

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

4. Jeremias S. FDA approves third pair of denosumab biosimilars. The Center for Biosimilars. March 4, 2025. Accessed July 9, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-third-pair-of-denosumab-biosimilars

5. Jeremias S. Wyost and Jubbonti launch as first denosumab biosimilars in the US. The Center for Biosimilars. June 2, 2025. Accessed July 9, 2025. 

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

6. Jeremias S. FDA, EMA approve second pair of denosumab biosimilars. The Center for Biosimilars. February 17, 2025. Accessed July 9, 2025. 

https://www.centerforbiosimilars.com/view/fda-ema-approve-second-pair-of-denosumab-biosimilars

The US biosimilar market expands with new denosumab options, enhancing treatment for patients with osteoporosis and bone-related metastases.

Two More Pairs of Denosumab Biosimilars Enter US Market

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

Despite the growing presence of biosimilar prescription drugs in the US health care market, a recent analysis revealed significant knowledge gaps and uncertainties among both consumers and health care professionals (HCPs).

 This widespread lack of understanding could hinder the full potential of biosimilars, which are poised to expand access to life-saving medications and potentially lower health care costs across the nation. The findings underscored an urgent need for clearer, more comprehensive educational initiatives to foster better understanding and adoption of these crucial therapeutic options.

The authors said their findings underscore an urgent need for clearer, more comprehensive educational initiatives to foster better understanding and adoption of these crucial therapeutic options. | Image credit: Alena - stock.adobe.com

The abbreviated approval pathway for biosimilars is rigorous, allowing for more affordable treatment options and increased patient access to crucial medications for conditions like chronic skin diseases, arthritis, and cancer. However, prior research had consistently shown a lack of familiarity and understanding of biosimilars among both patients and prescribers. Misconceptions around their efficacy, safety, and interchangeability had created hesitancy in their adoption.

With the FDA having issued draft guidance in 2020 on promotional labeling and advertising for biosimilars, particularly concerning disclosure statements, the present study aimed to experimentally test how different forms of disclosure impacted understanding and perceptions.

 The goal was to identify effective communication strategies that could inform and educate both groups in a neutral manner, dispelling misconceptions without unduly influencing perceptions.

The study employed an experimental design involving 379 consumers and 368 HCPs (primary care providers with prescribing authority) recruited via an online panel. Participants were randomized into one of seven biosimilar disclosure conditions or a control group.

Each condition presented a mock advertisement for "Kesterin," a fictitious biosimilar for rheumatoid arthritis. Disclosures varied by: identifying the product as a biosimilar; the comprehensiveness of the definition provided (ranging from basic to expanded details on safety, efficacy, source, dosage, and administration); and whether a specific reference product ("Mytrozen") was named. Consumer disclosures used lay language, while HCP disclosures used medical terminology. Researchers assessed the impact of these disclosures on participants' comprehension, perceptions of benefit and risk, attitudes, intentions (to use or prescribe), and preferences.

The study's results highlighted significant knowledge gaps. Overall, comprehension of biosimilar information was suboptimal, even when participants were provided with a definition. Only 48.5% to 62.0% of consumers and 68.4% to 88.4% of HCPs accurately understood core characteristics, such as comparable safety and efficacy.

Specifically, comprehension was lowest for the statement, "Kesterin has the same safety and efficacy as the original biologic," for both groups. Perceptions of benefit, comparative efficacy, and safety remained largely neutral across all groups, including the control, suggesting that existing perceptions were deeply ingrained and not easily shifted by brief disclosures.

Crucially, the content of the biosimilar definition generally did not significantly influence outcomes for consumers. However, for HCPs, expanded definitions led to more positive attitudes toward the biosimilar drug and stronger intentions to prescribe. For instance, HCPs exposed to the most comprehensive definition reported more positive attitudes (mean, 4.23) compared to those who only saw the "Kesterin is a biosimilar" statement (mean, 3.83; 

 = .014) or the control group (mean, 3.80; 

 = .009). Similarly, their intentions to prescribe were significantly higher with expanded definitions (mean = 3.76) compared to the control (mean, 3.21; 

 = .009) or the biosimilar-only condition (mean, 3.00; 

Both consumers and HCPs expressed a preference for these more detailed definitions. HCPs also specifically preferred seeing the named reference product, although this did not directly impact other study outcomes, possibly due to the fictitious nature of the named reference product. Notably, HCPs largely agreed that biosimilars could be used "interchangeably" with their reference product, which signaled a potential misunderstanding of the specific regulatory designation of "interchangeability."

These findings had significant implications for the biosimilar industry and the US health care system. The persistent knowledge gaps and neutral perceptions among both consumers and HCPs indicated that the full potential of biosimilars, including their cost-saving benefits and increased access to treatment, might not be fully realized.

"Our findings clearly signaled that there were knowledge gaps and uncertainty regarding biosimilar products among consumers and HCPs," the study authors concluded. "Further education was warranted around these products, and communications for both groups required careful testing to ensure that the information was understood and did not result in a negative perception of the product."

Researchers suggested that future educational efforts should focus on providing comprehensive and easily digestible information, particularly for HCPs, given their stated preference for expanded definitions and their increased prescribing intentions when presented with more detail. For the biosimilar industry, this means refining direct-to-consumer and professional-facing promotional materials to incorporate clearer, more informative disclosures that addressed core misconceptions about biosimilar equivalence, safety, and efficacy.

For the broader health care system, effective education was mentioned by the authors as paramount to fostering trust and increasing the adoption of these important therapeutic options, which will ultimately contribute to better patient outcomes and more sustainable health care spending.

1. Johnson M, Thompson JE, Tilley AA, O’Donoghue AC, Aikin KJ. Perceptions and preferences for defining biosimilar products in prescription drug promotion. 

2. FDA. Promotional labeling and advertising considerations for prescription biological reference and biosimilar products questions and answers: Guidance for industry. 2020. Accessed July 1, 2025. 

https://www.fda.gov/media/134862/download

Significant knowledge gaps about biosimilars persist among consumers and healthcare professionals, hindering their adoption and potential benefits in health care.

Consumers and Providers Face Biosimilar Knowledge Hurdles

 of nonmedical switching from the infliximab reference product to biosimilar CT‐P13 (Inflectra; Celltrion) found long-term persistence was similar between patients in the switched and non-switched cohorts after 4 years of follow-up. The investigators said the results “provide further reassurance that nonmedical switching is safe and clinically comparable to ongoing originator infliximab in clinically stable patients with IBD.”

Image credit: Sandor Kacso - stock.adobe.com

 shown nonmedical switching to the infliximab biosimilar CT‐P13 from the originator was safe and noninferior compared to continuing the reference product in patients with inflammatory bowel disease (IBD).

Although several studies have reported cost savings associated with switching to infliximab, and several countries and regions require new prescriptions of anti-tumor necrosis factor biologics to be biosimilars, Australia does not mandate prescribing biosimilars, “and a significant portion of [IBD] patients may remain on originator infliximab owing to clinician and patient reluctance to switch.”

Randomized controlled trials and real-world studies have found infliximab biosimilars are safe and effective in IBD, for both infliximab-naive and switched patients. However, longer-term outcomes “remain less well described,” the authors said. Furthermore, they added, since some studies have suggested switching may negatively affect long-term clinical outcomes due to the nocebo effect, there is a need for longer-term studies.

The prospective parallel cohort noninferiority study enrolled 345 patients with IBD in steroid-free clinical remission across multiple centers in Australia on the originator infliximab. Patients either continued treatment with the originator (n = 141) or switched to CT‐P13(n = 204). Independent of the study, 4 hospitals had decided to switch all stable patients to the biosimilar, while 3 had decided to continue to use the originator.

At 48 weeks, treatment persistence, the primary outcome, was 92% among patients in the biosimilar group, and 94% in the originator group. Among patients who did not change from their initial treatment (n = 297) during follow-up, there was no difference in the risk of disease worsening between groups (HR, 1.08; 95% CI, 0.68-1.72).

Trough drug levels were not different between switch and non-switch over time or at any single time period throughout the follow-up. However, the authors did find that patients who were receiving dose escalation prior to the start of the study had lower drug levels than those who weren’t. Also, dose escalation of more than 5 mg/kg every 8 weeks was significantly associated with disease worsening (HR, 1.89; 95% CI, 1.13-3.17).

Rates of antidrug antibodies (ADAs) were similar between groups. Develoment of ADAs occurred in 5 patients in the switch group and 4 who remained on the originator. Overall rates of ADAs were similar between groups, at 10% in the switch group and 11% in the reference product group. The authors added that all patients who developed “clinically significant” antibodies had a change in drug therapy sometime during follow-up.

At least 1 adverse event (AE) occurred in 49% of patients in the biosimilar group and 53% of the reference product group, with no significant difference between groups. The authors said most AEs were mild and did not affect treatment persistence. In the biosimilar group, 25 patients (12%) experienced an AE leading to discontinuation of infliximab treatment, as well as 15 (11%) of patients in the reference product group. AEs leading to discontinuation included infection, vasculitis, drug‐induced lupus, and one death, which was associated with a pre‐existing malignancy.

Rates of infliximab discontinuation were also not significantly different between groups, occurring 35% in the switched group and 38% of those who stayed on the reference product (HR, 0.87; 95% CI, 0.59-1.28). One patient switched back to the originator, after a change in symptoms without objective evidence of inflammation.

Reasons for discontinuation included disease worsening (22% of those who discontinued the biosimilar and 24% of those who discontinued the reference product), dose escalation (35% and 32%), antibody development (5% and 11%), and infliximab‐related adverse events (8% and 8%), and were comparable between groups. Regardless of group, patients with UC had a higher likelihood of treatment discontinuation than those with CD.

According to the authors, this is the longest real-world study to compare switched and non-switched groups of patients with IBD on infliximab. The authors concluded their findings “provide reassurance to clinicians, patients, and healthcare payers, alike, regarding the long‐term safety, clinical effectiveness, and pharmacokinetic profile of nonmedical switching.”

Suo P, Srinivasan A, Thin L, et al. Comparing long-term infliximab persistence following a switch to a biosimilar in patients with inflammatory bowel disease: no cause for concern. 

. 2025;40(5):1174-1181. doi:10.1111/jgh.16916

Long-term data from the SAME study confirm that switching to infliximab biosimilars is safe and effective for patients with inflammatory bowel disease (IBD).

Australian Patients With IBD Switched to Biosimilar Infliximab Maintain Long-Term Persistence

Here are the top 5 biosimilar articles for the week of June 30, 2025.

 use has risen significantly, reflecting evolving treatment patterns in inflammatory bowel disease (IBD) among children and young adults.

: 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 

: A real-world study reveals that pediatric patients with IBD achieve 

: Regulators and manufacturers advance biosimilars for 

, enhancing access to treatment in Europe and Latin America.

 raises critical concerns about FDA standards, physician trust, and patient safety in biosimilars.

The Top 5 Biosimilar Articles for the Week of June 30

Biosimilar SB12 demonstrated comparable efficacy and safety for paroxysmal nocturnal hemoglobinuria (PNH) to its reference drug, showing similar outcomes across diverse patient groups. | Image Credit: Innovative Creation - stock.adobe.com

Biosimilar SB12 or Epysqli (eculizumab-aagh; Samsung Bioepis) is equivalent to reference eculizumab (Soliris) for treating complement inhibitor-naïve patients with paroxysmal nocturnal hemoglobinuria (PNH), showing no significant differences in transfusion avoidance or hemoglobin stabilization across both Asian and non-Asian subgroups, according to a study published in 

PNH is a rare blood disorder that causes brown/dark-colored urine during late nights or early mornings, typically affecting men and women between 30 and 40 years old.

 PNH can lead to hemolytic anemia, chronic kidney disease, or thrombosis, and individuals with bone marrow disorders are at risk of developing PNH.

PNH arises from a somatic mutation in the phosphatidylinositol glycan class-A gene.

This genetic defect leads to a deficiency of crucial glycosylphosphatidylinositol-anchored proteins, specifically CD55 and CD59, on the surface of blood cells. The absence of these regulatory proteins results in uncontrolled activation of the complement system, which then attacks and destroys red blood cells, leading to intravascular hemolysis. Episodes of severe hemolysis, known as paroxysms, are often triggered by stressors such as surgery, infection, or inflammation.

The FDA approved SB12 in July 2024 for both PNH and atypical hemolytic uremic syndrome, based on results from phase 1 (

 This approval was the second eculizumab biosimilar approved, following Bkemv (eculizumab-aeeb) in May 2024.

Researchers conducted a randomized, double-blind phase 3 study between August 2019 and October 2021 at 24 centers across 8 countries to evaluate treatment sequences for PNH.

 There were 50 adult patients with PNH who were randomized to treatment sequence 1 (TS1, SB12-ECU; n = 25) or 2 (TS2, ECU-SB12; n = 25). Both treatments were administered intravenously, starting with 600 mg weekly for the first 4 weeks, increasing to 900 mg in the fifth week, and then 900 mg biweekly thereafter. At week 26, patients were switched to the alternative treatment, continuing until week 50.

The phase 3 study had Asian patients constituting 54% of the total enrollment. Of the 25 patients randomized to TS1 (SB12-ECU), 60% were Asian and 40% were non-Asian. For the 25 patients randomized to TS2 (ECU-SB12), the distribution was 48% Asian and 52% non-Asian.

The 95% CIs for the mean difference in lactate dehydrogenase (LDH) levels at week 26 between SB12 and eculizumab fell within the predefined equivalence margins for both Asian patients (SB12-ECU, –12.02; 95% CI, −126.87 to 102.83) and non-Asian patients (SB12-ECU, 76.12; 95% CI, −56.75 to 208.99), indicating that SB12 is equivalent to eculizumab in terms of LDH levels for both groups.

The 90% CI for the ratio of time-adjusted area under the effect curve of LDH between SB12 and eculizumab indicated equivalence in Asian patients (SB12/ECU, 1.01; 90% CI, 0.92-1.10), as it fell within the predefined equivalence margin. This comparable outcome was also observed in non-Asian patients, where the ratio was 1.15 with a 90% CI of 0.90 to 1.46.

Biosimilar SB12 demonstrated comparable efficacy and safety for paroxysmal nocturnal hemoglobinuria (PNH) to its reference drug, showing similar outcomes across diverse patient groups.