Brooke McCormick is an assistant editor for 

Brooke McCormick

Biosimilar ranibizumab has delivered visual and anatomical outcomes equivalent to reference anti-vascular endothelial growth factor (anti-VEGF) therapy across a range of retinal diseases in India, with the resulting cost savings measurably improving treatment initiation and adherence, according to a narrative review published in the 

Anti-VEGF biosimilars in India matched reference therapy, lowered costs, and improved treatment access and adherence for retinal diseases. | Image credit: Syda Productions - stock.adobe.com 

India’s Experience Highlights the Clinical Value of Anti-VEGF Biosimilars

The review synthesized phase 3 trial data, post-marketing surveillance, and large real-world cohorts on biosimilar anti-VEGF agents used to treat neovascular age-related macular degeneration (nAMD), diabetic macular edema (DME), retinal vein occlusion (RVO), myopic choroidal neovascularization, and retinopathy of prematurity. In 2015, India became the first country to approve an intravitreal ranibizumab biosimilar (Razumab; Intas Pharmaceuticals Ltd), years before similar products reached Europe or the US, and it now has one of the most diverse ophthalmic biosimilar markets in the world, with 5 ranibizumab biosimilars and 1 aflibercept biosimilar approved.

Across equivalence trials, ranibizumab biosimilars produced visual acuity gains of roughly 6 to 8 ETDRS letters in nAMD and about 8 letters in DME, alongside meaningful reductions in central retinal thickness within the first 3 to 6 months, findings that consistently met predefined equivalence margins against the reference molecule. Real-world Indian cohorts reinforced these results in RVO and myopic choroidal neovascularization, with functional and anatomical benefits sustained through follow-up periods of up to 48 weeks. Evidence, however, remains limited for polypoidal choroidal vasculopathy; the review authors called for dedicated prospective studies in that subgroup.

Large multicenter Indian datasets, including a comparative safety study of nearly 40,000 eyes, found that adverse events with biosimilar ranibizumab were predominantly mild and that serious ocular complications, including endophthalmitis, remained rare and comparable with established anti-VEGF safety benchmarks. In addition, anti-drug antibody rates stayed low and balanced between biosimilar and reference groups, with an early batch-specific cluster of sterile inflammation identified shortly after Razumab's 2015 launch being resolved through manufacturing and pharmacovigilance improvements.

Regarding cost, more than half of health care spending in India is out-of-pocket. Before biosimilars were widely available, many patients received far fewer anti-VEGF injections than those administered in controlled trials, a shortfall tied to worse long-term visual outcomes. With biosimilar adoption, multiple Indian centers reported improved adherence to loading and maintenance regimens and reduced treatment drop-out, effects the authors attributed to reduced per-injection cost enabling more continuous therapy, particularly for the prolonged, repeated dosing that nAMD and DME require.

Lessons From India for the US Anti-VEGF Biosimilar Market

The Indian experience offers a preview of dynamics now unfolding in the US, where the ophthalmology biosimilar market remains newer and considerably smaller. The FDA 

 its first ophthalmology biosimilar, ranibizumab (Byooviz; Samsung Bioepis/Harrow), in September 2021, followed by another for the same drug (Cimerli; Sandoz) in 2022

; both have since gained interchangeability status. A 2024 market analysis from Samsung Bioepis 

 that ranibizumab biosimilars had reached a 56% market share in the US at an average sales price of $891.

 with anti-VEGF biosimilars, with survey data showing a little more than a third reporting a complete understanding of them, a gap that could slow the kind of adoption curve seen in India.

 Regulatory and manufacturing hurdles have also persisted, as the presence of low-cost, off-label bevacizumab and the complexity of demonstrating ophthalmic biosimilarity have made market entry difficult even as additional ranibizumab biosimilars and the first wave of aflibercept biosimilars have entered the market.

Evidence Gaps Point to Future Research Needs

The current review’s authors also acknowledged their limitations, including the predominance of observational designs for non-nAMD indications and limited long-term treat-and-extend data.

 Another was the underrepresentation of myopic choroidal neovascularization, polypoidal choroidal vasculopathy, and ROP outcomes. Because of this, they suggested areas for further research.

“This review demonstrates that biosimilar anti-VEGFs offer a comparable efficacy and safety profile to innovator biologics in the management of chorioretinal vascular diseases,” the authors concluded. “The affordability of biosimilar anti-VEGF enhances its potential as an alternative, particularly in resource-limited settings, without compromising safety.”

Chakraborty D, Sinha TK, Boral S, Das A. Biosimilar anti-vascular endothelial growth factor agents: clinical outcomes, safety, and cost-effectiveness in India. 

. 2026;74(5):760-766. doi:10.4103/IJO.IJO_3222_25

Joszt L. Byooviz gains interchangeability status. 

. October 24, 2023. Accessed July 30, 2026. 

https://www.ajmc.com/view/byooviz-gains-interchangeability-status

Santoro C. Samsung Bioepis reports 2024 biosimilar market growth trends. 

. October 15, 2024. Accessed July 30, 2026. 

https://www.ajmc.com/view/samsung-bioepis-reports-2024-biosimilar-market-growth-trends

Joszt L. Retinal physicians report reservations around ophthalmology biosimilars. 

. February 20, 2023. Accessed July 30, 2026. 

https://www.ajmc.com/view/retinal-physicians-report-reservations-around-ophthalmology-biosimilars

Shaw ML. Getting ophthalmic biosimilars to market continues to prove difficult. 

. March 25, 2023. Accessed July 30, 2026. 

https://www.ajmc.com/view/getting-ophthalmic-biosimilars-to-market-continues-to-prove-difficult

Articles

Anti-VEGF biosimilars in India matched reference therapy, lowered costs, and improved treatment access and adherence for retinal diseases.

India's Anti-VEGF Biosimilars Cut Costs, Expand Access

While most patients who switched from originator natalizumab (Tysabri; Biogen) to the biosimilar (Tyruko; Polpharma Biologics) for 

 (RRMS) rated the 2 products as equivalent, a subset reported new adverse effects, and overall treatment satisfaction dropped after the switch, echoing a pattern seen across biosimilar classes: outcomes that look clean in blinded trials can shift once patients know which product they are receiving.

Real-world natalizumab biosimilar switching preserved relapsing-remitting MS outcomes but lowered treatment satisfaction, likely due to a nocebo effect. | Image Credit: AlexBlogoodf - stock.adobe.com

Patient Satisfaction Declined Despite Stable Clinical Outcomes After Biosimilar Switch

In the real-world cohort study published in 

, researchers at Amsterdam UMC followed 83 patients with RRMS who were switched from originator natalizumab to the first FDA-approved MS biosimilar as part of a hospitalwide, cost-driven conversion. Patients completed validated questionnaires and had serum drawn before and during biosimilar treatment, and all were aware of the brand switch.

Twelve patients (15%) reported experiencing more adverse effects with the biosimilar than with the originator, most commonly skin itching, fatigue, dizziness, headache, joint pain, and bowel issues. One patient developed a new skin rash that recurred with each biosimilar infusion and resolved only after switching back to the originator. 

Overall treatment satisfaction, measured with the Treatment Satisfaction Questionnaire for Medication, was significantly lower during biosimilar treatment (mean score [SD], 71.74 [22.4]) than with the originator (76.84 [17.6]; 

 = .02). No other patient-reported measures, including MS symptom impact, perceived effectiveness, adverse effect frequency, treatment convenience, or wearing-off symptoms, differed significantly between products. Similarly, no clinical relapses occurred after the switch.

Nocebo Effect May Explain Lower Satisfaction After Switch

The authors attributed the drop in satisfaction and uptick in reported adverse effects to a possible nocebo effect, a phenomenon in which negative expectations about a switched medication produce perceived harm unrelated to the drug's actual pharmacology. Because the study was not blinded and patients knew about the brand change, the design could not rule out this influence.

The results diverged from the blinded phase 3 Antelope trial (

), in which adverse event rates were similar between biosimilar and originator natalizumab.

 an even higher rate, with 28% of patients reporting new adverse effects after switching.

 The authors added that 2 newspaper reports from the United Kingdom of relapses and worsening symptoms following the switch, although not peer-reviewed, add to a broader narrative of real-world experiences that do not fully match trial data.

Nocebo effects have been documented in other biosimilar classes, including adalimumab and infliximab in inflammatory bowel disease and rheumatologic conditions, respectively, where nonmedical switches have 

 discontinuation rates far higher than those seen in blinded studies.

 A systematic review identified more than a dozen strategies, largely centered on patient and provider education and communication, to help mitigate nocebo-driven discontinuation during biosimilar switches.

The authors were careful to note that a nocebo effect likely does not explain everything, with the patient whose skin rash resolved after switching back to the originator, for instance, suggesting a product-specific reaction rather than a purely psychological response.

Biosimilar Shows Comparable Drug Levels, but John Cunningham Virus (JCV) Testing Raises Questions

Beyond patient-reported outcomes, the study assessed whether the biosimilar performed the same way pharmacologically. Among 31 patients with consistent dosing intervals, median trough natalizumab concentrations were 9.0 μg/mL with the originator and 7.6 μg/mL with the biosimilar; the difference, however, was not statistically significant, with a 90% CI for the geometric mean ratio (0.92-1.08) falling within standard equivalence margins.

A more complicated picture emerged around anti-JCV antibody testing, which is used to gauge risk of progressive multifocal leukoencephalopathy (PML), a rare but potentially fatal brain infection associated with natalizumab. Because the originator's JCV assay (STRATIFY) is not licensed for use with the biosimilar, Sandoz introduced a new test, the ImmunoWELL assay. 

In this cohort, ImmunoWELL flagged significantly more patients as JCV-positive than STRATIFY did, with several testing negative on STRATIFY but positive on ImmunoWELL, at index values suggesting meaningful PML risk. ImmunoWELL results were largely stable when patients were retested months later, but the researchers explained that the disagreement between the 2 assays could affect who is deemed eligible to start or continue natalizumab therapy. Similar assay discrepancies have prompted UK neurologists to publish interim consensus guidance on interpreting JCV results for patients on the biosimilar.

Successful Biosimilar Switching May Depend on Communication, JCV Monitoring

The findings come as the natalizumab biosimilar gains traction in a therapeutic area where drug costs have 

 substantial savings from biosimilar natalizumab adoption, and health system–wide conversions like the one in this study illustrate how payers and providers are already pursuing those cost-saving opportunities.

The current study suggests that although biosimilar natalizumab appears pharmacologically and clinically comparable to the originator, successful implementation may hinge on factors beyond the drug itself: how switches are communicated to patients and whether JCV testing protocols can be reconciled across assays.

 For managed care organizations weighing formulary conversions, the study reinforces that safety and efficacy equivalence alone may not guarantee smooth implementation, as patient communication and consistent risk-monitoring infrastructure may matter just as much.

The authors acknowledged several limitations, including that the nonblinded design may have influenced patient-reported outcomes through increased symptom awareness or observer bias. Additional limitations included the lack of clinical and MRI data, as well as the single-center design, which may limit generalizability. Still, they expressed confidence in their findings. 

“…patients can safely switch from originator to biosimilar natalizumab, although they may experience more side effects with the biosimilar, possibly due to a nocebo effect,” the authors wrote. “While the biosimilar appears highly similar to the originator in all aspects, discrepancies in JCV results of the ImmunoWELL assay compared to the STRATIFY assay may complicate the clinical use of biosimilar natalizumab.”

Gelissen LMY, Strijbis EMM, van Oosten BW, et al. Safety and patient experiences with the natalizumab biosimilar in multiple sclerosis treatment. 

. 2026;109:107147. doi:10.1016/j.msard.2026.107147

Santoro C. Biosimilar natalizumab-sztn shows comparable efficacy and safety to Tysabri in RRMS. 

. March 25, 2025. Accessed July 20, 2026. 

https://www.centerforbiosimilars.com/view/biosimilar-natalizumab-sztn-shows-comparable-efficacy-and-safety-to-tysabri-in-rrms

Høgestøl EA, Brustad ÅW, Celius EG, et al. Real-world experience with switching from originator to biosimilar natalizumab. 

. Published online February 7, 2025. doi:10.1101/2025.02.05.25320428

Jeremias S. Study on nonmedical switching for adalimumab biosimilars warns about nocebo effect. 

. April 27, 2023. Accessed July 20, 2026. 

https://www.centerforbiosimilars.com/view/study-on-nonmedical-switching-for-adalimumab-biosimilars-warns-about-nocebo-effect

Jeremias S. 13 strategies to avoid the nocebo effect during biosimilar switching. 

. December 17, 2024. Accessed July 20, 2026. 

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

Jeremias S. UK experts publish guidance on JC virus testing for natalizumab biosimilar Tyruko. 

. November 5, 2025. Accessed July 20, 2026. 

https://www.centerforbiosimilars.com/view/uk-experts-publish-guidance-on-jc-virus-testing-for-natalizumab-biosimilar-tyruko

Jeremias S. First natalizumab biosimilar Tyruko launches, expanding access in multiple sclerosis. 

. December 18, 2025. Accessed July 20, 2026. 

https://www.centerforbiosimilars.com/view/first-natalizumab-biosimilar-tyruko-launches-expanding-access-in-multiple-sclerosis

Li E, Goh A, Gupta S, et al. Budget impact analysis of biosimilar natalizumab in the US. 

. 2024;30(7):e191-e197. doi:10.37765/ajmc.2024.89558

Real-world natalizumab biosimilar switching preserved relapsing-remitting MS outcomes but lowered treatment satisfaction, likely due to a nocebo effect.


Real-World Natalizumab Biosimilar Switch Reduced Treatment Satisfaction Despite Stable Outcomes

A romosozumab biosimilar in late-stage development showed no meaningful difference in sclerostin binding or bone-signaling potency compared with the reference product, Evenity (Amgen/UCB), despite carrying a measurably different disulfide isoform profile, according to a study recently published in 

Compared with the RMP, the biosimilar contained less immunoglobulin G2 subclass (IgG2)-B and higher proportions of IgG2-A/B and IgG2-A. The findings represent one of the first systematic evaluations showing that a structural quality attribute unique to IgG2 antibodies can differ between an originator biologic and a biosimilar candidate without affecting biological activity.

A romosozumab biosimilar showed comparable sclerostin binding and bone-signaling potency to the reference product despite disulfide isoform differences. | Image Credit: crevis - stock.adobe.com

Why Disulfide Isoforms Matter for IgG2 Biosimilars

IgG2 antibodies contain 4 disulfide bonds in the hinge region that give rise to 3 naturally occurring structural variants known as IgG2-A, IgG2-A/B, and IgG2-B, which differ in how the light chains connect to the heavy-chain hinge. Secretory cells predominantly produce IgG2-A, which converts first to IgG2-A/B and then more gradually to IgG2-B once in circulation. Because these conformational differences can influence surface charge, hydrophobicity, and glycosylation, disulfide isoform distribution is increasingly considered a critical quality attribute for IgG2 biologics such as romosozumab, a sclerostin-neutralizing antibody used to treat osteoporosis.

Using reversed-phase high-performance liquid chromatography, investigators found the biosimilar contained 55.76% IgG2-B, 25.03% IgG2-A/B, and 19.21% IgG2-A compared with 62.12%, 20.22%, and 17.66%, respectively, in the RMP. A complementary electrophoresis method confirmed the biosimilar’s shift toward the more open, less compact isoforms. Accelerated, stress, and long-term stability studies also showed that the disulfide isoform profiles of both products remained stable over time, suggesting the differences arose during manufacturing rather than storage or circulation.

Assessing the Functional Impact of the Isoform Differences

To determine whether the altered isoform distribution affected function, investigators isolated individual isoforms from both products using 2 complementary methods: redox-based enrichment and low-pH cation-exchange chromatography. The isolated fractions were then evaluated for glycosylation patterns, sclerostin binding by surface plasmon resonance and ELISA, and bioactivity using a cell-based reporter assay measuring Wnt signaling reactivation.

Although the isoforms exhibited measurable physicochemical differences, including variations in high-mannose glycan content, these changes did not translate into functional differences. Fractions enriched for the more open isoforms contained higher levels of high-mannose glycans than the more compact IgG2-B-dominant fraction in both products. Because elevated high-mannose content has been associated with faster antibody clearance in other settings, the authors noted that it remains an important characteristic to monitor during 

Despite these structural distinctions, binding affinity and potency testing produced consistent results. Data from the enriched and fractionated isoforms, benchmarked against 10 RMP batches and 6 biosimilar batches, all fell within the reference product’s established quality range, demonstrating comparable sclerostin binding and Wnt pathway activation regardless of isoform composition. 

What This Means for Other IgG2 Biosimilars

The authors noted that this is not the first report of differing disulfide isoform profiles among IgG2 biosimilars. Previous research on denosumab biosimilars identified shifts in disulfide isoform composition within the reference product over time; however, that study did not determine whether those differences affected biological activity. The current romosozumab analysis addresses that question directly by showing that the observed structural differences did not alter in vitro potency. 

Still, the investigators cautioned against generalizing the findings to all IgG2 biosimilars. Because romosozumab neutralizes the soluble protein sclerostin, its mechanism differs from that of receptor-targeting IgG2 antibodies, whose biological activity can depend more heavily on antibody conformation. For IgG2 biosimilars that rely on receptor engagement or avidity-driven mechanisms, the authors recommend comprehensive evaluations of disulfide isoform profiles and their potential effects on physicochemical and biological properties.

The findings come as osteoporosis biosimilars continue to gain attention for their potential to expand access and lower costs. Denosumab biosimilars, for example, have been 

 as a way to improve access to treatment and ease costs associated with osteoporosis and cancer-related bone loss.

 that biosimilar competition in this space could reshape affordability and care delivery, provided rigorous analytical bridging supports claims of comparable efficacy and safety.

Overall, the authors concluded that despite differences in surface charge, hydrophobicity, and high-mannose content, the romosozumab biosimilar's disulfide isoforms performed comparably to the RMP.

“These findings suggest that the observed disulfide isoform profile differences do not compromise the potency of romosozumab under the conditions tested,” they wrote.

Zhao D, Liu Y, Wu C, et al. Similarity assessment of disulfide isoform profiles between the romosozumab biosimilar and the reference medicinal product. 

. 2026;16:21058. doi:10.1038/s41598-026-51578-9

Santoro C. Denosumab biosimilars approved with interchangeability to address osteoporosis, fracture risk. 

. February 18, 2025. Accessed July 16, 2026. 

https://www.ajmc.com/view/denosumab-biosimilars-approved-with-interchangeability-to-address-osteoporosis-fracture-risk

Postmenopausal osteoporosis: clinical burden, treatment barriers, and the evolving role of denosumab biosimilars. 

. February 18, 2026. Accessed July 16, 2026. 

https://www.ajmc.com/view/postmenopausal-osteoporosis-clinical-burden-treatment-barriers-and-the-evolving-role-of-denosumab-biosimilars

A romosozumab biosimilar showed comparable sclerostin binding and bone-signaling potency to the reference product despite disulfide isoform differences.


Romosozumab Biosimilar Matches Reference in Functional Testing Despite Disulfide Differences

Dr Prerakkumar Parikh talks about recent FDA approvals for ms biosimilars and the first tocilizumab biosimilar

Dr Prerakkumar Parikh Reacts to FDA Approvals for First Neurology, Tocilizumab Biosimilars

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, gives insight into the growing world of biosimilars and the role formulary placement plays in biosimilar adoption.

In the second half of 2023, the FDA approved the first 

, which is also the first neurology and first biosimilar indicated for multiple sclerosis, as well as the first 

. Additionally, the FDA approved the first 

From a PBM's perspective, what was your reaction to the FDA approvals of the first MS biosimilar and the first tocilizumab biosimilar?

Yeah, [these are] exciting times as more biosimilars are flowing to the market, especially for newer categories like multiple sclerosis. I'm pretty sure we will see some market shifts happening in that category. Interesting, both [the natalizumab and tocilizumab products] are under the medical benefit right now. So, I think it will probably follow the same success stories of the oncology biosimilars.

Can you explain the role of formulary placement and tiering by PBMs and how these decisions affect the cost-sharing burden for patients who choose biosimilars over reference biologics?

Absolutely. The tiering for some of the biosimilars that have came out are on the specialty tier. So far on the on the pharmacy benefit side, we are seeing the adalimumab biosimilar on that specialty tier along with the brand name product, Humira. So, what that will do is it will allow for access. At the same time, if you have a low-WAC [wholesale acquisition cost] biosimilar at the same level as Humira and if a patient is paying a percentage co-insurance on that specialty tier, a low-WAC biosimilar is going to reduce that cost for the patient as well.

Videos

Prerakkumar Parikh, PharmD, director of specialty clinical solutions at Magellan Rx Management, reacts to recent FDA approvals for the first natalizumab and tocilizumab biosimilars.

Image credit: Whitehurst Lab at UT Southwestern

At the Academy of Managed Care Pharmacy (AMCP)’s annual Nexus meeting, The Center for Biosimilars

 (CFB) spoke with Kimberly Maxfield, PhD, pharmacologist at the FDA, who clarified some of the major policy changes expected to impact the US biosimilar industry over the next few years and commented on how international policies could influence FDA policy decisions moving forward.

Within the FDA, Maxfield serves as the scientific lead on the Biosimilar User Fee Act (BsUFA) III in the FDA's Office of Therapeutic Biologics and Biosimilars.

CFB: What do you wish more people understood about what the FDA is doing to uplift the US biosimilar industry?

The biosimilar lifecycle includes many pieces of the health care market and industry. We have the development, we have the marketing, we have the formulary access, we have the clinician comfort. The FDA has purview in sort of that lifecycle, at the development phase, and in that education phase.

The regulatory science program is very focused on the time and cost of licensure, so it's very focused on the actual development program, the data package that's submitted as part of a 351(k) application.

However, the FDA is also doing a lot of educational efforts that are targeting patients, that are targeting providers, that are targeting pharmacists to inform them about what a biosimilar is and how it is different from a generic; that's just to increase comfort.

There's a lot of confusion between biosimilarity and interchangeability, and even in the FDA's efforts to streamline the development process, we're never compromising on the statutory requirements or the safety and efficacy. Everything we're doing is trying to build on our experience, to build on others' experience. In the product quality information for biosimilars, every biosimilar and every interchangeable is exactly the same.

, President Biden reauthorized the Biosimilar User Fee Act through 2027, which enables the FDA to assess and collect fees for biosimilars. Since the reauthorization, what actions has the FDA taken with this funding and what does it plan to achieve over the next 4 years?

BsUFA III included a lot of different enhancement areas, and that's all outlined in the 

, which is public online. Some of the things that we've done thus far is there's been additional meeting types that biosimilar developers can request that are related to how much data you have when you submit the request. Additionally, for BIA [Biosimilar Initial Advisory] meetings, those previously had requirements for analytical data and now no longer have those requirements.

Additionally, we have met some of the requirements involving the reg sci program [the regulatory science pilot program], which I know we'll talk about a little bit later. The other commitment that we've achieved so far is the labeling guidance, so a new labeling guide for biosimilar products came out at the end of August, and that was a commitment; the major highlight there would be the interchangeability statement is now no longer a part of the labeling.

CFB: A big part of BsUFA III is the creation of demonstration projects. What do these projects entail and what impact will they have on the biosimilar industry in the long run?

: The demonstration projects are part of the regulatory science pilot program commitment. So, the commitment was for the FDA to explore areas and fund support areas that will enhance the regulatory decision-making and scientific recommendations in regard to biosimilar development and interchangeable development.

As part of that letter, as part of that commitment, there are 2 aims, or demonstration projects. The first is advancing the development of interchangeable products, and the second is increasing the efficiency of biosimilar development. Those were our starting point for the reg sci program, where we have now since defined regulatory impacts and research priorities to inform our efforts to move that forward.

CFB: In the FDA's recent webinar on biosimilar development, there was a lot of discussion on the role of clinical efficacy testing in biosimilar development and whether it should be used in the future. How has the FDA's outlook on these tests evolved and where does the agency currently stand on them?

That's a really big area for biosimilar development right now. Before I jump into that, I just I did want to highlight that the FDA has licensed several biosimilars, but did not necessarily have certain clinical data associated with them. So, there's a couple examples: There are the pegfilgrastim products that used a pharmacodynamic biomarker instead of a comparative efficacy study, and then there's the insulin products where it was determined that clinical safety studies weren't necessary—again, they used another pharmacodynamic biomarker. And so that made those programs much smaller and more efficient.

Most recently, the natalizumab biosimilar [that was approved] at the end of August, again, instead of a clinical efficacy study uses a set of pharmacodynamic biomarkers. So, this is something the FDA has been working on or thinking about for a long time. And then moving forward, there's a lot of global discussion and harmonization about how to move this forward now that we have over a decade of experience and we now can see that the analytical data are much more sensitive at detecting differences than a clinical efficacy end point. There's just a lot of discussion about how to move that paradigm forward.

At AMCP Nexus, Kimberly Maxfield, PhD, pharmacologist at the FDA, delved into how the third reauthorization of the Biosimilar User Fee Act (BsUFA III) will shape the American biosimilar market and improve development efficiency over the next few years.

Q&A: Dr Kimberly Maxfield Explains How BsUFA III Will Advance the US Biosimilar Industry

Chelsee Jensen, PharmD, explains adalimumab pricing strategies

Dr Chelsee Jensen Discusses Pricing Strategies for Adalimumab Biosimilars

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, reacts to the interchangeability approval for Abrilada and attempts to explain the purpose of dual-pricing strategies for adalimumab biosimilars.

Several adalimumab products that entered the US market this year launched with 

. Can you explain why a company would use this pricing strategy and do you think this trend will continue in other markets?

I do think with the pharmacy benefit drugs, we might continue to see this trend. And this is happening because, again, from a manufacturer standpoint, in order to get on to some of these insurance formularies, we realize that some insurance companies have a historical precedence of being used to these large back end rebates. So that's, we'll see manufacturers potentially come into the market with 2 list prices to be more appealing to those insurer markets, whether they want the lower discount or the more deeper discount. 

But one thing that we'll have to kind of keep trending and watching out for in this space, especially with adalimumab, is what's happening to the patient. I know a lot of talk or assumption is that the patient will utilize manufacturer co-pay assistance. However, we have to recognize that not every single patient on an insurance plan is going to qualify for that. So are we truly opening up access? And I think that'll just be something to continue to watch as adalimumab biosimilars rollout.

Recently, Abrilada was approved as the second interchangeable adalimumab biosimilar. How do you think the interchangeability label will influence payer preferences and prescription habits in the adalimumab space?

I do think that interchangeable ability makes it much easier. Obviously, you do not need to intervene and contact the provider to change the prescription over. However, I think that smaller community sites could come up with alternative mechanisms such as potentially collaborative practice agreements if their state state laws allow that and that would still kind of get over that operational hurdle of that interchangeability. 

But again, I don't know that they don't necessarily have a huge impact on insurers uptaking biosimilars. I think they're probably going to be focused more on does the delivery of device match what that reference product is and what are those price points.

Chelsee Jensen, PharmD, BCPS, senior pharmacy specialist and pharmaceutical formulary manager at Mayo Clinic, explains the purpose of dual-pricing strategies for adalimumab biosimilars and predicts whether these strategies will occur in other treatment spaces.