Cameron Santoro is an associate editor for The Center for Biosimilars

Cameron Santoro

Here are the top 5 biosimilar articles for the week of March 31, 2025.

 demonstrated comparable efficacy, safety, and immunogenicity to reference drug Tysabri in patients with relapsing-remitting multiple sclerosis (RRMS), supporting its potential as a cost-effective treatment option.

 products does not affect drug effectiveness or treatment duration in patients who have psoriasis, according to a Danish study.

—fueled by its biosimilar portfolio and global expansion—highlights the booming profitability of biosimilars despite financial hurdles.

 lead biosimilar approvals because of their large market size, well-defined regulatory pathways, and technological feasibility, whereas other biologics encounter development challenges but may see increased adoption as regulatory frameworks advance.

denosumab biosimilars, Conexxence/Bomyntra

 (denosumab-bnht), expanding treatment options for osteoporosis, bone metastases, and other bone-related conditions, amidst a flurry of similar approvals and legal settlements.

To read all of these articles and more, visit 

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The Top 5 Biosimilar Articles for the Week of March 31

The ranibizumab biosimilar Ongavia exhibited significantly less improvement in visual acuity and retinal thickness compared with aflibercept (Eylea) in treating neovascular age-related macular degeneration (nAMD), highlighting a potential trade-off between economic savings and clinical efficacy. | Image Credit: Witoon - stock.adobe.com

Ranibizumab biosimilar (Ongavia) offers a lower cost alternative for neovascular age-related macular degeneration (nAMD) treatment, resulting in significantly less visual improvement and reduced retinal thickness reduction compared with aflibercept (Eylea), especially when strict monthly injection schedules were not maintained, according to a study published in 

Individuals aged 50 years and older have an increased risk of developing age-related macular degeneration (AMD) since it is the leading cause of severe visual impairment and blindness, accounting for over 8.7% of global blindness. In nAMD, the abnormal blood vessels grow under the retinal pigment epithelium and into the macula, causing fluid leakage, hemorrhage, and fibrosis, which leads to central vision impairment.

Vascular endothelial growth factor (VEGF) plays a vital role in the pathogenesis of nAMD, and anti-VEGF therapies are a common treatment for nAMD to prevent angiogenesis and fluid leakage to preserve macular function and vision. The FDA approved the anti-VEGF agents ranibizumab (Lucentis) and aflibercept in 2006 and 2011, respectively.

The patent for ranibizumab, a humanized monoclonal antibody fragment targeting VEGF growth factor A, expired in June 2020, allowing the development of biosimilars. Ongavia is a ranibizumab biosimilar that was developed by Teva Pharmaceuticals for the treatment of several ophthalmic conditions by the UK Medicines & Healthcare Regulatory Agency in May 2022.

 Ongavia costs a lot less than the originator, offering an economically attractive option for health care systems under financial strain.

“We aim to provide insights into the comparative performance of these anti-VEGF agents under real-world conditions, addressing both clinical efficacy and resource implications,” study authors stated.

Researchers conducted a single-center retrospective audit at a tertiary hospital ophthalmology medical retina unit and evaluated 2 types of intravitreal anti-VEGF injections initiated for new presentations of nAMD to the medical retina department. The study included 12 months of post-initial intravitreal injection outcome data from August 2022 to August 2024.

There was a total of 62 eyes that met the inclusion criteria, with 34 women and 28 men. Patients receiving Eylea (n = 36) had a significantly greater improvement in best-corrected visual acuity Early Treatment Diabetic Retinopathy Study (ETDRS) letters of 7.08 (4.12) compared with Ongavia (n = 26) with –1.9 (3.31; 

 = .018). The mean initial and end point BCVA for Eylea was 50.7 and 57.8 ETDRS letters, respectively. The mean initial and end point BCVA for Ongavia was 53.7 and 51.8 ETDRS letters, respectively.

Eylea demonstrated a greater reduction in central retinal thickness (CRT), decreasing it by 116.21 μm (35.61 μm), compared with Ongavia, which reduced CRT by 51.41 μm (22.21 μm; 

 = .002). The mean initial and end point CRT for Eylea was 330.8 μm and 214.6 μm, respectively. The mean initial and end point CRT for Ongavia was 318.8 μm and 267.7 μm, respectively.

On average, patients received injection intervals of 9.49 weeks for Eylea compared with 8.17 weeks for Ongavia. Researchers prescribed 164 out of 171 (96%) Ongavia injections at 4-week intervals, compared with 110 out of 207 (53%) Eylea injections. They prebooked the first 3 intravitreal injections for 4-week intervals but administered the second injection at an average of 5.3 weeks for Ongavia and 5 weeks for Eylea. They administered the third injection at an average of 6.4 weeks for Ongavia and 6.6 weeks for Eylea.


Regarding costs, biosimilar launches have resulted in both a 53% market share in biosimilar markets and a 53% reduction in average drug costs after 5 years of biosimilar competition, based on Samsung Bioepis’ First Quarter 2025 Biosimilar Market Report.

 However, data indicate that immunology and ophthalmology biosimilars yielded smaller discounts than oncology biosimilars.


The study may be limited by potential selection bias that could affect the visual gains data along with logistical challenges.

“Future studies should perform a thorough cost analysis to investigate the long-term cost implications and clinical efficacy of biosimilars under various administrative constraints to help guide their implementation,” study authors concluded.

1. Bilal A, Bilal M, Usman D, Elahi A, Al-Bermani A. A tertiary centre's experience with using ranibizumab biosimilar compared to aflibercept for neovascular age-related macular degeneration: a retrospective study. 

. 2024;16(12):e75586. Published 2024 Dec 12. doi:10.7759/cureus.75586

2. Jeremias S. Teva’s Lucentis biosimilar gains UK approval. The Center for Biosimilars

. May 17, 2022. Accessed March 31, 2025. 

https://www.centerforbiosimilars.com/view/teva-s-lucentis-biosimilar-gains-uk-approval

3. Jeremias S. Biosimilars drive cost savings and achieve 53% market share across treatment areas. The Center for Biosimilars. January 16, 2025. Accessed March 31, 2025. 

https://www.centerforbiosimilars.com/view/biosimilars-drive-cost-savings-and-achieve-53-market-share-across-treatment-areas

Articles

The ranibizumab biosimilar Ongavia exhibited significantly less improvement in visual acuity and retinal thickness compared with aflibercept (Eylea) in treating neovascular age-related macular degeneration (nAMD), highlighting a potential trade-off between economic savings and clinical efficacy.

Ranibizumab Biosimilar Shows Reduced Efficacy vs Aflibercept in nAMD

PBM Evolution Towards Value-Based Care Shifts to Transparent Pharmacy Pricing

Josh Canavan, PharmD, head of pharmacy at RazorMetrics, and Chris O'Dell, senior vice president of market solutions at Turquoise Health, foresee pharmacy benefit managers (PBMs) transitioning to value-based care, prioritizing patient outcomes and transparency.


Canavan highlights a shift from cost-centric models to those emphasizing patient health, while O'Dell predicts PBMs will eventually disclose contract rates, similar to health care price transparency, fostering informed discussions and potentially optimizing biosimilar adoption based on cost-effectiveness.

This transcript was lightly edited for clarity; captions were auto-generated.

How do you anticipate the role of PBMs will evolve, and do you foresee a significant shift towards more transparent and value-based contracting models?

I think PBMs are going to start to really look at long-term patient outcomes. Previously, PBMs have looked at the bottom line, the lowest cost medication, the lowest net cost that they can get. With the evolving landscape, we'll start to see more patient-centric medicine, and it focuses more on what the provider looks at.


Quality measures are becoming more important to PBMs. For example, with diabetic patients, the PBM may look at the patient on metformin; they're getting prescribed a medication that covers their disease, but with the focus on patient outcomes, now the PBM can start to look at if their A1C is under control. Has the patient received an eye exam? Is their blood pressure controlled?


There are more outcomes that they can look at that are focused on the patient and focused on how the provider can help the patient than simply, "Is the patient on a low-cost medication?"

The third one is PBM strategies aligning better with health professionals' goals. The way that the provider works is better aligned with how the PBM will measure this. The provider looks at the A1C, the provider wants the patient to have an eye exam, the provider wants the patient's blood pressure under control. If the PBM is aligned with what the provider wants, we're all on the same page here.

One of the things that might impact this at first is it's harder to measure these. At first, you may not be able to see the benefit of some of these longer-term goals, and so that might change the key performance metrics for some of these. But eventually, over time, we'll see major improvements in patient outcomes, which saves everybody money.


 I see PBMs having a lot of the same reactions that hospitals and payers did when the first price transparency data came out back in 2021. The first reaction that they had was, "I'm going to drag my feet; I'm not going to publish this data; I'm going to hide it. This is my secret sauce; these contracts are my secret sauce, and I'm not going to put them out there." Slowly, everyone started publishing their contracts, and now it's all visible.

I think that this idea that someone would be caught getting paid too much really didn't turn out to be true. It just is that now we have a really good understanding of who's making what along the way.

The first thing is, I think you're going to see a slow move toward it where there will be a lot of feet dragging, but at some point, you're going to see all of the PBMs begin to publish their contract rates with the pharmacies and with the payers. Things like spread pricing or rebates, which used to be fought over but probably fought over anecdotally, are now going to be highly transparent so that we can have a really good discussion about it.

There won't just be this mentality of "PBM bad"; it'll be like, "Well, it's complex; let's see what they're making." It'll be different by product, and it'll be different by marketing, and it'll be different by PBM, but we'll get to see all of that.

Around whether and how that will impact biosimilar adoption, I think that transparency will dictate where on the formulary you're seeing these biosimilars show up. There's a little bit of this model of "provide a big rebate and try to get the best position with the payer so that you're favorable on the formulary." I think that will probably be the model that gets most questioned. 

At the end of the day, if these are all clinically efficacious and you can see exactly what the rebate and discount model is along the way, now you don't have these weird back door arbitrage where it's the biggest kickback that means that the product is getting the best utilization. You can just get the lowest manufacturing cost equals the highest adoption. Hopefully, this is what we're all shooting for because it results in less out-of-pocket [costs] for the patient, or at least more transparency into what you'll pay before you get the [drug].

Josh Canavan, PharmD, RazorMetrics, and Chris O'Dell, Turquoise Health, predict pharmacy benefit managers (PBMs) will evolve toward value-based care, mirroring the broader shift toward open-cost structures.

PBM Evolution Toward Value-Based Care Shifts to Transparent Pharmacy Pricing

The Top 5 Biosimilar Articles for the Week of March 24

: Patients with moderate to severe plaque psoriasis who switched between the 

 and reference adalimumab did not impact immunogenicity, safety, or efficacy following up to 4 switches between both drugs.

 as the most effective strategy for reducing costs and increasing biosimilar uptake in the retail setting, while price-linked discounts and prescribing quotas have shown mixed or uncertain results.

: Patients with diabetic macular edema previously treated with a 

 in India experience comparable safety and efficacy after being switched to another ranibizumab biosimilar, demonstrating real-world safety of biosimilar-to-biosimilar switching.

Global biosimilar regulatory harmonization

 will be needed to reduce development costs and improve patient access, despite challenges posed by differing national requirements and regulatory frameworks, according to review authors.

 matched reference ustekinumab in efficacy and safety, while an adalimumab biosimilar proved interchangeable with reference adalimumab, according to posters at the American Academy of Dermatology (AAD) annual meeting.

Here are the top 5 biosimilar articles for the week of March 24, 2025. 

The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht) expanding treatment options for osteoporosis, bone metastases, and other bone-related conditions, amidst a flurry of similar approvals and legal settlements. | Image Credit: gguy - stock.adobe.com

The FDA has approved Fresenius Kabi Biopharma's denosumab biosimilars, Conexxence and Bomyntra (denosumab-bnht), for all indications of the reference products Prolia and Xgeva, respectively, further expanding access to more affordable treatment options for patients with osteoporosis, bone metastases, and other bone-related conditions.

Fresenius Kabi Biopharma announced the approval of its Biologics License Application for both denosumab biosimilars and a global settlement with Amgen.


“This marks our sixth FDA biosimilar approval, expanding our portfolio to provide more affordable therapies to patients in the US,” Sang-Jin Pak, MD, president of Fresenius Kabi Biopharma, said.

In March 2024, the FDA granted approval to Wyost/Jubbonti (denosumab-bddz; GP2411), marking it as the first biosimilar to reference Xgeva/Prolia (denosumab) in the US.

 A month ago, the FDA and the European Medicines Agency also approved another pair of biosimilars, Ospomyv/Xbryk (denosumab-dssb; SB16), referencing Prolia/Xgeva (denosumab).

 The FDA also approved Celltrion's denosumab biosimilars, Stoboclo and Osenvelt (denosumab-bmwo), earlier this month, again referencing Prolia and Xgeva, respectively.

Two comparative clinical studies supported the newest approval, which was based on comprehensive analytical development and similarity assessment.

 One study measured pharmacokinetic, pharmacodynamic (PD), and immunogenicity among healthy volunteers, and the second study measured efficacy, PD, safety, and immunogenicity in women with postmenopausal osteoporosis.

The FDA approved Conexxence (denosumab-bnht) for use in various adult patient populations at high risk for fractures, including osteoporosis, individuals undergoing certain cancer treatments that affect bone density, and patients receiving long-term glucocorticoid therapy. For dosage, clinicians administer a 60 mg/mL solution via a single-dose prefilled syringe.


Patients with postmenopausal osteoporosis experienced adverse events (AEs) including back pain, hypercholesterolemia, musculoskeletal pain, and cystitis. Men with osteoporosis experienced AEs such as back pain, arthralgia, and nasopharyngitis. Patients with glucocorticoid-induced osteoporosis commonly experienced AEs such as back pain, hypertension, bronchitis, and headache. Those with hormone ablation for cancer most commonly experienced AEs of arthralgia and back pain in patients with bone loss.

The FDA approved Bomyntra (denosumab-bnht) to prevent skeletal-related events in adult patients with multiple myeloma and bone metastases from solid tumors. The FDA also approved it to treat hypercalcemia of malignancy refractory to bisphosphonate therapy and giant cell tumor of bone in adults and skeletally mature adolescents.


Patients receive the approved dosage as a 120 mg/1.7 mL solution via single-dose vial or prefilled syringe. Those with bone metastasis from solid tumors commonly experienced fatigue/asthenia, hypophosphatemia, and nausea. Patients with multiple myeloma reported diarrhea, nausea, anemia, back pain, thrombocytopenia, peripheral edema, hypocalcemia, upper respiratory tract infection, rash, and headache.


Patients with giant cell tumor of bone experienced arthralgia, headache, nausea, back pain, fatigue, and pain in extremity. Finally, patients with hypercalcemia of malignancy experienced nausea, dyspnea, decreased appetite, headache, peripheral edema, vomiting, anemia, constipation, and diarrhea.


Fresenius Kabi Biopharma plans to launch the denosumab biosimilars in the US market mid-2025 and in Europe in the second half of 2025, pending regulatory approvals.

1. Fresenius receives FDA approval for their denosumab biosimilars and secures global settlement agreement. News release. Business Wire; March 27, 2025. Accessed March 27, 2025. 

https://www.businesswire.com/news/home/20250327908783/en/Fresenius-Receives-FDA-Approval-for-their-Denosumab-Biosimilars-and-Secures-Global-Settlement-Agreement

2. Jeremias S. FDA approves first denosumab biosimilars. The Center for Biosimilars

. March 5, 2024. Accessed March 27, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-first-denosumab-biosimilar

3. Jeremias S. FDA, EMA approve second pair of denosumab biosimilars. The Center for Biosimilars. February 17, 2025. Accessed March 27, 2025. 

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

4. Santoro C. FDA approves denosumab biosimilars Stoboclo and Osenvelt. 

. March 4, 2025. Accessed March 27, 2025. 

https://www.ajmc.com/view/fda-approves-denosumab-biosimilars-stoboclo-and-osenvelt

The FDA approved another set of denosumab biosimilars, Conexxence/Bomyntra (denosumab-bnht), expanding treatment options for osteoporosis, bone metastases, and other bone-related conditions, amidst a flurry of similar approvals and legal settlements.

FDA Approves Another Pair of Denosumab Biosimilars, Conexxence and Bomyntra 

Biosimilar natalizumab demonstrates comparable efficacy, safety, and immunogenicity to reference drug, Tysabri, in patients with relapsing-remitting multiple sclerosis (RRMS), supporting its potential as a cost-effective treatment option. | Image Credit: Vitalii Vodolazskyi - stock.adobe.com

Natalizumab-sztn (Tyruko; Sandoz) expressed efficacy and safety in patients with relapsing-remitting multiple sclerosis (RRMS) to confirm matching immunogenicity profiles between the biosimilar and reference natalizumab (Tysabri; Biogen), according to a study published in 

Multiple sclerosis (MS), a chronic inflammatory disease, is characterized by central nervous system lesions that can cause severe physical, cognitive, and other neurological defects.

 The approval of a biologic medicine in the 1990s changed MS treatment with disease-modifying therapies (DMTs). As reference biologic medications lost market exclusivity, biosimilars to branded reference biologics entered the market, potentially offering more cost-effective treatment options and expanding access to high-efficacy DMTs in MS.

Two randomized, comparative clinical trials compared natalizumab-sztn and reference natalizumab within the clinical development program of biosimilar natalizumab. The Antelope study (NCT04115488) enrolled patients with RRMS, and the second study measured pharmacokinetics (PK) and pharmacodynamics (PD) in healthy patients (EudraCT: 2019-003874-15).

Researchers conducted the Antelope study, a multicenter, double-blind, active-controlled, randomized, parallel-group trial, to assess the similarity in efficacy, safety, and immunogenicity of prolonged treatment with biosimilar natalizumab and the European (EU) approved reference natalizumab. Patients with RRMS were randomized to receive intravenous infusions of either 300 mg biosimilar or 300 mg of reference natalizumab every 4 weeks for 12 visits, totaling 12 infusions. Researchers rerandomized reference natalizumab at week 24 and switched 30 patients to continue treatment with the biosimilar for 24 weeks.

Researchers conducted a single-dose, randomized, double-blind, parallel-group PK/PD study in healthy patients (n = 453) to demonstrate similarity between natalizumab-sztn and US-licensed or EU-approved reference natalizumab. Patients were randomized based on their body weight to receive a 1 hour, 3 mg/kg infusion of biosimilar natalizumab, US reference product, or EU reference product.

The Antelope study enrolled 264 patients with RRMS, with 131 patients receiving biosimilar natalizumab and 133 patients receiving the EU reference product for over 48 weeks. The PK/PD comparative study enrolled 450 healthy participants—149 participants received biosimilar natalizumab, 150 received the US reference product, and 151 received the EU reference product.

Natalizumab-stzn and the EU reference product showed similar incidences of overall anti-drug antibody (ADA) (79.4% vs 73.7%, respectively) and neutralizing antibodies (NAb) (68.7% vs 66.2%, respectively) at week 24. The PK/PD comparative study found no detectable differences in ADA or NAb response dynamics between the biosimilar group and the US or EU reference natalizumab, supporting these findings. Natalizumab-sztn, US natalizumab, and EU natalizumab yielded similar overall incidences of treatment-emergent ADA (87.2%, 92%, and 86.8%, respectively).

Antelope showed that switching patients with RRMS from EU natalizumab to the biosimilar did not impact their treatment-related ADA/NAb immune or clinical responses. Before switching, 43.4% of patients in the switch arm (n = 30) tested ADA-positive, and 30% tested NAb-positive at week 24. Additionally, the PK/PD study demonstrated a matching overall incidence of ADA between treatment groups and matching ADA titer profiles over time.

The Antelope study reported few infusion-related reactions, with 10 occurring in the biosimilar group and 5 in the EU reference group. Patients switching from EU natalizumab to biosimilar natalizumab at week 24 experienced erythema and hypersensitivity reactions. The PK/PD study reported no hypersensitivity reactions.

The study highlights the absence of standardized methodology and reference materials for ADA testing, and the researchers cautioned to approach comparison of different assay outputs with caution. Post-authorization pharmacovigilance should monitor the ongoing evaluation of the incidence of progressive multifocal leukoencephalopathy (PML) for natalizumab-sztn so that the prescribing information for all natalizumab products advises close monitoring for symptoms of PML.

“We have demonstrated that the immunogenicity profiles of biosim-NTZ and ref-NTZ are indistinguishable in healthy subjects and patients with RRMS in the tested setting. These findings confirm the biosimilarity of biosim-NTZ and ref-NTZ with no safety or efficacy concerns identified to be associated with immunogenicity,” the study authors concluded.

1. Chamberlain P, Hemmer B, Höfler J, et al. Comparative immunogenicity assessment of biosimilar natalizumab to its reference medicine: a matching immunogenicity profile. 

. 2024;15:1414304. Published 2024 Dec 19. doi:10.3389/fimmu.2024.1414304

2. Biosimilar approvals. The Center for Biosimilars

. January 7, 2025. Accessed March 24, 2025. 

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

3. Greenberg B, Giovannoni G. A place for biosimilars in the changing multiple sclerosis treatment landscape. 

. 2023;77:104841. doi:10.1016/j.msard.2023.104841

Biosimilar natalizumab demonstrated comparable efficacy, safety, and immunogenicity to reference drug Tysabri in patients with relapsing-remitting multiple sclerosis (RRMS), supporting its potential as a cost-effective treatment option.

Biosimilar Natalizumab-sztn Shows Comparable Efficacy and Safety to Tysabri in RRMS

The Top 5 Biosimilar Articles for the Week of March 17

 market is poised for disruption with 3 FDA-approved biosimilars, at least 5 awaiting approval, and launches anticipated to start in May 2025, while ongoing patent litigation continues to shape the competitive landscape.

 are joining the fray, expanding access to lower-cost alternatives to blockbuster originator biologic, Janssen’s Stelara.

: Sarfaraz Niazi, PhD, urges the FDA to let the 

 create product release specifications for biosimilars to cut costs, speed development, and enhance accessibility.

Here are the top 5 biosimilar articles for the week of March 17, 2025.

Patients with moderate to severe plaque psoriasis who switched between the adalimumab biosimilar GP2017 and reference adalimumab did not impact immunogenicity, safety, or efficacy following up to 4 switches between both drugs. | Image Credit: pimentos - stock.adobe.com

The adalimumab biosimilar GP2017 and reference adalimumab used to treat patients with moderate to severe plaque psoriasis did not significantly impact immunogenicity, safety, or efficacy, even after multiple switches, suggesting potential cost savings and improved access to biosimilars, according to a study published in 

A standard approval process confirms that biosimilars have the same efficacy, safety, and immunogenicity profile as the reference biologic. In the US, interchangeability is a legal distinction that established the biosimilar pathway, but it is not well understood. Health care professionals and other stakeholders often hold misconceptions that believe interchangeable biosimilars are better than biosimilars without interchangeability designation. However, there is an ongoing discussion between clinicians about the necessity of an interchangeability designation in the US, with many believing the additional demand of efficacy and safety data goes beyond the required evidence for approval.

Last year, the FDA submitted draft guidance that argued biosimilars should receive interchangeability status without extensive switching studies, which would essentially remove interchangeability while maintaining status and complications.

 The Biologics Price Competition and Innovation Act may remove interchangeability in 2025, leaving an allowance for carrying over exclusivity to products with this status, speculated Sarfaraz K. Niazi, PhD.

Researchers designed the ADACCESS trial (NCT02016105) to assess biosimilarity between the biosimilar adalimumab-adaz (Sandoz; GP2017) and reference adalimumab (AbbVie; Humira) in patients with moderate to severe chronic plaque psoriasis.

 The ADACCESS study was a 51-week multicenter, randomized, double-blind controlled confirmatory efficacy and safety study. Researchers continuously treated patients with reference adalimumab (cH group) and had patients who experienced 4 switches between the reference drug and GP2017 (H2H group).

Using electrochemiluminescence (ECL) antidrug antibody (ADA) assays, the ADA signal-to-noise (S/N) ratio, a continuous variable, has been proposed as an alternative approach for assessing the magnitude of ADA response. Researchers define ADA S/N as the ratio of the ECL signal of the sample divided by the negative control signal. The study authors investigated potential differences in immunogenicity based on ADA S/N ratio as an alternative end point.

There were 63 participants in the cH group and 127 participants in the H2H group who were considered for the ADA analysis. At week 17, the cH group had 58 participants, and the H2H group had 122 participants. By week 41, or 6 weeks after the fourth switch, there were 46 participants in the cH group and 100 participants in the H2H group. Both week 17 and week 41 were all within the defined margin of –0.16 to 0.16. The 90% CIs remained within the margin for all other time points.

The efficacy was comparable between the cH arm and H2H switching arm, showing that switching does not impact efficacy. Adverse events (AEs) and serious AEs were comparable and similar in terms of System Organ Class and Preferred Term levels. There were no patterns or imbalances between treatment groups regarding AEs with a suspected causal relationship to the study medication, or other safety information relevant to the benefit-risk assessment.

The ADA S/N ratio limits the study because it is more sensitive to showing differences in immunogenicity than a pharmacokinetic end point following single-dose administration of GP2017 in healthy patients. The hypothesis neglects data-driven confirmation, and the study does not have a positive control. Clinical studies and real-world settings have not observed increased immunogenicity upon reference product to biosimilar switching or upon repeated biosimilar switches.

“This could lead to decreased costs for development of biosimilars, which may result in savings for healthcare systems and improved access for patients to these drugs,” study authors concluded.

LemkeL, BlauveltA, BrückmannI, et al. Comparing anti-drug antibody signal-to-noise ratios to assess immunogenicity and interchangeability in adalimumab biosimilar studies. 

. 24(12);1375-1385. doi:10.1080/14712598.2024.2428299

Humphreys S. Understanding interchangeable biosimilars at the federal and state levels. 

. 2023;29(7):545-548. doi:10.37765/ajmc.2023.89419

Jeremias S. FDA draft guidance removes switching study requirements for biosimilar interchangeability. The Center for Biosimilars®. June 20, 2024. Accessed March 20, 2025. 

https://www.centerforbiosimilars.com/view/fda-draft-guidance-removes-switching-study-requirements-for-biosimilar-interchangeability

Niazi SK. BioRationality– the evolution of the BPCIA and the bright future of biosimilars in the US. The Center for Biosimilars®. October 7, 2024. Accessed March 19, 2025. 

https://www.centerforbiosimilars.com/view/biorationality-the-evolution-of-the-bpcia-and-the-bright-future-of-biosimilars-in-the-us

Patients with moderate to severe plaque psoriasis who switched between the adalimumab biosimilar GP2017 and reference adalimumab did not impact immunogenicity, safety, or efficacy following up to 4 switches between both drugs.

Multiple Switches Between Adalimumab Biosimilar GP2017 and Humira for Psoriasis Maintain Biosimilarity

The Top 5 Biosimilar Articles for the Week of March 10

: A prospective cohort study found that switching back from the 

 to the reference infliximab did not affect clinical disease activity or safety in inflammatory bowel disease (IBD).

 of Zarxio in 2015, the US biosimilars market has surged to 67 approvals across 18 originators—though the journey has been anything but smooth, with adoption facing hurdles along the way.

: Sarfaraz Niazi, PhD, urges the FDA to let the USPharmacopeia (USP) 

 for biosimilars to cut costs, speed development, and enhance accessibility.

 (Stoboclo and Osenvelt) mark the third FDA green light for a biosimilar to treat osteoporosis and bone metastases.

: Celltrion's Omlyclo (omalizumab-igec) is the 

 to be approved for US patients, and it was approved with interchangeability, making it easier for patients to switch to the Xolair competitor.

Here are the top 5 biosimilar articles for the week of March 10, 2025.

Here are the top 5 biosimilar articles for the week of March 3, 2025.

: February brought policy updates and several biosimilar approvals, including the first FDA approval for an 

 (EMA) mandate high similarity between biosimilars and reference products, but their regulatory processes differ, especially with multiple reference products.

: Patients with inflammatory bowel disease (IBD) who 

 (Humira) to a biosimilar under a mandatory nonmedical switching policy maintained long-term safety, efficacy, and treatment persistence comparable with those who remained on the originator drug, according to a Canadian study.

 enter the US market, expanding access to more affordable options referencing Stelara (ustekinumab), one of the most profitable drugs in the world.