Maggie L. Shaw

FDA approves Celltrion's Eydenzelt, a new aflibercept biosimilar, enhancing treatment options for retinal diseases in the US. | Image credit: Tada Images - stock.adobe.com

The FDA has approved Eydenzelt (aflibercept-boav), an aflibercept biosimilar developed by Celltrion to reference Eylea (aflibercept), an anti–vascular endothelial growth factor used to treat retinal diseases.

The American approval comes after the same biosimilar received marketing authorization from the European Commission in February 2025.

"Timely access to effective therapies is essential for individuals affected by retinal diseases. We are proud to have Eydenzelt approved by the FDA, and we look forward to expanding the availability and access of biological treatments across the US," said Juby Jacob-Nara, PhD, senior vice president and chief medical officer at Celltrion USA.

 "With Eydenzelt demonstrating biosimilarity to its reference product, we believe this approval will mark a significant milestone in the treatment landscape of retinal diseases—helping physicians broaden their options and improving patient outcomes."

Aflibercept products are administered intravitreally in a physician's office and are designed to block the growth of new blood vessels and decrease vascular permeability in the eye, 2 factors involved in ocular angiogenesis.

Eydenzelt is approved for the treatment of neovascular (wet) age-related macular degeneration, macular edema following retinal vein occlusion, diabetic macular edema (DME), and diabetic retinopathy.

The FDA based its approval on a totality of evidence, including analytical, nonclinical, and clinical data.

In a randomized, double-masked, parallel-group, multicenter phase 3 study, the efficacy, safety, pharmacokinetics, and immunogenicity of Eydenzelt were compared with Eylea in patients with DME. 

The primary end point was the change in best corrected visual acuity from baseline to week 8, comparing Eydenzelt with Eylea. The 52-week trial enrolled 348 patients with DME. Results showed that Eydenzelt met the predefined equivalence criteria, and secondary end points related to efficacy, safety, and immunogenicity demonstrated trends consistent with those observed for Eylea.

Eydenzelt represents Celltrion’s first FDA-approved biologic product in ophthalmology. It is also the sixth aflibercept approval in the US, following the FDA's authorizations of Pavblu (aflibercept-ayyh), Enzeevu (aflibercept-abzv), Ahzantive (aflibercept-mrbb), Yesafili (aflibercept-jbvf), and Opuviz (aflibercept-yszy).

Celltrion receives U.S. FDA approval for Eydenzelt (aflibercept-boav), biosimilar referencing Eylea (aflibercept). News release. Celltrion. October 9, 2025. Accessed October 13, 2025. 

https://www.celltrion.com/en-us/company/media-center/press-release/4201

Jeremias S. EC approves Celltrion denosumab, aflibercept biosimilars. The Center for Biosimilars

. February 20, 2025. Accessed October 13, 2025. 

https://www.centerforbiosimilars.com/view/ec-approves-celltrion-denosumab-aflibercept-biosimilars

Jeremias S. FDA approves Pavblu for retinal conditions. The Center for Biosimilars. September 17, 2024. Accessed October 13, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-pavblu-for-retinal-conditions

Jeremias S. FDA approves biosimilar Enzeevu for eye conditions. The Center for Biosimilars. August 12, 2024. Accessed October 13, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-biosimilar-enzeevu-for-eye-conditions

Jeremias S. FDA approves first Eylea biosimilars. The Center for Biosimilars. May 20, 2024. Accessed October 13, 2025. 

https://www.centerforbiosimilars.com/view/fda-approves-first-eylea-biosimilars

Jeremias S. Ahzantive receives FDA approval as new Eylea biosimilar. The Center for Biosimilars. July 1, 2024. Accessed October 13, 2025.  

https://www.centerforbiosimilars.com/view/ahzantive-receives-fda-approval-as-new-eylea-biosimilar

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

Recent months have seen major developments in the international rollout of aflibercept biosimilars, with regulatory approvals, reimbursement milestones, and litigation settlements clearing the path for broader global access to affordable treatments for vision-threatening retinal diseases.

Recent approvals and settlements enhance global access to aflibercept biosimilars, improving treatment options for retinal diseases, like age-related macular degeneration and diabetic retinopathy. | Image credit: eevl - stock.adobe.com

United States: Sandoz Settlement Clears Path for Enzeevu

Sandoz announced a settlement with Regeneron Pharmaceuticals resolving all outstanding patent disputes over its aflibercept biosimilar, Enzeevu (aflibercept-abzv).

 Patent infringement proceedings, initially filed in 2024 under the Biologics Price Competition and Innovation Act, centered on as many as 46 patents covering the reference product, Eylea (aflibercept), some of which extend to 2040. Under the terms of the settlement, Sandoz is permitted to launch Enzeevu in the US in the fourth quarter of 2026, or earlier under certain circumstances.

Enzeevu received FDA approval in August 2024 with indications for neovascular age-related macular degeneration (nAMD). The product was also provisionally determined to be interchangeable with Eylea, although full interchangeability status remains subject to exclusivity protections. By aligning legal resolution with regulatory approval, Sandoz is positioned to strengthen its ophthalmology biosimilars portfolio and expand patient access to cost-saving alternatives in the US.

Europe: Alteogen Secures EC Approval for Eyluxvi

In Europe, the European Commission (EC) granted marketing authorization to Alteogen for Eyluxvi (ALT-L9), a biosimilar to Eylea.

 The decision followed a positive opinion issued by the Committee for Medicinal Products for Human Use in July 2025.

Eyluxvi is now approved across the European Union for multiple ophthalmic conditions, including nAMD, diabetic macular edema (DME), macular edema secondary to retinal vein occlusion (branch or central), and myopic choroidal neovascularization. The approval was supported by results of a phase 3 clinical trial conducted in 12 countries between 2022 and 2024. The study, involving 431 patients with nAMD, confirmed therapeutic equivalence between Eyluxvi and Eylea, demonstrating similar safety and efficacy.

For Alteogen, Eyluxvi represents its second biosimilar approval, following its trastuzumab biosimilar launched in China, and the company’s first ophthalmology biosimilar developed through fully independent research and development and global clinical trials. Alteogen leadership emphasized that the approval marks a significant milestone in both regulatory experience and commitment to improving patient access to ophthalmic therapies in Europe and beyond.

The news comes as STADA Arzneimittel announced its aflibercept biosimilar Afiveg received EC marketing authorization the same week.

Canada: Biocon Biologics Gains Ontario Reimbursement for Yesafili

In Canada, Biocon Biologics announced that its aflibercept biosimilar, Yesafili, has been added to the Ontario Drug Benefit Formulary.

 Ontario, Canada’s largest province, will now publicly fund Yesafili for the treatment of nAMD, DME, macular edema secondary to central or branch retinal vein occlusion, and myopic choroidal neovascularization.

Yesafili was the first aflibercept biosimilar approved by Health Canada, supported by a phase 3 study in patients with DME confirming no clinically meaningful differences from Eylea in efficacy, safety, or immunogenicity.

With retinal diseases such as wAMD affecting over 2 million Canadians, public reimbursement is expected to significantly reduce barriers to access while alleviating financial pressure on the health care system. Company leadership emphasized that the listing represents Biocon’s seventh biosimilar launch in Canada and underscores its role in building a sustainable biosimilars ecosystem across the country.

1. Sandoz reaches agreement with Regeneron, resolving all patent litigation related to its US aflibercept biosimilar. News release. Sandoz. September 9, 2025. Accessed September 19, 2025. 

https://www.sandoz.com/sandoz-reaches-agreement-with-regeneron-resolving-all-patent-litigation-related-to-its-us-aflibercept-biosimilar/

2. Alteogen receives European Commission approval for aflibercept biosimilar, Eyluxvi (ALT-L9). News release. Alteogen. September 17, 2025. Accessed September 19, 2025. 

https://www.yourcentralvalley.com/business/press-releases/cision/20250917CN75735/alteogen-receives-european-commission-approval-for-aflibercept-biosimilar-eyluxvi-alt-l9/

3. Jeremias S. EC approves new biosimilars for bone and eye conditions. The Center for Biosimilars

. September 19, 2025. Accessed September 19, 2025. 

https://www.centerforbiosimilars.com/view/ec-approves-new-biosimilars-for-bone-and-eye-conditions

4. Biocon Biologics' Yesafili (aflibercept) now publicly funded in Ontario, Canada for the advanced treatment of patients with retinal diseases. News release. Biocon Biologics. September 18, 2025. Accessed September 19, 2025. 

https://finance.yahoo.com/news/biocon-biologics-yesafili-aflibercept-now-131100372.html

Recent approvals and settlements enhance global access to aflibercept biosimilars, improving treatment options for age-related macular degeneration and diabetic retinopathy.

Global Aflibercept Biosimilar Progress Signals Rising Access for Retinal Disease Care

The FDA has approved Bosaya (denosumab-kyqq) and Aukelso (denosumab-kyqq), the sixth pair of denosumab biosimilars to receive the green light from the agency.

 The approvals, granted to Biocon Biologics, will provide more affordable treatment options for people with osteoporosis and cancer-related bone conditions.

The FDA has approved Bosaya and Aukelso, expanding affordable denosumab biosimilars for osteoporosis and bone-related cancers, enhancing treatment options. | Image Credit: wladimir1804 - stock.adobe.com

Bosaya is a biosimilar to the reference product Prolia, and Aukelso is a biosimilar to Xgeva. The FDA also granted a provisional interchangeability designation for both biosimilars. Clinical data demonstrated that both products had comparable quality, safety, and efficacy to their reference products.

Shreehas Tambe, CEO and managing director of Biocon Biologics, stated that the approvals were a significant milestone. "With Bosaya, we are proud to offer a more affordable treatment option for patients with osteoporosis, and with Aukelso, we are further expanding our oncology care portfolio," he said.

Bosaya was approved for treating postmenopausal women with osteoporosis at high risk for fracture and to increase bone mass in men with osteoporosis at high risk for fracture. It was also indicated for people with glucocorticoid-induced osteoporosis and for increasing bone mass in certain individuals receiving hormone ablation therapy for nonmetastatic prostate or breast cancer. Like its reference product, Bosaya carries a boxed warning for severe hypocalcemia in patients with advanced chronic kidney disease (CKD).

Aukelso was approved to prevent skeletal-related events in patients with multiple myeloma and bone metastases from solid tumors. It was also indicated to treat adults and skeletally mature adolescents with a giant cell tumor of bone and to treat hypercalcemia of malignancy that is refractory to bisphosphonate therapy. Key warnings include the risk of hypersensitivity reactions, severe symptomatic hypocalcemia, and osteonecrosis of the jaw (ONJ).

Denosumab is a human monoclonal antibody that works by targeting RANKL, a protein essential for the formation and survival of osteoclasts, which are the cells responsible for bone resorption. By inhibiting RANKL, denosumab reduces bone breakdown and increases bone mass and strength. In 2024, US sales for denosumab products totaled nearly $5 billion.

The approval of Bosaya and Aukelso followed a series of denosumab biosimilar approvals over the past year and a half, intensifying competition in the market for bone health treatments.

Previous denosumab biosimilar approvals included:

 (denosumab-bddz) from Sandoz were the first biosimilars approved, referencing Xgeva and Prolia, respectively.

 They were also granted interchangeability and launched in the US in June 2025.

 (referencing Xgeva) from Samsung Bioepis (denosumab-dssb) gained approval with an interchangeability designation.

 (referencing Xgeva) from Celltrion (denosumab-bmwo) were approved and launched in the US in July 2025.

 (referencing Xgeva) from Fresenius Kabi (denosumab-bnht) were approved for all indications of their reference products and became commercially available on July 1, 2025.

 (referencing Xgeva) from Shanghai Henlius Biotech and Organon (denosumab-nxxp) received approval, marking the fifth pair cleared by the FDA.

1. Biocon Biologics receives U.S. Food and Drug Administration approval for Bosaya and Aukelso, denosumab biosimilars. News release. Biocon Biologics. September 17, 2025. Accessed September 18, 2025. 

https://www.prnewswire.com/news-releases/biocon-biologics-receives-us-food-and-drug-administration-approval-for-bosaya-and-aukelso-denosumab-biosimilars-302559101.html

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

. March 5, 2024. Accessed September 2, 2025. 

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

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

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

4. Jeremias S. Two more pairs of denosumab biosimilars enter US market. The Center for Biosimilars. July 9, 2025. Accessed September 2, 2025.  

https://www.centerforbiosimilars.com/view/two-more-pairs-of-denosumab-biosimilars-enter-us-market

5. Santoro C. FDA approves another pair of denosumab biosimilars, Conexxence and Bomyntra. The Center for Biosimilars. March 27, 2025. Accessed September 2, 2025. 

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

6. Jeremias S. FDA greenlights fifth pair of denosumab biosimilars: Bildyos and Bilprevda. The Center for Biosimilars. September 2, 2025. Accessed September 18, 2025. 

https://www.centerforbiosimilars.com/view/fda-greenlights-fifth-pair-of-denosumab-biosimilars-bildyos-and-bilprevda

The FDA has approved Bosaya and Aukelso, expanding affordable denosumab biosimilars for osteoporosis and bone-related cancers and enhancing treatment options.

FDA Approves Biocon Biologics' Denosumab Biosimilars: Bosaya and Aukelso 

For people with rheumatoid arthritis who have achieved clinical remission, the decision to switch from an originator biologic to a biosimilar is a critical one for both their health and the sustainability of health care costs.

 has provided valuable evidence for this exact scenario, showing that patients who switched from originator infliximab to a biosimilar maintained their remission and stability, with minimal adverse events.

A recent Japanese study confirms that switching from originator infliximab to biosimilars maintains remission in rheumatoid arthritis patients, enhancing treatment accessibility. | Image credit: Valentina - stock.adobe.com

The study, known as the IFX-SIRIUS study I, was a 24-week, open-label, single-arm clinical trial that evaluated the efficacy and safety of a nonmedical switch from originator infliximab to the biosimilar CT-P13. While previous research had explored the safety of such switches using clinical disease activity indices, the authors of the study sought to provide a more robust analysis by incorporating high-sensitivity imaging modalities, such as musculoskeletal ultrasound (MSUS), along with clinical indices and serum biomarkers. According to the study's authors, this approach allowed for a more accurate and objective evaluation of disease activity at the joint level, providing an additional layer of confidence in the outcomes.

The study enrolled 19 patients with rheumatoid arthritis from 19 centers in Japan, with 18 patients included in the final analysis. The patient population had a median age of 63 years, and two-thirds of the participants were female. They had a median disease duration of 9 years and were on originator infliximab for a median of 6.4 years. A key inclusion criterion was that all patients were in a state of clinical remission, defined as a Disease Activity Score 28 (DAS28)-erythrocyte sedimentation rate of less than 2.6 at baseline. All patients were also taking methotrexate at the time of the switch.

The primary end point of the study was the proportion of patients who experienced a clinical relapse during the 24-week follow-up period. Of the 18 patients evaluated, 2 experienced a clinical relapse, which accounted for an 11.1% relapse rate. One patient relapsed at week 11 and the other at week 24, at which point they were discontinued from the study.

Beyond the primary end point, the study's secondary findings provided a compelling case for the biosimilar's efficacy. For the 17 patients who completed the study, there were no significant changes observed in the MSUS scores, including total grayscale and power Doppler scores. Clinical assessments also confirmed sustained remission, with no notable changes in key indices such as DAS28-ESR, DAS28-C-reactive protein, or the Health Assessment Questionnaire-Disability Index. Furthermore, the researchers found no apparent changes in the serum levels of multiple cytokines and chemokines, nor in other biomarkers like rheumatoid factor and anticyclic citrullinated peptide antibodies.

Safety data from the study also supported a positive outcome. Three nonserious adverse events were reported across the 18 patients: 1 case of eczema, 1 of dry dermatitis, and 1 of COVID-19. All were considered moderate in severity, and none resulted in a patient discontinuing the study.

"This study highlighted the potential for cost-effective biosimilars to maintain remission in patients with rheumatoid arthritis, suggesting significant implications for reducing treatment costs and improving accessibility," stated the authors in their conclusion.

From a managed care perspective, these findings are highly valuable. The high cost of originator biologics has been a persistent barrier to access and a driver of health care costs. The Japanese government, for instance, has actively promoted the use of biosimilars, citing the significant cost reduction—up to 38% compared with the originator in Japan as of December 2024—as a key factor in reducing national health care expenditures.

 The IFX-SIRIUS study provides a new layer of clinical data that supports the efficacy and safety of biosimilars in a real-world setting, potentially easing any remaining physician or payer caution about their use and addressing concerns about the nocebo effect.

Although the results are promising, the study's authors acknowledged several limitations. The small sample size of 18 patients meant that the initial plan to test for noninferiority could not be completed, and the analysis was limited to estimations. Additionally, the 24-week follow-up period was relatively short, and further studies are needed to assess long-term outcomes.

Despite these limitations, the authors maintained that the prospective evaluation using multiple assessment methods—clinical, imaging, and biomarkers—gives the results considerable clinical value for managed care organizations and health care providers considering the nonmedical switch to biosimilars for patients who are already in remission.

1. Kvien TK, Betteridge N, Brüchmann I, et al.Beyond cost: observations on clinical and patient benefits of biosimilars in real-world settings. 

. 2025;39(4):537-553. doi:10.1007/s40259-025-00727-z

2. Xia L, Miao G, Yang X, et al. Efficacy and safety of SYSA1902 versus reference ustekinumab in moderate-to-severe plaque psoriasis: a multicenter, randomized, phase III study. 

. 2025;93(1):115-123.  doi:10.1016/j.jaad.2025.03.018

3. Shimizu T, Kawashiri S-y, Koga T, et al. Switching from originator infliximab to biosimilar infliximab in Japanese patients with rheumatoid arthritis achieving clinical remission (the IFX-SIRIUS study I): an interventional, multicenter, open-label, single-arm clinical trial with clinical, ultrasound and biomarker assessments. 

. Published online August 22, 2025. doi:10.5582/ddt.2025.01044

A recent Japanese study confirms that switching from originator infliximab to biosimilars maintains remission in patients who have rheumatoid arthritis, enhancing treatment accessibility.

Japanese Trial Supports Widespread Use, Safety of Infliximab Biosimilar Use

A 10-year prospective follow-up of 244 healthy stem cell donors found no new safety concerns with Sandoz’s filgrastim biosimilar, reinforcing its long-term safety for donor mobilization. | Image credit: sola_sola - stock.adobe.com

A 10-year prospective surveillance study of healthy stem cell donors who received the Sandoz biosimilar filgrastim (Zarzio, marketed as Filgrastim Hexal in Germany) for hematopoietic stem and progenitor cell (HSPC) mobilization reported no evidence of long-term safety concerns, providing reassurance for the continued use of granulocyte colony-stimulating factors (G-CSFs) in donor mobilization.

) study enrolled 244 adult, healthy, unrelated stem cell donors from the Deutsche Stammzellspenderdatei registry at 2 German centers. Participants received at least 1 dose of Sandoz’s filgrastim biosimilar, Zarzio, administered subcutaneously for up to 5 days to mobilize stem cells for collection by leukapheresis. Median donor age was 34 years (mean [SD], 35.8 [9.8] years; range, 19-60 years), and approximately three-fourths of participants were male. Median body mass index was 26.9 kg/m², placing the cohort in the overweight category.

Follow-up included structured assessments of physical and mental health, self-reported outcomes via the SF-12 questionnaire, and adverse event (AE) reporting at baseline, 1, 6, and 12 months after apheresis, and annually for 10 years.

Nearly all donors (95%) reported at least 1 AE during the initial mobilization period, with bone pain being the most common. After this period, a total of 564 AEs were documented, with median onset occurring about 4 years after mobilization (3.86 years for women and 4.02 years for men).

The majority of AEs were musculoskeletal or connective tissue disorders (n = 134) and infections or infestations (n = 130). Other categories included gastrointestinal (n = 29), endocrine (n = 18), and vascular disorders (n = 16). A total of 98 serious AEs were reported in 56 donors, but none were deemed related to biosimilar filgrastim.

Age and sex differences emerged: younger donors had significantly lower AE rates compared with older donors (rate ratio, 0.64; 95% CI, 0.43–0.95; 

 = .026). Female donors experienced higher annual AE rates than male donors (0.40 vs 0.21 AEs/year; rate ratio, 1.87; 95% CI, 1.32–2.64; 

Twelve women reported 13 pregnancies following donation, resulting in 14 live births. Pregnancy-related AEs—such as gestational diabetes, cervical incompetence, and gestational hypertension—occurred only once each, with no clustering or suspected relationship to prior biosimilar filgrastim exposure. No miscarriages, congenital anomalies, or neonatal complications were reported.

SF-12 assessments indicated that donors maintained superior average physical health scores compared with the general German population, even after 10 years (53.0 [6.9] vs 43.1 [6.9]; 

 < .0001). Mental health scores remained comparable to population averages. Neither long-term declines in health nor increased incidence of malignancies were observed. Importantly, the COVID-19 pandemic did not appear to affect donor well-being during follow-up.

Sandoz, the developer of Zarzio, funded the study. Authors concluded that the findings confirm the established safety profile of filgrastim biosimilars and provide critical long-term reassurance for donor safety in the context of allogeneic transplantation.

“No new or excessive adverse events were identified during a 10-year follow-up of mobilized stem cell donors and therefore reassure about the overall safety of stem cell mobilization with G-CSF in healthy volunteers,” wrote the investigators.

The results bolster confidence in biosimilar filgrastim products as safe, cost-effective alternatives to reference filgrastim for HSPC mobilization, supporting their continued integration into transplantation practice and managed care formularies.

A Brief History of Zarzio/Zarxio in the EU and US

Sandoz’s filgrastim biosimilar was first approved in Europe in 2009 under the brand name Zarzio.

 Approval was based on phase 3 confirmatory clinical data—the most sensitive population being patients with breast cancer undergoing myelosuppressive chemotherapy—and regulatory extrapolation of other indications such as stem cell mobilization and chronic neutropenia. Over the subsequent decade, real-world evidence, including the MONITOR-GCSF study (

) across 12 European countries (n = 1447), supported Zarzio’s efficacy and safety in oncology treatments.

In the US, Sandoz’s biosimilar (filgrastim-sndz, branded as Zarxio) became the first FDA-approved biosimilar on March 6, 2015, under the Biologics Price Competition and Innovation Act pathway.

 Its approval was grounded in a robust "totality of evidence," which included structural/functional characterization, nonclinical and clinical comparability, and the PIONEER trial data (

) showing equivalent reductions in severe neutropenia durations vs the reference product.

 The product launched in the US in September 2015 and offered patient support through Sandoz One Source.

Zarxio’s transatlantic approval signified a major biosimilar milestone, leveraging its extensive EU track record (>7.5 million patient-days of exposure) to facilitate FDA acceptance.


1. Heyn J, Bräuninger S, Becker P, et al. Healthy volunteer stem cell donors followed up 10 years after stimulation with biosimilar filgrastim. 

 2025;65(8):1418-1426. doi:10.1111/trf.18317

2. Davio K. A decade of biosimilar filgrastim experience highlights the scientific basis for extrapolation, study says. The Center for Biosimilars

. September 17, 2019. Accessed August 21, 2025. 

https://www.centerforbiosimilars.com/view/a-decade-of-biosimilar-filgrastim-experience-highlights-the-scientific-basis-for-extrapolation-study-says

3. Jeremias S. From Amjevita to Zarxio: a decade of US biosimilar approvals. The Center for Biosimilars. March 6, 2025. Accessed August 21, 2025. 

https://www.centerforbiosimilars.com/view/from-amjevita-to-zarxio-a-decade-of-us-biosimilar-approvals

4. FDA approves first biosimilar Zarxio (filgrastim-sndz) from Sandoz. News release. Sandoz. March 6, 2015. Accessed August 21, 2025. 

https://www.novartis.com/news/media-releases/fda-approves-first-biosimilar-zarxiotm-filgrastim-sndz-from-sandoz

A 10-year prospective follow-up of 244 healthy stem cell donors found no new safety concerns with Sandoz’s filgrastim biosimilar, reinforcing its long-term safety for donor mobilization.

Ten Years of Data Support Safety of Biosimilar Filgrastim for Donor Mobilization

The FDA expanded an indication for a tocilizumab biosimilar to include cytokine release syndrome, Kashiv BioSciences and MS Pharma partnered on an omalizumab biosimilar for the Middle East and North Africa, and Lupin teamed with Sandoz on a ranibizumab biosimilar to improve global access to affordable biologics.

Discover the latest advancements in biosimilars, including tocilizumab's new indication, and partnerships for omalizumab and ranibizumab..

Tocilizumab Biosimilar Indication Expansion

 for the intravenous (IV) formulation of tocilizumab-anoh (Avtozma; Celltrion), a biosimilar to Actemra, to include treatment of cytokine release syndrome (CRS) in adults and children 2 years and older.

 This aligns Avtozma IV’s indications fully with the reference product, broadening therapeutic options for a potentially life-threatening complication of chimeric antigen T-cell therapy. CRS, caused by excessive release of proinflammatory cytokines like interleukin (IL)-6, can lead to severe inflammation, organ damage, and multi-organ failure. Tocilizumab-anoh, an IL-6 receptor antagonist, blocks IL-6 signaling to mitigate the inflammatory cascade while preserving the effects of immunotherapy. The FDA decision was supported by robust biosimilarity data, including a global phase 3 trial in rheumatoid arthritis, which also underpinned earlier approvals for multiple inflammatory conditions. Avtozma IV will be available in the US on August 31, 2025, following a patent settlement with Genentech, offering a cost-effective alternative that may reduce health care costs.

Kashiv BioSciences and MS Pharma have signed a 

 for ADL-018, Kashiv’s biosimilar candidate to Xolair (omalizumab), covering the Middle East and North Africa (MENA) region.

 Xolair generated about $4.5 billion in global sales and $60 million in MENA in 2024, according to IQVIA. Under the deal, Kashiv will handle product development, while MS Pharma will manage licensing, distribution, and commercialization, with the option for local manufacturing at its biologics facility in Saudi Arabia.

The companies emphasized their shared commitment to expanding access to biologic therapies and growing their specialty portfolios. MS Pharma aims to submit for regulatory approval in MENA in Q4 2025. Omalizumab is used to treat chronic urticaria, severe allergic asthma, chronic rhinosinusitis with nasal polyps, and immunoglobulin E–mediated food allergies. ADL-018 remains investigational and has not yet been approved or deemed biosimilar by any regulatory authority.

Lupin and Sandoz Partner on Ranibizumab Biosimilar

 with Sandoz to develop and commercialize a biosimilar version of ranibizumab, a treatment for retinal disorders such as age-related macular degeneration and diabetic macular edema.

 Under the arrangement, Lupin will oversee manufacturing and regulatory submissions, while Sandoz will manage commercialization in select global markets, with exclusive and semi-exclusive rights in those regions.

The partnership aims to improve patient access to affordable therapies for vision-threatening conditions. Lupin will focus on meeting stringent regulatory requirements during production and filing, and Sandoz will utilize its strong market presence to ensure effective distribution. The collaboration is expected to expand treatment availability in key regions and contribute to lowering health care costs associated with retinal disease management.

1. Serani S. FDA expands approval for tocilizumab biosimilar to treat CRS. Targeted Oncology

https://www.targetedonc.com/view/fda-expands-approval-for-tocilizumab-biosimilar-to-treat-crs

2. Levy S. Kashiv BioSciences, MS Pharma ink deal for Xolair biosimilar. Drug Store News. August 12, 2025. Accessed August 12, 2025. 

https://drugstorenews.com/kashiv-biosciences-ms-pharma-ink-deal-xolair-biosimilar

3. Chian M. Lupin Partners with Sandoz to develop and commercialize biosimilar ranibizumab for retinal disorders. Gene Online. August 12, 2025. Accessed August 12, 2025. 

https://www.geneonline.com/lupin-partners-with-sandoz-to-develop-and-commercialize-biosimilar-ranibizumab-for-retinal-disorders/

Discover the latest advancements in biosimilars, including tocilizumab's new indication, and partnerships for omalizumab and ranibizumab.

Biosimilar Business Recap: Updates on Tocilizumab, Omalizumab, and Ranibizumab Products

Despite early price advantages and long-standing regulatory approval, biosimilar insulin glargine has yet to gain significant traction in the UK market.

 A comprehensive analysis of primary care prescribing data from 2020 to 2024 across all 4 nations of the UK revealed that originator insulin products, particularly Lantus (insulin glargine), continue to dominate prescriptions, raising questions about the effectiveness of market-based strategies alone in promoting biosimilar adoption.

Biosimilar insulin glargine struggles for market share in the UK, facing pricing challenges and prescriber inertia despite regulatory support and cost-saving potential. | Image credit: millaf - stock.adobe.com

, point to persistent barriers to biosimilar uptake and underscore the complexity of achieving cost savings in biologic prescribing through competition alone.

Since biosimilar insulin glargine first entered the UK market in 2014, there have been high hopes that these agents would drive down the cost of long-acting insulin therapy for patients with diabetes.

 Today, several biosimilar insulin glargine products are approved by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA), including Abasaglar (biosimilar to Lantus), Semglee, and most recently, Insulin Glargine Medac.

 These biosimilars offer clinically comparable efficacy and safety to the originator product, Lantus, yet they continue to face resistance in widespread clinical adoption, only obtaining  24% market share in England, 5% in Northern Ireland, 24% in Scotland, and 11% in Wales in 2024, even after the MHRA declared all biosimilars as interchangeable with their reference products in 2022.

The present study, which reviewed prescribing patterns and pricing across England, Northern Ireland, Scotland, and Wales, found that Lantus consistently remained the most prescribed insulin glargine product throughout the study period.

 In fact, by 2024, Lantus was not only the market leader but also the least expensive option in all 4 nations—a reversal of expectations that further eroded incentives for biosimilar use. In England, for example, Lantus accounted for 66% of all insulin glargine prescriptions in 2020 and 65% in 2024, while biosimilars increased only slightly from 15% to 24% over the same period. Abasaglar was prescribed 6 times more often than Semglee, while use of generic descriptions declined by 63%.

Northern Ireland saw even less movement toward biosimilars. Lantus made up 90% of prescriptions across the 5-year span, and biosimilar usage barely nudged upward from 4% to 5%. In Scotland, total insulin glargine prescriptions declined by 13% from their 2020 peak, but Lantus maintained a 62% to 63% share. Although Semglee became available in mid-2023, biosimilar use only modestly increased from 20% to 24%. Wales showed a similar pattern, with Lantus holding 80% of the market by 2024 and biosimilar uptake climbing gradually from 7% to 11%.

A key factor dampening biosimilar growth was pricing. In mid-2021, Lantus underwent a series of price reductions that made it the least expensive insulin glargine product in every nation.

 By 2024, the actual price per pre-filled device in England had dropped to £6.83 for Lantus compared with £6.93 for Abasaglar.

 These price dynamics were similar in Scotland and Wales, even though only gross ingredient costs were available for those regions. Rather than allowing biosimilars to undercut the originator, Lantus’ manufacturer appears to have adjusted its pricing strategy to neutralize competitive threats and retain market share.

Despite support from the MHRA for biosimilar interchangeability, national prescribing guidelines from the British National Formulary do not permit automatic substitution, meaning that brand switching must be initiated by prescribers. This regulatory friction, combined with prescriber familiarity with Lantus and potentially limited awareness of the cost implications, may help explain why biosimilar adoption remains modest a decade after market entry.

These findings echo earlier concerns that the potential cost savings from biosimilars will remain unrealized without active measures to support their uptake. Although the UK continues to lead globally in biosimilar regulation and access, the case of insulin glargine demonstrates that achieving meaningful shifts in prescribing requires more than regulatory approval and competitive pricing. Addressing inertia in prescriber behavior, clarifying policy around switching, and better aligning economic incentives may be necessary steps to fully unlock the value of biosimilars in the UK health care system.

1. Agirrezabal I, Sánchez-Iriso E, Mandar K, Cabasés JM. Real-world budget impact of the adoption of insulin glargine biosimilars in primary care in England (2015–2018). 

. 2020.43(8):1767-1773. doi:10.2337/dc19-2395

2. Alsaif M, Blumer Z. Insulin glargine biosimilar prescribing and cost trends in the United Kingdom’s primary care from 2020 to 2024. 

. 2025;13(3):85. doi:10.3390/pharmacy13030085

3. Semglee summary of product characteristics. European Medicines Agency. Accessed July 5, 2025. 

https://www.ema.europa.eu/en/documents/product-information/semglee-epar-product-information_en.pdf

4. Abasaglar summary of product characteristics. European Medicines Agency. Accessed July 5, 2025. 

https://www.ema.europa.eu/en/documents/product-information/abasaglar-epar-product-information_en.pdf

5. Guidance on the licensing of biosimilar products. MHRA. February 27, 2025. Accessed July 5, 2025. 

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

6. Press release: Sanofi cuts U.S. list price of Lantus, its most-prescribed insulin, by 78% and caps out-of-pocket Lantus costs at $35 for all patients with commercial insurance. News release. Sanofi. March 16, 2023. Accessed July 5, 2025. 

http://sanofi.com/en/media-room/press-releases/2023/2023-03-16-20-06-43-2629188

Biosimilar insulin glargine struggles for market share in the UK, facing pricing challenges and prescriber inertia despite regulatory support and cost-saving potential.

Low Prices Fail to Boost Insulin Biosimilar Uptake in the UK

CT-P47, a biosimilar candidate to tocilizumab, has shown promising results in the treatment of rheumatoid arthritis (RA), according to findings from a phase 3 clinical trial conducted at 22 centers in Poland.

Over the course of a year, CT-P47 demonstrated comparable efficacy, safety, and immunogenicity to the reference product (Actemra/RoActemra), including among patients who transitioned from the originator biologic. The findings, 

, may strengthen payer and provider confidence in switching to biosimilars as a cost-effective alternative for RA care.

Tocilizumab’s Role and the Biosimilar Landscape

Tocilizumab, an interleukin-6 (IL-6) receptor inhibitor, has played a central role in RA management for over a decade. RA is a chronic autoimmune disease marked by inflammation and joint destruction, driven in part by elevated IL-6 activity.

The US and European markets for tocilizumab biosimilars are experiencing rapid growth. In the US, the FDA has approved several tocilizumab biosimilars, including Biogen's Tofidence (tocilizumab-bavi) in September 2023, Fresenius Kabi's Tyenne (tocilizumab-aazg) in March 2024, and most recently, Celltrion's CT-P47 (Avtozma; tocilizumab-anoh) in January 2025.

 Similarly, the European Commission has granted marketing authorization for multiple biosimilars, including Tyenne in November 2023, Tofidence in June 2024, and Avtozma in February 2025.

Despite the effectiveness of these biosimilars, the high cost of biologics like tocilizumab has limited access for some patients and driven interest in lower-cost biosimilar options.

Although biosimilars are increasingly entering the market, long-term data remain essential to validate their clinical equivalence. The European League Against Rheumatism (EULAR) has endorsed the use of biosimilars when supported by evidence of comparable efficacy and safety, but real-world data on switching remain limited. This trial aims to address that gap.

CT-P47 emerges as a promising tocilizumab biosimilar, demonstrating comparable efficacy and safety in rheumatoid arthritis treatment, enhancing access and affordability.