Yesafili (aflibercept-jbvf) / Biocon - LARVOL DELTA

Fédération France Macula Practical Guidelines for the Use of Anti-VEGF Biosimilars (PubMed, J Fr Ophtalmol) - "Anti-VEGF biosimilars are expected to play an increasingly important role in retinal care by expanding treatment accessibility and contributing to healthcare sustainability. Their successful implementation requires a thorough understanding of regulatory requirements, careful patient selection, and continued post-marketing surveillance. These recommendations provide a practical framework for the integration of biosimilars into contemporary retinal practice."

Clinical guideline • Journal • Ophthalmology • Retinal Disorders

Real-world retinal vasculitis events reported with FDA-approved intravitreal anti-VEGF and complement inhibitor agents: an analysis of FAERS data. (PubMed, Retina) - "FAERS reporting identified RVAEs across included intravitreal therapies, but cannot establish incidence, causality, or comparative risk, underscoring the need for vigilant reporting and ongoing post-marketing safety surveillance."

FDA event • Journal • Real-world evidence • Inflammation • Ocular Inflammation • Retinal Vein Occlusion • Vasculitis

Biocon Announces U.S. Commercial Launch of Yesafili, a Biosimilar to Regeneron’s Eylea 2 mg (Businesswire) - "The product was approved previously and granted interchangeable designation by the U.S. Food and Drug Administration in May 2024....YESAFILI is a vascular endothelial growth factor (VEGF) inhibitor indicated for the treatment of patients with: (i) Neovascular (Wet) Age-Related Macular Degeneration (AMD); (ii) Macular Edema Following Retinal Vein Occlusion (RVO); (iii) Diabetic Macular Edema (DME); (iv) Diabetic Retinopathy (DR)."

Biosimilar launch • Diabetic Macular Edema • Diabetic Retinopathy • Macular Edema • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Safety and Efficacy of Biosimilar Aflibercept MYL‑1701P in Diabetic Macular Oedema: 20‑Week Extension Results Following the INSIGHT Pivotal Trial (Biocon Press Release) - "This publication reports results from a 20‑week, multicenter, open‑label extension study enrolling participants with Diabetic Macular Edema (DME) who completed the 52‑week global Phase III INSIGHT trial...The results demonstrated comparable safety, efficacy, and immunogenicity profiles between participants who continued on MYL‑1701P and those who switched from reference aflibercept."

P3 data • Diabetic Macular Edema

Comparability of Aflibercept Biosimilar with Reference Aflibercept in Diabetic Macular Edema: Subgroup Analysis of the Pivotal Phase‑III INSIGHT Randomized Clinical Trial (Biocon Press Release) - "The subgroup analyses showed clinically comparable changes in best corrected visual acuity and central subfield thickness between MYL‑1701P and reference aflibercept across most subgroups at both early and later timepoints. The findings support clinical equivalence between the aflibercept biosimilar and reference product within the evaluated subgroups."

P3 data • Diabetic Macular Edema

Safety and efficacy of biosimilar aflibercept MYL-1701P in diabetic macular oedema: 20-week extension results following the INSIGHT pivotal trial. (PubMed, BMJ Open Ophthalmol) - P3 | "The study had certain limitations, including participation from one geographical area, an open-label design and small number of participants. Despite the limited number of exposures in the switch arm, it still constituted a reasonable exposure, and similar safety, efficacy and immunogenicity profiles were observed between those who continued receiving MYL-1701P and those who switched from reference aflibercept to MYL-1701P in the 20-week extension study of the pivotal trial."

Clinical • Journal • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders

Aflibercept biosimilar use and real-world outcomes in various retinal diseases: the AURA Korea study. (PubMed, Sci Rep) - "One case (0.09%) of rhegmatogenous retinal detachment occurred; no intraocular inflammation or other serious adverse events were observed. These findings support the real-world effectiveness and safety of SB15 (Afilivu®) in both treatment-naïve and switching populations across diverse retinal diseases."

Journal • Real-world evidence • Age-related Macular Degeneration • Diabetic Macular Edema • Inflammation • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Clinical efficacy and safety of aflibercept biosimilars in neovascular age-related macular degeneration: a systematic review and meta-analysis of randomised controlled trials. (PubMed, Br J Ophthalmol) - "Aflibercept biosimilars demonstrated no significant difference in efficacy at 8 weeks and 52 weeks as well as safety relative to reference aflibercept in eyes with treatment-naïve nAMD following an on-label aflibercept treatment protocol; however, real-world extended durability remains untested. These findings were supported by a low risk of bias and a high-certainty of evidence using the Grading of Recommendations, Assessment, Development and Evaluations tool."

Journal • Retrospective data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Real-World Utilization and Initial Experience with Aflibercept-ayyh (PAVBLU®) for Retinal Disorders in United States Retina Practices: A Descriptive Retrospective Analysis. (PubMed, Ophthalmol Ther) - "In this descriptive real-world analysis, aflibercept-ayyh was associated with stable visual acuity in previously treated eyes and vision improvement in treatment-naïve eyes, with no new or unexpected safety findings, consistent with expectations for aflibercept and the established body of evidence supporting biosimilarity between aflibercept-ayyh and reference aflibercept, EYLEA®)."

Journal • Real-world evidence • Retrospective data • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Hematological Disorders • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Uveitis • Vasculitis • Wet Age-related Macular Degeneration

Biosimilars of anti-VEGF agents in retinal diseases: a narrative review of regulatory, clinical, and pharmacoeconomic aspects. (PubMed, Int J Retina Vitreous) - "Although real-world data for aflibercept biosimilars are currently limited, emerging evidence for ranibizumab biosimilars supports comparable outcomes. Approved anti-VEGF biosimilars represent safe, effective, and cost-saving alternatives for retinal diseases. With robust analytical and clinical evidence supporting biosimilarity, vitreoretinal specialists can confidently adopt these agents. Successful integration requires understanding of regulatory science, evidence-based switching protocols, and healthcare system collaborations to maximize patient benefits while maintaining treatment standards. Future research should focus on long-term outcomes, broader implementation studies, and pharmacovigilance monitoring."

HEOR • Journal • Review • Age-related Macular Degeneration • Cardiovascular • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Comparability of aflibercept biosimilar with reference aflibercept in diabetic macular edema: subgroup analysis of the pivotal Phase-III insight randomized clinical trial. (PubMed, Expert Opin Biol Ther) - P3 | "Phase-III INSIGHT study subgroup analyses observed best corrected visual acuity (BCVA) and central subfield thickness (CST) outcomes at Week 8/52 in diabetic macular edema treated with aflibercept biosimilar (MYL-1701P/Yesafili™) or reference aflibercept (Eylea®). The exploratory subgroup analyses supported clinical equivalence between MYL-1701P and reference aflibercept showing clinically comparable changes in BCVA/CST across most subgroups. ClinicalTrials.gov identifier is NCT03610646."

Clinical • Journal • P3 data • Diabetic Macular Edema • Ophthalmology

Real-World Evidence From 1,000 Eyes Treated With Aflibercept-ayyh (Pavblu): Safety and Early Vision Outcomes. (ARVO 2026) - "Purpose To describe the real-world demographics, utilization, safety outcomes and visual acuity outcomes among the first 1,000 patient eyes treated with Pavblu, a biosimilar to aflibercept, for neovascular age-related macular degeneration (nAMD), diabetic retinopathy (DR), diabetic macular edema (DME), or retinal vein occlusion (RVO) within a large retina network in the United States (U.S). Two AESIs, both uveitis (iritis), occurred among 3,730 injections, with no instances of endophthalmitis, retinal detachment, vasculitis, or vitreous hemorrhage observed. Conclusions These early data suggest that aflibercept-ayyh (Pavblu) is a well-tolerated and effective biosimilar treatment option for nAMD, DR, DME and RVO."

Clinical • HEOR • Real-world • Real-world evidence • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Macular Degeneration • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Uveitis • Wet Age-related Macular Degeneration

Association between screening duration and treatment outcomes in the clinical trials of ranibizumab and aflibercept for neovascular age-related macular degeneration. (PubMed, Sci Rep) - "This post hoc analysis investigated whether screening duration influences treatment outcomes in two multinational phase 3 randomized clinical trials, SB11 (ranibizumab biosimilar) and SB15 (aflibercept biosimilar), comprising a total of 1,152 participants (704 from the SB11 trial and 448 from the SB15 trial) with nAMD. Linear regression coefficients for screening duration were not statistically significant for BCVA or CST at week 8 (BCVA: B =  - 0.058, P = 0.242; CST: B =  - 0.050, P = 0.908) or at week 48 (BCVA: B =  - 0.015, P = 0.843; CST: B = 0.036, P = 0.930). These findings suggest that a screening period of up to 21 days does not adversely affect treatment efficacy in clinical trial settings and support the clinical feasibility of short pre-treatment delays."

Clinical • Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Aflibercept-ayyh (aflibercept 2 mg biosimilar) for treatment-naïve retinal vascular diseases: early real-world experience - the apex study. (PubMed, Expert Opin Biol Ther) - "To evaluate the early real-world efficacy of intravitreal aflibercept 2 mg biosimilar (aflibercept-ayyh, Pavblu, Amgen, U.S.A.) across common retinal vascular diseases in treatment-naïve eyes...No intraocular inflammation, vascular occlusion, endophthalmitis, or systemic adverse events occurred; cataract progression was observed in 0.7% of eyes. Aflibercept-ayyh demonstrated significant early visual and anatomical improvements across major retinal vascular diseases with a favorable short-term safety profile."

Journal • Real-world evidence • Cardiovascular • Cataract • Inflammation • Ocular Infections • Ocular Inflammation • Ophthalmology • Retinal Vein Occlusion

Efficacy and Safety of the Proposed Biosimilar Aflibercept, SDZ-AFL, in Patients With Neovascular Age-Related Macular Degeneration: 52-Week Results From the Phase 3 Mylight Study: Erratum. (PubMed, Retina) - No abstract available

Journal • P3 data • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Beyond Cost: Faricimab as a Driver of Service Efficiency and Quality in Neovascular Age-Related Macular Degeneration Care. (PubMed, Ophthalmol Ther) - "In capacity-constrained settings, more durable options like faricimab can unlock operational capacity, enabling health systems to treat more patients, reduce delays, and more effectively achieve quality standards. These improvements not only help preserve vision but also generate economic value, as operational efficiencies can reduce service and litigation costs, complementing potential reductions in acquisition costs."

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Efficacy and safety of aflibercept biosimilars compared to aflibercept in the treatment of neovascular age-related macular degeneration: a systematic review and meta-analysis. (PubMed, Front Pharmacol) - "This study aimed to evaluate the aflibercept biosimilars compared to the reference product aflibercept (Eylea®) in terms of efficacy, safety, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD)...There were no statistically significant differences in visual and anatomical outcomes between the aflibercept biosimilars (SB15, P041, SDZ-AFL, AVT06, SCD411, ABP 938, and QL1207) and the reference aflibercept...Based on the seven included randomized controlled clinical trials, aflibercept biosimilars demonstrated comparable safety and efficacy to the reference aflibercept. Future research requires more rigorous studies."

Clinical • Journal • Retrospective data • Review • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Aflibercept 2 mg Biosimilar (aflibercept-ayyh, Pavblu): Experience of safety in clinical settings-APEX- safety study. (PubMed, Eye (Lond)) - No abstract available

Journal

Short-term outcomes of aflibercept biosimilar SB15 in macular edema secondary to retinal vein occlusion. (PubMed, BMC Ophthalmol) - No abstract available

Journal • Macular Edema • Ophthalmology • Retinal Vein Occlusion

A Phase III Randomized Trial Comparing Efficacy, Safety, and Immunogenicity of ZRC-3285 vs. Eylea® in Patients with Wet Age-Related Macular Degeneration. (PubMed, Ophthalmol Ther) - "Efficacy, immunogenicity, and safety profiles of ZRC-3285 were found to be similar to those of Eylea®."

Journal • P3 data • Age-related Macular Degeneration • Diabetic Retinopathy • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Therapeutic Equivalence of Eyluxvi (Aflibercept) to Eylea in Neovascular Age-Related Macular Degeneration: ALTERA Trial (Randomized). (PubMed, Ophthalmol Ther) - P3 | "This study demonstrated therapeutic equivalence between Eyluxvi and Eylea in nAMD treatment, with comparable anatomical outcomes and safety profiles. These findings support the development of Eyluxvi as an aflibercept biosimilar, potentially increasing treatment accessibility for patients with nAMD."

Journal • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Randomised, double-masked trial to compare the efficacy, safety and immunogenicity of the biosimilar aflibercept FYB203 with reference aflibercept in patients with neovascular age-related macular degeneration. (PubMed, BMJ Open Ophthalmol) - P3 | "Although conducted during the COVID-19 pandemic in a potentially vulnerable elderly population and affected by geopolitical disruption in Ukraine, mitigation measures minimised the overall impact of these events. FYB203 demonstrated therapeutic equivalence to reference aflibercept in patients with nAMD, supporting similar clinical performance across all approved indications."

Clinical • Journal • Age-related Macular Degeneration • Diabetic Retinopathy • Infectious Disease • Macular Degeneration • Novel Coronavirus Disease • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Biocon Biologics signs settlement and license agreement to commercialize biosimilar Aflibercept (Indian Pharma Post) - "These agreements grant Biocon Biologics the necessary clearance to globally commercialize Yesafili, its biosimilar Aflibercept (40mg/ml)....By executing this agreement, all pending litigation between Biocon Biologics, Regeneron, and Bayer will be dismissed. The resolution enables the launch of Yesafili in the United Kingdom in January 2026 and in the remaining settled countries starting in March 2026, or potentially sooner under certain conditions. The specific financial and legal terms of the settlement remain confidential."

Biosimilar launch • Licensing / partnership • Ophthalmology

Efficacy and safety of aflibercept biosimilars compared to reference aflibercept for retinal diseases: A systematic review and meta-analysis. (PubMed, Surv Ophthalmol) - "Biosimilar aflibercept show similar efficacy and safety to the original for nAMD and DME, with no significant differences in key outcomes. They offer a cost-effective alternative that offers similar clinical benefits while improving treatment accessibility."

Journal • Retrospective data • Review • Age-related Macular Degeneration • Diabetic Macular Edema • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

The Cost of Pressure: Quantifying the Consequences of Clinical Strain in Ophthalmology (ISPOR-EU 2025) - "Innovative therapies that are more durable in clinical practice have the potential to significantly improve key clinical service indicators, reduce service pressures and mitigate litigation-related costs."

Clinical • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration