Byooviz (ranibizumab-nuna) / Samsung, AffaMed Therap, Biogen, Harrow Health - LARVOL DELTA

Samsung Bioepis and Harrow Present Interim Data from a Large-Scale Post-Marketing Surveillance Study on SB11 (BYOOVIZ/ AMELIVU), a Biosimilar to Lucentis (ranibizumab), at ASRS 2026 (GlobeNewswire) - "The interim report includes data from 298 patients (182 treatment-naïve, 116 switched) out of 305 patients who had been enrolled in the study as of the interim data cutoff....The mean (standard deviation; SD) BCVA improved by -0.10 (0.29) in the treatment-naïve patients and -0.03 (0.24) in switched patients (P= 0.0239). Mean (SD) CST improved by -95 (125) µm in the treatment-naïve patients and -53 (108) µm in switched patients (P= 0.0168). Across different indications, there was no statistically significant difference in BCVA (P=0.6312) and CST (P=0.1686) outcome. In contrast, disease duration was significantly associated with BCVA (P= 0.0003) and CST (P=0.001) outcomes, suggesting that earlier treatment may lead to a better visual prognosis. No new safety concerns were identified."

P4 data • Ophthalmology • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Harrow…announced the commercial launch of BYOOVIZ (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTIS (ranibizumab) and developed by Samsung Bioepis Co., Ltd (GlobeNewswire) - "The launch follows Harrow's exclusive U.S. commercialization agreement with Samsung Bioepis, one of the world's leading biosimilar developers and manufacturers....BYOOVIZ was approved by the U.S. Food and Drug Administration (FDA) as the first ophthalmology biosimilar in the U.S. for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV)."

Biosimilar launch • Macular Edema • Retinal Vein Occlusion • 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

Switching to the Biosimilar Ranibizumab-nuna for the Intravitreal Treatment of Retinal Diseases - a Real-World Study. (PubMed, Klin Monbl Augenheilkd) - "Certain decline in VA is also be observed in real-world outcomes for Lucentis and may reflect underlying disease progression rather than reduced efficacy of the biosimilar. Overall, Byooviz seems to be a viable alternative for patients previously treated with Lucentis."

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

A Study to Evaluate the Usability of the SB11 PFS in Trial Participants With Wet AMD, Macular Oedema Secondary to RVO, or mCNV (clinicaltrials.gov) - P2 | N=30 | Completed | Sponsor: Samsung Bioepis Co., Ltd.

New P2 trial • Age-related Macular Degeneration • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • 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

SB11-2002: An open-label, single group, single-dose clinical study to evaluate the usability of the pre-filled syringe (PFS) of SB11 in trial participants with Neovascular Age-Related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Myopic Choroidal Neovascularization (mCNV) (clinicaltrialsregister.eu) - P1/2 | N=30 | Recruiting | Sponsor: Samsung Bioepis Co. Ltd. | Not yet recruiting ➔ Recruiting

Enrollment open • Age-related Macular Degeneration • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

U.S. trends of anti-vascular endothelial growth factor use from 2017-2023: An analysis of medicare, medicaid, and commercial insurance. (PubMed, PLoS One) - "Aflibercept 2 mg was the most common drug used overall from 2017-2023. Faricimab had the highest absolute and relative increase in utilization from 2022-2023. Patients with Medicare B or C were significantly more likely to receive aflibercept over bevacizumab."

Journal • Medicare • Reimbursement • Retrospective data • US reimbursement • Ophthalmology

Samsung Bioepis Co., Ltd. today announced that the company has begun direct commercialization of BYOOVIZ, a biosimilar to Lucentis (ranibizumab), in Europe. (Businesswire) - "Pre-filled syringe (PFS) presentation to become available in Europe in the second quarter of 2026."

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

Samsung Bioepis Co., Ltd. today announced that the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for BYOOVIZ pre-filled syringe (PFS), a biosimilar referencing Lucentis (ranibizumab). (Businesswire) - "The PFS presentation is expected to be available in the market starting in the second quarter of 2026."

Biosimilar launch • CHMP • Diabetic Macular Edema • Diabetic Retinopathy • Wet Age-related Macular Degeneration

Samsung Bioepis to Commercialize BYOOVIZ (ranibizumab) in Europe from January 2026 (Businesswire) - "Samsung Bioepis Co., Ltd. announced today that the company has entered into an Asset Purchase Agreement (APA) with Biogen regarding Samsung Bioepis’ two ophthalmology assets: BYOOVIZ (ranibizumab), a biosimilar referencing Lucentisi (ranibizumab) and OPUVIZ (aflibercept), a biosimilar referencing Eyleaii (aflibercept) — in Europe."

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

Harrow Enters into Commercialization Agreement with Samsung Bioepis for Ophthalmology Biosimilars Portfolio in the United States (Businesswire) - "Harrow...announced that it has entered into a definitive agreement with Samsung Bioepis Co...to secure the exclusive U.S. commercial rights to the ophthalmology biosimilar portfolio of Samsung Bioepis — BYOOVIZ (ranibizumab-nuna), an FDA-approved biosimilar referencing LUCENTISi (ranibizumab), and OPUVIZ (aflibercept-yszy), an FDA-approved biosimilar referencing EYLEAii (aflibercept) — two of the most widely used anti-VEGF therapies for retinal diseases....Harrow will assume full responsibility for commercialization of BYOOVIZ in the U.S. upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis. The transition is expected to be completed by the end of 2025."

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

Drugs for age-related macular degeneration. (PubMed, Med Lett Drugs Ther) - No abstract available

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

Optimizing Treatment Pathways for nAMD: Balancing Durability and Costs in the UK (ISPOR-EU 2024) - "In the United Kingdom, patients receive ranibizumab, its biosimilars, aflibercept 2mg, brolucizumab, the more recently approved faricimab, or aflibercept 8mg... The study showed that ranibizumab biosimilars and aflibercept 2mg remain effective, innovative, and potentially cost-saving treatment options for retinal conditions such as nAMD. While faricimab and aflibercept 8mg show potential benefits in durability, their higher acquisition costs require careful evaluation against budget constraints."

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

Usability of the SB11 Pre-filled Syringe (PFS) in Patients with Retinal Diseases. (PubMed, Adv Ther) - P2 | "This study showed that HCPs were able to successfully prepare and administer the SB11 PFS via IVT injection. No unexpected safety issues were identified. The SB11 PFS is a promising alternative for therapeutic administration of SB11 in patients with retinal disease."

Journal • Age-related Macular Degeneration • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Association of baseline factors with 1-year outcomes in the SB11-ranibizumab equivalence trial: A post hoc analysis. (PubMed, Asia Pac J Ophthalmol (Phila)) - "Post hoc analyses of the SB11-rRBZ equivalence study showed that baseline age, BCVA, CST, and total lesion area were prognostic factors for visual and anatomical outcomes of nAMD, while subgroup analyses demonstrated comparable results for SB11 and rRBZ. Collectively, the results appear comparable to similar RCTs of anti-vascular endothelial growth factor reference products for nAMD and strengthen confidence in the biosimilarity of SB11."

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

Anti-VEGF Molecule Utilization in Ophthalmology and Potential Impact of Market Dynamics after Biosimilar Entry (ISPOR 2024) - "Aflibercept, brolucizumab, faricimab, and ranibizumab with primarily approved ophthalmic indications are included... The usage of established and newer anti-VEGFs has increased significantly in the past 5 years and will likely increase further due to aging population. Biosimilars could offer a more cost-effective treatment option and significant savings. Yet, in 30% of the examined countries there is little evidence of ranibizumab biosimilars to date, presumably due to unfavorable market conditions."

Ophthalmology

Trends in Anti-VEGF Intravitreal Injections over 4 Years in a Large Retinal Practice (ARVO 2024) - "Anti-VEGF IVIs utilized were aflibercept (ALF) bevacizumab (BEVA), faricimab-svoa (FAR), ranibizumab 0.5 milligrams (mg) (RAN 0.5), ranibizumab 0.3 mg (RAN 0.3) ranibizumab-eqrn (RANe), ranibizumab-nuna (RANn) and brolucizumab (BROL)... Approved for treatment of diabetic retinopathy in May 2019, ALF has become the most used anti-VEGF IVI. ALF displayed an 85% increase in usage from 2019-2020, it steadily rose after. BEVA, the only off label anti-VEGF, usage percentage dropped over the 5 years."

Diabetic Retinopathy • Ophthalmology • Retinal Disorders

Key Clinical Findings on the Efficacy, Safety Profile and Immunogenicity of Biosimilar SB11 (Modern Retina) - "Expert retina specialists discuss the efficacy and safety data of the ranibizumab biosimilar, SB11 [BYOOVIZ (ranibizumab)], and explore the practical implications of biosimilars in the broader real-world context. This program is intended for health care providers in UK, Canada, and Switzerland. This program focuses on EU regulations and may differ from other jurisdictions. In UK, Canada, and Switzerland, the SmPC and regulatory requirements may differ from those of the FDA and EMA."

Real-world • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Wet Age-related Macular Degeneration

BYOOVIZ is confusing with BEOVU: Federal Court finds violation of Novartis’ trademark rights (JD Supra) - "In a decision dated January 24, 2024, Justice Pallotta allowed Novartis’ application, finding that Biogen and Samsung’s use of the trademark BYOOVIZ in association with an ophthalmologic drug violates Novartis’ rights in its registered trademark BEOVU: Novartis AG v Biogen Inc, 2024 FC 52."

Corporate lawsuit • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO (clinicaltrials.gov) - P2 | N=34 | Completed | Sponsor: Samsung Bioepis Co., Ltd. | Active, not recruiting ➔ Completed

Trial completion • Age-related Macular Degeneration • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

A Study to Evaluate the Usability of the SB11 PFS in Subjects With Wet AMD or Macular Oedema Secondary to RVO (clinicaltrials.gov) - P2 | N=34 | Active, not recruiting | Sponsor: Samsung Bioepis Co., Ltd.

New P2 trial • Age-related Macular Degeneration • Macular Degeneration • Macular Edema • Ophthalmology • Retinal Disorders • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Public reimbursement for biosimilar BYOOVIZ to treat serious retinal disorders now secured in four provinces and two national benefits programs (BioSpace) - "Biogen Canada Inc. is pleased to announce that Ontario, New Brunswick, and Prince Edward Island have joined Quebec to reimburse PrBYOOVIZ™ (ranibizumab injection), an anti-vascular endothelial growth factor (anti-VEGF) biosimilar therapy for certain eye conditions affecting the retina. In addition, BYOOVIZ is now covered by the Non-Insured Health Benefits (NIHB) and Veterans Affairs Canada (VAC) Health Care Benefits programs."

Reimbursement • Age-related Macular Degeneration • Diabetic Macular Edema • Diabetic Retinopathy • Ophthalmology • Wet Age-related Macular Degeneration

VIDEO: Efficacy, safety of biosimilars discussed at ASRS annual meeting (Healio) - "...Esther M. Bowie, MD, discusses findings presented at the ASRS annual meeting on the efficacy and safety of ranibizumab biosimilars. The study, which evaluated 3,964 patients, was presented by Carl C. Awh, MD, FASRS....In addition, Bowie discussed phase 3 findings presented by Min Sagong, MD, PhD, on SB15, an aflibercept biosimilar, after 1 year of treatment in patients with neovascular age-related macular degeneration."

Clinical data • P3 data • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Systematic review of efficacy and meta-analysis of safety of ranibizumab biosimilars relative to reference ranibizumab anti-VEGF therapy for nAMD treatment. (PubMed, BMJ Open Ophthalmol) - "This systematic review of four RCTs demonstrated no significant difference in visual outcomes, retinal thickness outcomes, as well as meta-analysis of adverse events between biosimilar and reference ranibizumab therapies for nAMD treatment."

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