Opuviz (aflibercept-yszy) / AffaMed Therap, Biogen, Samsung, Harrow Health, Samil Pharma, Teva - LARVOL DELTA

Samsung Bioepis Co., Ltd. today announced the launch of OPUVIZ 40 mg/mL solution in pre-filled syringe (PFS), a biosimilar referencing Eylea (aflibercept), across Europe, starting today (Business Korea) - "Samsung Bioepis launched OPUVIZ 40 mg/mL solution for injection in a vial in May this year....OPUVIZ was first approved as 40 mg/mL solution for injection in a vial by the European Commission (EC) in November 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 for adults for the treatment of neovascular (wet) age related macular degeneration (AMD), visual impairment due to macular oedema secondary to retinal vein occlusion (RVO; branch or central RVO), visual impairment due to diabetic macular oedema (DME), and visual impairment due to myopic choroidal neovascularisation (myopic CNV)."

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

Teva and Samsung Bioepis Enter Commercialization Agreement for OPUVIZ, a Biosimilar Referencing Eylea (aflibercept), in Canada (Financial Times) - "Under the agreement, Samsung Bioepis is responsible for registration and manufacture of the products, while Teva Canada (a subsidiary of Teva Pharmaceutical Industries Ltd.) is responsible for commercialization....Teva Canada will provide further details on the anticipated Canadian market launch of OPUVIZ at the appropriate time."

Licensing / partnership • Diabetic Macular Edema • Diabetic Retinopathy • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

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

Samsung Bioepis Launches OPUVIZ (Aflibercept) 40 mg/mL Vial Across Europe, to Treat Ophthalmic Conditions (Businesswire)

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

Anti-Vascular Endothelial Growth Factor Biosimilars for Use in the Aging Eye. (PubMed, Drugs Aging) - "Several biosimilars for anti-VEGF drugs including bevacizumab, ranibizumab, and aflibercept are in various stages of development and approval (e.g. Afilivu, Yesafili, Enzeevu, Ahzantive, AVT-06, ABP 938, and ALT L9)...This review explores the current landscape of anti-VEGF biosimilars, their clinical efficacy, safety profiles, and the economic implications for treating the aging eye. It also addresses the challenges and future directions in the integration of biosimilars into routine ophthalmic practice."

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

Aflibercept Biosimilar Showed Improvements in RVO-Associated Macular Edema (AJMC) - "There were 29 eyes from 29 patients included in the study...The mean logMAR BCVA was 0.64 (0.36) at baseline for patients with BRVO, which progressed to 0.45 (0.26) at the first visit and 0.41 (0.32) at the last follow-up. Mean CRT decreased from 527.1 (181.9) µm at baseline to 285.1 (99.5) µm at the final follow-up. A total of 19 eyes had complete resolution of retinal fluid after 1 injection, although 11 experienced fluid recurrence after follow-up...The researchers concluded that SB15 led to significant improvements in BCVA and anatomical outcomes in the BRVO group in particular after a mean of 1.7 injections."

Clinical data • Macular Edema • Retinal Vein Occlusion

Samil Pharmaceutical: "Aphilivu Secures Business Stability Through Global Patent Agreement" [Google translation] (HIT News)

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

Samsung Bioepis clears US path for Eylea biosimilar launch in 2027 (Korea Biomedical Review) - "Samsung Bioepis has secured a settlement and license agreement with Regeneron Pharmaceuticals that will allow it to launch its Eylea (aflibercept) biosimilar in the United States beginning in January 2027, the company said Thursday...The agreement resolves patent disputes related to Opuviz (aflibercept-yszy), Samsung Bioepis' biosimilar to Eylea 2 mg, following a previous settlement covering Europe and other global markets. Financial and other terms of the US agreement were not disclosed."

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

Aphilivu rebounds in South Korea, logs 1.6 billion won sales in two months (Chosun Biz) - "Samsung Bioepis has developed a prefilled syringe type of Aphilivu and plans to introduce it in the domestic market through Samil Pharmaceutical as early as the first quarter."

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

The Korean biosimilar maker said Friday that the agreement allows it to commercialize SB15, its biosimilar to Regeneron’s blockbuster eye drug Eylea 2 milligrams (aflibercept 40 mg/mL), in markets excluding the United States and Canada. (Korea Biomedical Review) - "Samsung Bioepis has reached a settlement with Regeneron and Bayer that clears the way for commercial launches of its Eylea biosimilar in Europe, after more than a year in which the product had regulatory approvals but no workable path to market amid patent disputes...Samsung Bioepis said it can begin selling in the United Kingdom in January, expand to the rest of Europe from April and launch in additional 'settled countries,' excluding Korea, from May 2026...Financial terms were not disclosed, and the company said other provisions are confidential...Sam Chun Dang has already begun exports to Canada, Europe, the United Kingdom and Korea and expects sales in Japan and the United States to start in 2026."

Biosimilar launch • Licensing / partnership • Diabetic Macular Edema • Diabetic Retinopathy • Retinal Vein Occlusion • 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

Celltrion and Samsung Bioepis halt the launch of Ilia similar in the US…What’s left is Samchundang Pharmaceutical? (FNTIMES) - "Celltrion and Samsung Bioepis are experiencing setbacks in the US launch of their biosimilar (generic drug) for macular degeneration treatment 'Eylea'....According to an industry source on the 10th, the US Federal Circuit Court of Appeals did not accept Celltrion's request to overturn the decision of the first trial court to ban the launch of Eylea's biosimilar on the 5th (local time)....This has made it unlikely for domestic bio companies to settle in the US market with Opuviz for the time being. Opuviz's material patent in the US expires in May of this year, but its formulation patent expires in June 2027....The company plans to apply for product approval for Ilia biosimilar 'SCD411' to the FDA within this year. Samchundang Pharmaceutical believes that SCD411 can be launched locally starting in the second half of next year....Alteogen will enter the US market after 2027."

Biosimilar launch • Age-related Macular Degeneration • Macular Degeneration • Wet Age-related Macular Degeneration

Aptamer based immunotherapy: a potential solid tumor therapeutic. (PubMed, Front Immunol) - "This review provides an overview of the recent advances in aptamer-based technologies with specific key clinical trials involving AON-D21 and AM003. The use of aptamers is expanded by the development of SOMAmers, X-aptamers, and bioinformatics. To make aptamer-based drugs a major part of cancer treatment, future research should concentrate more on resolving existing issues and expanding their beneficial uses."

Journal • Review • Oncology • Solid Tumor

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

Samsung Bioepis and Biogen Receive European Commission (EC) Approval for Aflibercept Biosimilar, OPUVIZ (GlobeNewswire) - "Samsung Bioepis Co., Ltd. and Biogen Inc. (Nasdaq: BIIB) today announced that the European Commission (EC) has approved OPUVIZ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), developed and registered by Samsung Bioepis....The EC approval was based on a totality of evidence including analytical, non-clinical data, and clinical data."

EMA approval • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Samsung Bioepis and Biogen Receive Positive CHMP Opinion for Aflibercept Biosimilar, OPUVIZ (GlobeNewswire) - "Samsung Bioepis Co., Ltd. and Biogen Inc...announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion for OPUVIZ 40 mg/mL solution for injection in a vial, a biosimilar referencing Eylea (aflibercept), also known as SB15....The CHMP’s positive opinion was based on a totality of evidence including analytical, non-clinical data, and clinical data."

CHMP • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Samsung Bioepis Sets New Pricing Benchmark with Afilivu (HIT News) - "Samsung Bioepis has made history by being the first to release a biosimilar of a biologic drug with expired patents, significantly impacting the pricing of subsequent drugs....Samsung Bioepis listed 'Afliivu,' a biosimilar of the macular degeneration treatment Eylea (ingredient: aflibercept), on the reimbursement list as of May 1st this year. The maximum price was set at $257.70, approximately 49% of the original biologic Eylea's maximum price of $521.84. While biosimilars are typically priced at 70% of the original, Samsung Bioepis voluntarily lowered the price as a strategic decision."

Reimbursement • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Comparison of the efficacy and safety of SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration. (PubMed, Sci Rep) - "To compare the efficacy and safety of the proposed aflibercept biosimilar SCD411 and reference aflibercept in patients with neovascular age-related macular degeneration, this randomized, double-masked, parallel-group, multicenter study was conducted in 14 countries from 13 August 2020 to 8 September 2022. In conclusion, SCD411 has equivalent efficacy compared with reference aflibercept in patients with neovascular age-related macular degeneration and has a comparable safety profile. The results support the potential use of SCD411 for the treatment of neovascular age-related macular degeneration."

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

Analytical Characterization for Similarity Assessment Between an Aflibercept Biosimilar SB15 and Reference Product (Eylea®). (PubMed, Ophthalmol Ther) - "Based on a comprehensive analytical similarity assessment of structural, physicochemical, and biological properties, SB15 was demonstrated to be highly similar to US/EU-aflibercept RP, supporting safe and effective use of SB15."

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

Samil Pharm to start selling Samsung Bioepis’ Eylea biosimilar from May 1 (Korea Biomedical Review) - "Samil Pharmaceutical said it will launch Afilivu (aflibercept), an Eylea biosimilar developed by Samsung Bioepis to treat macular degeneration, in the Korean market on May 1. The announcement follows the partnership agreement signed between Samil Pharm and Samsung Bioepis in February, granting distribution rights for Afilivu in the Korean market."

Biosimilar launch • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Post Hoc Analysis of a Phase 3 Trial on SB15 (Proposed Aflibercept Biosimilar): Assessment on Pre-to-Post Switching Efficacy and Safety in Neovascular Age-related Macular Degeneration (ARVO 2024) - "Our findings from this post hoc analysis were consistent with results from pivotal trial that efficacy and safety appeared comparable between AFL to SB15 and biosimilarity between these agents were maintained after switching."

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

Samsung Bioepis “SB15 has similar efficacy to the original drug in 亞 patients” [Google translation] (Hankyung) - P3 | N=449 | NCT04450329 | Sponsor: Samsung Bioepis Co., Ltd. | "Samsung Bioepis announced...that as a result of a global phase 3 follow-up study on 'SB15', a biosimilar (biopharmaceutical generic) of the eye disease treatment 'Eylea', similar efficacy to the original drug was confirmed in patients in Asia....Compared to before administration of the treatment, the SB15 administration group's vision improved to the extent of being able to see up to 8.3 letters using glasses and lenses."

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

Samsung Bioepis, Samil Pharm to co-market Eylea biosimilar (Korea Biomedical Review) - "Samsung Bioepis and Samil Pharmaceutical have announced a marketing partnership for the local sales of SB15, a biosimilar referencing Eylea....The collaboration between Samsung Bioepis and Samil Pharmaceutical on SB15 marks their second partnership in the field of ophthalmology."

Licensing / partnership • Age-related Macular Degeneration • Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial. (PubMed, BMJ Open Ophthalmol) - "Efficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants."

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