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

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

Regulator suspends clinical trial of Samsung Bioepis' Eylea biosimilar for misconduct (Korea Biomedical Review) - "The Ministry of Food and Drug Safety (MFDS) said it imposed an administrative penalty equivalent to a 1.5-month suspension of clinical trials on Samsung Bioepis for violating regulatory requirements in conducting a clinical study. The clinical trial, 'SB15-3001,' was aimed to compare the efficacy, safety, pharmacokinetics, and immunogenicity of SB15, an Eylea (ingredient: aflibercept) biosimilar. The original drug treats neovascular age-related macular degeneration."

Trial suspension • Age-related Macular Degeneration • Ophthalmology • Wet Age-related Macular Degeneration

Samsung Bioepis presented a post-hoc analysis of the Phase 3 clinical study results for SB15 at EURETINA 2023 (Modern Retina) - "Samsung Bioepis presented a post-hoc analysis of the Phase 3 clinical study results for SB15...The efficacy was well-maintained post-switching as the mean BCVA letter score (~Snellen equivalent) was 65.3 (20/50) at Week 32 (pre-switching) and 65.8 (20/50) at Week 56 (post-switching) for the AFL/SB15 group compared with 65.2 (20/50) at Week 32 and 65.8 (20/50) at Week 56 within AFL/AFL group. Also, there was no difference in efficacy between the two groups post-switching as the least square (LS) mean for change from W32 in BCVA at week 56 for AFL/AFL was 0.0 letters and 0.2 letters for AFL/SB15 (difference: 0.3 [95% CI: -1.2, 1.8] letters)."

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

Samsung Bioepis Presents Post-hoc Analysis of Phase 3 Clinical Trial for SB15, a Proposed Biosimilar to Eyleaⁱ (Aflibercept), at EURETINA 2023 (GlobeNewswire) - "Samsung Bioepis Co., Ltd. today announced that it presented a post-hoc analysis of the Phase 3 clinical study results for SB15, a proposed biosimilar to Eylea (aflibercept), at EURETINA 2023 being held from October 5 to 8 in Amsterdam, the Netherlands....The efficacy was well-maintained post-switching as the mean BCVA letter score (~Snellen equivalent) was 65.3 (20/50) at Week 32 (pre-switching) and 65.8 (20/50) at Week 56 (post-switching) for the AFL/SB15 group compared with 65.2 (20/50) at Week 32 and 65.8 (20/50) at Week 56 within AFL/AFL group. Also, there was no difference in efficacy between the two groups post-switching as the least square (LS) mean for change from W32 in BCVA at week 56 for AFL/AFL was 0.0 letters and 0.2 letters for AFL/SB15 (difference: 0.3 [95% CI: -1.2, 1.8] letters)."

Retrospective data • Age-related Macular Degeneration • 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

Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration: A Phase 3 Randomized Clinical Trial. (PubMed, JAMA Ophthalmol) - P3 | "In this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD. ClinicalTrials.gov Identifier: NCT04450329."

Clinical • Journal • P3 data • Age-related Macular Degeneration • Fibrosis • Hematological Disorders • Immunology • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

1-Year Outcomes of Phase 3 Study for SB15, Proposed biosimilar to Eylea (aflibercept), Presented at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting (GlobeNewswire) - P3 | N=449 | NCT04450329 | Sponsor: Samsung Bioepis Co., Ltd. | "Samsung Bioepis Co., Ltd. today announced that 1-year outcomes of the Phase 3 study for SB15, a proposed biosimilar to Eylea (aflibercept), were presented at the 2023...ARVO Annual Meeting....At the meeting, researchers presented 56-week results from the Phase 3 clinical study between SB15 and reference aflibercept (AFL) in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK)....Out of the total 449 patients with neovascular age-related macular degeneration (nAMD), 438 patients were first randomized 1:1 to receive either SB15 or AFL....SB15 demonstrates comparable efficacy, safety, immunogenicity, and pharmacokinetics profiles to reference aflibercept up to Week 56. Switching group had similar efficacy and safety compared to the continuing groups without treatment-emergent issues such as loss of efficacy, increased adverse events, or increased immunogenicity."

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

Samsung Bioepis to Present New Data for SB15, a proposed biosimilar to Eylea (aflibercept), at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting (GlobeNewswire) - "Samsung Bioepis Co., Ltd. today announced that it will present new data on SB15, a proposed biosimilar to Eylea (aflibercept), at the 2023 Association for Research in Vision and Ophthalmology (ARVO) Annual Meeting held from April 23 to 27, in New Orleans, Louisiana....researchers will present new analytical data on similarity between SB15 and reference product in terms of structural and physicochemical properties and biological functions, as well as 56-week results from the Phase 3 randomized clinical study between SB15 and the reference product in terms of efficacy, safety, immunogenicity, and pharmacokinetics (PK)."

PK/PD data • Age-related Macular Degeneration • Ophthalmology

Phase III Randomized Clinical Trial Comparing SB15 with Reference Aflibercept in Neovascular Age-Related Macular Degeneration (ARVO 2023) - "Layman Abstract (optional): Provide a 50-200 word description of your work that non-scientists can understand. Describe the big picture and the implications of your findings, not the study itself and the associated details."

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