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

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

Biosimilar BYOOVIZ now reimbursed in Quebec to treat serious retinal disorders (Yahoo Finance) - "Biogen Canada Inc. is pleased to announce that Quebec has become the first province to reimburse BYOOVIZ™ (ranibizumab injection), an anti-vascular endothelial growth factor (anti-VEGF) biosimilar therapy for certain eye conditions affecting the retina....Reimbursement in Quebec follows a positive reimbursement recommendation by the Institut national d'excellence en santé et en services sociaux (INESSS) in December 2022 and the successful completion in May 2023 of the pan-Canadian Pharmaceutical Alliance (pCPA) negotiation process for BYOOVIZ."

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

Efficacy and Safety of Biosimilar Ranibizumab-nuna and Ranibizumabeqrn in Clnical Use by a Consortium of Retina Specialists (ASRS 2023) - No abstract available

Clinical

Samsung Bioepis launches Lucentis biosimilar in Canada, Germany (The Korea Herald) - "South Korean biotech firm Samsung Bioepis is expanding into the global market with SB11, a biosimilar drug used to treat ophthalmologic diseases such as macular degeneration....SB11 was introduced to the Canadian market last Wednesday through its partner company Biogen, following an earlier launch in Germany on Feb. 23."

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

Physicochemical and Biological Stability Assessment of SB11 (Ranibizumab Biosimilar) Under Ambient and In-Use Storage for Intravitreal Administration. (PubMed, Ophthalmol Ther) - "SB11 was stable for longer periods and at higher temperatures than what is stated in the labels of the reference product (Lucentis) and SB11. The physicochemical properties, biological activity, and sub-visible particulates of SB11 in both tested settings (unopened vials at room temperature and in-use product withdrawn into syringes) were maintained under the described storage periods. This information can help to avoid unnecessary delays in patient treatment without any loss in quality and biological activity, lower the workload of health care providers and reduce costs associated with drug waste."

Journal • Ophthalmology

Immunogenicity With Ranibizumab Biosimilar SB11 (Byooviz) and Reference Product Lucentis and Association With Efficacy, Safety, and Pharmacokinetics: A Post Hoc Analysis of a Phase 3 Randomized Clinical Trial. (PubMed, JAMA Ophthalmol) - P3 | "These findings support the biosimilarity of SB11 and RBZ, with no safety concern identified for SB11 vs RBZ associated with immunogenicity. ClinicalTrials.gov Identifier: NCT03150589."

Clinical • Journal • P3 data • PK/PD data • Retrospective data • Age-related Macular Degeneration • Immunology • Inflammation • Macular Degeneration • Ophthalmology • Retinal Disorders • Wet Age-related Macular Degeneration

Samsung Bioepis Presents Data from its Ophthalmology Biosimilar Portfolio at American Academy of Ophthalmology (AAO) 2022 Annual Meeting (GlobeNewswire) - "Samsung Bioepis Co., Ltd. today announced that three scientific abstracts relating to its ophthalmology biosimilar portfolio will be presented at the American Academy of Ophthalmology (AAO) 2022 Annual Meeting being held from September 30 to October 3, 2022 in Chicago, United States....The primary endpoint was met in terms of change from baseline in best corrected visual acuity (BCVA) at week 8, and the 32-week interim analysis demonstrated comparability in other secondary efficacy endpoints, safety, immunogenicity, and PK between SB15 and reference aflibercept....A post-hoc analysis of the Phase 3 study on SB11, a biosimilar referencing LUCENTIS (ranibizumab), analyzed the association of immunogenicity with one-year results of SB11 in nAMD....Another post-hoc analysis of the Phase 3 study on SB11 determined baseline factors associated with one-year efficacy outcomes in nAMD."

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

"US FDA’s Byooviz Review By The Numbers https://t.co/kIEKfIqSle #PinkSheet" (@PharmaPinkSheet)

Review

Drug approval reports (FDA) - Labelling update for BYOOVIZ (ranibizumab-nuna) approved on 15th Aug, 2022.

sBLA • Age-related Macular Degeneration • Ophthalmology • Retinal Vein Occlusion • Wet Age-related Macular Degeneration

Samsung Bioepis, Lucentis biosimilar 'SB11' additionally proves its equivalence with the original [Google translation] (Chosun Biz) - P3 | N=705 | NCT03150589 | Sponsor: Samsung Bioepis Co., Ltd. | "Samsung Bioepis announced the research results of SB11 (Lucentis biosimilar, ranibizumab), an ophthalmic disease treatment, at the American Society of Retina Specialists (ASRS) conference...the results of post-hoc analysis of phase 3 clinical data for macular degeneration patients through an oral presentation session held at the conference...As a result of performing a risk statistical analysis, it was confirmed that visual acuity and anatomical measurements were similar between SB11 and the original drug."

Retrospective data • Age-related Macular Degeneration • Ophthalmology

Baseline Factors Associated With 1-Year Outcomes in Phase III Comparison of SB11 (Approved Ranibizumab Biosimilar) With Reference Ranibizumab in nAMD (ASRS 2022) - No abstract available

P3 data

Sambaepis ’SB11’ Phase 3 clinical trial results “Equal to the original… Approved in the US and Europe“ [Google translation] (Kiho Ilbo) - P3 | N=705 | "Samsung Bioepis announced the results of the phase 3 clinical trial of 'SB11' (Lucentis biosimilar, ingredient name ranibizumab) at the 'The Korean Retina Society (KRS) Summer Conference' held online on the 11th....'The results of the clinical trial confirmed that SB11 and the original drug were equivalent in efficacy, safety, immunogenicity, and pharmacokinetics.'"

P3 data • Age-related Macular Degeneration • Ophthalmology

"Biogen, Samsung Bioepis launch ranibizumab-nuna in US More: https://t.co/7ZaJwSZWRO #Ophthalmology #Ophthotwitter #Retina @biogen @SamsungBioepis" (@OphthTimes)

Launch US • Ophthalmology