An Open-label, Single Group, Single-dose Clinical Study to Evaluate the Usability of the Pre-filled Syringe of SB11 in Subjects With Neovascular Age-Related Macular Degeneration or Macular Oedema Secondary to Retinal Vein Occlusion

This is a open label, multicenter, Phase II study to evaluate the usability of the pre-filled syringe (PFS) of SB11 (ranibizumab biosimilar). Healthcare Professionals (HCPs) followed the Instructions for Use (IFU) to prepare and administer SB11 PFS with intravitreal injection to subjects with nAMD or Macular Oedema Secondary to RVO.

Start Date21 Nov 2023

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

CTRI/2018/05/013650

/ CompletedPhase 3

A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity between SB11 (proposed ranibizumab biosimilar) and LucentisÂ® in Subjects with Neovascular Age-related Macular Degeneration

Start Date07 May 2018

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

NCT03150589

/ CompletedPhase 3

A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics and Immunogenicity Between SB11 and Lucentis® in Subjects With Neovascular Age-related Macular Degeneration

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB11 compared to Lucentis® in subjects with neovascular AMD.

Start Date14 Mar 2018

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

100 Clinical Results associated with Ranibizumab-nuna

100 Translational Medicine associated with Ranibizumab-nuna

100 Patents (Medical) associated with Ranibizumab-nuna

Literatures (Medical) associated with Ranibizumab-nuna

01 Sep 2024·JOURNAL OF PROSTHETIC DENTISTRY

Cameo and intaglio surface stability and variability of additively, subtractively, and conventionally manufactured occlusal devices after long-term storage

Article

Author: Yilmaz, Burak ; Marques, Vinicius Rizzo ; Orgev, Ahmet ; Cakmak, Gulce ; Donmez, Mustafa Borga ; Kahveci, Cigdem ; Almogbel, Lolowh

STATEMENT OF PROBLEM:

Additive and subtractive manufacturing have become alternative technologies for fabricating occlusal devices. However, knowledge of the long-term stability of occlusal devices fabricated using these recent technologies is limited.

PURPOSE:

The purpose of this in vitro study was to evaluate the cameo and intaglio surface stability and variability of additively, subtractively, and conventionally manufactured occlusal devices after 18 months of storage.

MATERIAL AND METHODS:

A standard tessellation language (STL) file of a dentate maxillary typodont was used to design a master occlusal device. The STL file of this design was used to fabricate occlusal devices additively either with a digital light processing (AM-1) or a continuous liquid interface production (AM-2) printer, subtractively with 2 different 5-axis milling units (SM-1 and SM-2), and conventionally (TM-HP) (n=10). STL files of each device's cameo and intaglio surfaces were generated using a laboratory scanner after fabrication and after 18 months of storage in a moist environment. These generated files were imported into an analysis software program (Geomagic Control X) to analyze the dimensional stability of tested devices by using the root mean square method. The average deviation values defined the variability of measured changes over time. Cameo and intaglio surface deviations were analyzed using the Kruskal-Wallis and Dunn tests, while the variability of measured deviations was analyzed with 1-way analysis of variance and the Tukey HSD tests (α=.05).

RESULTS:

Significant differences were observed among tested devices when the intaglio surface deviations and the cameo surface variability were considered (P<.001). SM-2 had significantly higher intaglio surface deviations than AM-1, SM-1, and AM-2 (P≤.036). Among the test groups, AM-1 had the greatest cameo surface variability (P≤.004).

CONCLUSIONS:

SM-2 resulted in lower intaglio surface stability than the additive and the other subtractive manufacturing technologies, while AM-1 led to the highest cameo surface variability among the test groups.

01 Aug 2024·ADVANCES IN THERAPY

Usability of the SB11 Pre-filled Syringe (PFS) in Patients with Retinal Diseases

Article

Author: Lee, Jiwon ; Wylęgała, Edward ; Lee, Yujin ; Orski, Michał ; Zalewski, Dominik ; Oleksy, Piotr ; Kim, Sunji

INTRODUCTION:

SB11 (Byooviz™; Samsung Bioepis Co., Ltd.) is a ranibizumab (Lucentis^®; Genentech, Inc.) biosimilar targeting vascular endothelial growth factor A for the treatment of retinal diseases. The pre-filled syringe (PFS) presentation of SB11 offers an alternative administration method to the vial, with the potential for enhanced safety and efficient syringe preparation. The objective of this study was to assess the ability of healthcare professionals (HCPs) to follow the instructions for use to prepare and administer SB11 PFS intravitreal (IVT) injections to patients with neovascular age-related macular degeneration (nAMD) or macular edema secondary to retinal vein occlusion (RVO).

METHODS:

This study was an open-label, single-arm, single-dose clinical study to evaluate the usability of the SB11 PFS in patients with nAMD or macular edema secondary to RVO. Four HCPs prepared and administered 0.5 mg SB11 PFS IVT injections to 34 patients. Product use task completion (12 tasks in total) was assessed by independent observers. Safety was assessed up to 7 days after injection of the investigational product.

RESULTS:

A total of 34 patients were enrolled and completed the study. All 12 tasks were successfully completed in 34 (100%) patients without a use-related failure. Most patients (32 patients, 94.1%) experienced no adverse events (AEs), whereas 2 (5.9%) patients experienced three treatment-emergent AEs (TEAEs) which were mild to moderate in severity. There were no severe or serious TEAEs reported during the study.

CONCLUSIONS:

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.

TRIAL REGISTRATION:

ClinicalTrials.gov identifier NCT06176963; EudraCT number 2021-003566-12.

01 May 2024·Asia-Pacific Journal of Ophthalmology

Association of baseline factors with 1-year outcomes in the SB11-ranibizumab equivalence trial: A post hoc analysis

Article

Author: Kim, Taehyung ; Jung, Jin Ah ; Woo, Se Joon ; Bressler, Neil M ; Oh, Inkyung ; Kim, Mercy Yeeun

PURPOSE:

To identify baseline factors associated with 1-year outcomes when treating neovascular age-related macular degeneration (nAMD) with ranibizumab biosimilar SB11 or reference ranibizumab (rRBZ), and to compare efficacy of the two products within subgroups judged to be clinically relevant.

DESIGN:

Post hoc analysis of a prospective, equivalence phase 3 randomized clinical trial (RCT) METHODS: 705 patients with nAMD were randomized 1:1 to receive SB11 or rRBZ for 48 weeks. Pooled and randomized groups were used to identify baseline factors associated with clinical outcomes at Week 52 using multiple linear regression models. Significant factors identified in regression analyses were confirmed in analyses of variance. Subgroup analyses comparing best-corrected visual acuity (BCVA) changes between SB11 and rRBZ were conducted.

RESULTS:

634 (89.9%) participants completed the 52-week visit. Regression analyses showed that younger age, lower BCVA, and smaller total lesion area at baseline were associated with greater BCVA gain at Week 52, while older age, lower BCVA, and thicker central subfield thickness (CST) at baseline were predictors of greater CST reduction in the pooled group. Subgroup analyses demonstrated that BCVA outcomes appeared comparable for the SB11 and rRBZ groups.

CONCLUSION:

Post hoc analyses of the SB11-rRBZ equivalence study showed that baseline age, BCVA, CST, and total lesion area were prognostic factors for visual or 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.

News (Medical) associated with Ranibizumab-nuna

19 Jun 2025

·www.einpresswire.com

Seeing Beyond Sight: New Frontiers in AMD Treatment-Gene Therapy and Biosimilars Take Center Stage | CI Intelligence

Pioneering AMD therapies-gene therapy, biosimilars, long‑acting biologics-promise durable vision gains and reduced injection burden for aging populations. AMD treatment is entering a transformative era, where precision gene therapy and extended-duration biologics are redefining care. The market is poised to benefit both patients and healthcare systems.” — DataM Intelligence AUSTIN, TX, UNITED STATES, June 19, 2025 / EINPresswire.com / -- Revolutionizing AMD Care: From Monthly Injections to One-Time Gene Therapies In a watershed moment for retinal health, the Age-Related Macular Degeneration (AMD) therapeutics market is poised for transformation. A new wave of innovative treatments—from gene therapy to long-acting anti-VEGF biologics and biosimilars—is reshaping care protocols and expanding access for millions worldwide. With the global burden of AMD projected to surpass 300 million by 2040, the urgency to reduce injection frequency, slow disease progression, and improve affordability has never been more critical. Download CI Sample Report: https://www.datamintelligence.com/strategic-insights/ci/age-related-macular-degeneration-amd 🌍 Market Snapshot: AMD Therapeutics Poised for Growth - The global AMD therapeutics market was valued at approximately $14.24 billion in 2024, with expectations to reach $24.22 billion by 2033, registering a 6–8% CAGR over the forecast period. - North America remains the leading market due to high disease prevalence and early access to biologics, while Asia-Pacific is emerging rapidly with aging populations and increasing healthcare access. - Biosimilar competition, reimbursement reforms, and gene therapy innovations are key drivers shaping this growth trajectory. 🧬 Disease Overview: AMD at a Glance Age-related macular degeneration affects the macula—the central portion of the retina responsible for sharp, straight-ahead vision. It is the leading cause of irreversible vision loss in people aged 50 and older. Two Forms of AMD: - Dry AMD (Atrophic): The most common form, accounting for about 80% of cases. Characterized by thinning of the macula and drusen deposits. - Wet AMD (Neovascular): Less common but more severe. Marked by abnormal blood vessel growth beneath the retina, leading to leakage, scarring, and rapid vision loss. 💊 Current Therapies: Anti-VEGF Dominates, But GA Drugs Rising Wet AMD: Approved Therapies - Eylea (Aflibercept): VEGF and PlGF inhibitor, long-standing market leader. - Lucentis (Ranibizumab): Anti-VEGF monoclonal antibody fragment, widely adopted globally. - Beovu (Brolucizumab): Longer dosing intervals, though safety remains under scrutiny. - Vabysmo (Faricimab): Dual inhibition of VEGF-A and Ang-2; allows for 16-week dosing intervals. - Off-label Avastin (Bevacizumab): Economical alternative, frequently used off-label. Recent Developments: Biosimilars: Byooviz (ranibizumab-nuna), Yesafili, and Opuviz (aflibercept biosimilars) are now FDA-approved, offering cost-effective alternatives with similar efficacy. Dry AMD / Geographic Atrophy (GA): - Syfovre (Pegcetacoplan): First FDA-approved therapy for GA, slows disease progression by up to 36% by inhibiting complement C3. - Izervay (Avacincaptad Pegol): Approved in 2023; targets complement C5 to reduce retinal degeneration in GA. - AREDS2 Supplements and Photobiomodulation Therapy offer supportive care for early or intermediate dry AMD. 🔬 Emerging Therapies and Pipeline Highlights The AMD pipeline is robust, focusing on durable solutions and novel mechanisms of action. For Dry AMD (GA): - ALK-001 (Alkeus Pharmaceuticals): A modified vitamin A derivative in Phase II/III trials aimed at slowing photoreceptor degeneration. - Tinlarebant (Belite Bio): Oral therapy reducing retinal vitamin A buildup to slow GA progression (Phase III). For Wet AMD: - ABBV-RGX-314 (REGENXBIO/AbbVie): Gene therapy delivering anti-VEGF via subretinal or suprachoroidal injection. Phase III underway, with potential to eliminate frequent injections. - 4D-150 (4D Molecular Therapeutics): Intravitreal gene therapy targeting VEGF-A and VEGF-C for sustained delivery—Phase III trials are ongoing. Other Novel Agents: - UBX1325 (Unity Biotechnology): Senolytic targeting aging retinal cells to improve vision in AMD and DME. - Complement Inhibitors in Development: Aimed at upstream and downstream components (e.g., CFB, CFD, FD inhibitors). Ask For Customized CI Sample Report as per Your Business Requirement: https://www.datamintelligence.com/strategic-insights/ci/age-related-macular-degeneration-amd 📈 Market Opportunities & Forecasting - The wet AMD market continues to dominate revenue, but geographic atrophy (GA) is a growing segment due to newly approved treatments and expanding patient population. - Gene therapy and biosimilars are expected to drive a paradigm shift by improving durability and lowering long-term costs. - Market revenue is projected to grow from $14.24 billion (2024) to $24.22 billion by 2033, largely fueled by treatment innovation and the rising global prevalence of AMD. 🔍 Unmet Needs: The Next Frontier in AMD Care Despite progress, critical gaps remain: - Treatment Burden: Monthly injections are unsustainable for many elderly patients. Gene therapies and extended-interval dosing are key solutions. - Lack of Cure for Dry AMD: GA treatments slow degeneration but cannot reverse damage. - Global Access & Cost: High biologic prices remain a barrier in low- and middle-income countries. Biosimilars and oral agents offer scalable alternatives. - Delayed Detection: Early AMD often goes undiagnosed. Greater emphasis on screening and AI-enabled imaging is needed. - Personalized Medicine: Genotype-based AMD therapies remain underdeveloped, despite promising biomarker research. 🏆 Competitive Landscape and Strategic Positioning Key Players in Wet AMD: - Regeneron: Market leader with Eylea/Eylea HD. Facing competition from biosimilars and Roche’s Vabysmo. - Roche/Genentech: Innovator with Vabysmo and sustained delivery devices. - Novartis: With Beovu, pursuing longer dosing intervals. Leading in Dry AMD: - Apellis (Syfovre) and Astellas/Iveric Bio (Izervay) have pioneered complement-targeted approaches. Emerging Innovators: - REGENXBIO and Adverum Biotech: Leading the charge in gene therapy, aiming to provide one-time, durable treatment solutions. - Samsung Bioepis, Biocon, Polpharma: Disrupting the pricing landscape with Lucentis and Eylea biosimilars. Book Free CI Consultation Report: https://www.datamintelligence.com/strategic-insights/ci/age-related-macular-degeneration-amd 🎯 Target Opportunity Profile (TOP): Strategic Drug Benchmarking Ideal Drug Profile: - Wet AMD: ORR > 90%, injection frequency ≤ every 16 weeks, subcutaneous/gene therapy option. - GA: ≥30% reduction in lesion growth, good safety profile, ideally oral or less invasive. - Gene Therapy: One-time treatment, durable for 2–5+ years, minimal side effects. Benchmarking Snapshot: - Eylea HD: 12–16 week interval; market leader. - Vabysmo: Dual-target; fast-growing market share. - Syfovre & Izervay: First-movers in GA. - RGX-314 & 4D-150: Future disruptors with one-time treatment potential. - Yesafili, Opuviz: Cost-effective alternatives, expanding access. 💡 Conclusion: A Clearer Vision for Millions The Age-Related Macular Degeneration (AMD) landscape is evolving from high-frequency, high-cost injection therapies toward smarter, longer-lasting, and more accessible treatments. From breakthrough gene therapies to affordable biosimilars and the first-ever drugs for geographic atrophy, this is an era defined by innovation and opportunity. As the AMD patient population swells worldwide, driven by aging demographics, these advancements are not just medically vital—they’re a necessity for sustainable and equitable eye care. Read Related CI Report: 1. Atypical Hemolytic-Uremic Syndrome Therapeutic 2. Chronic Rhinosinusitis with Nasal Polyps Sai Kumar DataM Intelligence 4market Research LLP +1 877-441-4866 sai.k@datamintelligence.com Visit us on social media: LinkedIn X Legal Disclaimer: EIN Presswire provides this news content "as is" without warranty of any kind. We do not accept any responsibility or liability for the accuracy, content, images, videos, licenses, completeness, legality, or reliability of the information contained in this article. If you have any complaints or copyright issues related to this article, kindly contact the author above.

Phase 3Drug ApprovalGene Therapy

05 Mar 2025

·www.pharmaceutical-technology.com

Sandoz said it expects net sales to grow by a mid-single digit percentage in constant currencies in 2025. Image credit: Shutterstock/ T. Schneider. Sandoz reported a 9% growth in net sales of generics and biosimilars to third parties for 2024, marking a strong first financial year as an independent company. After completing its spin-off from Novartis in October 2023, Sandoz has been busy launching new products and simplifying its business. Whilst generics made up the bulk of the Swiss company’s $10.4bn in net sales in 2024, biosimilars pushed more of the growth. Generics brought in $7.5bn for growth at constant exchange rates of 2%, whereas biosimilar sales grew 30% to bring in $2.8bn. Investor reaction to the earnings suggested that performance was in line with expectations. Shares in the company opened almost 1% higher following the announcement. Sandoz has a market cap of $19.2bn. Sandoz’s earnings report come at a time when geopolitical events have significantly impacted market fluctuations. The company issued a guidance on the potential fallout from trade tariffs imposed by the US government on Canada, Mexico, and China. Levies on imported goods could negatively impact the biopharma industry such as raising drug prices and worsening shortages. “The US accounts for just under 20% of our global revenues, as we are a European-based company with strong growth potential in the US, but not dependent on any one market. Potential tariffs on imports from China and Canada are included in our 2025 guidance. For Europe, it is still too early to model,” Sandoz CEO Richard Saynor said in a statement to Pharmaceutical Technology . Sandoz pointed to the uptake of its Humira biosimilar Hyrimoz in the US through a private-label agreement with CVS biosimilar subsidiary Cordavis as one of the drivers of its biosimilar business growth. Humira, AbbVie’s mega blockbuster, was once the world’s bestselling drug, bringing in revenue of $21.2bn in 2022, and the launch of several biosimilars has represented a sizeable loss-of-exclusivity value. Along with autoimmune diseases, Sandoz has been active in the ophthalmologic space. The US Food and Drug Administration (FDA) approved Sandoz’s Enzeevu (aflibercept-abzv), the drugmaker’s biosimilar for wet age-related macular degeneration (AMD), in August 2024. Despite battling for AMD market share against products from rivals Biocon Biologics and Samsung Bioepis, Sandoz consolidated its position in March 2024 with a $170m acquisition of Cimerli (ranibizumab-eqrn), a biosimilar approved for a range of retinal diseases. In its generics business, price erosion led to a decline in US sales, the company said. Sandoz also cited the divestment of its China operations as an offset to international growth. South Africa-based Aspen Pharmaceuticals bought Sandoz’s Chinese business for $100m at the tail-end of 2023. 2025 outlook During the call, Sandoz highlighted several strategic business decisions, including a reduction in the number of its internal manufacturing sites to 15, down from 18 in 2023. The company boosted the capacity at remaining sites and consolidated the number of its external suppliers. Saynor told Pharmaceutical Technology : “This allows us to simplify our supply chain and optimise capacity usage and processes. Ultimately, it helps us to secure supply, stabilise our cost basis, and increase patient access to critical medicines worldwide.” Looking ahead to 2025, Sandoz said it expects net sales to grow by a mid-single digit percentage in constant currencies. Sandoz has already launched Stelara biosimilar Pyzchiva (ustekinumab-ttwe) in the US and has eyes on launching the Tysabri biosimilar Tyruko in the country in 2025 too. Whilst experiencing significant growth, the biosimilar market has been saturated with lawsuits. Johnson & Johnson (J&J) recently, for example, sued Samsung Bioepis over a breach of contract for Stelara. Nevertheless, GlobalData forecasts biosimilar sales to increase from 5.7% in 2022 to 18.3% in 2032 through the eight major markets (8MM: US, France, Germany, Italy, Spain, UK, Japan, and China). GlobalData is the parent company of Pharmaceutical Technology.

AcquisitionDrug ApprovalBiosimilarPatent Expiration

18 Nov 2024

·pipelinereview.com

Samsung Bioepis and Biogen Receive European Commission (EC) Approval for Aflibercept Biosimilar, OPUVIZ

INCHEON, South Korea and CAMBRIDGE, MA, USA I November 18, 2024 I 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 1,2 (aflibercept), developed and registered by Samsung Bioepis. OPUVIZ, also known as SB15, is approved in adult patients 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). “Retinal disorders are affecting millions of people’s lives in Europe, yet many patients face barriers to treatment due to high costs,” said Byoungin Jung, Vice President, Regulatory Affairs at Samsung Bioepis. “The EC approval for OPUVIZ represents a major step toward our goal of expanding access to vital biologic therapies for those in need. We will continue working to expand access to our quality-assured, safe and effective biosimilars to improve patient’s quality of life and support sustainability of healthcare systems.” “This approval is an exciting milestone for both patients and healthcare systems in Europe. OPUVIZ has the potential to create a new treatment option for eligible patients, while also easing the burden of costs associated with these retinal conditions,” said Wolfram Schmidt, Head of Europe at Biogen. “We are delighted to continue our partnership with Samsung Bioepis, with the approval of our fifth biosimilar treatment option in Europe.” The EC approval was based on a totality of evidence including analytical, non-clinical data, and clinical data. A randomized, double-masked, parallel group, multicenter Phase 3 study demonstrated equivalent efficacy and comparable safety, immunogenicity, and pharmacokinetics (PK) profiles between SB15 and reference aflibercept (AFL). 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 and 56-week analysis demonstrated comparability in other secondary efficacy, safety, immunogenicity, and PK endpoints between SB15 and AFL. 3, 4 OPUVIZ is the second ophthalmology biosimilar approved in Europe and fifth biosimilar in the portfolio developed by Samsung Bioepis with commercialization rights held by Biogen, which includes BYOOVIZ™ (ranibizumab), BENEPALI™ (etanercept), IMRALDI™ (adalimumab) and FLIXABI™ (infliximab). In November 2019, Samsung Bioepis and Biogen announced that they had entered into a commercialization agreement for two ophthalmology biosimilar candidates, BYOOVIZ (SB11, ranibizumab) and OPUVIZ (SB15, aflibercept), in the U.S., Canada, Europe and certain other markets. About the SB15 Phase 3 study 3,4 The study is a randomized, double-masked, parallel group phase 3 study conducted at 56 centers in 10 countries from June 2020 to March 2022, including follow-up through 56 weeks. Of 549 screened participants, 449 participants 50 years and older with treatment-naive nAMD were randomized 1:1 to receive either SB15 (n = 224) or AFL (n = 225). At Week 32, patients were re-randomized to either continue SB15 or AFL, or switch from AFL to SB15 resulting in three treatment groups; continuing SB15 (SB15/SB15, n=219), continuing AFL (AFL/AFL, n=108), switching from AFL to SB15 (AFL/SB15, n=111). In total, 425 patients completed up to Week 56. Key efficacy endpoints of the study were 1) change from baseline in best corrected visual acuity (BCVA), 2) change from baseline in central subfield thickness (CST), and 3) proportion of patients with intra or sub-retinal fluid. About Samsung Bioepis Co., Ltd. Established in 2012, Samsung Bioepis is a biopharmaceutical company committed to realizing healthcare that is accessible to everyone. Through innovations in product development and a firm commitment to quality, Samsung Bioepis aims to become the world’s leading biopharmaceutical company. Samsung Bioepis continues to advance a broad pipeline of biosimilar candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, and endocrinology. For more information, please visit: www.samsungbioepis.com and follow us on social media – X , LinkedIn . About Biogen Founded in 1978, Biogen is a leading biotechnology company that pioneers innovative science to deliver new medicines to transform patients’ lives and to create value for shareholders and our communities. We apply deep understanding of human biology and leverage different modalities to advance first-in-class treatments or therapies that deliver superior outcomes. Our approach is to take bold risks, balanced with return on investment to deliver long-term growth. We routinely post information that may be important to investors on our website at www.biogen.com . Follow us on social media – Facebook , LinkedIn , X , YouTube . References: SOURCE: Samsung Bioepis

Phase 3Clinical ResultDrug ApprovalLicense out/in

100 Deals associated with Ranibizumab-nuna

External Link

KEGG	Wiki	ATC	Drug Bank
-	-	S01LA04	-

R&D Status

Approved

10 top approved records.

to view more data

Indication	Country/Location	Organization	Date
Age Related Macular Degeneration	South Korea	Samsung Bioepis Co., Ltd.	04 Nov 2024
Blindness	South Korea	Samsung Bioepis Co., Ltd.	04 Nov 2024
Vision, Low	South Korea	Samsung Bioepis Co., Ltd.	04 Nov 2024
Myopic choroidal neovascularization	United States	Samsung Bioepis Co., Ltd.	17 Sep 2021
Retinal vein occlusion-related macular edema	United States	Samsung Bioepis Co., Ltd.	17 Sep 2021
Choroidal Neovascularization	European Union	Samsung Bioepis Co., Ltd.	18 Aug 2021
Choroidal Neovascularization	Iceland	Samsung Bioepis Co., Ltd.	18 Aug 2021
Choroidal Neovascularization	Liechtenstein	Samsung Bioepis Co., Ltd.	18 Aug 2021
Choroidal Neovascularization	Norway	Samsung Bioepis Co., Ltd.	18 Aug 2021
Diabetic macular oedema	European Union	Samsung Bioepis Co., Ltd.	18 Aug 2021
Diabetic macular oedema	Iceland	Samsung Bioepis Co., Ltd.	18 Aug 2021
Diabetic macular oedema	Liechtenstein	Samsung Bioepis Co., Ltd.	18 Aug 2021
Diabetic macular oedema	Norway	Samsung Bioepis Co., Ltd.	18 Aug 2021
Macular Edema	European Union	Samsung Bioepis Co., Ltd.	18 Aug 2021
Macular Edema	Iceland	Samsung Bioepis Co., Ltd.	18 Aug 2021
Macular Edema	Liechtenstein	Samsung Bioepis Co., Ltd.	18 Aug 2021
Macular Edema	Norway	Samsung Bioepis Co., Ltd.	18 Aug 2021
Proliferative retinopathy with diabetes mellitus	European Union	Samsung Bioepis Co., Ltd.	18 Aug 2021
Proliferative retinopathy with diabetes mellitus	Iceland	Samsung Bioepis Co., Ltd.	18 Aug 2021
Proliferative retinopathy with diabetes mellitus	Liechtenstein	Samsung Bioepis Co., Ltd.	18 Aug 2021

Developing

10 top R&D records.

to view more data

Indication	Highest Phase	Country/Location	Organization	Date
Wet Macular Degeneration	Phase 2	Poland	Samsung Bioepis Co., Ltd.	21 Nov 2023
Diabetic Retinopathy	IND Approval	China	Samsung Bioepis Co., Ltd.	30 Aug 2022

Clinical Result

Indication

Phase

Evaluation

View All Results

Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT06176963 (SB11 Pre-filled Syringe, CTgov)	Phase 2	Retinal vein occlusion-related macular edema \| Retinal Vein Occlusion \| Macular Edema ... View more	34	SB11 PFS	wttalrydji = blnjrjsamj ymvedzyygw (dgcbumpdvg, yhxfeohedz - yljfsmkepe) View more	-	30 Dec 2024
EURETINA2023	Not Applicable	-	-	SB11	xfjmmsmawe(dqzbwjaqgh) = myxkmfndiv lehkxannha (uaudhaqdyl )	-	05 Oct 2023
				rRBZ	xfjmmsmawe(dqzbwjaqgh) = dtljvbitfp lehkxannha (uaudhaqdyl )
APAO2023	Phase 3	Age Related Macular Degeneration	705	SB11 (BYOOVIZ, Ranibizumab-Nuna)	vbrbwvuwlk(ribfocywjv) = zuifezdurn xfbxgsunoj (urtqykwboq, 0.76) View more	Positive	23 Feb 2023
NCT03150589 (Pubmed)	Phase 3	Age Related Macular Degeneration \| Wet age-related macular degeneration	705	SB11	qhhlfuklxy(gnteprczqn) = IOI-related events occurred in 1 of 32 overall ADA-positive participants (3.1%) and 4 of 620 overall ADA-negative participants (0.6%) zhuihqzkyo (ggipaufage ) View more	-	15 Dec 2022
				RBZ
NCT03150589 (CTgov)	Phase 3	Wet age-related macular degeneration	705	SB11 (Proposed ranibizumab biosimilar) (SB11 (Proposed Ranibizumab Biosimilar))	sjpcjkxawj(twjyeleptx) = lgidfvfzme udrdhiqumk (hjqowwnakh, 0.51) View more	-	21 May 2021
				ranibizumab+Lucentis (Lucentis (Ranibizumab))	sjpcjkxawj(twjyeleptx) = sovnnpxqwv udrdhiqumk (hjqowwnakh, 0.51) View more
NCT03150589 (Pubmed \| JAMA Ophthalmol) Manual	Phase 3	Wet age-related macular degeneration	705	SB11	olriyalvza(fqzuuwpgvw) = xihywnmjob orfksrioqw (jqwrzgajds ) View more	Similar	01 Jan 2021
				Ranibizumab	olriyalvza(fqzuuwpgvw) = hoxlufbdsf orfksrioqw (jqwrzgajds ) View more
PO393 (AAO2020)	Phase 3	Wet age-related macular degeneration	705	SB11	ppygbtzonq(nuvkgopkwy) = royfpxfkjs rjrsscghxe (aercktvlcm, 0.76)	Positive	13 Nov 2020
				Ranibizumab	ppygbtzonq(nuvkgopkwy) = yzblmfkwas rjrsscghxe (aercktvlcm, 0.74)

Translational Medicine

Boost your research with our translational medicine data.

view full example data

Deal

Boost your decision using our deal data.

view full example data

Core Patent

Boost your research with our Core Patent data.

view full example data

Clinical Trial

Identify the latest clinical trials across global registries.

view full example data

Approval

Accelerate your research with the latest regulatory approval information.

view full example data

Biosimilar

Competitive landscape of biosimilars in different countries/locations. Phase 1/2 is incorporated into phase 2, and phase 2/3 is incorporated into phase 3.

view full example data

Regulation

Understand key drug designations in just a few clicks with Synapse.

view full example data

AI Agents Built for Biopharma Breakthroughs

Accelerate discovery. Empower decisions. Transform outcomes.

Get started for free today!

Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.

Start your data trial now!

Synapse data is also accessible to external entities via APIs or data packages. Empower better decisions with the latest in pharmaceutical intelligence.

Bio

Bio Sequences Search & Analysis

Chemical

Chemical Structures Search & Analysis