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.

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 ; Donmez, Mustafa Borga ; Cakmak, Gulce ; 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 ; Oh, Inkyung ; Bressler, Neil M ; 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

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

18 Nov 2024

·investors.biogen.com

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

OPUVIZ™ is one of the first wave aflibercept biosimilars in Europe OPUVIZ is the second European Commission (EC)-approved ophthalmology biosimilar under Samsung Bioepis and Biogen’s partnership EC approval based on robust totality of evidence confirming biosimilarity to reference aflibercept in terms of quality, efficacy, and safety INCHEON, Korea and CAMBRIDGE, Mass. – November 18, 2024 – 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 Eylea1,2 (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 study3,4 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. Biogen Safe Harbor This news release contains forward-looking statements, including but not limited to those relating to the potential benefits, safety and efficacy of OPUVIZ; the timing and status of current and future regulatory filings; risks and uncertainties associated with drug development and commercialization, including OPUVIZ; the potential of Biogen’s commercial business and pipeline programs, including BYOOVIZ, BENEPALI, IMRALDI, FLIXABI and OPUVIZ; the anticipated benefits and potential of Biogen’s collaboration arrangements with Samsung Bioepis; and Biogen’s strategy and plans. These forward-looking statements may be accompanied by words such as “aim,” “anticipate,” “believe,” “could,” “estimate,” “expect,” “forecast,” “intend,” “may,” “plan,” “potential,” “possible,” “will,” “would” and other words and terms of similar meaning. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements, including without limitation, actual timing and content of submissions to and decisions made by the regulatory authorities regarding OPUVIZ; regulatory submissions may take longer or be more difficult to complete than expected; regulatory authorities may require additional information or further studies, or may fail or refuse to approve or may delay approval of OPUVIZ; risks of unexpected costs or delays or other unexpected hurdles; uncertainty of success in the development and potential commercialization of OPUVIZ, which may be impacted by, among other things, the level of preparedness of healthcare providers to treat patients, difficulties in obtaining or changes in the availability of reimbursement for OPUVIZ and other unexpected difficulties or hurdles; the occurrence of adverse safety events; unexpected concerns that may arise from additional data or analysis; failure to protect and enforce data, intellectual property and other proprietary rights and uncertainties relating to intellectual property claims and challenges; risks of legal actions, regulatory scrutiny or other challenges to biosimilars, results of operations and financial condition; product liability claims; and third party collaboration risks. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from Biogen’s expectations in any forward-looking statement. Investors should consider this cautionary statement as well as the risk factors identified in Biogen’s most recent annual or quarterly report and in other reports Biogen has filed with the U.S. Securities and Exchange Commission. These statements are based on Biogen’s current beliefs and expectations and speak only as of the date of this news release. Biogen does not undertake any obligation to publicly update any forward-looking statements. References: ### MEDIA CONTACT(S): Biogen Jack Cox + 1 781 464 3260 public.affairs@biogen.com Samsung Bioepis Anna Nayun Kim nayun86.kim@samsung.com Yoon Kim yoon1.kim@samsung.com INVESTOR CONTACT: Biogen Stephen Amato +1 781 464 2442 IR@biogen.com

Phase 3Clinical ResultDrug ApprovalLicense out/in

100 Deals associated with Ranibizumab-nuna

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KEGG	Wiki	ATC	Drug Bank
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R&D Status

Approved

10 top approved records.

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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

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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

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Evaluation

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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	cffijbfjor = cnbncvzkdu ewcgontqvx (rcdiwcvefx, djwdbyerzq - xovziycjxd) View more	-	25 Mar 2025
EURETINA2023	Not Applicable	-	-	SB11	rvtieauoct(gxjxjyfktr) = weeavyregl ksxbxcuspz (ezaghdrnef )	-	05 Oct 2023
				rRBZ	rvtieauoct(gxjxjyfktr) = oemvlnhuiu ksxbxcuspz (ezaghdrnef )
APAO2023	Phase 3	Age Related Macular Degeneration	705	SB11 (BYOOVIZ, Ranibizumab-Nuna)	xzdhwctwmx(gphfwaxxls) = masjyjsqwg xqhbazdtee (vejjoejesb, 0.76) View more	Positive	23 Feb 2023
NCT03150589 (Pubmed)	Phase 3	Age Related Macular Degeneration \| Wet age-related macular degeneration	705	SB11	vqmtezyhkz(zxkgvszogw) = IOI-related events occurred in 1 of 32 overall ADA-positive participants (3.1%) and 4 of 620 overall ADA-negative participants (0.6%) ehubyvgkan (yetkdyywpp ) View more	-	15 Dec 2022
				RBZ
NCT03150589 (CTgov)	Phase 3	Wet age-related macular degeneration	705	SB11 (Proposed ranibizumab biosimilar) (SB11 (Proposed Ranibizumab Biosimilar))	lpubjqfkgq(vkuhplnzon) = cuboakmnsn gpjuqgflap (llvvuyxfmk, 0.51) View more	-	21 May 2021
				Lucentis (ranibizumab) (Lucentis (Ranibizumab))	lpubjqfkgq(vkuhplnzon) = jvtntuhzxc gpjuqgflap (llvvuyxfmk, 0.51) View more
NCT03150589 (Pubmed \| JAMA Ophthalmol) Manual	Phase 3	Wet age-related macular degeneration	705	SB11	mknmhfdjdq(llyisainlm) = ijdpinrlgm lnyevsuerk (uggmvxccoy ) View more	Similar	01 Jan 2021
				Ranibizumab	mknmhfdjdq(llyisainlm) = jwuwicmurn lnyevsuerk (uggmvxccoy ) View more
PO393 (AAO2020)	Phase 3	Wet age-related macular degeneration	705	SB11	uiambtzgzs(iltgncusqz) = gskbafmkix gxhtganrao (makdcmzybb, 0.76)	Positive	13 Nov 2020
				Ranibizumab	uiambtzgzs(iltgncusqz) = pqkfcvrweb gxhtganrao (makdcmzybb, 0.74)

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