A Phase III Randomised, Double-masked, Parallel Group, Multicentre Study to Compare the Efficacy, Safety, Pharmacokinetics, and Immunogenicity Between SB15 (Proposed Aflibercept Biosimilar) and Eylea® in Subjects With Neovascular Age-related Macular Degeneration

This is a randomised, double-masked, parallel group, multicentre study to evaluate the efficacy, safety, Pharmacokinetics (PK), and immunogenicity of SB15 compared to Eylea® in subjects with neovascular AMD.

Start Date23 Jun 2020

Sponsor / Collaborator

Samsung Bioepis Co., Ltd.

100 Clinical Results associated with AFLIBERCEPT-YSZY

100 Translational Medicine associated with AFLIBERCEPT-YSZY

100 Patents (Medical) associated with AFLIBERCEPT-YSZY

Literatures (Medical) associated with AFLIBERCEPT-YSZY

09 Jan 2025·Journal of Physical Chemistry Letters

Evaluating the Synergistic Effects of Multi-Epitope Nanobodies on BA.2.86 Variant Immune Escape

Article

Author: Liu, Jinxin ; Zhang, Enhao ; Duan, Lili ; Xu, Xiaole ; Zhang, John Z. H. ; Luo, Song ; Liang, Houde

Addressing the frequent emergence of SARS-CoV-2 mutant strains requires therapeutic approaches with innovative neutralization mechanisms. The targeting of multivalent nanobodies can enhance potency and reduce the risk of viral escape, positioning them as promising drug candidates. Here, the synergistic mechanisms of the two types of nanobodies are investigated deeply. Our research revealed that the Fu2-1-Fu2-2 system exhibited significant synergy, whereas the Sb#15-Sb#68 system demonstrated antagonism, in which entropy was the dominant contributor to antagonism. Conformational analysis further demonstrated that the presence of a monomeric nanobody influenced the flexibility of residues near other epitopes, thereby affecting the overall synergy of the systems. Moreover, we identified that changes in the hydrogen bond network and the charge of residues played a critical role in the binding between nanobodies and spike. We hope this study will provide novel insights into the development of multivalent nanobody combinations.

01 Aug 2024·Ophthalmology and Therapy

Analytical Characterization for Similarity Assessment Between an Aflibercept Biosimilar SB15 and Reference Product (Eylea®)

Article

Author: Lee, Jaeil ; Kim, Beom Chan ; Lee, Hangyeore ; Song, Jinsu ; Lee, Soye ; Kim, Dayoung ; Huh, Jongcheol ; Lee, Jungmin

INTRODUCTION:

SB15 is a proposed biosimilar product of reference aflibercept (Eylea^®), an approved biological drug product for retinal diseases including neovascular age-related macular degeneration (nAMD). This study aimed to assess the analytical similarity between SB15 and its commercially available reference product (RP) sourced from the United States (US-aflibercept) and European Union (EU-aflibercept) in terms of structural, physicochemical, and biological properties.

METHODS:

A panel of state-of-the-art analytical methods was used for the comprehensive characterization of SB15 and US/EU-aflibercept. In terms of the structural and physicochemical properties, primary structure; post-translational modifications (PTM); higher-order structure; purity and impurities; charge variants; and glycosylation were compared. In addition, biological characterization including mechanism of action (MoA)-related and Fc-related biological activities was conducted.

RESULTS:

Analytical similarity between SB15 and US/EU-aflibercept was demonstrated. The primary and higher-order structure of SB15 was confirmed to be comparable to that of US/EU-aflibercept. In addition, there were no meaningful differences in the physicochemical properties in terms of size and charge heterogeneity between SB15 and its RP. SB15 and RP were similar in biological activities including MoA-related binding activities, potencies, and Fc-related biological functions. Consequently, SB15 was confirmed to be highly similar to US/EU-aflibercept.

CONCLUSIONS:

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.

01 Dec 2023·BMJ open ophthalmology

Biosimilar SB15 versus reference aflibercept in neovascular age-related macular degeneration: 1-year and switching results of a phase 3 clinical trial

Article

Author: Studnička, Jan ; Oh, Inkyung ; Csutak, Adrienne ; Yun, Cheolmin ; Ernest, Jan ; Vajas, Attila ; Sadda, SriniVas R ; Jang, Hyerin ; Choi, Wooree ; Enyedi, Lajos ; Tóth-Molnár, Edit ; Patel, Sunil ; Wylegala, Edward ; Veith, Miroslav ; Woo, Se Joon ; Astakhov, Sergei ; Sagong, Min ; Orski, Michal ; Bradvica, Mario

Background/aims:

To evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of SB15 versus reference aflibercept (AFL), and switching from AFL to SB15 in neovascular age-related macular degeneration (nAMD).

Design:

Prospective, double-masked, randomised, phase 3 trial.

Methods:

Participants with nAMD were randomised 1:1 to receive SB15 (N=224 participants) or AFL (N=225). At week 32, participants either continued on SB15 (SB15/SB15, N=219) or AFL (AFL/AFL, N=108), or switched from AFL to SB15 (AFL/SB15, N=111). This manuscript reports 1-year and switching results of secondary efficacy endpoints such as changes from baseline to week 56 in best-corrected visual acuity (BCVA), central subfield thickness (CST, from internal limiting membrane (ILM) to retinal pigment epithelium), and total retinal thickness (TRT, from ILM to Bruch’s membrane). Additional endpoints included safety, PK and immunogenicity.

Results:

Efficacy results were comparable between groups. The least squares mean (LSmean) change in BCVA from baseline to week 56 was 7.4 letters for SB15/SB15 and 7.0 letters for AFL/AFL (difference (95% CI)=0.4 (−2.5 to 3.2)). The LSmean changes from baseline to week 56 in CST and TRT were −119.2 µm and −132.4 µm for SB15/SB15 and −126.6 µm and −136.3 µm for AFL/AFL, respectively (CST: difference (95% CI)=7.4 µm (−6.11 to 20.96); TRT: difference (95% CI)=3.9 µm (−18.35 to 26.10)). Switched and non-switched participants showed similar LSmean changes in BCVA from baseline to week 56 (AFL/SB15, 7.9 letters vs AFL/AFL, 7.8 letters; difference (95% CI)=0.0 (−2.8 to 2.8)). Safety, PK and immunogenicity were comparable between groups.

Conclusions:

Efficacy, safety, PK and immunogenicity were comparable between SB15 and AFL and between switched and non-switched participants.

News (Medical) associated with AFLIBERCEPT-YSZY

21 Aug 2025

·www.biospace.com

Two FDA Decisions for Regeneron’s Eylea HD Delayed Into Q4

iStock, Natalya Kosarevich The delays, first revealed in Regeneron’s Q2 report, were chalked up to manufacturing issues at Novo Nordisk-owned plants. The FDA has pushed back its target decision date for two of Regeneron’s supplemental applications for a high-dose formulation of Eylea. After initially setting a decision date for Aug. 19 , the agency now expects to deliver verdicts in the fourth quarter. The delay applies to Regeneron’s application to use Eylea HD for patients with macular edema after retinal vein occlusion, as well as the proposal to expand its dosing schedule to include a monthly regimen across approved indications. There do not appear to be problems with the safety or efficacy of Eylea HD in the affected applications. Instead, the review extension is linked to findings at a Catalent manufacturing site. Novo Nordisk, which acquired the CDMO giant in February last year, has already responded to the FDA’s observations, but the regulator considered the submission a major amendment to the affected applications. “It is our understanding that the FDA will be able to act expeditiously on these applications once the manufacturing issues have been resolved,” Regeneron wrote on Wednesday. Meanwhile, Eylea HD vials will remain available in the U.S. for the already approved indications and dosing schedules. Regeneron alluded to the delay earlier this month during second-quarter earnings on Aug. 1, revealing that the FDA would need to extend its review for the two Eylea HD applications. At the time, Novo hadn’t yet addressed the FDA’s concerns at the production facility, and Regeneron wasn’t able to provide an updated timeline for the decisions. “Based on our discussions, we believe that there’s nothing significant left to be done,” CEO Leonard Schleifer said during an investor call at the time. “We are expecting, once the resolution of the filling issues has occurred, to receive favorable action, we hope, from the FDA.” Despite an expected approval, the delays still represent a setback for Regeneron’s Eylea franchise, which once dominated the retinal disease market but has since steadily lost market share to Roche’s Vabysmo. Soon, Eylea will also have to contend with biosimilars after the FDA signed off on two interchangeable copycats in May 2024. One of these, Biocon Biologics’ Yesafili, is expected to hit U.S. shelves late next year . The U.S. launch for the other biosimilar, branded Opuviz and marketed by Samsung Bioepis and Biogen, is still uncertain. Still, the updated FDA timeline likely puts the launch of the new Eylea versions ahead of investor expectations, BMO Capital Markets analysts noted on Wednesday. “Given recent biosimilar competition and subsequent market erosion for Eylea, we appreciate a shorter path to regulatory approval as Regeneron attempts to regain market share for the franchise,” the firm wrote. In the second quarter, the Eylea franchise suffered a 25% year-on-year sales dip, though its $1.15 billion in revenue still came 9% ahead of consensus forecasts.

Drug Approval

17 Jul 2025

·www.businesswire.com

Samsung Bioepis Enters into a Partnership with Harrow for Commercialization of Ophthalmology Biosimilars Portfolio in the United States

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. (“Samsung Bioepis”) announced today that the company has entered into a license, development and commercialization agreement (DCA) with Harrow (Nasdaq: HROW), for Samsung Bioepis’ ophthalmology portfolio — BYOOVIZ® (ranibizumab-nuna), a biosimilar referencing LUCENTISi (ranibizumab) and OPUVIZ™ (aflibercept-yszy), a biosimilar referencing EYLEAii (aflibercept) — in the United States. The commercial license will become effective upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis, which is expected to be completed by the end of 2025. We will work closely with both Biogen and Harrow to ensure a seamless transition and the continued delivery of services to our customers and patients in the US market. In October 2024, Biogen notified Samsung Bioepis of its decision to terminate the 2019 Development and Commercialization Agreement within the US and Canada. Samsung Bioepis has been closely working with Biogen on the transfer of commercialization rights for BYOOVIZ and OPUVIZ back to Samsung Bioepis in these regions. Harrow will assume full responsibility for commercialization of BYOOVIZ and OPUVIZ in the US upon completion of the transition of commercial rights from Biogen back to Samsung Bioepis. BYOOVIZ was approved by the U.S. Food and Drug Administration (FDA) in September 2021 as the first ophthalmology biosimilar in the US for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). BYOOVIZ has been commercially available in the US since June 2022. OPUVIZ was approved in May 2024 for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). “We are pleased to partner with Harrow, a leading eyecare pharmaceutical company with strong capabilities in commercialization of ophthalmic pharmaceutical products in the North American market. We will work closely with both Biogen and Harrow to ensure a seamless transition and the continued delivery of services to our customers and patients in the US market,” said Josh Sang Hyun Lee, Vice President and Business Development Team Leader at Samsung Bioepis. “Samsung Bioepis remains committed to expanding access and widening treatment options for healthcare systems, healthcare professionals, and patients, by providing affordable and high-quality biologic medicines around the world.” About BYOOVIZ (ranibizumab-nuna) BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use. BYOOVIZ (ranibizumab-nuna) is biosimilar to LUCENTIS (ranibizumab injection). BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection. Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP. Please see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE. About OPUVIZ (aflibercept-yszy) OPUVIZ (aflibercept-yszy) injection, for intravitreal use. OPUVIZ (aflibercept-yszy) is biosimilar to EYLEA (aflibercept). OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. Please see Prescribing Information for OPUVIZ (aflibercept-yszy) HERE. 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 – LinkedIn, X. i Lucentis is a trademark of Genentech, Inc. ii Eylea is a trademark of Regeneron Pharmaceuticals, Inc.

License out/inDrug Approval

17 Jul 2025

·www.businesswire.com

Harrow Enters into Commercialization Agreement with Samsung Bioepis for Ophthalmology Biosimilars Portfolio in the United States

NASHVILLE--(BUSINESS WIRE)--Harrow (Nasdaq: HROW), a leading North American eyecare pharmaceutical company, today announced that it has entered into a definitive agreement with Samsung Bioepis Co. Ltd. (hereafter “Samsung Bioepis”) 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. BYOOVIZ has been commercialized by Biogen in the U.S. since its initial launch in June 2022. In October 2024, Biogen notified Samsung Bioepis of their decision to terminate the 2019 Development and Commercialization Agreement within the U.S. and Canada. Samsung Bioepis has been closely working with Biogen on the transfer of commercialization rights for BYOOVIZ and OPUVIZ back to Samsung Bioepis in these regions. 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. This strategic acquisition enhances Harrow’s position as the leading full-spectrum ophthalmic pharmaceuticals provider in the U.S., expands its pipeline with high-value biosimilars for sight‑threatening retinal diseases, and reinforces its commitment to delivering value-oriented innovation to the U.S. eyecare market. “This transformational acquisition marks a pivotal moment for Harrow and reinforces our commitment to delivering innovation, accessibility, and value to the U.S. ophthalmology community,” said Mark L. Baum, Chairman and Chief Executive Officer of Harrow. “We are excited to leverage our growing commercial presence within the retina specialist community, built over the past year, and partner with Samsung Bioepis, globally recognized for its scientific excellence in biologics and biosimilars. These ophthalmic assets are among the most highly regarded in the market, and we are looking forward to bringing these products to U.S. physicians and patients.” Transaction Highlights Acquired Rights : Harrow gains exclusive U.S. commercial rights to Samsung Bioepis’ portfolio of ophthalmic biosimilars, including BYOOVIZ ® (“bio-viss”) and OPUVIZ™ (“op-u-vis”): BYOOVIZ (ranibizumab-nuna) 0.05mL injection, the first FDA-approved LUCENTIS biosimilar indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). OPUVIZ (aflibercept-yszy) 0.05mL injection , an FDA-approved EYLEA biosimilar indicated for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). BYOOVIZ (ranibizumab-nuna) 0.05mL injection, the first FDA-approved LUCENTIS biosimilar indicated for the treatment of patients with Neovascular (Wet) Age-Related Macular Degeneration (AMD), Macular Edema following Retinal Vein Occlusion (RVO), and Myopic Choroidal Neovascularization (mCNV). OPUVIZ (aflibercept-yszy) 0.05mL injection , an FDA-approved EYLEA biosimilar indicated for the treatment of patients with Wet AMD, Macular Edema following RVO, Diabetic Macular Edema (DME), and Diabetic Retinopathy (DR). Market Opportunity : The retinal disease treatment market represents a $9 billion opportunity iii in the U.S., with biosimilars expected to expand patient access and affordability. Execution-Ready Platform: Harrow will leverage its established commercial infrastructure and national reach to accelerate the market impact of these biosimilars. Harrow is committed to reshaping the Wet AMD treatment landscape by offering an FDA-approved, on-label, and affordable alternative to existing anti-VEGF therapies. The market is dominated by EYLEA, LUCENTIS, VABYSMO, and compounded Avastin, which continues to be used off-label due to its low cost, despite not being formulated or approved for ocular administration. Current anti-VEGF therapies are among the most expensive drug categories covered under Medicare Part B, with annual spending in the U.S. exceeding $4.2 billioniv. Harrow’s acquisition of these products has the potential to substantially lower the financial burden on Medicare and commercial plans, while improving access and affordability for patients. About BYOOVIZ (ranibizumab-nuna) BYOOVIZ (ranibizumab-nuna) injection, for intravitreal use. BYOOVIZ (ranibizumab-nuna) is biosimilar to LUCENTIS (ranibizumab injection). BYOOVIZ, a vascular endothelial growth factor (VEGF) inhibitor, is indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Myopic Choroidal Neovascularization (mCNV) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis and retinal detachments may occur following intravitreal injections. Patients should be monitored following the injection. Increases in intraocular pressure (IOP) have been noted both pre- and post-intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (reported more frequently in ranibizumab treated subjects than control subjects) are conjunctival hemorrhage, eye pain, vitreous floaters, and increased IOP. Please see Prescribing Information for BYOOVIZ (ranibizumab-nuna) HERE. About OPUVIZ (aflibercept-yszy) OPUVIZ (aflibercept-yszy) injection, for intravitreal use. OPUVIZ (aflibercept-yszy) is biosimilar to EYLEA (aflibercept). OPUVIZ is a vascular endothelial growth factor (VEGF) inhibitor, indicated for the treatment of patients with: Neovascular (Wet) Age-Related Macular Degeneration (AMD) Macular Edema Following Retinal Vein Occlusion (RVO) Diabetic Macular Edema (DME) Diabetic Retinopathy (DR) Select Important Safety Information WARNING AND PRECAUTIONS Endophthalmitis, retinal detachments, and retinal vasculitis with or without occlusion may occur following intravitreal injections. Patients and/or caregivers should be instructed to report any signs and/or symptoms suggestive of endophthalmitis, retinal detachment, or retinal vasculitis without delay and should be managed appropriately. Increases in intraocular pressure have been seen within 60 minutes of an intravitreal injection. There is a potential risk of arterial thromboembolic events following intravitreal use of VEGF inhibitors. ADVERSE REACTIONS The most common adverse reactions (≥5%) reported in patients receiving aflibercept were conjunctival hemorrhage, eye pain, cataract, vitreous detachment, vitreous floaters, and intraocular pressure increased. Please see Prescribing Information for OPUVIZ (aflibercept-yszy) HERE. About Harrow Harrow, Inc. (Nasdaq: HROW) is a leading eyecare pharmaceutical company engaged in the discovery, development, and commercialization of innovative ophthalmic pharmaceutical products for the North American market. Harrow helps eyecare professionals preserve the gift of sight by making its portfolio of pharmaceutical products accessible and affordable to millions of patients each year. For more information about Harrow, please visit harrow.com. Forward-Looking Statements This press release contains “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Any statements in this release that are not historical facts may be considered such “forward-looking statements.” Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Some of the potential risks and uncertainties that could cause actual results to differ from those predicted include, among others, risks related to: liquidity or results of operations; our ability to successfully implement our business plan, develop and commercialize our products, product candidates and proprietary formulations in a timely manner or at all, identify and acquire additional products, manage our pharmacy operations, service our debt, obtain financing necessary to operate our business, recruit and retain qualified personnel, manage any growth we may experience and successfully realize the benefits of our previous acquisitions and any other acquisitions and collaborative arrangements we may pursue; competition from pharmaceutical companies, outsourcing facilities and pharmacies; general economic and business conditions, including inflation and supply chain challenges; regulatory and legal risks, including litigation matters, and other uncertainties related to our pharmacy operations and the pharmacy and pharmaceutical business in general; physician interest in and market acceptance of our current and any future formulations and compounding pharmacies generally. These and additional risks and uncertainties are more fully described in Harrow’s filings with the Securities and Exchange Commission (SEC), including its Annual Report on Form 10-K for the year ended December 31, 2024, subsequent Quarterly Reports on Form 10-Q, and other filings with the SEC. Such documents may be read free of charge on the SEC’s web site at sec.gov. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Harrow undertakes no obligation to update any forward-looking statements to reflect new information, events, or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. i Lucentis is a trademark of Genentech, Inc. ii Eylea is a trademark of Regeneron Pharmaceuticals, Inc. iii Company annual reports & Biopharma AVASTIN estimates iv https://www.reviewofoptometry.com/news/article/annual-medicare-expense-for-antivegf-injections-tops-4-billion-study-finds

AcquisitionDrug ApprovalLicense out/in

100 Deals associated with AFLIBERCEPT-YSZY

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R&D Status

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Indication	Country/Location	Organization	Date
Diabetic Retinopathy	United States	Samsung Bioepis Co., Ltd.	20 May 2024
Diabetic macular oedema	South Korea	Samsung Bioepis Co., Ltd.	23 Feb 2024
Myopic choroidal neovascularization	South Korea	Samsung Bioepis Co., Ltd.	23 Feb 2024
Retinal vein occlusion-related macular edema	South Korea	Samsung Bioepis Co., Ltd.	23 Feb 2024
Wet age-related macular degeneration	South Korea	Samsung Bioepis Co., Ltd.	23 Feb 2024

Clinical Result

Indication

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT04450329 (CTgov)	Phase 3	Wet age-related macular degeneration	449	SB15 (Proposed aflibercept biosimilar) (SB15 (Proposed Aflibercept Biosimilar))	gonfetsnzt(zesnkmanzi) = kuezygksmb llhobxrkmi (kspikicbqs, 0.56) View more	-	05 Feb 2024
				SB15 (Proposed aflibercept biosimilar)+Eylea (Eylea (Aflibercept))	gonfetsnzt(zesnkmanzi) = ajgupqqoxz llhobxrkmi (kspikicbqs, 0.57) View more
EURETINA2023 Manual	Phase 3	Age Related Macular Degeneration	449	SB15	dbzorzsear(dsqpmgwgcn) = cpoofncsww dsuscyrbto (lhmohgtmms )	Similar	05 Oct 2023
				Aflibercept	dbzorzsear(dsqpmgwgcn) = nivphwygxq dsuscyrbto (lhmohgtmms )
EURETINA2023 Manual	Phase 3	Wet age-related macular degeneration	438	SB15	ffzsmgdnhm(ilszbbnnjz) = ypucvmybhm mnbsghwnoz (svgutfbhcq ) View more	Positive	05 Oct 2023
				Aflibercept	ffzsmgdnhm(ilszbbnnjz) = axojpceyjw mnbsghwnoz (svgutfbhcq ) View more
EURETINA2023	Not Applicable	Wet age-related macular degeneration	-	SB15	lifkudslho(buweelrlvq) = vlfznurqeu qyvjwydury (vantohrstz ) View more	-	05 Oct 2023
				AFL	lifkudslho(buweelrlvq) = uhzqfiwdwn qyvjwydury (vantohrstz ) View more
NCT04450329 (Pubmed)	Phase 3	Wet age-related macular degeneration	449	SB15	cczekvpkwm(qnartfqhlp) = rbtvhwopsk qglapmfoss (eborxqasir ) View more	-	08 Jun 2023
				AFL	cczekvpkwm(qnartfqhlp) = ieuffdgccm qglapmfoss (eborxqasir ) View more
NCT04450329 (ARVO2023)	Phase 3	Wet age-related macular degeneration	449	SB15 2 mg	hrrjglyazv(scbwcucmhe) = sraihkurdi focchixldy (lxwltnfbhv )	Positive	01 Jun 2023
				Aflibercept	hrrjglyazv(scbwcucmhe) = zspuwtxgqv focchixldy (lxwltnfbhv )
AAO2022	Phase 3	Wet age-related macular degeneration	-	SB15	naarwitgru(wsalnigocc) = nnxirloccj ztnxpfubpc (emvcohwdwm )	Positive	29 Sep 2022
				Aflibercept	naarwitgru(wsalnigocc) = eaeixgqirn ztnxpfubpc (emvcohwdwm )

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