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 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 ; Jang, Hyerin ; Sadda, SriniVas R ; Choi, Wooree ; Enyedi, Lajos ; Tóth-Molnár, Edit ; Patel, Sunil ; Wylegala, Edward ; Veith, Miroslav ; Astakhov, Sergei ; Woo, Se Joon ; 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.

01 Jul 2023·JAMA ophthalmology

Efficacy and Safety of the Aflibercept Biosimilar SB15 in Neovascular Age-Related Macular Degeneration

Article

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

Importance:

Aflibercept biosimilars can expand available treatment options in retinal diseases and have the potential to improve patient access to safe and effective therapy.

Objective:

To establish equivalence in efficacy and similarity in safety, pharmacokinetics, and immunogenicity of SB15 and reference aflibercept (AFL) in neovascular age-related macular degeneration (nAMD).

Design, Setting, and Participants:

This was a randomized double-masked parallel group phase 3 trial 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 included and randomly assigned to SB15 (n = 224) or AFL (n = 225). Key exclusion criteria included considerable scarring, fibrosis, atrophy, and hemorrhage. This report includes results up to the end of the parallel group period at week 32. Of the 449 randomized participants, 438 (97.6%) completed week 32 follow-up.

Intervention:

Participants were randomized 1:1 to receive 2 mg of SB15 or AFL every 4 weeks for the first 12 weeks (3 injections), followed by dosing every 8 weeks up to week 48, with final assessments at week 56.

Main Outcomes and Measures:

The primary end point was the change in best-corrected visual acuity (BCVA) from baseline to week 8 with predefined equivalence margins of −3 letters to 3 letters. Other key end points were changes in BCVA and central subfield thickness up to week 32, safety, pharmacokinetics, and immunogenicity.

Results:

The mean (SD) age among the 449 included participants was 74.0 (8.1) years, and 250 participants (55.7%) were female. Baseline demographic characteristics and most disease characteristics were comparable between treatment groups. The least squares mean change in BCVA from baseline to week 8 in the SB15 group was equivalent to that in the AFL group (6.7 letters vs 6.6 letters, respectively; difference, 0.1 letters; 95% CI, −1.3 to 1.4). Comparable efficacy between treatment groups was maintained up to week 32 (least squares mean change from baseline in BCVA: SB15, 7.6 letters vs AFL, 6.5 letters; least squares mean change from baseline in central subfield thickness: SB15, −110.4 μm vs AFL, −115.7 μm). No clinically relevant differences were observed in the incidence of treatment-emergent adverse events (TEAEs) (SB15, 107/224 [47.8%] vs AFL, 98/224 [43.8%]) and ocular TEAEs in the study eye (SB15, 41/224 [18.3%] vs AFL, 28/224 [12.5%]). The serum concentration profiles and cumulative incidences of overall antidrug antibody positive participants were comparable.

Conclusions and Relevance:

In this phase 3 randomized clinical trial, SB15 and AFL showed equivalent efficacy and comparable safety, pharmacokinetics, and immunogenicity in participants with nAMD.

Trial Registration:

ClinicalTrials.gov Identifier: NCT04450329

News (Medical) associated with AFLIBERCEPT-YSZY

26 Jan 2026

·www.biospace.com

Samsung Epis Holdings Reports Fourth Quarter and Fiscal Year 2025 Financial Results

In its first financial results announcement after the spin-off, Samsung Bioepis recorded FY2025 revenue of KRW 1.672 trillion, highest annual revenue in its 14-year history Excluding milestone revenue, annual sales revenue grew 28% year-over-year (YoY), recording KRW 1.626 trillion, with 101% YoY growth in operating profit to KRW 330.8 billion INCHEON, Korea--(BUSINESS WIRE)-- #ADCs --Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced financial results for the fourth quarter and fiscal year 2025. “We are very pleased to report strong year-to-date sales growth in our first financial results following the spin-off. Our organic growth has been driven by solid performance across our biosimilars portfolio," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We are continuing to make meaningful progress in our regulatory and commercial milestones with our existing biosimilars portfolio, while strategically investing in our future pipeline with a disciplined, long-term approach. We aim to drive sustainable growth and create long-term value for our shareholders, so that we can remain committed to improving patient access worldwide.” Samsung Bioepis Fourth Quarter & Fiscal Year 2025 Results In the fourth quarter of 2025, Samsung Bioepis achieved a consolidated revenue of KRW 429.4 billion with an operating profit of KRW 29.2 billion. Revenue and operating profit based on product sales (excluding milestone revenue) in the fourth quarter increased by 23% and 14% year-over-year (YoY), respectively. Full-year 2025 (FY2025) revenue reached KRW 1.672 trillion (+9%) while operating profit stood at KRW 375.9 billion (-14%). Excluding milestone revenue, sales revenue and operating profit stood at KRW 1.626 trillion (+28%) and KRW 330.8 billion (+101%), respectively. [Consolidated Earnings, KRW billion] Q4’23 Q4’24 Q4’25 YoY Change FY23 FY24 FY25 YoY Change Revenue 288.9 397.4 429.4 +32.0 1 (+8%) 1,020.3 1,537.7 1,672.0 +134.3 1 (+9%) Excluding Milestone Revenue 288.9 347.0 425.2 +78.2 (+23%) 1,008.3 1,266.8 1,626.9 +360.1 (+28%) Operating Profit 78.2 72.3 29.2 -43.1 (-60%) 205.4 435.4 375.9 -59.5 (-14%) Excluding Milestone Revenue 78.2 21.9 25.0 +3.1 (+14%) 193.4 164.5 330.8 +166.3 (+101%) The growth was driven by Samsung Bioepis’ continued global expansion through product launches, regulatory approvals, and new partnerships. EPYSQLI™ (SB12), a biosimilar to Soliris 2 (eculizumab), indicated for the treatment of Paroxysmal Nocturnal Hemoglobinuria (PNH), atypical Hemolytic Uremic Syndrome (aHUS), and generalized Myasthenia Gravis (gMG), was launched in the United States (US) in April 2025 through its commercialization partner Teva Pharmaceuticals, improving access for patients with rare diseases. OBODENCE™ / OSPOMYV™ 3 (SB16), a biosimilar to Prolia 4 (denosumab), and XBRYK™ (SB16), a biosimilar to Xgeva 3 (denosumab), were approved by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) in February 2025. In Europe, OBODENCE was launched in December 2025, consequently followed by the launch of XBRYK in January 2026. As of January 2026, four products are directly commercialized by Samsung Bioepis in Europe, namely EPYSQLI (eculizumab), OBODENCE (denosumab), XBRYK (denosumab), and BYOOVIZ™ (ranibizumab). 5 PYZCHIVA™ (SB17), a biosimilar to Stelara 6 (ustekinumab), was launched in the US in partnership with Sandoz in February 2025. PYZCHIVA has also been available as private label brands since the second and third quarter of 2025. In Japan, SB17 was approved as Ustekinumab BS Subcutaneous Injection 45mg Syringes 「NIPRO」 by Pharmaceuticals and Medical Devices Agency (PMDA) in December 2025. It is the first product to gain marketing approval in Japan under the partnership with NIPRO CORPORATION entered in June 2025. Samsung Bioepis entered into a partnership agreement with Harrow for commercialization of BYOOVIZ (SB11), a biosimilar referencing Lucentis 7 (ranibizumab) and OPUVIZ™ (SB15), a biosimilar referencing Eylea 8 (aflibercept), in the US. Fiscal Year 2026 Outlook Samsung Epis Holdings is actively supporting its subsidiaries' core businesses under the holding company structure, with a goal of increasing global biosimilar sales by more than 10% compared YoY. Samsung Bioepis plans to secure 20 biosimilars in its portfolio by 2030, including dupilumab, guselkumab, ixekizumab, trastuzumab deruxtecan, vedolizumab, and ocrelizumab. Beyond biosimilars, the company has also embarked on its novel therapeutic development. It plans to have one novel therapeutic candidate enter into clinical study every year, starting with SBE303. SBE303 is Samsung Bioepis’ first novel antibody-drug conjugate (ADC) engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including bladder cancer, urothelial cancer, lung cancer, and breast cancer. 9 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year. Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform. About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . 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 biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Epis NexLab Co., Ltd. Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: . 1 The year-over-year (YoY) change in operating profit is reflective of the ‘milestone payment’ – a payment system that pays out upon completion of specific milestones within a project’s development. 2 Soliris is a trademark of Alexion Pharmaceuticals, Inc. 3 SB16 was approved under different names in Europe and the US; OBODENCE in Europe and OSPOMYV in the US 4 Prolia and Xgeva are trademarks of Amgen Inc. 5 In Europe, Samsung Bioepis has assumed full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026. 6 Stelara is a trademark of Johnson & Johnson Corporation. 7 Lucentis is a trademark of Genentech Inc. 8 Eylea is a trademark of Regeneron Pharmaceuticals, Inc 9 Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101. Contacts Media Contact Yoon Kim, yoon1.kim@samsung.com Anna Nayun Kim, nayun86.kim@samsung.com

Drug ApprovalPhase 1

15 Jan 2026

·www.biospace.com

Samsung Epis Holdings Delivers Business Updates at the 44th J.P. Morgan Healthcare Conference

Samsung Bioepis plans to secure 20 biosimilars in its products and pipeline by 2030 The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab, in addition to pembrolizumab currently in Phase 1 and 3 clinical studies Having secured investigational new drug application (IND) clearance from the U.S. Food and Drug Administration (FDA), SBE303, Samsung Bioepis’ novel antibody-drug conjugate (ADC) engineered to target Nectin-4, will enter into the Phase 1 first-in-human clinical trial this year Samsung Bioepis plans to add one novel therapeutic candidate in clinical study every year INCHEON, Korea--(BUSINESS WIRE)-- #ADC --Samsung Epis Holdings (KRX: 0126Z0) today shared corporate progress and updates at the 44th J.P. Morgan Healthcare Conference. "2026 is a monumental year for us, as we enter into a new chapter for our company. Today, we are announcing six additional candidates in our biosimilar pipeline, including vedolizumab and dupilumab. We are making great progress to secure 20 biosimilars in our portfolio by 2030," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We also received the investigational new drug application (IND) clearance for the first novel therapeutic candidate developed by Samsung Bioepis, and plan to advance our clinical program this year. As we broaden our portfolio beyond biosimilars, we will continue our development efforts in antibody-drug conjugates (ADCs), leveraging our innovative research and development platform to expand viable treatment options for patients with unmet needs.” Samsung Bioepis Biosimilar Updates Samsung Bioepis currently has 11 biosimilars for 10 unique biological molecules approved and launched in more than 40 countries. 1 The company has pembrolizumab biosimilar undergoing Phase 1 and 3 clinical studies, and plans to secure 20 biosimilars in its portfolio by 2030. The new pipeline will include dupilumab, guselkumab, ixekizumab, fam-trastuzumab deruxtecan-nxki, vedolizumab, and ocrelizumab. Novel Therapeutics Updates In December 2025, the FDA has cleared the IND Application for SBE303. SBE303 is Samsung Bioepis’ first novel ADC engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer. 2 The Phase 1 first-in-human clinical trial, aiming to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of SBE303 in participants with advanced refractory solid tumors, is set to begin this year. Samsung Bioepis plans to have one novel therapeutic candidate enter into clinical study every year. Epis NexLab, the new subsidiary under Samsung Epis Holdings, has launched a project to develop a peptide-based drug delivery platform. Samsung Bioepis Biosimilars Portfolio Code Name (Brand Name 3 ) Non-proprietary Name Reference Product Status 4 SB5 (IMRALDI™, HADLIMA™, ADALLOCE™) Adalimumab Humira Launch SB4 (BENEPALI™, BRENZYS™, ETOLOCE™) Etanercept Enbrel Launch SB2 (FLIXABI™, RENFLEXIS™, REMALOCE™) Infliximab Remicade Launch SB3 (ONTRUZANT™, SAMFENET™) Trastuzumab Herceptin Launch SB8 (AYBINTIO™) Bevacizumab Avastin Launch SB11 (BYOOVIZ™, AMELIVU™) Ranibizumab Lucentis Launch SB12 (EPYSQLI™) Eculizumab Soliris Launch SB15 (OPUVIZ™, AFILIVU™) Aflibercept Eylea Launch SB16 (OBODENCE™, OSPOMYV™) Denosumab Prolia Launch SB16 (XBRYK™) Denosumab Xgeva Launch SB17 (PYZCHIVA™, EPYZTEK™) Ustekinumab Stelara Launch SB27 Pembrolizumab Keytruda Phase 1 and 3 Samsung Bioepis Biosimilar Candidates in Early Stage Development Non-proprietary Name Reference Product Dupilumab Dupixent Guselkumab Tremfya Ixekizumab Taltz Vedolizumab Entyvio Ocrelizumab Ocrevus Fam-trastuzumab deruxtecan-nxki Enhertu About Samsung Epis Holdings Co., Ltd. As an investment holdings company dedicated to biopharmaceuticals and biotechnology, Samsung Epis Holdings aims to maximize corporate and shareholder value through proactive R&D and investment and optimize business strategies for its subsidiaries, Samsung Bioepis and Epis NexLab. Samsung Epis Holdings continues to embrace future challenges and drive innovation by identifying new growth drivers and strengthening global collaboration platforms, thereby laying a solid foundation for the continued growth of its subsidiaries. For more information about Samsung Epis Holdings, please visit: . 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 biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, neurology, and endocrinology. For more information, please visit and follow us on LinkedIn and X . About Epis NexLab Co., Ltd. Established in 2025 as a 100% owned subsidiary of Samsung Epis Holdings, Epis NexLab is committed to driving innovation through the development of next-generation biotechnology platforms. By transforming highly scalable peptide-related technologies into development platforms, Epis NexLab is focused on the discovery of innovative treatment modalities for the development of multiple therapeutic candidates targeting a wide range of diseases. For more information about Epis NexLab, please visit: . 1 “more than 40 countries” signifies countries where Samsung Bioepis has commercial presence, with one or more products. 2 Li K, Zhou Y, Zang M, Jin X, Li X. Therapeutic prospects of nectin-4 in cancer: applications and value. Front Oncol. 2024 Mar 28;14:1354543. doi: 10.3389/fonc.2024.1354543. PMID: 38606099; PMCID: PMC11007101. 3 Different brand names for different regions and countries. 4 “Launch” signifies launch in one or more markets and does not necessarily indicate launch in all markets worldwide Contacts Media Contact Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com

Phase 1INDADC

29 Oct 2025

·www.businesswire.com

Samsung Bioepis to Commercialize BYOOVIZ ® (ranibizumab) in Europe from January 2026

INCHEON, Korea--(BUSINESS WIRE)--Samsung Bioepis Co., Ltd. announced today that the company has entered into an Asset Purchase Agreement (APA) with Biogen regarding Samsung Bioepis’ two ophthalmology assets: BYOOVIZ® (ranibizumab), a biosimilar referencing Lucentisi (ranibizumab) and OPUVIZ™ (aflibercept), a biosimilar referencing Eyleaii (aflibercept) — in Europe. Samsung Bioepis will have full responsibility for commercialization of BYOOVIZ upon the transfer of commercial rights from Biogen back to Samsung Bioepis, effective as of January 2026. We are pleased to announce our direct commercialization initiative for BYOOVIZ in Europe. We will work closely with Biogen to ensure a seamless transition and the continued delivery of services to our customers and patients in Europe. “We are pleased to announce our direct commercialization initiative for BYOOVIZ in Europe. We will work closely with Biogen to ensure a seamless transition and the continued delivery of services to our customers and patients in Europe,” said Linda Choi MacDonald, Executive Vice President and Global Head of Commercial, at Samsung Bioepis. “Samsung Bioepis will continue to broaden our reach to patients across Europe by reinforcing our leadership and expertise in biosimilars.” BYOOVIZ (ranibizumab) was approved by the European Commission (EC) in August 2021 as the first ophthalmology biosimilar in Europe 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 became commercially available in several countries within Europe from March 2023. OPUVIZ (aflibercept) was approved by the EC in November 2024 and by the Medicines and Healthcare products Regulatory Agency (MHRA) in April 2025 for the treatment of patients with Wet AMD, Visual Impairment due to Macular Oedema Secondary to RVO, Visual Impairment due to Diabetic Macular Edema (DME), and Visual Impairment due to mCNV. OPUVIZ will not be launched until after the lapse or revocation of relevant patent(s) for the reference biologic Eylea that also covers OPUVIZ in Europe. 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. Lucentis is a trademark of Genentech, Inc. Eylea is a trademark of Bayer AG

Drug 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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Evaluation

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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))	vohtuskhzr(yhogqwhole) = hyrypocvlk ucgvfulwpj (tbaedpzzsl, 0.56) View more	-	05 Feb 2024
				SB15 (Proposed aflibercept biosimilar)+Eylea (Eylea (Aflibercept))	vohtuskhzr(yhogqwhole) = bffyonsexj ucgvfulwpj (tbaedpzzsl, 0.57) View more
EURETINA2023 Manual	Phase 3	Wet age-related macular degeneration	438	SB15	rmohtgfrtg(uavctrrmlu) = svfkjwgzpj tkwyzkpuip (rnissawnya ) View more	Positive	05 Oct 2023
				Aflibercept	rmohtgfrtg(uavctrrmlu) = bqmtexkdld tkwyzkpuip (rnissawnya ) View more
EURETINA2023 Manual	Phase 3	Age Related Macular Degeneration	449	SB15	tzdbusvaad(omtoetbttc) = wpxrdgezlg zekafvmkvm (rluxsergdx )	Similar	05 Oct 2023
				Aflibercept	tzdbusvaad(omtoetbttc) = smcoabwzji zekafvmkvm (rluxsergdx )
EURETINA2023	Not Applicable	Wet age-related macular degeneration	-	SB15	hlzpfcqfpx(ootadmdsps) = fxlmcnkher ljjgsudzea (wrxypncvmj ) View more	-	05 Oct 2023
				AFL	hlzpfcqfpx(ootadmdsps) = hclmiqojqw ljjgsudzea (wrxypncvmj ) View more
NCT04450329 (Pubmed)	Phase 3	Wet age-related macular degeneration	449	SB15	krobttbggh(qmsufivqla) = qacegmvbzc gjcthshwnw (leuxyaiuuy ) View more	-	08 Jun 2023
				AFL	krobttbggh(qmsufivqla) = wkqpxjlvvb gjcthshwnw (leuxyaiuuy ) View more
NCT04450329 (ARVO2023)	Phase 3	Wet age-related macular degeneration	449	SB15 2 mg	cbouwsmjna(jzcmpalxee) = qoftyhwgaq phogklnxze (zgzhoswwmm )	Positive	01 Jun 2023
				Aflibercept	cbouwsmjna(jzcmpalxee) = pctfblrwoi phogklnxze (zgzhoswwmm )
AAO2022	Phase 3	-	-	SB15	iekoypxsei(cdjdzjucjn) = uetqazlaly jmqvtdgmcl (lpcrmlmrsg )	Positive	29 Sep 2022
				Aflibercept	iekoypxsei(cdjdzjucjn) = wafdtcqffl jmqvtdgmcl (lpcrmlmrsg )

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