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

01 Apr 2026·DRUGS & AGING

Anti-Vascular Endothelial Growth Factor Biosimilars for Use in the Aging Eye

Review

Author: Kuppermann, Baruch D ; Sharma, Ashish ; Sheth, Jay U

Anti-vascular endothelial growth factor (anti-VEGF) therapies have revolutionized the treatment of neovascular age-related macular degeneration (nAMD), a leading cause of vision loss, in addition to other retinal vascular diseases such as diabetic macular edema (DME), retinal vein occlusions (RVO). Biosimilars, which are nearly identical versions of original biologic drugs, offer a promising alternative to these costly treatments. Several biosimilars for anti-VEGF drugs including bevacizumab, ranibizumab, and aflibercept are in various stages of development and approval (e.g. Afilivu, Yesafili, Enzeevu, Ahzantive, AVT-06, ABP 938, and ALT L9). These biosimilars have shown comparable results in improving visual acuity and reducing retinal fluid in patients with nAMD but their adoption in clinical practice faces challenges, including regulatory hurdles, physician and patient acceptance, and the need for extensive post-marketing surveillance to monitor long-term safety and efficacy. However, as more data becomes available and biosimilars gain approval, they are expected to become an integral component in the management of nAMD. This review explores the current landscape of anti-VEGF biosimilars, their clinical efficacy, safety profiles, and the economic implications for treating the aging eye. It also addresses the challenges and future directions in the integration of biosimilars into routine ophthalmic practice.

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 ; Song, Jinsu ; Lee, Hangyeore ; 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.

News (Medical) associated with AFLIBERCEPT-YSZY

24 Jul 2026

·www.biospace.com

Samsung Epis Holdings Reports Second Quarter and Half-Year 2026 Financial Results

Samsung Bioepis reports revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026, recording 6% year-over-year growth Expanding direct commercialization in Europe to five products with the launch of OPUVIZ™ 40 mg/mL vial, a biosimilar to Eylea 1 (aflibercept) First to announce preliminary results from Phase 1, 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda 2 (pembrolizumab) Samsung Epis Holdings continuing to secure next-generation growth engines through establishment of a global R&D hub in China INCHEON, Korea--(BUSINESS WIRE)-- #biosimilars --Samsung Epis Holdings (KRX: 0126Z0), an investment company dedicated to innovations in biopharmaceuticals and biotechnology, today announced its financial results for the second quarter and first half of fiscal year 2026. “We delivered solid first-half 2026 results, achieving 6% growth year-over-year. This performance demonstrates the resilience of our biosimilar portfolio in the global market," said Kyung-Ah Kim, President and Chief Executive Officer (CEO) of Samsung Epis Holdings. “We remain confident in our growth trajectory; increasing product demand in Europe and the US is expected to be reflected sequentially in the second-half results, which would result in steady business performance for the fiscal year.” Second Quarter and First Half 2026 Results – Samsung Bioepis Samsung Bioepis, a 100% owned subsidiary of Samsung Epis Holdings, recorded revenue of 847.1 billion KRW and an operating profit of 230.6 billion KRW in the first half of 2026. This represents an increase of 45.5 billion KRW (+6%) in revenue and 12.8 billion KRW (+6%) in operating profit compared to the same period last year. ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); For the second quarter, the company recorded revenue of 392.2 billion KRW and an operating profit of 86.6 billion KRW; revenue and operating profit decreased by 8.8 billion KRW (-2%) and by 3.2 billion KRW (-4%) respectively compared to the same period last year. [Samsung Bioepis Earnings, KRW billion] H1’25 H1’26 YoY Change Q2’25 Q2’26 YoY Change Revenue 801.6 847.1 45.5 (+6%) 401.0 392.2 -8.8 (-2%) Operating Profit 217.8 230.6 12.8 (+6%) 89.8 86.6 -3.2 (-4%) Business Updates Samsung Bioepis has expanded direct commercialization in Europe to five products with the launch of OPUVIZ (aflibercept) 40 mg/mL vial in May 2026. In the US, the company has expanded its market presence with the introduction of OSPOMYV ® (denosumab-dssb). Furthermore, the company is expanding its commercial footprint in international markets, including Japan where it launched its first biosimilar product in May 2026 through partnership with NIPRO Corporation. The company also announced the expansion of its global development and commercialization agreement with Organon to commercialize PYZCHIVA ® (ustekinumab), a biosimilar referencing Stelara 3 (ustekinumab), in Canada. In June 2026, the company announced preliminary results from Phase 1 and Phase 3 clinical studies for SB27, a biosimilar candidate referencing Keytruda (pembrolizumab). Phase 1 study demonstrated pharmacokinetic (PK) equivalence between SB27 and Keytruda while Phase 3 study demonstrated equivalent objective response rate (ORR) at Week 24. Both studies are expected to be completed within 2026. SBE303, the company's first novel antibody-drug conjugate (ADC) candidate, entered the global Phase 1 clinical study in March. SBE303 is engineered to bind to Nectin-4, an adhesion protein that is specifically expressed in tumor cells, including urothelial cancer, lung cancer, and breast cancer. Nonclinical characterization of SBE303 was presented at the 2026 American Association for Cancer Research (AACR) Annual Meeting in April, highlighting its anti-tumor efficacy, safety, tolerability pro a promising ability to work in combination with existing immuno-oncology therapies. Second Quarter and First Half 2026 Results – Samsung Epis Holdings Samsung Epis Holdings recorded consolidated revenue of 845.8 billion KRW and an operating profit of 149.3 billion KRW in the first half of 2026, reflecting non-cash accounting adjustments. For the second quarter, the company achieved revenue of 391.9 billion KRW and an operating profit of 58.8 billion KRW. Samsung Epis Holdings is stabilizing its business under the holding company structure based on the solid performance of its core subsidiary, Samsung Bioepis, and established its first overseas R&D base in China to strengthen its novel therapeutic development capabilities. Disclaimer This document contains ‘forward-looking statements’ regarding future expectations, projections, plans, and anticipation. ‘Forward-looking statements’ are matters that pertain to the Company’s future business and financial performance, and are subject to uncertainties such as trends in domestic and international financial markets, including but not limited to fluctuations in exchange rates and/or interest rates. ‘Forward-looking statements,’ by their nature, addresses matters that may be uncertain; actual results may be materially different from those expressed in this document. 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. As a wholly owned subsidiary of Samsung Epis Holdings, 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 . 1 Eylea is a trademark of Bayer AG 2 Keytruda is a trademark of Merck Sharp & Dohme. 3 Stelara is a trademark of Johnson & Johnson Corporation. Contacts Media Contact Anna Nayun Kim, nayun86.kim@samsung.com Yoon Kim, yoon1.kim@samsung.com

09 Jul 2026

·www.biospace.com

Teva and Samsung Bioepis Enter Commercialization Agreement for OPUVIZ®, a Biosimilar Referencing Eylea® (aflibercept), in Canada

TORONTO, Canada and INCHEON, South Korea , July 9, 2026 /CNW/ - Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) (TASE: TEVA) and Samsung Bioepis Co., Ltd. today announced that the companies have entered into a license and commercialization agreement for OPUVIZ ® (aflibercept), a biosimilar referencing Eylea ®1 (aflibercept), in Canada. Under the agreement, Samsung Bioepis is responsible for registration and manufacture of the products, while Teva Canada (a subsidiary of Teva Pharmaceutical Industries Ltd.) is responsible for commercialization. "This agreement is an important step in strengthening our biosimilars portfolio in Canada," said Fabien Paquette, General Manager, Teva Canada. "It continues to build on our momentum in biosimilars, to expand our ophthalmology footprint, and reflects our commitment to bringing high-quality treatment options to Canadian patients and healthcare professionals through strategic partnerships." "This agreement represents an important step in advancing our growth strategy in North America and expanding access of ophthalmic biologic medicines in Canada," said Kwang Ryu, Vice President and Team Leader of Business Development at Samsung Bioepis. "Through our collaboration with Teva we are committed to expanding access to high-quality treatment options in Canada and helping more patients benefit from timely and sustainable care." OPUVIZ received Health Canada approval in October 2025 and is indicated for the treatment of neovascular (wet) age-related macular degeneration (AMD), visual impairment resulting from macular edema secondary to central retinal vein occlusion (CRVO) or branch retinal vein occlusion (BRVO), diabetic macular edema (DME), and myopic choroidal neovascularization (mCNV). Samsung Bioepis' aflibercept biosimilar is also available in Europe and in Republic of Korea. Teva Canada will provide further details on the anticipated Canadian market launch of OPUVIZ ® at the appropriate time. Please see Product Monograph for OPUVIZ (aflibercept) including important safety information HERE . DISCLAIMER This press release is intended solely for the purpose of sharing the availability of OPUVIZ in Canada. This document should not be construed as medical advice or as an endorsement of any product or treatment. Regulatory approval status and prescribing information may vary by country; please refer to local product information for any medicinal products mentioned herein. Information in this press release may include data on investigational compounds or unapproved indications. Such information is shared for scientific discussion purposes only and does not represent an assertion of safety or efficacy for any unapproved use. This press release may contain forward-looking statements, including statements regarding clinical development programs, regulatory submissions, potential approvals, and future therapeutic potential. These statements are based on current expectations and assumptions and are subject to risks and uncertainties that could cause actual results to differ materially. Forward-looking statements are not guarantees of future performance. Samsung Bioepis undertakes no obligation to update any forward-looking statements contained in this press release. About Teva Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) is transforming into a leading innovative biopharmaceutical company, enabled by a world-class generics business. For over 120 years, Teva's commitment to bettering health has never wavered. From innovating in the fields of neuroscience and immunology to providing complex generic medicines, biosimilars, and pharmacy brands worldwide, Teva is dedicated to addressing patients' needs, now and in the future. At Teva, We Are All In For Better Health . To learn more about how, 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. As a wholly owned subsidiary of Samsung Epis Holdings, Samsung Bioepis continues to advance a broad pipeline of biologic candidates that cover a spectrum of therapeutic areas, including immunology, oncology, ophthalmology, hematology, nephrology, endocrinology and neurology. For more information, please visit and follow us on LinkedIn and X . Teva Cautionary Note Regarding Forward Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, which are based on management's current beliefs and expectations and are subject to substantial risks and uncertainties, both known and unknown, that could cause our future results, performance or achievements to differ significantly from that expressed or implied by such forward-looking statements. You can identify these forward-looking statements by the use of words such as "should," "expect," "anticipate," "estimate," "target," "may," "project," "intend," "plan," "believe" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Important factors that could cause or contribute to such differences include risks relating to: our ability to successfully execute our license, development and commercialization agreement with Samsung Bioepis Co., Ltd. for OPUVIZ (aflibercept), a biosimilar referencing Eylea ® ; our ability to successfully commercialize OPUVIZ (aflibercept) in Canada; our ability to successfully compete in the marketplace including our ability to develop and commercialize additional pharmaceutical products; our ability to successfully execute on our Pivot to Growth strategy, including to expand our innovative and biosimilar medicines pipeline and profitably commercialize the innovative medicines and biosimilar portfolio, whether organically or through business development, and to execute on our organizational transformation and to achieve expected cost savings; and other factors discussed in this press release, in our Quarterly Report on Form 10-Q for the first quarter of 2026 and in our Annual Report on Form 10-K for the year ended December 31, 2025, including in the sections captioned "Risk Factors" and Forward-Looking Statements." Forward-looking statements speak only as of the date on which they are made, and we assume no obligation to update or revise any forward-looking statements or other information contained herein, whether as a result of new information, future events or otherwise. You are cautioned not to put undue reliance on these forward-looking statements. 1 Eylea ® is a trademark of Regeneron Pharmaceuticals, Inc. SOURCE Teva Canada

License out/inDrug Approval

02 Jul 2026

·retinalphysician.com

Byooviz Returns to US Market Through Harrow Partnership

Samsung Bioepis has announced the relaunch of Byooviz (ranibizumab-nuna) in the United States in partnership with Harrow. In July 2025, Samsung Bioepis entered into a commercialization agreement with Harrow for Byooviz, a biosimilar referencing ranibizumab (Lucentis; Genentech), and Opuviz (aflibercept-yszy), a biosimilar referencing aflibercept (Eylea; Regeneron). Following the full transition of commercialization rights from Biogen back to Samsung Bioepis at the end of 2025, Harrow assumed responsibility for commercialization of both products in the United States, while Samsung Bioepis remains responsible for their development, regulatory registration, and manufacturing, according to a company press release. Byooviz was approved by the US Food and Drug Administration (FDA) in September 2021 as the first ophthalmic biosimilar in the United States for the treatment of neovascular age-related macular degeneration, macular edema following retinal vein occlusion, and myopic choroidal neovascularization. The FDA granted Byooviz an interchangeability designation in October 2023. Outside the United States, Byooviz was approved by the European Commission and the United Kingdom in August 2021, and in Canada in March 2022. Samsung Bioepis is responsible for the product's direct commercialization in Europe. RP

Drug ApprovalLicense out/inBreakthrough Therapy

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))	kkadtqveji(becuflhbyr) = cmxdykzfas xktplaiqqd (cnsnczhzyd, 0.56) View more	-	05 Feb 2024
				SB15 (Proposed aflibercept biosimilar)+Eylea (Eylea (Aflibercept))	kkadtqveji(becuflhbyr) = gjkquvqqpm xktplaiqqd (cnsnczhzyd, 0.57) View more
EURETINA2023 Manual	Phase 3	Wet age-related macular degeneration	438	SB15	hhdexjxuht(hxljljsfuf) = zadbvezrzb iwgomlbyke (ggafynhjrr ) View more	Positive	05 Oct 2023
				Aflibercept	hhdexjxuht(hxljljsfuf) = ixzpwdpnyz iwgomlbyke (ggafynhjrr ) View more
EURETINA2023 Manual	Phase 3	Age Related Macular Degeneration	449	SB15	rirdueremg(adsgoltlzu) = zyhouqzrfw ifaflnfaxc (wlzbemakpb )	Similar	05 Oct 2023
				Aflibercept	rirdueremg(adsgoltlzu) = ulaszslhxn ifaflnfaxc (wlzbemakpb )
EURETINA2023	Not Applicable	Wet age-related macular degeneration	-	SB15	afbvzleoxt(vntejazvbi) = shfnjaxjcm lubgqdysot (jpmosnpnub ) View more	-	05 Oct 2023
				AFL	afbvzleoxt(vntejazvbi) = wmxqudwtxy lubgqdysot (jpmosnpnub ) View more
NCT04450329 (Pubmed)	Phase 3	Wet age-related macular degeneration	449	SB15	urcunpdhdc(ebpozvrdfx) = znnxzmzmag buyxfepopd (wtwzldctwr ) View more	-	08 Jun 2023
				AFL	urcunpdhdc(ebpozvrdfx) = ksonainxdw buyxfepopd (wtwzldctwr ) View more
NCT04450329 (ARVO2023)	Phase 3	Wet age-related macular degeneration	449	SB15 2 mg	npdgdtfedn(uqfgsoisxt) = bfqkgvnqll uwlbqxyysv (bfiiyofktm )	Positive	01 Jun 2023
				Aflibercept	npdgdtfedn(uqfgsoisxt) = dhtetlwetd uwlbqxyysv (bfiiyofktm )
AAO2022	Phase 3	-	-	SB15	cjeresmxaf(aqpnzyudkx) = pkfqcelvxl gpwddjlvkh (pxkkafnzcz )	Positive	29 Sep 2022
				Aflibercept	cjeresmxaf(aqpnzyudkx) = dsjmtubhbl gpwddjlvkh (pxkkafnzcz )

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