阿柏西普生物类似药（Alvotech）(Aflibercept biosimilar (Alvotech)) - 药物靶点：PGF x VEGF-A_在研适应症：年龄相关性黄斑变性，糖尿病性黄斑水肿，近视脉络膜新生血管_专利_临床

概要

基本信息

药物类型

Fc融合蛋白、生物类似药

别名

Aflibercept Biosimilar (Alvotech hf)、阿柏西普生物类似药（Alvotech hf）、AVT-06

+ [5]

靶点

PGF x VEGF-A

作用方式

抑制剂

作用机制

PGF抑制剂(胎盘生长因子抑制剂)、VEGF-A抑制剂(血管内皮生长因子A抑制剂)

治疗领域

心血管疾病遗传病与畸形内分泌与代谢疾病+ [2]

在研适应症

年龄相关性黄斑变性糖尿病性黄斑水肿近视脉络膜新生血管+ [4]

非在研适应症-

原研机构

Alvotech hf

在研机构

Advanz Pharma Ltd.

Alvotech hf

Fuji Pharma Co., Ltd.

+ [3]

非在研机构-

权益机构

Fuji Pharma Co., Ltd.

Alvotech hf

Polifarma SpA

+ [7]

最高研发阶段批准上市

首次获批日期

欧盟 (2025-08-18),

糖尿病性黄斑水肿近视脉络膜新生血管视网膜静脉阻塞相关黄斑水肿+ [1]

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 4715606

当前序列信息引自: *****

关联

5

项与阿柏西普生物类似药（Alvotech）相关的临床试验

NCT07489131

/ Recruiting临床3期

A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared With Eylea HD in Participants With Diabetic Macular Edema

This is a Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT29 Compared with Eylea HD in Participants with Diabetic Macular Edema.

开始日期2026-04-22

申办/合作机构

Alvotech Swiss AG

CTIS2023-505225-13-00

/ Not yet recruiting临床3期

Single-arm, open label, multicenter clinical study to evaluate the handling and safety of AVT06 pre-filled syringe (PFS) in subjects with chorioretinal vascular disease followed by an optional extension phase of AVT06 pre-filled syringe (PFS).

开始日期2024-03-11

申办/合作机构

Alvotech Swiss AG

NCT05155293

/ Completed临床3期

A Randomized, Double-masked, Parallel-group, Multicenter Clinical Study to Evaluate the Efficacy and Safety of AVT06 Compared With EU-Eylea® in Subjects With Neovascular (Wet) Age-related Macular Degeneration (ALVOEYE)

This is a randomized, double-masked, parallel-group, multicenter, therapeutic equivalence study evaluating the efficacy, safety, and immunogenicity of AVT06 compared with Eylea in subjects with neovascular (wet) AMD.

开始日期2022-06-28

申办/合作机构

Alvotech Swiss AG

100 项与阿柏西普生物类似药（Alvotech）相关的临床结果

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100 项与阿柏西普生物类似药（Alvotech）相关的转化医学

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100 项与阿柏西普生物类似药（Alvotech）相关的专利（医药）

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2

项与阿柏西普生物类似药（Alvotech）相关的文献（医药）

2025-07-03·EXPERT OPINION ON BIOLOGICAL THERAPY

A randomized, double-masked parallel-group, multicenter clinical study evaluating the efficacy and safety of the biosimilar candidate AVT06 compared to the reference product aflibercept in participants with neovascular age-related macular degeneration

Article

作者: Agostini, Hansjürgen ; Balčiūnienė, Vilma Jūratė ; Otto, Hendrik ; Soni, Riken ; Rai, Masna ; Sattar, Abid ; Berti, Fausto ; Ozols, Kaspars ; Baumane, Kristine ; Hamdi, Sabrina ; Cirillo, Silvia ; Leutz, Steffen

BACKGROUND:

This study compared efficacy, pharmacokinetics (PK), immunogenicity, and safety between AVT06, proposed biosimilar to reference product (RP) aflibercept (Eylea®), in participants with neovascular age-related macular degeneration (nAMD).

METHODS:

In this randomized, double-masked, multicenter, active-controlled trial, treatment naïve participants received intravitreal injections of AVT06 or RP (2 mg) over 48 weeks. The primary endpoint was the change from baseline to Week 8 in best-corrected visual acuity (BCVA). Secondary endpoints included BCVA improvements and changes in Central Subfield Thickness (CST). PK, immunogenicity, and safety were also assessed.

RESULTS:

The 90% and 95% confidence intervals (-0.60, 2.14 and -0.86, 2.40, respectively) in least squares mean difference in BCVA letter score from baseline to Week 8 were contained within the pre-specified equivalence margin of ETDRS BCVA letter score of [-3.5 to 3.5], supporting the demonstration of comparative efficacy. Secondary efficacy outcomes were also comparable. PK analyses supported systemic safety. There were no clinically meaningful differences in immunogenicity profiles. Safety profiles were similar; most treatment-emergent adverse events were mild and unrelated to the study drug.

CONCLUSIONS:

Results supported a demonstration of comparable efficacy between AVT06 and RP aflibercept. Similar PK, immunogenicity, and safety profiles were also shown.

CLINICAL TRIAL REGISTRATION:

ClinicalTrials.gov identifier is NCT05155293; ClinicalTrialsRegister.eu identifier is 2021-003651-42.

Frontiers in Pharmacology

Efficacy and safety of aflibercept biosimilars compared to aflibercept in the treatment of neovascular age-related macular degeneration: a systematic review and meta-analysis

Review

作者: Zhou, Yating ; Wang, Zixun ; Zhan, Zongyue ; Liu, Chen

Background:

This study aimed to evaluate the aflibercept biosimilars compared to the reference product aflibercept (Eylea®) in terms of efficacy, safety, and immunogenicity in patients with neovascular age-related macular degeneration (nAMD).

Methods:

We searched PubMed, Web of Science, Cochrane Library, and Embase from inception to 13 August 2025. We included studies reporting changes in best-corrected visual acuity (BCVA), changes in central subfield thickness (CST), changes in the leakage lesion of choroidal neovascularization (CNV), and adverse events from baseline to endpoint. All statistical analyses were performed using Stata 18.0 software and assessed the certainty of evidence for each outcome using the GRADE approach.

Results:

A total of seven studies involving 2,829 participants were included. There were no statistically significant differences in visual and anatomical outcomes between the aflibercept biosimilars (SB15, P041, SDZ-AFL, AVT06, SCD411, ABP 938, and QL1207) and the reference aflibercept. No significant differences were detected between aflibercept biosimilars and the reference aflibercept with respect to serious ocular and non-ocular adverse events [relative risk (RR) = 1.71, 95% confidence interval (CI): 0.70, 4.19; I2 = 0.0%, P = 0.913; RR = 1.08, 95% CI: 0.82, 1.42; I2 = 0.0%, P = 0.936, respectively). Although a slightly higher rate of treatment-emergent adverse events (TEAEs) was noted in the biosimilar group (RR = 1.07, 95% CI: 1.00–1.15; I 2 = 26.1%), the difference was not statistically significant ( P = 0.248).

Conclusion:

Based on the seven included randomized controlled clinical trials, aflibercept biosimilars demonstrated comparable safety and efficacy to the reference aflibercept. Future research requires more rigorous studies.

76

项与阿柏西普生物类似药（Alvotech）相关的新闻（医药）

2026-08-27

·GlobeNewswire-Health Care

Alvotech to present at upcoming investor conferences in September

REYKJAVIK, ICELAND (August 27, 2026) — Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Robert Wessman, Founder and Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in September as follows: Morgan Stanley 24th Annual Global Healthcare Conference in New York – Fireside chat on Tuesday, September 15, 2026 at 12:20 pm ET (16:20 GMT)Deutsche Bank's 2026 Healthcare Summit in New York – Hosting investor meetings on Thursday, September 17, 2026. A live webcast of the fireside chat will be available to the general public and can be accessed in the Investors Section of Alvotech's website under Events and Presentations. After the event, a recording will be available for replay for 90 days. For further information, contact: MediaBenedikt StefanssonSarah MacLeodalvotech.media@alvotech.com InvestorsDr. Balaji V PrasadBenedikt StefanssonMikaela Vilchezalvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.

生物类似药

2026-08-27

·GlobeNewswire-Health Care

Alvotech to present at upcoming investor conferences in September

REYKJAVIK, Iceland, Aug. 27, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Robert Wessman, Founder and Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in September as follows: Morgan Stanley 24th Annual Global Healthcare Conference in New York – Fireside chat on Tuesday, September 15, 2026 at 12:20 pm ET (16:20 GMT)Deutsche Bank's 2026 Healthcare Summit in New York – Hosting investor meetings on Thursday, September 17, 2026. A live webcast of the fireside chat will be available to the general public and can be accessed in the Investors Section of Alvotech's website under Events and Presentations. After the event, a recording will be available for replay for 90 days. For further information, contact: MediaBenedikt StefanssonSarah MacLeodalvotech.media@alvotech.com InvestorsDr. Balaji V PrasadBenedikt StefanssonMikaela Vilchezalvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit https://www.alvotech.com. None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn, Facebook, Instagram, and YouTube.

生物类似药

2026-08-27

·BioSpace

Alvotech to present at upcoming investor conferences in September 2026

REYKJAVIK, ICELAND (August 27, 2026) — Alvotech (NASDAQ: ALVO; ALVO-SDB), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that Robert Wessman, Founder and Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in September as follows: Morgan Stanley 24 th Annual Global Healthcare Conference in New York – Fireside chat on Tuesday, September 15, 2026 at 12:20 pm ET (16:20 GMT) Deutsche Bank's 2026 Healthcare Summit in New York – Hosting investor meetings on Thursday, September 17, 2026. A live webcast of the fireside chat will be available to the general public and can be accessed in the Investors Section of Alvotech's website under Events and Presentations . After the event, a recording will be available for replay for 90 days. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad Benedikt Stefansson Mikaela Vilchez alvotech.ir@alvotech.com About Alvotech Alvotech is a biotechnology company, founded by Robert Wessman, focused solely on the development and manufacture of biosimilar medicines for patients worldwide. Alvotech seeks to be a global leader in the biosimilar space by delivering high-quality, cost-effective products and services, enabled by a fully integrated approach and broad in-house capabilities. Five biosimilars are already approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept) and Prolia®/Xgeva® (denosumab). The current development pipeline includes disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, and cancer. Alvotech has formed a network of strategic commercial partnerships to provide global reach and leverage local expertise in markets that include the United States, Europe, Japan, China, and other Asian countries and large parts of South America, Africa and the Middle East. For more information, please visit None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our website or follow us on social media on LinkedIn , Facebook , Instagram , and YouTube .

生物类似药

100 项与阿柏西普生物类似药（Alvotech）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L01XX44 S01LA05	-

研发状态

批准上市

10 条最早获批的记录,

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适应症	国家/地区	公司	日期
年龄相关性黄斑变性	日本	Fuji Pharma Co., Ltd.	2025-09-19
糖尿病性黄斑水肿	欧盟	Advanz Pharma Ltd.	2025-08-18
糖尿病性黄斑水肿	欧盟	STADA Arzneimittel AG	2025-08-18
糖尿病性黄斑水肿	冰岛	STADA Arzneimittel AG	2025-08-18
糖尿病性黄斑水肿	冰岛	Advanz Pharma Ltd.	2025-08-18
糖尿病性黄斑水肿	列支敦士登	Advanz Pharma Ltd.	2025-08-18
糖尿病性黄斑水肿	列支敦士登	STADA Arzneimittel AG	2025-08-18
糖尿病性黄斑水肿	挪威	STADA Arzneimittel AG	2025-08-18
糖尿病性黄斑水肿	挪威	Advanz Pharma Ltd.	2025-08-18
近视脉络膜新生血管	欧盟	Advanz Pharma Ltd.	2025-08-18
近视脉络膜新生血管	欧盟	STADA Arzneimittel AG	2025-08-18
近视脉络膜新生血管	冰岛	Advanz Pharma Ltd.	2025-08-18
近视脉络膜新生血管	冰岛	STADA Arzneimittel AG	2025-08-18
近视脉络膜新生血管	列支敦士登	Advanz Pharma Ltd.	2025-08-18
近视脉络膜新生血管	列支敦士登	STADA Arzneimittel AG	2025-08-18
近视脉络膜新生血管	挪威	STADA Arzneimittel AG	2025-08-18
近视脉络膜新生血管	挪威	Advanz Pharma Ltd.	2025-08-18
视网膜静脉阻塞相关黄斑水肿	欧盟	STADA Arzneimittel AG	2025-08-18
视网膜静脉阻塞相关黄斑水肿	欧盟	Advanz Pharma Ltd.	2025-08-18
视网膜静脉阻塞相关黄斑水肿	冰岛	STADA Arzneimittel AG	2025-08-18

未上市

10 条进展最快的记录,

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适应症	最高研发状态	国家/地区	公司	日期
视网膜血管疾病	临床3期	美国	Alvotech Swiss AG	2024-03-11
视网膜血管疾病	临床3期	拉脱维亚	Alvotech Swiss AG	2024-03-11
视网膜静脉阻塞	临床3期	美国	Alvotech Swiss AG	2024-03-11
视网膜静脉阻塞	临床3期	拉脱维亚	Alvotech Swiss AG	2024-03-11

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临床结果

适应症

分期

评价

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT05155293 ( AVT06-GL-C01 \| ALVOEYE, GlobeNewswire) 人工标引	临床3期	湿性年龄相关性黄斑变性	-	AVT06	鬱窪淵鹽積壓網獵選艱(餘築鬱壓構夢鹽膚構鏇) = results demonstrating therapeutic equivalence between Alvotech’s biosimilar candidate and Eylea 壓壓繭鏇積鏇顧製夢餘 (廠顧壓範壓衊鏇廠選鏇 ) 达到	相似	2024-01-03
				Eylea