戈利木单抗生物类似药（Alvotech）(Golimumab biosimilar (Alvotech)) - 药物靶点：TNF-α_在研适应症：强直性脊柱炎，非放射性轴性脊柱关节炎，多关节型幼年特发性关节炎_专利_临床

概要

基本信息

药物类型

生物类似药、单克隆抗体

别名

Golimumab Biosimilar (Alvotech hf)、戈利木单抗生物类似药（Alvotech hf）、AVT05

+ [4]

靶点

TNF-α

作用方式

抑制剂

作用机制

TNF-α抑制剂(肿瘤坏死因子α抑制剂)

治疗领域

免疫系统疾病感染消化系统疾病+ [2]

在研适应症

强直性脊柱炎非放射性轴性脊柱关节炎多关节型幼年特发性关节炎+ [8]

非在研适应症-

原研机构

Alvotech hf

在研机构

AlvotechAdvanz Pharma Ltd.

Fuji Pharma Co., Ltd.

+ [5]

非在研机构-

权益机构

Fuji Pharma Co., Ltd.

Alvotech hf

STADA Arzneimittel AG

+ [6]

最高研发阶段批准上市

首次获批日期

日本 (2025-09-19),

类风湿关节炎

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 10217CDR2-L

当前序列信息引自: *****

Sequence Code 34550CDR3-L

当前序列信息引自: *****

Sequence Code 208354L

当前序列信息引自: *****

Sequence Code 1694337H

当前序列信息引自: *****

Sequence Code 13027041CDR2-H

当前序列信息引自: *****

Sequence Code 535237464CDR3-H

当前序列信息引自: *****

Sequence Code 559603504CDR1-L

当前序列信息引自: *****

Sequence Code 1167865419CDR1-H

当前序列信息引自: *****

关联

2

项与戈利木单抗生物类似药（Alvotech）相关的临床试验

NCT05842213

/ Completed临床3期

Randomized, Double-blind, 2-arm Multicenter Study to Investigate the Efficacy, Safety and Immunogenicity Between Subcutaneous AVT05 and EU-approved Simponi® in Subjects with Moderate to Severe Rheumatoid Arthritis

This is a study to compare the efficacy, safety and immunogenicity of AVT05 versus EU-Simponi® in combination with methotrexate (MTX) in subjects with moderate to severe rheumatoid arthritis (RA).
The study will consist of up to 4-week Screening Period, a 48-week Treatment Period, and a 4-week Safety Follow-up Period.

开始日期2023-03-30

申办/合作机构

Alvotech Swiss AG

NCT05632211

/ Completed临床1期

A First-in-human, Randomized, Parallel Group, Double-blind, 3-arm Study to Investigate the Comparative PK, Safety, and Tolerability Between Subcutaneous AVT05, US-licensed Simponi®, and EU-approved Simponi® in Healthy Adult Participants

Rationale:
Alvotech is developing AVT05 globally as a proposed biosimilar to the reference product Simponi (golimumab) for subcutaneous (SC) use. This is a first-in-human (FIH) clinical study with AVT05. The study aims to demonstrate pharmacokinetic (PK) similarity of the proposed biosimilar test product AVT05 and the reference products EU approved Simponi and US-licensed Simponi, in addition to evaluating the safety and tolerability of AVT05, when administered as a single 50 mg/0.5 mL SC dose.

开始日期2022-12-16

申办/合作机构

Alvotech Swiss AG

[+1]

100 项与戈利木单抗生物类似药（Alvotech）相关的临床结果

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100 项与戈利木单抗生物类似药（Alvotech）相关的转化医学

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100 项与戈利木单抗生物类似药（Alvotech）相关的专利（医药）

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2

项与戈利木单抗生物类似药（Alvotech）相关的文献（医药）

2026-01-01·BIODRUGS

Pharmacokinetic Similarity of Biosimiliar AVT05 Versus Reference Product Golimumab in Healthy Adults: A Double-Blind, Three-Arm, Parallel-Group Study

Article

作者: Wynne, Chris ; Lorch, Ulrike ; Rai, Masna ; Ashdown, Thomas ; Berti, Fausto ; Krantz, Edrich ; Leutz, Steffen ; Ruffieux, Ruth ; Vashishta, Laxmikant ; Luque, Monica ; Katial, Rohit ; Petrovic, Katarina ; Sattar, Abid

BACKGROUND:

AVT05, a recombinant, human, immunoglobulin G1қ monoclonal antibody, is a biosimilar to Simponi^®.

OBJECTIVES:

The purpose of this study was to investigate the pharmacokinetic (PK) similarity, safety, tolerability, and immunogenicity between AVT05 and US-licensed and European Union (EU)-approved reference product (RP) golimumab (US-RP and EU-RP, respectively) in healthy adult participants.

METHODS:

Three hundred and thirty-six healthy male and female participants aged 18-55 years were randomized in a 1:1:1 ratio to AVT05, US-RP, or EU-RP. Participants received a single 50 mg/0.5 mL subcutaneous injection on Day 1 and were followed until Day 75. The primary PK endpoints were maximum serum concentration (C_max) and area under the serum concentration-time curve from time zero to infinity (AUC_0-inf). Pharmacokinetic similarity was demonstrated if the 90% confidence intervals for the geometric mean ratio for both AUC_0-inf and C_max were entirely contained within the prespecified margins of 80.00% and 125.00% for all six pairwise treatment comparisons. Secondary endpoints were additional PK parameters (area under the concentration-time curve from time zero to the last quantifiable concentration, time to C_max, terminal elimination rate constant, terminal elimination half-life, apparent volume of distribution, and apparent clearance), safety, tolerability, and immunogenicity.

RESULTS:

Demographic and baseline characteristics were balanced between the treatment groups. The 90% confidence intervals for the geometric means ratio for the protein-adjusted primary PK parameters were entirely contained within the prespecified margins of 80.00% and 125.00% (C_max [AVT05/US-RP 89.45, 106.75; AVT05/EU-RP 92.33, 110.15; EU-RP/US-RP 88.64, 105.92]; AUC_0-inf [AVT05/US-RP 94.35, 108.40; AVT05/EU-RP 98.46, 113.13; EU-RP/US-RP 89.36, 102.76]), supporting the demonstration of PK similarity. The secondary PK parameters were also comparable between the treatment arms. The mean serum golimumab concentrations through Day 75 post-dose were similar between treatment arms. Overall, 66.1% of participants experienced at least one treatment-emergent adverse event (TEAE) during the study period. The frequency of TEAEs was comparable across the treatment arms. The majority of TEAEs were mild to moderate in severity. There were two serious TEAEs reported (one [0.9%] each in AVT05 and EU-RP arms), neither of which was considered treatment related. Local administration site reactions were mild in severity and observed in 6.1%, 10.8%, and 5.5% of participants in the AVT05, EU-RP, and US-RP arms, respectively. Overall, 87 (75.7%), 92 (82.9%), and 89 (80.9%) participants in the AVT05, EU-RP, and US-RP arms, respectively, were anti-drug antibody positive; among those 66 (57.4%), 68 (61.3%), and 61 (55.5%) participants, respectively, were neutralizing antibody positive at least once during the study. The primary PK parameters (AUC_0-inf and C_max) were slightly lower in antidrug antibody-positive participants compared with antidrug antibody-negative participants.

CONCLUSIONS:

Following single-dose administration, the study supported a demonstration of PK similarity between AVT05 and EU-RP and US-RP in healthy participants. Safety, tolerability, and immunogenicity profiles were comparable between the treatment arms.

CLINICAL TRIAL REGISTRATION:

The trial is registered at ClinicalTrials.gov (CT.gov identifier: NCT05632211).

2026-01-01·BIODRUGS

Efficacy and Safety of Biosimilar AVT05 Versus Reference Product Golimumab in Combination with Methotrexate in Moderate-to-Severe Rheumatoid Arthritis: 52-Week Results of a Randomized, Parallel-Group, Double-Blind Study

Article

作者: Sattar, Abid ; Rai, Masna ; Zhelyazkova, Kristina ; Petrovic, Katarina ; Berti, Fausto ; Leutz, Steffen ; Bucknall, Richard ; Vashishta, Laxmikant ; Luque, Monica

BACKGROUND:

Golimumab is a safe and effective treatment for patients with rheumatoid arthritis. Biosimilars to the reference product (RP; Simponi^®) may make treatment more accessible.

OBJECTIVES:

The aim of this study was to assess the efficacy of AVT05, a golimumab biosimilar, and RP, each used in combination with methotrexate, in participants with moderate-to-severe rheumatoid arthritis.

METHODS:

This was a 52-week, randomized, double-blind, two-arm, parallel-group, active-controlled study. Participants were randomized 1:1 to receive AVT05 (n = 251) or RP (n = 251), 50 mg subcutaneously once every 4 weeks to Week 12 inclusive. Randomization was stratified by the baseline Disease Activity Score-28 for Rheumatoid Arthritis using C-Reactive Protein (DAS28-CRP) [≤ 5.1 and > 5.1]. The primary endpoint was the change from baseline in DAS28-CRP at Week 16. At Week 16, responder participants (DAS28-CRP decreased by > 0.6 from baseline and disease activity DAS28-CRP ≤ 5.1) initially enrolled in the AVT05 arm continued to receive AVT05 every 4 weeks. Responder participants initially randomized to RP were re-randomized 1:1 to either continue receiving RP or switch to AVT05. Non-responders were discontinued from the study drug. Change from baseline in DAS28-CRP response criteria at weeks 4, 8, 12, 24, 32, 40, 48, and 52 and percentage of subjects achieving American College of Rheumatology 20/50/70 at weeks 4, 8, 12, 16, 24, 32, 40, 48, and 52 were assessed as secondary endpoints. Safety and immunogenicity endpoints were also assessed.

RESULTS:

At Week 16, the least squares mean (standard error) change from baseline in DAS28-CRP in AVT05 and RP was - 2.89 (0.058) and - 2.98 (0.058), respectively. The two-sided 95% confidence interval of the least squares mean difference (0.09; standard error 0.082) was entirely contained within the prespecified equivalence margin of - 0.6, 0.6 (- 0.07, 0.25), supporting a demonstration of comparative efficacy. Two sensitivity analyses (one [S1] without exclusion of any data because of intercurrent events, and one [S2] excluding data following intercurrent events or relevant protocol deviations) supported the robustness of the primary endpoint estimates (S1 95% confidence interval - 0.07, 0.25; S2 95% confidence interval - 0.07, 0.25). There were no notable differences in subgroup analyses. Secondary efficacy analyses were consistent with the primary endpoint, including in participants who switched treatments. Overall safety profiles showed no clinically meaningful differences between treatments, including in participants who switched treatments. Immunogenicity profiles were comparable between treatment arms at all timepoints, including in participants who switched treatments.

CONCLUSIONS:

Analysis of the change in DAS28-CRP from baseline to Week 16 supported the assessment of comparative efficacy between AVT05 and RP golimumab. Secondary efficacy endpoints were consistent with this, including in participants who switched. AVT05 had a safety and immunogenicity profile similar to that observed for RP at all timepoints, including in participants who switched treatments.

CLINICAL TRIAL REGISTRATION:

The trial is registered at ClinicalTrials.gov (ClinicalTrials.gov identifier: NCT05842213) and the EU Clinical Trials Register (EudraCT Number: 2022-001825-63).

79

项与戈利木单抗生物类似药（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 项与戈利木单抗生物类似药（Alvotech）相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	-	L04AB06	-

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
强直性脊柱炎	欧盟	Advanz Pharma Ltd.	2025-11-17
强直性脊柱炎	冰岛	Advanz Pharma Ltd.	2025-11-17
强直性脊柱炎	列支敦士登	Advanz Pharma Ltd.	2025-11-17
强直性脊柱炎	挪威	Advanz Pharma Ltd.	2025-11-17
非放射性轴性脊柱关节炎	欧盟	Advanz Pharma Ltd.	2025-11-17
非放射性轴性脊柱关节炎	冰岛	Advanz Pharma Ltd.	2025-11-17
非放射性轴性脊柱关节炎	列支敦士登	Advanz Pharma Ltd.	2025-11-17
非放射性轴性脊柱关节炎	挪威	Advanz Pharma Ltd.	2025-11-17
多关节型幼年特发性关节炎	欧盟	Advanz Pharma Ltd.	2025-11-17
多关节型幼年特发性关节炎	冰岛	Advanz Pharma Ltd.	2025-11-17
多关节型幼年特发性关节炎	列支敦士登	Advanz Pharma Ltd.	2025-11-17
多关节型幼年特发性关节炎	挪威	Advanz Pharma Ltd.	2025-11-17
活动性中度溃疡性结肠炎	欧盟	Advanz Pharma Ltd.	2025-11-17
活动性中度溃疡性结肠炎	冰岛	Advanz Pharma Ltd.	2025-11-17
活动性中度溃疡性结肠炎	列支敦士登	Advanz Pharma Ltd.	2025-11-17
活动性中度溃疡性结肠炎	挪威	Advanz Pharma Ltd.	2025-11-17
活动性重度溃疡性结肠炎	欧盟	Advanz Pharma Ltd.	2025-11-17
活动性重度溃疡性结肠炎	冰岛	Advanz Pharma Ltd.	2025-11-17
活动性重度溃疡性结肠炎	列支敦士登	Advanz Pharma Ltd.	2025-11-17
活动性重度溃疡性结肠炎	挪威	Advanz Pharma Ltd.	2025-11-17

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
免疫系统疾病	临床前	冰岛	Alvotech hf	-

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临床结果

适应症

分期

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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


NCT05632211 (Pubmed \| BioDrugs)	临床3期	-	336	AVT05	艱選選蓋鏇範選膚鏇餘(獵淵憲餘膚簾鏇繭窪製) = The 90% confidence intervals for the geometric means ratio for the protein-adjusted primary PK parameters were entirely contained within the prespecified margins of 80.00% and 125.00% (AUC0-inf [AVT05/US-RP 94.35, 108.40; AVT05/EU-RP 98.46, 113.13; EU-RP/US-RP 89.36, 102.76]) 願衊繭鑰艱觸襯鬱繭範 (簾網憲獵顧淵願遞窪構 ) 更多	积极	2025-11-10
				US-licensed reference product (Simponi™)
NCT05632211 (CTgov)	临床1期	-	336	AVT05 (AVT05 50mg s.c.)	範選糧蓋範鬱襯鹽蓋顧(襯鑰淵積範糧繭網餘齋) = 範鏇構簾淵醖醖廠願窪築醖鬱淵醖鑰鹽淵繭廠 (構艱醖積蓋衊艱廠餘鏇, 52) 更多	-	2025-05-28
				Simponi (EU Simponi 50mg s.c.)	範選糧蓋範鬱襯鹽蓋顧(襯鑰淵積範糧繭網餘齋) = 糧遞築餘糧鹽憲窪觸築築醖鬱淵醖鑰鹽淵繭廠 (構艱醖積蓋衊艱廠餘鏇, 50) 更多
NCT05842213 (ACR2024)	临床3期	类风湿关节炎	502	AVT05	鏇衊淵憲淵鏇鑰憲衊鬱(膚廠製築選獵齋簾壓餘) = 夢鏇鏇壓觸廠獵膚鹹網淵積餘夢糧蓋窪醖積繭 (鏇顧遞願廠齋選膚繭齋 ) 更多	积极	2024-11-10
				Reference Golimumab	鏇衊淵憲淵鏇鑰憲衊鬱(膚廠製築選獵齋簾壓餘) = 糧觸範夢蓋廠積窪構蓋淵積餘夢糧蓋窪醖積繭 (鏇顧遞願廠齋選膚繭齋 ) 更多
NCT05632211 (Biospace) 人工标引	N/A	类风湿关节炎	-	AVT05	範齋製齋選網獵醖艱壓(壓醖獵襯選製淵顧願鹹) = met its primary endpoints 網獵衊壓築窪網積鹽廠 (糧廠鑰襯構鏇餘鹽積繭 ) 更多	积极	2023-11-29
				Simponi