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

Advanz Pharma Ltd.

JAMP Pharma Corp.

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

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Sequence Code 34550CDR3-L

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Sequence Code 208354L

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Sequence Code 1694337H

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Sequence Code 13027041CDR2-H

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Sequence Code 535237464CDR3-H

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Sequence Code 559603504CDR1-L

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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 ; Ashdown, Thomas ; Rai, Masna ; 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).

74

项与戈利木单抗生物类似药（Alvotech）相关的新闻（医药）

2026-08-10

·BioSpace

Alvotech to Report Financial Results for H1 2026

REYKJAVIK, ICELAND (August 10, 2026) — Alvotech (NASDAQ: ALVO; ALVO-SDB) (the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that it will release its financial results for the first half of 2026 on Wednesday, August 19, 2026, after the U.S. market close. The Company will also host a webcast with a live Q&A on Thursday, August 20, 2026, at 08:00 ET (12:00 GMT, 13:00 BST, 14:00 CEST). To listen to the webcast, please register here: H1 2026 webcast To participate in the Q&A, please register here: Q&A registration Slides and other materials will be made available on alvotech.com/financials before the call. For further information, contact: ezstandalone.cmd.push(function () { ezstandalone.showAds(131); }); Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad (US) Benedikt Stefansson (IS) 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, osteoporosis, respiratory disease, 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 . For more information, please visit our website or follow us on social media on LinkedIn , Facebook , Instagram and YouTube . None of the information on the Alvotech website shall be deemed part of this press release.

财报生物类似药

2026-07-29

·GlobeNewswire-Health Care

Alvotech announces successful closure of FDA inspection of manufacturing facility

REYKJAVIK, ICELAND (July 29, 2026) — Alvotech (NASDAQ: ALVO; ALVO-SDB) (the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S Food and Drug Administration (FDA) has closed its inspection of the company’s manufacturing facility in Reykjavik, Iceland, conducted in May 2026. The FDA has confirmed the inspection classification of the manufacturing site is Voluntary Action Indicated (VAI). “This is an important milestone for Alvotech and reflects the significant work our teams have undertaken to further strengthen our quality systems and manufacturing operations,” said Lisa Graver, CEO of Alvotech. “With the conclusion of the FDA’s recent inspection, we are confident that the actions we have taken have effectively addressed the observations identified. We continue to work with the FDA to advance our recent Biologics Licence Applications towards approval.” Alvotech continues to advance its pipeline of biosimilar candidates. The company recently announced the resubmission of Biologics License Applications (BLAs) for AVT05, Alvotech’s biosimilar to Simponi® (golimumab), and AVT06, Alvotech’s biosimilar to Eylea® (aflibercept), and the acceptance by the FDA of the submission of a BLA for AVT16, Alvotech’s proposed biosimilar to Entyvio® (vedolizumab) to the FDA in June 2026. Alvotech continues to work closely with health authorities worldwide to bring high-quality, affordable biologic medicines to patients. For further information, contact: MediaBenedikt StefanssonSarah MacLeodalvotech.media@alvotech.com InvestorsDr. Balaji V Prasad (US)Benedikt Stefansson (IS)alvotech.ir@alvotech.com About AlvotechAlvotech 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 13 disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, 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. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube. None of the information on the Alvotech website shall be deemed part of this press release. Use of trademarks Simponi® and Simponi Aria® are trademarks of Johnson & Johnson. Eylea® is a trademark of Regeneron Pharmaceuticals Inc. Entyvio® is a registered trademark of Millennium Pharmaceuticals, Inc.

生物类似药上市批准

2026-07-29

·GlobeNewswire-Health Care

Alvotech announces successful closure of FDA inspection of manufacturing facility

REYKJAVIK, Iceland, July 29, 2026 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO; ALVO-SDB) (the “Company”), a global biotechnology company specializing in the development and manufacture of biosimilar medicines for patients worldwide, today announced that the U.S. Food and Drug Administration (FDA) has closed its inspection of the company’s manufacturing facility in Reykjavik, Iceland, conducted in May 2026. The FDA has confirmed the inspection classification of the manufacturing site is Voluntary Action Indicated (VAI). “This is an important milestone for Alvotech and reflects the significant work our teams have undertaken to further strengthen our quality systems and manufacturing operations,” said Lisa Graver, CEO of Alvotech. “With the conclusion of the FDA’s recent inspection, we are confident that the actions we have taken have effectively addressed the observations identified. We continue to work with the FDA to advance our recent Biologics Licence Applications towards approval.” Alvotech continues to advance its pipeline of biosimilar candidates. The company recently announced the resubmission of Biologics License Applications (BLAs) for AVT05, Alvotech’s biosimilar to Simponi® (golimumab), and AVT06, Alvotech’s biosimilar to Eylea® (aflibercept), and the acceptance by the FDA of the submission of a BLA for AVT16, Alvotech’s proposed biosimilar to Entyvio® (vedolizumab) to the FDA in June 2026. Alvotech continues to work closely with health authorities worldwide to bring high-quality, affordable biologic medicines to patients. For further information, contact: MediaBenedikt StefanssonSarah MacLeodalvotech.media@alvotech.com InvestorsDr. Balaji V Prasad (US)Benedikt Stefansson (IS)alvotech.ir@alvotech.com About AlvotechAlvotech 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 13 disclosed biosimilar candidates aimed at treating autoimmune disorders, eye disorders, osteoporosis, respiratory disease, 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. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube. None of the information on the Alvotech website shall be deemed part of this press release. Use of trademarks Simponi® and Simponi Aria® are trademarks of Johnson & Johnson. Eylea® is a trademark of Regeneron Pharmaceuticals Inc. Entyvio® is a registered trademark of Millennium Pharmaceuticals, Inc.

生物类似药上市批准

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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

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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

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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	繭鹹鹹窪觸繭遞積遞糧(醖繭糧憲鑰積構築製簾) = 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]) 觸觸積餘壓鹹壓鏇餘醖 (壓鹹壓構範壓築觸壓襯 ) 更多	积极	2025-11-10
				US-licensed reference product (Simponi™)
NCT05632211 (CTgov)	临床1期	-	336	AVT05 (AVT05 50mg s.c.)	壓廠鬱糧願鹽醖餘壓積(餘艱顧壓簾積餘淵糧糧) = 網築鹹膚鹹遞夢壓襯壓遞蓋衊憲艱範範餘膚構 (積衊衊觸廠鹹製築遞憲, 52) 更多	-	2025-05-28
				Simponi (EU Simponi 50mg s.c.)	壓廠鬱糧願鹽醖餘壓積(餘艱顧壓簾積餘淵糧糧) = 築夢廠衊獵鏇願積鏇夢遞蓋衊憲艱範範餘膚構 (積衊衊觸廠鹹製築遞憲, 50) 更多
NCT05842213 (ACR2024)	临床3期	类风湿关节炎	502	AVT05	簾憲網鹽製獵製鏇餘顧(觸鹽簾壓夢憲網顧夢構) = 鏇製顧顧艱遞窪淵製淵鏇鬱壓齋構蓋鹽製壓選 (膚襯淵積築鏇糧衊鹹襯 ) 更多	积极	2024-11-10
				Reference Golimumab	簾憲網鹽製獵製鏇餘顧(觸鹽簾壓夢憲網顧夢構) = 淵蓋鏇遞鬱獵糧糧壓壓鏇鬱壓齋構蓋鹽製壓選 (膚襯淵積築鏇糧衊鹹襯 ) 更多
NCT05632211 (Biospace) 人工标引	N/A	类风湿关节炎	-	AVT05	鹹膚鏇醖夢壓築憲網願(艱選遞觸醖構構鑰糧築) = met its primary endpoints 蓋醖鑰廠憲蓋獵膚醖餘 (選膚壓鬱遞膚淵蓋衊廠 ) 更多	积极	2023-11-29
				Simponi