阿达木单抗生物类似药 (Alvotech)(Adalimumab biosimilar(Alvotech)) - 药物靶点：TNF-α_在研适应症：多关节型幼年特发性关节炎，活动性中度克罗恩病，活动性重度克罗恩病_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

Adalimumab Biosimilar (Alvotech hf)、阿达木单抗生物类似药（Alvotech hf）、AVT-02

+ [8]

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+ [3]

在研适应症

多关节型幼年特发性关节炎活动性中度克罗恩病活动性重度克罗恩病+ [20]

非在研适应症

自身炎症性疾病慢性大斑块银屑病

原研机构

Alvotech hf

在研机构

STADA Arzneimittel AGCipla Australia Pty Ltd.

JAMP Pharma Corp.

+ [5]

非在研机构

Alvotech Swiss AGAlvotech Holdings SA

权益机构

Teva Pharmaceutical Industries Ltd.

Alvotech hfCipla BioTec Ltd.

+ [7]

最高研发阶段批准上市

首次获批日期

欧盟 (2021-11-12),

强直性脊柱炎银屑病关节炎中轴性脊柱关节炎+ [14]

最高研发阶段(中国)-

特殊审评-

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结构/序列

Sequence Code 26792L

当前序列信息引自: *****

Sequence Code 88699H

当前序列信息引自: *****

关联

10

项与阿达木单抗生物类似药 (Alvotech) 相关的临床试验

NCT05913817

/ CompletedN/A

The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multiple Indications.

The purpose of the Phase IV study is to investigate the effects of both Volume and Citrate on Injection Site Pain (ISP), adherence, patient satisfaction, Quality of Life, and Disease Assessment in the Canadian Adalimumab Market.
The phase IV study is an observational, pan-Canadian, multidisciplinary study aiming to enroll 600 patients across 50-70 sites across 3 different Therapeutic Areas (GI, Rheum, Derm).

开始日期2023-01-09

申办/合作机构

JAMP Pharma Corp.

NCT04453137

/ Completed临床3期

Multicenter, Double-Blind, Randomized, Parallel-group, Study Evaluating PK, Efficacy, Safety, and Immunogenicity in Patients With Plaque Psoriasis Receiving Humira® or AVT02 Followed by a Safety Extension Phase of AVT02

Pharmacokinetic, Efficacy, Safety, and Immunogenicity Between Patients with Moderate to Severe Chronic Plaque Psoriasis Receiving Humira® and Patients with Moderate to Severe Chronic Plaque Psoriasis

开始日期2020-06-30

申办/合作机构

Alvotech Swiss AG

NCT04224194

/ Completed临床3期

Assessment of Real-life Patient Handling Experience of AVT02 Administered Subcutaneous With an Auto-Injector in Patients With Moderate to Severe Active RA

To assess the real-life patient handling experience with the use of an autoinjector in patients with moderate to severe active Rheumatoid Arthritis (RA) who self-inject AVT02 subcutaneously (SC).

开始日期2019-11-04

申办/合作机构

Alvotech Swiss AG

100 项与阿达木单抗生物类似药 (Alvotech) 相关的临床结果

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100 项与阿达木单抗生物类似药 (Alvotech) 相关的转化医学

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100 项与阿达木单抗生物类似药 (Alvotech) 相关的专利（医药）

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10

项与阿达木单抗生物类似药 (Alvotech) 相关的文献（医药）

2026-06-01·Rheumatology and Therapy

Evaluation of Injection Site Pain and Adherence in Patients Transitioning from a High to Low Volume Adalimumab Formulation (AVT02, Simlandi®) Across Multiple Indications (EASE PAIN)

Article

作者: Vender, Ronald B ; Narula, Neeraj ; Afif, Waqqas ; Thorne, Carter ; Steinhart, A Hillary ; Lynde, Charles W ; Bessette, Louis ; Shahrokh, Dara K ; Rao, Jaggi ; Sutton, Evelyn

INTRODUCTION:

Injection site pain (ISP) is a frequent concern with subcutaneous adalimumab therapy and may negatively affect treatment adherence and patient satisfaction. AVT02 is a high-concentration, low-volume (40 mg/0.4 mL), citrate-free biosimilar of reference product (RP) adalimumab (40 mg/0.8 mL; citrate-containing). The EASE PAIN study evaluated the real-world impact of switching from adalimumab RP or another biosimilar to AVT02 on ISP and patient-reported outcomes over 180 days.

METHODS:

The EASE PAIN study (NCT05913817) was a national, observational, prospective phase IV study with a 6-month follow-up. The study enrolled Canadian patients with gastrointestinal conditions (Crohn's disease [CD], ulcerative colitis [UC]), rheumatological conditions (rheumatoid arthritis [RA], ankylosing spondylitis [AS], psoriatic arthritis [PsA]) or dermatological conditions (hidradenitis suppurativa [HS], psoriasis [PsO]). Participants were eligible if their treating physician had already decided to switch them from a high-volume RP or alternative adalimumab biosimilar to low-volume AVT02. The study assessed ISP measured via the Visual Analog Scale (VAS), adherence via the compliance rate, patient satisfaction and perception of change in pain via the Likert scale, injection site reactions (ISR) via a checklist (bleeding, burning, erythema, itching, soreness, swelling), quality of life based on EQ-5D-5L, and disease activity via the patient and physician global assessment scores for participants up to day 180 after switching. Healthcare utilization was measured as per the frequency, type, and volume of medical services accessed.

RESULTS:

The intention-to-treat (ITT) population comprised 324 participants. Following the first administration of AVT02, mean ISP VAS scores improved by - 19.9 ± 26.1 mm compared with baseline. Adherence rate was 93.4% overall. More than 74.4% of patients reported being mostly or completely satisfied with treatment, and 76.9% of the participants perceived AVT02 as less painful as measured by the 5-Likert scale. Moreover, a lower number of patients experienced ISRs after their first dose of AVT02 (36 patients; 12.4%) compared with their last dose of high-volume adalimumab (124 patients; 42.3%). Quality-of-life scores remained stable throughout follow-up. No clinically meaningful changes were observed in disease activity or healthcare utilization.

CONCLUSIONS:

In this real-world Canadian study, switching from adalimumab RP or alternative biosimilar to AVT02 was associated with reductions in ISP and reactions while maintaining high adherence, patient satisfaction, quality of life, and disease control across multiple indications.

TRIAL REGISTRATION:

This trial is registered with ClinicalTrials.gov: NCT05913817.

2024-01-01·Immunotherapy advances

Ex vivo comparative immunogenicity assessment (EVCIA) to determine relative immunogenicity in chronic plaque psoriasis in participants receiving Humira® or undergoing repeated switches between Humira® and AVT02

Article

作者: Guenzi, Eric ; Reznichenko, Nataliya ; Mazy, Aurélie ; Schockaert, Jana ; Haliduola, Halimu N ; Richter, Kathleen ; Berti, Fausto

Summary:

Immunogenicity against biologic medicines is ubiquitous, and it is traditionally measured by the final humoral response. However, the onset of a sustained immunogenic response begins at the cellular level with activation of T cells and maturation of naïve B cells into plasma cells. Ex vivo comparative immunogenicity assessment (EVCIA) of cellular immunogenicity in participants with moderate-to-severe chronic plaque psoriasis in the AVT02-GL-302 study, who received either reference product (RP) alone (non-switching arm) or switched between RP and AVT02 (switching arm) after 1:1 randomization at week 12. Peripheral blood mononuclear cells (PBMCs) were collected and cryopreserved from 28 participants at: baseline (before treatment) (week 1); pre-randomization (week 12); and week 16 and week 28 in both switching and non-switching arms. PBMCs were thawed and re-exposed to either medium alone (negative control), RP, AVT02, keyhole limpet hemocyanin (KLH) (positive control), RP+KLH, or AVT02+KLH. Samples from 10 participants (predetermined average cell viability of 75% across all timepoints) from each arm were analyzed for cytokine release after 24 hours and for Th-cell proliferation, 6 days post-seeding. Until week 28, cytokine release and Th-cell proliferation was similar at all time points in both switching and non-switching arms. Overall cellular immune response was elevated post-KLH re-exposure at all timepoints. The comparable ex vivo cellular immunogenicity between switching and non-switching arms complements the confirmation of interchangeability in the main study. Given the sensitivity of novel EVCIA, detecting cellular immunogenicity could be a potential outcome in predicting the immunogenicity of biologic medicines.

2024-01-01·Therapeutic advances in chronic disease

The totality of evidence approach in the development of AVT02 (adalimumab), a biosimilar to Humira

Review

作者: Berger, Verena ; Ómarsdóttir, Sesselja ; McClellan, Joseph E. ; Roy, Nivedita ; Michel, Cecilia ; Berti, Fausto

The development of a biosimilar is based on comparative structural, physicochemical, functional and clinical assessments. The sum of these analyses encompasses the ‘totality of evidence’, which demonstrates no clinically meaningful differences between the biosimilar and the reference product (RP). Once biosimilarity has been established, provided there is suitable scientific justification, clinical data may be extrapolated to other indications of the RP. AVT02 has been developed as a biosimilar to high-concentration, low-volume Humira (adalimumab), an anti-tumour necrosis factor-alpha monoclonal antibody approved for various chronic inflammatory indications. The totality of evidence for AVT02 is described, supporting its approval as an adalimumab biosimilar for all approved indications globally. Analytical similarity assessments using mass spectrometry methods demonstrated identical amino acid sequences for AVT02 and the RP, with high similarity in terms of primary structure, post-translational modifications and higher-order structural attributes. The mechanism of action was assessed by various cell-based potency assays and binding assays, and the results demonstrated that AVT02 is highly similar to the RP. No clinically meaningful differences in terms of purity, potency and safety were observed, and minor differences in a few physiochemical attributes did not impact the in vitro biologic activity and were not considered clinically relevant. Clinical similarity was demonstrated by comparing the pharmacokinetic, efficacy, safety and immunogenicity profiles of AVT02 with those of the RP. Clinical studies supported similar pharmacokinetic and comparable immunogenicity profiles between AVT02 and the RP in healthy participants and participants with moderate-to-severe chronic plaque psoriasis, with no new safety signals detected. The totality of evidence described demonstrates the biosimilarity of AVT02 to the RP, thereby fulfilling the scientific and regulatory requirements for AVT02 as a high-concentration biosimilar for the treatment of chronic plaque psoriasis and all approved indications of the RP.

168

项与阿达木单抗生物类似药 (Alvotech) 相关的新闻（医药）

2026-06-03

·BioSpace

Alvotech to present at upcoming investor conferences in June 2026

REYKJAVIK, Iceland, June 02, 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 Robert Wessman, Alvotech's Founder and Executive Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in June as follows: Jefferies Global Healthcare Conference in New York – fireside chat on Thursday, June 4, 2026 at 9:20 am ET Goldman Sachs 47 th Annual Global Healthcare Conference in Miami – fireside chat Monday, June 8, 2026 at 8:40 am ET UBS Virtual Generics and Biosimilars Day – fireside chat on Wednesday, June 10, 2026 at 10:30 am ET The live audio webcasts will be available to investors and the general public and can be accessed in the Investors Section of Alvotech’s website under News and Events – Events and Presentations . After the event, a recording will also be available for up to 90 days. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad Benedikt Stefansson 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 nine 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 . None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal , and our website or follow us on social media on LinkedIn , Facebook , Instagram and YouTube .

2026-06-02

·investors.alvotech.com

Alvotech to present at upcoming investor conferences in June

REYKJAVIK, ICELAND (June 2, 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 Robert Wessman, Alvotech's Founder and Executive Chairman, and Dr. Balaji V. Prasad, Chief Strategy Officer, will participate in the upcoming investor conferences in June as follows: Jefferies Global Healthcare Conference in New York – fireside chat on Thursday, June 4, 2026 at 9:20 am ET (13:20 GMT) Goldman Sachs 47th Annual Global Healthcare Conference in Miami – fireside chat Monday, June 8, 2026 at 8:40 am ET (12:40 GMT) UBS Virtual Generics and Biosimilars Day – fireside chat on Wednesday, June 10, 2026 at 10:30 am ET (14:30 GMT) The live audio webcasts will be available to investors and the general public and can be accessed in the Investors Section of Alvotech’s website under News and Events – Events and Presentations. After the event, a recording will also be available for up to 90 days. For further information, contact: Media Benedikt Stefansson Sarah MacLeod alvotech.media@alvotech.com Investors Dr. Balaji V Prasad Benedikt Stefansson 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 nine 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. None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal, and our website or follow us on social media on LinkedIn, Facebook, Instagram and YouTube.

生物类似药

2026-06-01

·BioSpace

Alvotech and Islandsbanki renew Market Making Agreement for ALVO Shares Trading on Nasdaq Iceland

REYKJAVIK, ICELAND (June 1, 2026) — Alvotech (Nasdaq: ALVO) and Islandsbanki have renewed and amended their existing market making agreement. According to the agreement, Islandsbanki places bids and offers for ALVO shares trading on the Nasdaq Iceland Main Market (the “Exchange”) for a minimum amount with a fixed spread between the bid and offer price. The objective of the market-making agreement is to increase trade in Alvotech’s shares, liquidity and transparent price formation. As a market maker, Islandsbanki will post bid and ask quotes on the Exchange with an aggregate market value of at least ISK 8 million prior to the start of daily trading. Both the bid and ask quotes shall be refreshed as soon as possible but no later than 15 minutes after being executed in full. Islandsbanki aims to maintain more than one bid and/or ask quote for Alvotech’s shares such that the total market value of outstanding quotes is at least ISK 8 million at all times, but the bank is not obligated to maintain multiple bid or ask quotes. Islandsbanki also reserves the right to post additional bid and ask quotes even if existing quotes remain unexecuted. The maximum spread between bid and ask quotes is 2.5%, calculated as the volume weighted average of the bid and ask quotes for Alvotech’s shares posted by Islandsbanki as market maker at any given time. The daily net volume of trades by Islandsbanki as a market maker in Alvotech’s shares shall be limited to ISK 16 million. This amount is calculated as the difference between bids and asks by Islandsbanki that have been executed in full. When the maximum amount is reached, Islandsbanki is under no further obligation during that day to post either a bid or ask quote, depending on which side has been filled. Once a quote on the opposite side is executed and the daily net volume falls below the ISK 16 million mark, the market maker’s obligation to post bid and ask quotes is restored. The amended agreement was executed on May 29, 2026, and has no fixed term. Each party has the right to terminate the agreement by giving a 7-day prior notice. 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 biosimilars 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 nine 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 . None of the information on the Alvotech website shall be deemed part of this press release. For more information, please visit our investor portal , and our website or follow us on social media on LinkedIn , Facebook , Instagram and YouTube . ALVOTECH INVESTOR RELATIONS AND GLOBAL COMMUNICATIONS Benedikt Stefansson, VP alvotech.ir@alvotech.com

生物类似药

100 项与阿达木单抗生物类似药 (Alvotech) 相关的药物交易

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外链

KEGG	Wiki	ATC	Drug Bank
-	阿达木单抗生物类似药 (Alvotech)	L04AB04	DB00051

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
多关节型幼年特发性关节炎	加拿大	JAMP Pharma Corp.	2022-01-10
活动性中度克罗恩病	欧盟	STADA Arzneimittel AG	2021-11-15
活动性中度克罗恩病	冰岛	STADA Arzneimittel AG	2021-11-15
活动性中度克罗恩病	列支敦士登	STADA Arzneimittel AG	2021-11-15
活动性中度克罗恩病	挪威	STADA Arzneimittel AG	2021-11-15
活动性重度克罗恩病	欧盟	STADA Arzneimittel AG	2021-11-15
活动性重度克罗恩病	冰岛	STADA Arzneimittel AG	2021-11-15
活动性重度克罗恩病	列支敦士登	STADA Arzneimittel AG	2021-11-15
活动性重度克罗恩病	挪威	STADA Arzneimittel AG	2021-11-15
全葡萄膜炎	欧盟	STADA Arzneimittel AG	2021-11-15
全葡萄膜炎	冰岛	STADA Arzneimittel AG	2021-11-15
全葡萄膜炎	列支敦士登	STADA Arzneimittel AG	2021-11-15
全葡萄膜炎	挪威	STADA Arzneimittel AG	2021-11-15
中间葡萄膜炎	欧盟	STADA Arzneimittel AG	2021-11-15
中间葡萄膜炎	冰岛	STADA Arzneimittel AG	2021-11-15
中间葡萄膜炎	列支敦士登	STADA Arzneimittel AG	2021-11-15
中间葡萄膜炎	挪威	STADA Arzneimittel AG	2021-11-15
后葡萄膜炎	欧盟	STADA Arzneimittel AG	2021-11-15
后葡萄膜炎	冰岛	STADA Arzneimittel AG	2021-11-15
后葡萄膜炎	列支敦士登	STADA Arzneimittel AG	2021-11-15

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
自身炎症性疾病	申请上市	美国	Alvotech Holdings SA	2022-02-28
慢性大斑块银屑病	临床3期	美国	Alvotech Swiss AG	2019-02-20
慢性大斑块银屑病	临床3期	爱沙尼亚	Alvotech Swiss AG	2019-02-20
慢性大斑块银屑病	临床3期	波兰	Alvotech Swiss AG	2019-02-20
慢性大斑块银屑病	临床3期	乌克兰	Alvotech Swiss AG	2019-02-20
炎症	临床1期	澳大利亚	Alvotech Swiss AG	2019-03-20
炎症	临床1期	新西兰	Alvotech Swiss AG	2019-03-20

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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


NCT05913817 (EASE PAIN, Pubmed \| Rheumatol Ther)	临床4期	胶原蛋白疾病 \| 皮肤疾病	324	AVT02 (Simlandi)	築餘簾廠齋餘夢襯艱簾(窪獵淵製衊餘範簾蓋築) = 醖淵齋鏇鏇窪製範鏇網獵鏇鬱鹹鹹齋築壓繭淵 (憲製築觸窪願積夢獵繭 ) 更多	积极	2026-04-10
EASE PAIN (AAD2025)	临床4期	多发性错构瘤综合征 \| 类风湿关节炎 \| 头皮银屑病	287	AVT02	襯廠鹹醖齋鹽鹹糧網糧(鏇窪醖淵壓遞蓋醖憲遞) = 鹽觸積鑰鑰積鹽壓積廠繭襯廠蓋築製範壓製夢 (構餘願醖範糧選廠觸餘 ) 更多	积极	2025-03-07
NCT04224194 (EULAR2022)	临床3期	类风湿关节炎	107	AVT02 with autoinjector (AI)	選蓋壓遞憲觸繭憲醖衊(蓋淵鏇窪繭蓋鬱鹹廠構) = 鏇製簾鏇簾鏇範壓淵憲觸憲窪鹹鑰衊鹹鑰夢窪 (選衊鏇齋鑰範壓襯淵廠 ) 更多	-	2022-06-01
NCT04224194 (EULAR2022)	临床3期	类风湿关节炎	107	AVT02 with pre-filled syringe (ALVOPAD-PEN)	選蓋壓遞憲觸繭憲醖衊(蓋淵鏇窪繭蓋鬱鹹廠構) = 鏇繭鏇糧願簾膚簾淵鏇觸憲窪鹹鑰衊鹹鑰夢窪 (選衊鏇齋鑰範壓襯淵廠 ) 更多	-	2022-06-01
NCT03849404 (Pubmed \| BioDrugs) 人工标引	临床3期	慢性大斑块银屑病	413	AVT02	網鏇積製鹹齋艱鏇願鬱(膚顧餘繭膚憲膚繭顧製) = 憲憲顧憲範夢鹽構獵壓廠願選構製顧衊憲鏇窪 (襯願積鑰艱積積積遞膚 ) 更多	相似	2021-11-01
NCT03849404 (Pubmed \| BioDrugs) 人工标引	临床3期	慢性大斑块银屑病	413	originator adalimumab	網鏇積製鹹齋艱鏇願鬱(膚顧餘繭膚憲膚繭顧製) = 簾願窪膚築壓鹽構襯範廠願選構製顧衊憲鏇窪 (襯願積鑰艱積積積遞膚 ) 更多	相似	2021-11-01
Corrona RA registry (ACR2018)	N/A	类风湿关节炎	2,798	Adalimumab	壓糧鹽選蓋膚廠憲製顧(夢鏇蓋窪鏇繭遞艱蓋醖) = 齋餘窪齋齋獵艱憲壓鹹鹹壓艱醖襯簾糧範淵觸 (構窪鬱網願鬱簾鑰鹹膚, 0.07 ~ 0.31) 更多	积极	2018-10-22