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更新于：2026-04-02
Adalimumab biosimilar(Alvotech)
阿达木单抗生物类似药 (Alvotech)
更新于：2026-04-02
概要
基本信息
原研机构 |
最高研发阶段批准上市 |
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
The Evaluation of Injection Site Pain and Adherence in Patients Switching From a Low To High Concentration Adalimumab (AVT-02) Across Multiple Indications.
NCT04453137
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
NCT04224194
Assessment of Real-life Patient Handling Experience of AVT02 Administered Subcutaneous With an Auto-Injector in Patients With Moderate to Severe Active RA
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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9
项与 阿达木单抗生物类似药 (Alvotech) 相关的文献（医药）2024-01-01Immunotherapy 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.
2024-01-01Therapeutic 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.
2023-11-01Journal of comparative effectiveness research
Navigating adalimumab biosimilars: an expert opinion
Review
作者: Habauzit, Caroline ; Abitbol, Vered ; Marotte, Hubert ; Benkhalifa, Salim
The patent expiry of Humira
®
in 2018 opened up the current European market to eight adalimumab biosimilars – (in alphabetical order) Amgevita
®
, Amsparity
®
, Hulio
®
, Hukyndra
®
, Hyrimoz
®
, Idacio
®
, Imraldi
®
and Yuflyma
®
– for the treatment of various immune and inflammatory conditions. Amjevita, Hadlima
®
, Hyrimoz and Yuflyma have recently become available in the USA, with others expected to reach this market in 2023 as the US patent protection for Humira ends. Although adalimumab biosimilars demonstrate efficacy, safety and immunogenicity similar to the originator, they may differ in product excipient(s) and preservatives, along with their device type(s). Physicians may find it both difficult and time consuming to navigate their way among the array of available adalimumab biosimilars when they need to make a treatment decision. This article explores the characteristics of various adalimumab biosimilars to help clinicians navigate the various options available across Europe and the USA. In addition to drug selection, effective patient–physician communication is needed to nurture realistic patient expectations and minimise potential nocebo effects when prescribing biosimilars.
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) |
研发状态
批准上市
10 条最早获批的记录, 后查看更多信息
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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 | 2022-01-10 | |
| 活动性中度克罗恩病 | 欧盟 | 2021-11-15 | |
| 活动性中度克罗恩病 | 冰岛 | 2021-11-15 | |
| 活动性中度克罗恩病 | 列支敦士登 | 2021-11-15 | |
| 活动性中度克罗恩病 | 挪威 | 2021-11-15 | |
| 活动性重度克罗恩病 | 欧盟 | 2021-11-15 | |
| 活动性重度克罗恩病 | 冰岛 | 2021-11-15 | |
| 活动性重度克罗恩病 | 列支敦士登 | 2021-11-15 | |
| 活动性重度克罗恩病 | 挪威 | 2021-11-15 | |
| 全葡萄膜炎 | 欧盟 | 2021-11-15 | |
| 全葡萄膜炎 | 冰岛 | 2021-11-15 | |
| 全葡萄膜炎 | 列支敦士登 | 2021-11-15 | |
| 全葡萄膜炎 | 挪威 | 2021-11-15 | |
| 中间葡萄膜炎 | 欧盟 | 2021-11-15 | |
| 中间葡萄膜炎 | 冰岛 | 2021-11-15 | |
| 中间葡萄膜炎 | 列支敦士登 | 2021-11-15 | |
| 中间葡萄膜炎 | 挪威 | 2021-11-15 | |
| 后葡萄膜炎 | 欧盟 | 2021-11-15 | |
| 后葡萄膜炎 | 冰岛 | 2021-11-15 | |
| 后葡萄膜炎 | 列支敦士登 | 2021-11-15 |
未上市
10 条进展最快的记录, 后查看更多信息
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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 | 2022-02-28 | |
| 慢性大斑块银屑病 | 临床3期 | 美国 | 2019-02-20 | |
| 慢性大斑块银屑病 | 临床3期 | 爱沙尼亚 | 2019-02-20 | |
| 慢性大斑块银屑病 | 临床3期 | 波兰 | 2019-02-20 | |
| 慢性大斑块银屑病 | 临床3期 | 乌克兰 | 2019-02-20 | |
| 炎症 | 临床1期 | 澳大利亚 | 2019-03-20 | |
| 炎症 | 临床1期 | 新西兰 | 2019-03-20 |
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临床结果
临床结果
适应症
分期
评价
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临床4期 | 287 | 憲蓋範壓壓構糧醖淵顧(壓選憲鹽齋憲範醖網顧) = 齋鏇糧淵糧網願衊觸膚 憲齋糧選繭選鏇網顧膚 (網醖顧鹹鏇衊範夢簾製 ) 更多 | 积极 | 2025-03-07 | |||
临床3期 | 107 | AVT02 with autoinjector (AI) | 顧淵鹹夢觸觸醖齋範膚(夢遞壓遞範齋選襯繭餘) = 齋蓋醖簾遞淵艱遞獵鑰 簾鏇淵衊簾鑰築鏇鬱艱 (築憲觸壓繭廠淵淵餘製 ) 更多 | - | 2022-06-01 | ||
AVT02 with pre-filled syringe (ALVOPAD-PEN) | 顧淵鹹夢觸觸醖齋範膚(夢遞壓遞範齋選襯繭餘) = 繭範齋繭艱窪蓋觸鹽壓 簾鏇淵衊簾鑰築鏇鬱艱 (築憲觸壓繭廠淵淵餘製 ) 更多 | ||||||
临床3期 | 413 | 餘餘選醖鏇淵醖繭範鬱(淵製壓獵衊鹽觸鹽糧構) = 鏇鏇窪廠膚獵鏇鑰鏇簾 願淵簾糧鹹齋鏇壓蓋選 (衊淵膚醖蓋鬱範襯鬱繭 ) 更多 | 相似 | 2021-11-01 | |||
餘餘選醖鏇淵醖繭範鬱(淵製壓獵衊鹽觸鹽糧構) = 淵醖鹽鏇範淵觸願構膚 願淵簾糧鹹齋鏇壓蓋選 (衊淵膚醖蓋鬱範襯鬱繭 ) 更多 | |||||||
N/A | 2,798 | 襯鏇築製衊糧積憲壓製(鹹獵醖願構積壓選獵網) = 遞製糧艱齋願廠壓觸糧 艱鑰鏇獵憲鑰鹹顧鹽齋 (艱糧繭構壓鏇鏇鑰簾築, 0.07 ~ 0.31) 更多 | 积极 | 2018-10-22 |
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